Breast Reconstruction Following Mastectomy or Lumpectomy

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Medical Coverage Policy

Effective Date .................... 3/15/2024

Next Review Date .............. 3/15/2025

Coverage Policy Number ............. 0178

Breast Reconstruction Following

Mastectomy or Lumpectomy

Table of Contents

Overview ............................................ 2

Coverage Policy .................................... 2

Health Equity Considerations .................. 5

General Background ............................. 5

Medicare Coverage Determinations ....... 28

Appendix ........................................... 28

Coding Information ............................. 29

References ........................................ 34

Revision Details ................................. 48

Related Coverage Resources

Botulinum Therapy

Breast Implant Removal

Breast Reduction

Complex Lymphedema Therapy (Complete

Decongestive Therapy)

Compression Devices

Gynecomastia Surgery

Injectable Fillers

Panniculectomy and Abdominoplasty

Redundant Skin Surgery

Scar Revision

Surgical Treatment of Chest Wall Deformities

Surgical Treatments for Lymphedema and

Lipedema

Tissue-Engineered Skin Substitutes

Treatment of Gender Dysphoria

INSTRUCTIONS FOR USE

The following Coverage Policy applies to health benefit plans administered by Cigna Companies.

Certain Cigna Companies and/or lines of business only provide utilization review services to clients

and do not make coverage determinations. References to standard benefit plan language and

coverage determinations do not apply to those clients. Coverage Policies are intended to provide

guidance in interpreting certain standard benefit plans administered by Cigna Companies. Please

note, the terms of a customer’s particular benefit plan document [Group Service Agreement,

Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan

document] may differ significantly from the standard benefit plans upon which these Coverage

Policies are based. For example, a customer’s benefit plan document may contain a specific

exclusion related to a topic addressed in a Coverage Policy. In the event of a conflict, a customer’s

benefit plan document always supersedes the information in the Coverage Policies. In the absence

of a controlling federal or state coverage mandate, benefits are ultimately determined by the

terms of the applicable benefit plan document. Coverage determinations in each specific instance

require consideration of 1) the terms of the applicable benefit plan document in effect on the date

of service; 2) any applicable laws/regulations; 3) any relevant collateral source materials including

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Coverage Policies and; 4) the specific facts of the particular situation. Each coverage request

should be reviewed on its own merits. Medical directors are expected to exercise clinical judgment

where appropriate and have discretion in making individual coverage determinations. Where

coverage for care or services does not depend on specific circumstances, reimbursement will only

be provided if a requested service(s) is submitted in accordance with the relevant criteria outlined

in the applicable Coverage Policy, including covered diagnosis and/or procedure code(s).

Reimbursement is not allowed for services when billed for conditions or diagnoses that are not

covered under this Coverage Policy (see “Coding Information” below). When billing, providers

must use the most appropriate codes as of the effective date of the submission. Claims submitted

for services that are not accompanied by covered code(s) under the applicable Coverage Policy

will be denied as not covered. Coverage Policies relate exclusively to the administration of health

benefit plans. Coverage Policies are not recommendations for treatment and should never be used

as treatment guidelines. In certain markets, delegated vendor guidelines may be used to support

medical necessity and other coverage determinations.

Overview

This Coverage Policy addresses reconstructive breast surgery and external breast prostheses and

mastectomy bras following mastectomy or lumpectomy.

• For treatments related to lymphedema, see Cigna Medical Coverage Policies:

 0354 Compression Devices

 0531 Surgical Treatments for Lymphedema and Lipedema

 Cobranded Cigna/American Specialty Health Coverage Policy Guideline 157 Complex

Lymphedema Therapy (Complete Decongestive Therapy).

• For breast reconstruction related to gender dysphoria treatment, see Cigna Medical

Coverage Policy 0266 Gender Dysphoria Treatment.

• For the surgical treatment of gynecomastia, see Cigna Medical Coverage Policy 0195

Gynecomastia Surgery.

• For breast reduction surgery on the non-diseased/contralateral breast following a

mastectomy or lumpectomy, see Cigna Medical Coverage Policy 0152 Breast Reduction.

• For surgical procedures for the excision of redundant or excessive skin, see Cigna Medical

Coverage Policy 0470 Redundant Skin Surgery.

Coverage Policy

Coverage for breast reconstruction* and breast prostheses following mastectomy or

lumpectomy is governed by federal and/or state mandates.

Breast Reconstruction

*Please note: Coverage for breast reconstruction services following mastectomy and

lumpectomy is available to both females and males. In addition, a diagnosis of breast

cancer is not required for breast reconstruction services to be covered, and the timing

of reconstructive services is not a factor in coverage.

Breast reconstruction following mastectomy or lumpectomy is considered medically

necessary for EITHER of the following:

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• breast reconstruction procedures performed on the diseased/affected breast (i.e.,

breast on which the mastectomy/lumpectomy was performed), including:

 areolar and nipple reconstruction (e.g., correction of inverted nipple)

 areolar and nipple tattooing

 autologous fat transplant (i.e., liposuction, lipoinjection, lipofilling, lipomodeling)

 breast implant removal and subsequent reimplantation

 capsulectomy

 capsulotomy

 flat closure chest wall reconstruction

 implantation of tissue expander

 implantation of U.S. Food and Drug Administration (FDA)-approved internal breast

prosthesis

 oncoplastic reconstruction (e.g., breast reduction, mastopexy)

 reconstructive surgical revisions

 tissue/muscle reconstruction (i.e., flap procedures)

• breast reconstruction procedures performed on the

nondiseased/unaffected/contralateral breast, in order to produce a symmetrical

appearance, including:

 areolar and nipple reconstruction

 areolar and nipple tattooing

 augmentation mammoplasty

 augmentation with implantation of FDA-approved internal breast prosthesis when the

unaffected breast is smaller than the smallest available internal prosthesis

 autologous fat transplant (i.e., liposuction, lipoinjection, lipofilling, lipomodeling)

 breast implant removal and subsequent reimplantation when performed to produce a

symmetrical appearance

 breast reduction by mammoplasty or mastopexy

 capsulectomy

 capsulotomy

 reconstructive surgery revisions to produce a symmetrical appearance

Intraoperative assessment of tissue perfusion is considered an integral part of the

breast reconstruction procedure and not separately reimbursable.

The following products* are considered medically necessary when used in association

with a medically necessary breast reconstruction procedure:

• AlloDerm

™

• AlloMax

™

• Cortiva

™

• DermACELL

™

• FlexHD

Acellular Hydrated Dermis

The following products* when used in association with a breast reconstruction

procedure are considered not medically necessary (this list may not be all-inclusive):

• ARTIA

™

Reconstructive Tissue Matrix

• Avance

Nerve Graft

• BellaDerm

Acellular Hydrated Dermis

• Biodesign

Nipple Reconstruction Cylinder

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• DermaMatrix Acellular Dermis

• DuraSorb

Monofilament Mesh/ Polydioxanone Surgical Scaffold™

• GalaFLEX

Scaffold

• GalaFLEX 3DR Scaffold (formerly known as GalaFORM

™

3D)

• GalaFLEX 3D Scaffold (formerly known as GalaSHAPE

™

3D)

• Juvederm

• OviTex

• Permacol

™

• Phasix

™

Mesh

• Radiesse

• Renuva

Allograft Adipose Matrix

• SERI

™

Surgical Scaffold

• SimpliDerm™

• Strattice

™

Reconstructive Tissue Matrix

• SurgiMend

• Veritas Collagen Matrix

*Note: Refer to the table in Appendix A for a list of products and the associated CPT and

HCPCS codes.

The following breast reconstruction procedures are considered experimental,

investigational or unproven for this indication:

• the use of adipose-derived stem cells in autologous fat transplantation

• xenograft cartilage grafting

Suction lipectomy, ultrasonically-assisted suction lipectomy (liposuction) or excision of

redundant skin for correction of surgically-induced donor site asymmetry (e.g., trunk or

extremity) or tissue protruding at the end of a scar (e.g., dog ear, standing cone) that

results from one or more flap breast reconstruction procedures is considered cosmetic

in nature and not medically necessary.

Removal of either a saline-filled OR silicone gel-filled breast implant when associated

with breast reconstruction following mastectomy or lumpectomy for ANY indication,

including for the purpose of producing a symmetrical appearance of the nondiseased

breast is considered medically necessary. Refer to the Breast Implant Removal Medical

Coverage Policy for additional information on breast implant removal.

Following removal of a breast implant, the subsequent surgical implantation of a new

U.S. Food and Drug Administration (FDA)-approved breast implant is considered

medically necessary for EITHER of the following:

• breast reconstruction of a diseased or affected breast following mastectomy or lumpectomy

• creation of a symmetrical appearance in the contralateral/nondiseased breast following

mastectomy or lumpectomy in the opposite breast

External Breast Prostheses and Mastectomy Bras

External breast prostheses and mastectomy bras following mastectomy or lumpectomy

are covered under the core medical benefits of the plan.

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Health Equity Considerations

Morrow, et al. (2014) conducted a retrospective analysis of women in Los Angeles and Detroit

diagnosed with breast cancer who underwent mastectomy and remained disease free at four years

to evaluate for breast reconstruction correlates and possible unmet needs of reconstruction.

Women (n=485) aged 20–79 years were included in the study if they: were diagnosed with ductal

carcinoma in situ (DCIS) or invasive breast cancer between June 2005-February 2007, reported to

the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) program

registries, could complete a questionnaire in English or Spanish, underwent mastectomy and

remained disease free at four years. Participants were excluded if they: had stage IV breast

cancer, died prior to the initial survey, or were Asian because of enrollment in other studies. In

order to ensure sufficient representation of racial/ethnic minorities, Latina and Black women were

oversampled. The primary outcome was whether or not a women underwent breast reconstruction

at any time post mastectomy. Patient satisfaction with various aspects of the reconstruction

decision making process (i.e., satisfaction with their decision to have reconstruction, whether they

regret their reconstruction choice, satisfaction about being informed about reconstructive issues)

and reasons why a participant did not have reconstruction or delayed reconstruction were

secondary outcomes. Patient demographics (i.e., age, education, race/ethnicity, partner status,

income, insurance, smoking status), clinical/treatment factors (i.e., staging, comorbidities, breast

size, chemotherapy, radiation, timing of reconstruction), and geographic location were

independent variables that were considered. Follow-up via patient surveys took place at a mean of

nine- and 50-months post cancer diagnosis. Overall, 41.6% of the 485 patients treated with

mastectomy who remained disease-free had breast reconstruction; 24.8% (n=146) of the

procedures were done at the time of mastectomy, and 16.8% (n=76) were delayed. Surgery with

implants or tissue expanders was the most common type of reconstruction (61.9%). Compared

with respondents, non-respondents to the follow-up survey were more likely to be Black (35.2%

versus 26.7%; p<0.001) or Latina (17.2% versus 13.3%; p=0.002), more likely to have stage II

or III disease (54.9% versus 37.8%; p<0.001), and more likely to have received mastectomy

(37.5% versus 30.8%; p<0.001). Black patients, those with a high school or lower education

level, those without private insurance, women with any major co-morbid condition, older women,

those residing in Los Angeles County, and those patients who received chemotherapy were

significantly less likely to undergo reconstruction than their counterparts. A total of 13.3% of

women reported being dissatisfied with the decision-making process and was associated with

being Black or Latina (p=0.032) but not with lower income or education levels. The most common

reasons among all women for not undergoing reconstruction was a desire to avoid additional

surgery (48.5%), the opinion that reconstruction was unimportant (33.8%), and fear of implants

(36.3%). However, ethnic minority groups were less likely to report the desire to avoid additional

surgery (70.0% for non-Black, non-Latina patients versus 39.7% and 34.1% for Blacks and

Latinas, respectively; p<0.001) or that reconstruction was not important (42.4% for non-Black,

non-Latina patients versus 21.6% and 31.3% for Blacks and Latinas, respectively; p=0.043).

More Latinas reported concerns about cancer detection interference, procedure complications, or

not being able to take time off from work or family. More Blacks and Latinas reported not having

insurance coverage as a barrier to reconstruction. The study is limited by the small geographic

sampling, retrospective study design, and possible errors in patient recall. This study highlights

the need for additional patient level education on factors that negatively impact the breast

reconstruction decision making process especially among minority women.

General Background

Breast reconstruction is designed to reduce post-mastectomy complications and to establish

symmetry between the surgical breast and the contralateral breast. Surgical procedures that are

performed to establish symmetry can include: breast reduction; breast augmentation with an

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FDA-approved breast implant; and/or areola-with-nipple reconstruction and nipple-area tattooing.

Breast reconstruction after mastectomy has evolved over the last century to become an integral

component of therapy for patients with breast cancer. Reconstruction can occur immediately after

a mastectomy or be delayed for weeks or years until a patient undergoes radiation,

chemotherapy, or decides whether they want breast reconstruction.

Prosthetic Reconstruction

Breast Implants: Breast implants can be inserted at the same time as the mastectomy (e.g.,

direct-to-implant breast reconstruction or one-stage immediate breast reconstruction) or in two

stages, using an implanted tissue expander in the first stage followed by removal of the expander

and insertion of a permanent breast implant (e.g., two-stage reconstruction or two-stage delayed

reconstruction). The FDA-approved implant is placed either deep in the breast on the pectoral

fascia (submammary) or beneath the pectoralis major. The advantages of tissue expander implant

reconstruction are the reliability, simplicity, and avoidance of donor-site morbidity. Complications

associated with the use of breast implants can occur in the immediate perioperative period or

years later. Such complications include exposure, extrusion, or infection of the implants.

Longer

term problems also include asymmetry, capsular contracture, malposition of the implant, rupture,

and pain. These conditions, when they become clinically significant, may require removal of the

implant (American Cancer Society [ACS], 2024; Roehl, et al., 2012; Roostaeian, et al., 2012).

Indications for implant reconstruction include: bilateral reconstruction, individuals requiring

augmentation in addition to reconstruction, individuals not suited for long surgery, a lack of

abdominal tissue, individual unwilling to have additional scars on either their back or abdomen,

and a small breast mound with minimal ptosis. Relative contraindications to implant reconstruction

include: young age (i.e., may need implant replaced multiple times), individual unwilling to follow

up, or very large or ptotic breast. The contraindications to implant reconstruction include: silicone

allergy, fear of implants, previously failed implants, or the need for adjuvant radiation therapy

(Roehl, et al., 2012).

Surgical complications associated with breast implantation are like those encountered with other

breast surgeries: infection, bleeding, change in nipple sensation (e.g., hypersensitivity or

hyposensitivity), malposition, delayed healing, and anesthetic accidents.

Although implantable breast prostheses may be inserted for either reconstructive or cosmetic

reasons, clinically significant post-implant complications may occur, necessitating removal of the

implants. Local complications associated with implanted breast prostheses include: capsular

contracture, persistent infection, silicone implant extrusion, tissue necrosis and silicone implant

rupture. These conditions, when they become clinically significant, may require removal of the

implant. Additionally, the presence of an implant may interfere with the diagnosis or treatment of

breast cancer. Infections that may occur in or around an implant include wound infections, as well

as infections within a capsular contracture or because of a ruptured implant. Removal of the

implant may be necessary when the infection does not respond to antibiotics. Unstable or

weakened tissue and/or interruption in wound healing may result in the implant breaking through

the skin or extrusion. Necrotic tissue may form around the implant, requiring implant removal.

Silicone gel-filled implant rupture may cause the contents to leak into the surrounding tissues.

U.S. Food and Drug Administration (FDA): In the FDA labeling for approved breast implants

(FDA, 2021c), Mentor Corp., Santa Barbara, CA; Ideal Implant

®,

Inc., Dallas, TX; Allergan Corp.

(formerly Inamed), Irvine, CA and Sientra, Inc., Santa Barbara, CA are listed as manufacturers of

silicone and saline breast implants.

FDA-approved saline-filled implants:

• Allergan Medical RTV Saline-Filled Breast Implant

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• Ideal Implant Saline-Filled Breast Implant (PMA Number: P120011)

• Mentor Saline-Filled and Spectrum

™

Breast Implants (PMA Number: P990075)

The FDA approved saline-filled breast implants for breast augmentation in women age 18 or older

and for breast reconstruction in women of any age. They are also used in revision surgeries, which

correct or improve the result of an original surgery.

FDA-approved silicone gel-filled breast implants:

• Allergan Natrelle

410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implant

• Mentor MemoryGel

(PMA Number: P030053)

• Mentor MemoryShape™ Silicone Gel-Filled Breast Implant (PMA Number: P060028)

• Sientra

Silicone Gel Breast Implant (PMA Number: P070004)

The FDA labeling for silicone and saline breast implantation states that breast implant surgery

should not be performed in women with: an active infection, existing cancer or precancer of a

breast that has not been adequately treated, or who are pregnant or nursing.

In June 2011 (updated 2018), the FDA released a report updating the clinical and scientific

information for silicone gel-filled breast implants, including preliminary safety data from studies

conducted by the manufacturers as a condition of their November 2006 approval. The conclusion

in the report states that, “Based on the totality of the evidence, the FDA believes that silicone gel-

filled breast implants have a reasonable assurance of safety and effectiveness when used as

labeled. Despite frequent local complications and adverse outcomes, the benefits and risks of

breast implants are sufficiently well understood for women to make informed decisions about their

use.” Manufacturers and physicians should continue to provide balanced and up-to-date

information to women considering breast implants to help inform their decisions (FDA, 2018). On

July 24, 2019, the FDA requested that Allergan, recall specific models of their textured breast

implants from the U.S. market due to the risk of breast implant-associated anaplastic large cell

lymphoma (BIA-ALCL). The FDA's analysis was attributed to a new worldwide reported total of 573

unique BIA-ALCL cases including 33 patient deaths. Of the 573 cases of BIA-ALCL, 481 are

reported to have Allergan breast implants at the time of diagnosis. (FDA, 2019b; FDA, 2019c).

In September 2022, the FDA issued a safety communication informing the public about emerging

and rare reports of squamous cell carcinoma (SCC) and various lymphomas in the scar tissue that

forms around smooth and textured and saline and silicone breast implants. Ten medical device

reports (MDRs) about SCC and 12 MDRs about various lymphomas related to breast implants have

been reported to the FDA as of September 1, 2022 and in some cases, people were diagnosed

years after having the breast implants. The following recommendations were provided for people

who have or are considering breast implants:

• “If you are considering breast implants or if you have them, learn more about the risks and

benefits of breast implants.

• If you have breast implants, you do not need to change your routine medical care or

follow-up.

• Be aware that cases of SCC and various lymphomas in the capsule around the breast

implant have been reported.

• Monitor your breast implants for as long as you have them. If you notice any abnormal

changes in your breasts or implants, promptly talk to your surgeon or health care provider.

• If you do not have symptoms, the FDA does not recommend the removal of breast

implants because of this safety communication.

• If you have breast implants and experience a problem, the FDA encourages you to file a

report through MedWatch, the FDA Safety Information and Adverse Event Reporting

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program. Your report, along with information from other sources, can provide information

that helps improve patient safety.”

The following recommendations were provided for health care providers:

• “Continue to provide routine care and support to your patients with breast implants.

• Be aware that cases of SCC and various lymphomas in the capsule around the breast

implant have been reported.

• When examining breast implant specimens (for example, seroma, capsule, devices) for

diagnostic evaluation, characterize all findings and potential diagnoses.

• Report cases of SCC, lymphomas, and any other cancers in the capsule around the breast

implant to the FDA. Prompt reporting of adverse events can help the FDA identify and

better understand the risks associated with medical devices (FDA, 2022a)”

Tissue Expanders

Following mastectomy, some individuals have inadequate elasticity in the remaining tissue to

accommodate and support a breast implant. For these individuals, tissue expanders can be

inserted under the chest muscle or skin. The expander is an empty balloon-like container that,

over time, is injected with saline to cause the tissue to expand. The tissue expander is surgically

removed once an adequate pocket has been established, and the permanent implant is then

inserted. The most appropriate patients for this type of reconstruction are individuals who do not

qualify for autogenous reconstruction, individuals who do not want additional scars from other

donor sites, individuals who prefer a typically quicker postoperative recovery period, and

individuals who have relatively small breasts. Contraindication for this type of reconstruction are

mastectomy flaps that are too thin for adequate implant coverage and the completed or planned

use of adjuvant radiation therapy because of higher implant complication rates (ACS, 2019; Hu, et

al., 2007).

Tissue Flap Procedures

Autologous tissue/muscle breast flap reconstruction procedures are safe and effective and are a

well-established standard of care. Methods of autologous tissue breast reconstruction include local

flaps and distant flaps. Local flaps rely on transposition of muscle, subcutaneous tissue, and skin

into the mastectomy defect and remain attached to the native blood supply of the muscle (e.g.,

latissimus dorsi myocutaneous (LD) flap, pedicled transverse rectus abdominus myocutaneous

(TRAM) flap). Distant flap breast reconstruction requires the use of microvascular free-tissue

transfer (e.g., free TRAM flap, deep inferior epigastric perforator [DIEP] flap, superficial inferior

epigastric artery perforator [SIEP] flap, inferior or superior gluteal flap, superior gluteal artery

perforator flap, Reubens flap, transverse upper gracilis (TUG) flap). Breast reconstruction using

these donor sites relies on harvesting the flap with its vascular pedicle, which is anastomosed

using microsurgical technique to appropriate recipient vessels in the mastectomy site. The two

most common types of tissue flap procedures are the TRAM flap and the LD flap. Other tissue flap

surgeries are more specialized and may not be available everywhere. The choice of procedure for

a given individual is affected by age, health, contralateral breast size and shape, personal

preference, and the expertise of the reconstructive surgeon (ACS, 2019, Roehl, et al., 2012;

Spear et al., 2007; Mehrara et al., 2006; Alderman et al., 2006; Garvey et al., 2006; Bajaj et al.,

2006; Wechselberger, et al., 2004; Behnam et al., 2003).

Deep Inferior Epigastric Perforator (DIEP) Flap: A modification of the free TRAM flap is the

deep inferior epigastric perforator (DIEP) flap. This flap does not harvest any muscle or fascia

from the abdomen, and reportedly has significantly less donor-site morbidity than the usual TRAM

flap. Patients are thought to have reduced postoperative pain, a lower risk of abdominal bulge or

hernia, and less postoperative abdominal donor-site weakness. In reducing the amount of

disturbance to the abdominal wall donor site, however, use of the DIEP flap unavoidably reduces

the number of perforators supplying blood to the flap. This could potentially lead to a reduced

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supply of blood to the flap, thereby causing an increase in partial flap loss and fat necrosis

(American Society of Plastic Surgeons [ASPS], 2017; Kroll, 2000).

Latissimus Dorsi Myocutaneous (LD) Flap: The LD flap moves muscle and skin from the back

to reconstruct the breast. The LD flap is ideally suited for single-stage reconstruction for

individuals with small breasts and a moderate degree of ptosis and for patients with no available

abdominal donor site due to scars or lack of tissue. The LD flap can be used to correct

lumpectomy defects which require a smaller implant or no implant. Some individuals may have

weakness in their back, shoulder, or arm after this surgery. Relative contraindications to the LD

flap include: planned postoperative radiation therapy, bilateral reconstruction, and significant

breast ptosis. Contraindications to the LD flap include: previous lateral thoracotomy and

individuals with large breast volume who do not desire reduction (Roehl, et al., 2012).

Rubens Flap: The Rubens flap is based on the circumflex iliac vessels and is an option for

individuals who have an excess of soft tissue over the hips. Because this reconstructive procedure

is limited in bulk and skin envelope, and often requires a balancing procedure on the contralateral

hip, it is not usually considered as a first option for breast reconstruction (Roehl, et al., 2012).

Superficial Inferior Epigastric Perforator/Artery (SIEP/SIEA) Flap: The skin and fat of the

lower abdomen are supplied by perforators (vessels that perforate the rectus abdominis muscle),

including the superficial inferior epigastric artery (SIEA). For this type of reconstruction, an

elliptical flap of tissue is transferred from the lower abdomen to the chest while still allowing a

tension-free closure of the donor site in the abdomen. The apex of the triangular flap becomes the

tail of the reconstructed breast. The internal mammary artery perforators or thoracodorsal vessels

are often a good size match for the SIEA; these are anastomosed to the perforators of the graft

using microsurgical technique. Construction of an SIEA flap presents several technical challenges

and cannot be used in all cases (Hayes, 2014, reviewed 2016).

Superior or Inferior Gluteal Free Flap: The superior or inferior gluteal free flap requires skin,

fat, blood vessels, and muscle to be removed from the gluteus maximus to reconstruct the breast.

This technique is an option when the abdomen is no longer an alternative for flap transfer. This

flap is technically complex and has complications including: seroma, sciatica, unfavorable scar

location, and asymmetrical buttock contour (Roehl, et al., 2012).

Thoracodorsal Artery Perforator (TDAP) Flap: The TDAP flap is a rarely chosen source for

autogenous tissue breast reconstruction. The TDAP flap is an evolution of the LD flap. The TDAP

flap allows for collection of skin and soft tissue from the upper back without sacrifice of muscle

tissue. The flap is based on proximal perforating vessels that originate from the thoracodorsal

artery and vein. These vessels pass through the latissimus dorsi muscle and into the overlying

skin and fat (DellaCroce, 2015, updated 2023).

Transverse Rectus Abdominus Myocutaneous (TRAM) Flap: The TRAM flap is the most

commonly performed autologous reconstructive procedure and is considered the gold standard in

breast reconstruction because of the lower abdominal tissue’s similarities in consistency with

breast tissue and its aesthetic appearance. There are three types of TRAM flaps: unipedicle,

bipedicle, or free. Pedicle flaps involve leaving the flap attached to its original blood supply and

tunneling it under the skin to the breast area. Free flap involves cutting the flap free of skin, fat,

blood vessels, and muscle from its original location and attaching the flap to blood vessels in the

chest area. These procedures are indicated for individuals with (Zenn, 2021a, 2021b, 2023; Roehl,

et al., 2012):

• large tissue requirement after mastectomy

• history of radiation to the chest wall

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• small or large opposite breast that is difficult to match with an implant

• previous failure of implant reconstruction

• excess lower abdominal tissue

Abdominal complications resulting from this surgery include loss of abdominal strength, abdominal

bulge and hernia formations. It is recommended that reconstruction be delayed when adjuvant

chemotherapy is planned, because complications of the reconstruction can be detrimental in

beginning the individual’s therapy.

Numerous factors place an individual at higher risk for complications and are therefore considered

relative contraindications to TRAM flap surgery (e.g., cardiac and/or pulmonary disease, diabetes,

history of pulmonary embolus or deep venous thrombosis) (Zenn, 2021a, 2021b, 2023; ASPS,

2017; Roehl, et al., 2012):

Transverse Upper Gracilis (TUG) Flap: The TUG flap is taken from the upper inner thigh area.

Part or all of the gracilis muscle is included with the flap to ensure the most reliable blood supply.

This is a breast reconstructive option for those individuals who have limited flap donor sites.

Candidates for TUG flap breast reconstruction include individuals desiring autogenous breast

reconstruction with sufficient upper inner thigh tissue but who have had a previous

abdominoplasty, or a flap taken from their abdomen. Very thin or athletic individuals who have

insufficient abdominal donor tissue may be candidates for the TUG flap. This flap may be referred

to as the TUG Perforator Flap which, as a perforator flap, it is a flap made of skin and fat only (no

muscle). The TUG Myocutaneous Flap includes skin, fat, a portion of the gracillis muscle and the

blood vessels associated with it to keep it alive. It is not usually considered as a first option for

breast reconstruction.

Omental Free Flap (LHOFF)/Omental Fat-Augmented Free Flap (O-FAFF): An omental flap

can be retrieved by laparoscopic or open approach and can be free or pedicled. During the free

flap procedure, the greater omentum is detached from the colon and stomach and the right

gastroepiploic vein and artery are clipped and connected to the internal mammary artery via

microsurgery. Reported advantages of an omental flap include: minimal blood loss, minimal donor

site morbidity, mimics the feel of a natural breast, low risk of ischemic complications, can be used

in obese individuals, and shows unique phenomenon of size gain. Limitations have been reported

as: unpredictable volume and not suitable for reconstruction in whole breast mastectomy.

Contraindications include: omental malignant nodules, omental cake, or malignant ascites, and

marked abdominal adhesions (Khater, et al., 2017; Zaha, et al., 2006; Cothier-Savey, et al.,

2001).

Flat Closure Chest Wall Reconstruction: Some individuals may elect to forgo breast

reconstruction for a variety of personal reasons. Others may not be candidates for breast

reconstruction due to health issues (e.g, obesity, blood circulation issues). In these situations, flat

closure chest wall reconstruction is an option. The National Cancer Institute defines an “aesthetic

flat closure” as “A type of surgery that is done to rebuild the shape of the chest wall after one or

both breasts are removed. An aesthetic flat closure may also be done after removal of a breast

implant that was used to restore breast shape. During an aesthetic flat closure, extra skin, fat,

and other tissue in the breast area are removed. The remaining tissue is then tightened and

smoothed out so that the chest wall appears flat.” (NCI, 2024; ACS, 2021)

Intraoperative Assessment of Tissue Perfusion

One of the reported causes of early complications following breast reconstructive procedures is

considered to be inadequate tissue perfusion. Accurate and reliable intraoperative evaluation of

tissue perfusion is needed to reduce complications and improve clinical outcomes. Besides clinical

judgement, several technologies to assess tissue vascularity have been evaluated in studies and

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are used clinically (e.g., intraoperative laser angiography using indocyanine green (ICG);

fluorescein, doppler) (Gurtner, et al., 2013). One device that is used is the SPY

Fluorescent

Imaging System (Stryker, Kalamazoo, MI; formerly Novadaq Technologies Inc., Mississauga,

Ontario) (510(k) Number: K083898). Intra-operative assessment of tissue perfusion is considered

an integral part of a breast reconstruction procedure.

Reconstruction of the Nipple-Areolar Complex

This portion of the breast reconstruction is usually performed as a second or third stage after the

breast mound has been constructed. The recreation of the nipple-areolar complex involves various

proposed techniques such as skin grafts, autologous and xenograft cartilage grafts, local tissue

flaps, tissue-engineered structures, and tattooing and/or transplantation of nipple-areolar tissue

from the opposite breast. It has been reported that within 12 months, most reconstructed nipples

undergo a 50% reduction in projection. Therefore, the nipple should be made larger than desired

during the initial surgery. The rebuilding of the nipple-areolar area is conducted first, and the

tattooing procedure is done when swelling has subsided, usually 3–6 weeks after nipple creation.

Successful nipple-areola reconstruction is expected to maintain nipple projection and areola size;

however, longevity of this reconstruction is highly variable and is influenced by factors such as

tissue thickness, scar contracture, trauma and radiation. Tattooing is commonly repeated (Chun,

2017, updated 2023; Beckenstein, 2014; Roehl, et al., 2012; Heitland, et al., 2006; Guerra, et al.,

2003).

Local tissue flaps are the most frequently performed methods of nipple reconstruction. Nipple

reconstruction with local flaps is achieved with various techniques, each with its own proponents

and benefits. These include the skate flap, bell flap, double opposing tab flap, star flap, top-hat

flap, twin flap, propeller flap, S flap, rolled dermal-fat flap, and autologous cartilage. Acellular

dermal matrices used alone or in conjunction with local flaps are being proposed as well as

injectable materials for nipple reconstruction. Some have also advocated creating a more stable

de-epithelialized skin base for the reconstructed nipple to minimize loss of projection (Chun, 2017,

updated 2021; Beckenstein, 2014).

Loss of nipple projection commonly occurs a few years after reconstruction. This problem may be

reduced with the use of bell and double opposing tab flaps. Various procedures such as re-

elevating the flap; inserting autologous dermal tissue, autologous or banked cartilage; and using

filler injection or AlloDerm are proposed as secondary nipple reconstruction procedures.

Discoloration and uneven pigment distribution may occur over time and can usually be corrected

with tattooing (Chun, 2017, updated 2021).

In a systematic review, Winocour et al. (2016) reported the efficacy, projection, and complication

rates of different materials used in nipple reconstruction. A total of 31 retrospective and

prospective studies with controlled and uncontrolled conditions reporting on outcomes of

autologous, allogeneic, and synthetic grafts in nipple reconstruction were included. The authors

reported heterogeneity in the type of material used within each category and inconsistent

methodology used in outcomes assessment in nipple reconstruction. Overall, the quality of

evidence is low. Synthetic materials have higher complication rates and allogeneic grafts have

nipple projection comparable to that of autologous grafts. The authors reported that further

investigation with high-level evidence is necessary to determine the optimal material for nipple

reconstruction.

Xenograft Cartilage Grafting: The use of cartilage is another method of nipple reconstruction,

particularly in prosthetic reconstruction where there might be a soft-tissue deficiency. The

procedure is applicable to both unilateral and bilateral nipple reconstruction, is reported to be an

easy procedure to perform, does not involve a donor site, and maintains long-lasting projection. A

reported disadvantage of donated cartilage is that the resulting nipple is unnaturally firm. If the

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grafts are placed too superficially and do not have a smooth contour, they can extrude through

the skin, warranting revision and/or removal. Caution is recommended with thin skin flaps or

irradiated tissue which can also make extrusion more likely. The use of simple nipple–areola

tattooing is recommended for these patients. Autologous cartilage grafting in breast

reconstruction procedures is the standard of care. There is a lack of lack of evidence in the peer

reviewed published literature on the long-term outcomes, safety and efficacy of Xenograft

cartilage use in breast reconstructive procedures.

Juvederm

: Juvederm (Allergan, Irvin, TX) Voluma

XC hyaluronic acid filler has been proposed

to reshape nipples after reconstruction of the breast following mastectomy. On October 22, 2013,

Juvederm Voluma XC received FDA premarket approval (PMA). The FDA indications for use state

that the device is indicated for deep (subcutaneous and/or supraperiosteal) injection for cheek

augmentation to correct age-related volume deficit in the midface in adults over the age of 21.

Breast reconstruction is not specifically mentioned as an approved FDA indication (PMA Number:

P110033). Evidence in the published, peer-reviewed scientific literature supporting the use of this

product in breast reconstructive procedures is lacking and its role is unclear.

Radiesse

: Radiesse (BioForm Medical, Inc., San Mateo, CA) has been proposed to reshape

nipples after reconstruction of the breast following mastectomy. Radiesse injections consist of very

small, smooth calcium hydroxylapatite (CaHA) microspheres that are suspended in a water-based

gel carrier. Radiesse has received PMA approval by the FDA as a medical device for subdermal

implantation for two indications: correction of moderate to severe facial wrinkles and folds such as

nasolabial folds and the correction of facial fat loss in people with human immunodeficiency virus

(PMA Number: P050037). There remains a lack of evidence in the peer reviewed published

literature on the long-term outcomes, safety and efficacy of Radiesse in breast reconstructive

procedures.

Cook Biodesign

Nipple Reconstruction Cylinder: The Cook Biodesign Nipple Reconstruction

Cylinder (Cook Biotech Incorporated, West Lafayette, IN) is a porcine non-cross-linked, non-

dermis-based biologic graft material that is marketed for breast procedures including breast

reconstruction, breast revision and mastopexy. It may be used in combination with Biodesign

Tissue Generation Matrix. On June 20, 2011, the Cook Biodesign Nipple Reconstruction Cylinder

received FDA 510(k) approval. The FDA indications for use states it is intended for implantation to

reinforce soft tissue where weakness exists in plastic and reconstructive surgery of the nipple. The

cylinder is supplied sterile and is intended for one-time use. The Biodesign Nipple Reconstruction

Cylinder is a rolled Small Intestinal Submucosa (SIS) mesh and available in sizes from 0.7 cm to

1.0 cm in diameter and 1.0 cm to 2.5 cm in length. The cylinder is a scaffold which becomes

infiltrated by the host cells during the body’s natural repair process. The device is implanted using

a skin flap procedure that prevents migration of the device. The clinical performance of the

Biodesign Nipple Reconstruction Cylinder was assessed in two case studies and anecdotal evidence

of 186 device implants. Of the 188 implants, complications included device extrusion (number of

extrusions not given). Follow-up periods ranged from 2 to 12 months. The clinical studies showed

the Biodesign Nipple Reconstruction Cylinder as substantially equivalent to its predicates in its

application (510(k) Number: K110402).

In the first multi-center prospective study, Collins et al. (2016) reported on the use of the

Biodesign Nipple Reconstruction Cylinder (NRC) during reconstruction of the nipple after

mastectomy in patients with a history of breast cancer and mastectomy. Unilateral or bilateral

nipple reconstruction was performed. Skin flaps were raised, the NRC was placed beneath the

flaps as a stent, and the site was protected for up to four weeks with a nipple shield. Nipple

projection was measured for 12 months after surgery. Patient satisfaction was measured, and

adverse events were recorded. Follow-up examinations were performed at one week, and then at

one, three, six, and 12 months after surgery. A total of 82 nipple reconstructions were performed

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in 50 patients. Related postoperative adverse events were minor but reported in eight

reconstructions (9.8%) representing seven patients (14.0%). Average projection at six and 12

months was 4.1 ± 1.6 mm and 3.8 ± 1.5 mm, respectively, compared with 10.5 ± 2.2 mm one

week after surgery. Of patients completing the satisfaction questionnaire at 12 months, 70/75

(93.3%) of reconstructions were rated "pleased" or "very pleased" with the overall outcome.

Overall, 45/46 (97.8%) patients would recommend nipple reconstruction to other women. This

study is limited by the small homogenous sample size, lack of a control group and short-term

follow-up.

There is a lack of evidence in the peer reviewed published literature regarding the long-term

outcomes and efficacy of the Cook Biodesign Nipple Reconstruction Cylinder for use in breast

reconstruction or for any other indication.

Contralateral Breast

Although the goal of breast reconstruction is to maintain symmetry, the process may leave the

opposite or contralateral breast larger or smaller than the surgical breast. To correct this

asymmetry, a mastopexy or reduction mammoplasty may be performed on the contralateral

breast. If the reconstructed breast is larger, then an augmentation mammoplasty with implant

may be performed on the nondiseased breast (Roehl, et al., 2012).

Oncoplastic Reconstruction

Oncoplastic procedures are performed immediately or one to two weeks after lumpectomy, once

final pathology is available. They include rearrangement of the remaining breast tissue through a

variety of techniques, often adhering to breast reduction principles. In addition, more tissue can

be brought into the breast to correct the volume deficit, often in the form of a latissimus dorsi

flap. Indications for these procedures depend on the patient’s preoperative breast size, available

remaining breast tissue, and overall goals for ultimate breast size and shape. All these procedures

are done prior to radiation to prevent contracture of the lumpectomy defect and distortion of the

nipple-areolar complex (Roehl, et al., 2012).

Radiation Tattoo Markers: Ink markers are tattooed as landmarks before radiotherapy of breast

cancer with the purpose of obtaining a precise radiation field. These tattoos are permanent and

are the size of a freckle. Individuals may have these tattoo markers removed via laser or punch

biopsy excision as a part of the overall breast reconstruction procedure (Bregnhoj, et al., 2010).

Nonsurgical Options

Some women may choose not to have breast reconstruction or are poor candidates for

reconstruction. For these women, an external breast prosthesis and/or mastectomy bras are

additional options (Hu, et al., 2007).

Skin Substitutes

During breast reconstruction, acellular dermal skin substitutes (i.e., AlloDerm

, AlloMax

™

DermACELL

and FlexHD

) are primarily used in the setting of tissue expander and breast implant

reconstruction. Patients should be in overall good health and have no underlying condition that

would restrict blood flow or interfere with the normal healing process (e.g., uncontrolled diabetes,

hypertension, previous surgery). These matrixes may be indicated when there is insufficient tissue

expander or implant coverage by the pectoralis major muscle and additional coverage is required,

as may be the case in a very thin patient; if there is viable but compromised or thin post-

mastectomy skin flaps that are at risk of dehiscence or necrosis; or if there is a need to re-

establish the inframammary fold and lateral mammary fold landmarks. When used in appropriate

candidates, these skin substitutes are proposed to improve control over placement of the

inframammary fold and final breast contour, enhance use of available mastectomy skin, reduce

the number of expander fills necessary, reduce time to complete expansion and eventual implant

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exchange, potential improved management of a threatened implant, reduce the need for

explantation and the potential for reduction in the incidence of capsular contracture. However,

there are ongoing concerns regarding the increased risk of seroma and infection, a higher risk of

an implant having to be removed, and tissue flap death (ACS, 2019; Nguyen, et al., 2011; Sbitany

and Serletti, 2011).

There is a paucity of data comparing the skin substitute products directly. The products vary in

many aspects, including the source of tissue, processing, storage, surgical preparation and

available sizes. The most familiar product to most plastic surgeons, AlloDerm, was the first human

dermis product available in 1994 (Cheng, et al., 2012).

U.S. Food and Drug Administration (FDA)

Depending on the purpose of the product and how it functions, skin substitutes are regulated by

the FDA premarket approval (PMA) process, 510(k) premarket notification process, or the FDA

regulations for banked human tissue.

Products that are classified by the FDA under the PMA process as a class III, high-risk device

require clinical data to support their claims for use. These devices may be used as a long-term

skin substitute or a temporary synthetic skin substitute. They actively promote healing by

interacting directly or indirectly with the body tissues.

Other wound care devices are approved by the 510(k) process, and their primary purpose is to

protect the wound and provide a scaffold for healing. They may or may not be integrated into the

body tissue. Some devices are rejected by the body after approximately ten days to several weeks

and removed prior to definitive wound therapy or skin grafting.

In 2021, the FDA issued a safety communication regarding acellular dermal matrix (ADM)

products indicating that higher complication rates may be present in certain ADMs used in

implant-based breast reconstruction. ADMs are developed from either human (e.g., FlexHD,

AlloMax, AlloDerm) or animal skin (e.g., SurgiMend) and have had the cells removed leaving

behind the support structure for use. The FDA has not approved any ADMs for the indication of

implant-based breast reconstruction. The FDA’s safety communication cited a prospective corhort

study evaluating safety outcomes (i.e., reoperation, explantation, infection) from implant-based

breast reconstruction surgeries after mastectomy in multiple centers in the United States and

Canada that showed significantly higher complication rates in patients with FlexHD and AlloMax

ADMs two years after surgery compared to a control group that did not receive an ADM. The FDA

pointed to a need for additional, high-quality studies evaluating the safety and efficacy of ADMs.

As a result of their analysis, the FDA has given the following recommendations for health care

providers:

• “Discuss the potential benefits and risks of all relevant treatment options with your patients

as part of a shared decision-making process.

• Be aware that the FDA has not approved or cleared any ADM products for use in implant-

based breast reconstruction. Data analyzed by the FDA and published literature suggest

that some ADMs may have higher risk profiles than others.

• Be aware that the FDA does not recommend reoperation or removal of implanted ADM as a

preventive measure.

• Report any patient adverse events to the FDA MedWatch program, using the information in

the Reporting Problems with Your Device page” (FDA, 2021d).

Donated skin that requires minimal processing and is not significantly changed in structure from

its natural form is classified by the FDA as banked human tissue, is not considered a medical

device, and does not require PMA or 510(k) approval. Donated skin (human cells or tissue)

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intended for implantation, transplantation, infusion, or transfer into a human recipient is regulated

as a human cell, tissue, and cellular and tissue-based product (HCT/P) by the Center for Biologics

Evaluation and Research (CBER) (FDA, 2021). The American Association of Tissue Banks (AATB)

sets standards for the safety and use of donated human tissue (AATB, 2019). AATB oversees a

voluntary accreditation program and the FDA focuses on preventing the transmission of

communicable diseases by requiring donor screening and testing. Tissue establishments must

product is AlloDerm, an acellular dermal matrix (FDA, 2004).

The following skin substitutes are derived from human tissue and therefore subject to the rules

and regulations for banked human tissue developed by the American Association of Tissue Banks

(AATB) (this list may not be all-inclusive):

• Alloderm

• Allomax

• Cortiva

• DermACell

• DermaMatrix

• FlexHD

• hMatrix

• Repriza

The safety and efficacy of the skin substitutes listed below are supported by the evidence in the

published peer-reviewed scientific literature and/or are established treatment options for post-

mastectomy breast reconstruction.

AlloDerm

™

: AlloDerm (Allergan

™

, Parsippany, NJ [formerly LifeCell

™

Corporation, Branchburg,

NJ]) is an acellular dermal matrix allograft classified as banked human tissue by the FDA because

it is minimally processed and not significantly changed in structure from the natural material.

AlloDerm is an established treatment option and is supported by the evidence in the published

peer-reviewed scientific literature for tissue repair during postmastectomy breast reconstruction

(Lee, et al., 2018; McCarthy, et al., 2012; Cheng, et al., 2012; Vardanian, et al., 2012; Jansen

and Macadam, 2011; Salzberg, et al., 2011; Joanna, et al., 2011; Antony, et al., 2010; Haddock,

et al., 2010; Spear, et al., 2008; Bindingnavele, et al., 2007; Breuing and Colwell, 2007;

Zienowicz, et al., 2007; Gamboa-Bobadilla, 2006; Glasberg, et al., 2006; Salzberg, 2006;

Breuing, et al., 2005; Nahabedian, 2005). Various forms of AlloDerm are available including

AlloDerm

™

Regenerative Tissue Matrix, AlloDerm Select

™

Tissue Matrix and AlloDerm Select Duo

™

Tissue Matrix Bilateral Pair (Allergan Aesthetics, 2023; Hayes, 2019, reviewed 2020).

AlloMax

™

: AlloMax Surgical Graft (Bard Davol, Inc. Warwick, RI) is an acellular non-cross-linked

human dermis allograft. Because AlloMax is a natural human product it is classified as banked

human tissue and does not require FDA approval. It is regulated by the American Association of

Tissue Banks and the FDA guidelines for banked human tissue. AlloMax Surgical Graft is available

in multiple sizes. The AlloMax Surgical Graft for Breast Reconstruction (previously marketed as

NeoForm™) is proposed for post-mastectomy breast reconstruction and is an established skin

substitute for this indication (Venturi, et al., 2013; Bard, 2017).

Cortiva

Cortiva (RTI Surgical, Alachua, FL) is a non-crosslinked, cadaveric human acellular dermal matrix

processed by Tutoplast technology using low-dose gamma irradiation. The matrix is FDA regulated

as human cell, tissue, and cellular and tissue-based product (361 HCT/P) and proposed for the

repair, replacement, reconstruction or augmentation of soft tissue, including supplemental support

and reinforcement of soft tissue in breast reconstruction and hernia repair. There are three

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products: Cortiva, Cortiva 1.0 mm and Cortiva 1 mm tailored allograft dermis. The matrixes are

offered in regular and 1 mm thicknesses and supplied in a range of sizes from 2x4 cm to 16x20

cm (RTI, Inc., 2021; Centers for Medicare and Medicaid Services [CMS], 2015). Cortiva has

evolved into an acceptable tissue substitute for breast reconstruction and a randomized controlled

trial with short-term follow-up reported that outcomes with Cortiva were not inferior to outcomes

using AlloDerm.

Parikh, et al. (2018) reported the outcomes of a phase 2 randomized controlled trial that

compared outcomes following breast reconstruction surgery using Cortiva 1 mm allograft or

AlloDerm Ready to Use (RTU) regenerative tissue matrix. The 16x8 cm graft was used as a sling

to support tissue expanders placed in the submuscular location in one study arm, and prepectoral

reconstructions with tissue expanders (TEs) or direct-to-implants (DTI) in a second study arm.

The interim analysis of the submuscular reconstruction group is reported herein. Breasts

reconstructed with AlloDerm RTU (n=17 patients; 28 breasts) or Cortiva 1 mm (n=17 patients; 31

breasts) submuscular TE, completed the interim analysis. During the study a significant shift to

prepectoral reconstructions was noted and the prepectoral arm of the study was added to optimize

enrollment rates. Patients who underwent prepectoral breast reconstruction with either DTI or TE

supported by a 20x16 cm ADM sheet were compared in a separate study arm. The decision to

proceed with prepectoral or submuscular reconstruction with either a TE or DTI was determined

preoperatively. Female patients, aged 22–70 years old, undergoing immediate prosthetic

reconstruction following therapeutic or prophylactic skin- or nipple-sparing mastectomy with a

body mass index (BMI) less than 36 kg/m

were included. Excluded patients were those who were

pregnant or breastfeeding immediately before mastectomy. The primary outcome measure was

premature explantation of the TE before exchange, or unintended explantation of a DTI

reconstruction during the first three months postoperatively. Secondary outcome measures

included other complications (e.g., seroma, cellulitis, wound or ADM dehiscence, skin flap

necrosis). Patients undergoing TE placement in either study arm were followed until there was TE

exchange with an implant, flap, or both, or there was premature removal of the device. Patients

undergoing DTI reconstruction were followed for at least three months following surgery. Patients

undergoing reoperation of the surgical site without device exchange or removal were kept in the

study. Patients underwent planned exchange of TEs for implants or flaps within 145.6 ± 51.6 days

in the AlloDerm group and 167.0 ± 61.5 days in the Cortiva 1 mm group (p=0.27), not

statistically significant. Most patient were exchanged with breast implant alone, but 14.3% in the

AlloDerm group and 26.6% in the Cortiva group (p=0.25) received an autologous flap, not

statistically significant. There was no significant difference between the group in integration of the

ADM to the mastectomy flap (p=0.69), in drain removal between the groups or in physical well-

being, or satisfaction with information or plastic surgeon. A significant difference was seen in

detectable seroma in the AlloDerm (n=3) vs. the Cortiva group (n=0). Premature explantation

was performed in no Alloderm breast vs. one breast with Coriva. The initial size of the TE selected

was significantly larger in patients reconstructed with Cortiva 1 mm (p=0.02). The AlloDerm RTU

group was comprised of a significantly higher proportion of patients who had never smoked

(p=0.009). This interim analysis of submuscular reconstructions patients revealed no evidence of

inferiority of outcomes of AlloDerm vs. Cortiva. Limitations of the study include the small patient

population and short-term follow-up.

DermACELL

™

: DermACELL (LifeNet Health

, Virginia Beach, VA) is an acellular human dermis

allograft collagen scaffold proposed for the treatment of breast reconstruction. LifeNet Health is

registered with the FDA as an establishment producing tissue- and cellular-based products.

MatrACELL

is a patented process that removes > 97% of donor DNA that renders Demacell

acellular. Terminal sterilization is performed by low dose gamma irradiation. The use of

DermACELL for breast reconstruction has evolved into an accepted standard of practice. Although

the evidence supporting DermACELL for breast reconstruction is primarily in the form of case

series and retrospective reviews, outcomes reported a significant improvement in time to drainage

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removal and fewer “red breast episodes” compared to AlloDerm (Pittman, et al., 2016). Zenn et

al. (2016) reported that DermACELL was as good as Alloderm RTU in the occurrence of

postoperative infection, implant loss, seroma and hematoma. Other studies have also reported

favorable outcomes with DermACELL (Bullocks, et al., 2014; Vashi, 2014). Therefore, DermACELL

has evolved into an accepted skin substitute for breast reconstruction (Swisher, et al., 2022;

Ortiz, 2017; Chang and Liu, 2017; Pittman, et al., 2016; Zenn, et al., 2016; Bullocks, et al.,

2014; Vashi, 2014).

FlexHD

Acellular Hydrated Dermis: FlexHD Acellular Hydrated Dermis (Musculoskeletal

Transplant Foundation, Edison, NJ) is a matrix derived from donated human allograft skin. The

product is regulated by the American Association of Tissue Banks and the FDA guidelines for

banked human tissue. FlexHD is indicated for the replacement of damaged or inadequate

integumental tissue or for the repair, reinforcement or supplemental support of soft tissue defects.

Flex HD is available in multiple sizes and configurations including the FlexHD Pliable PRE™ which is

a deeper cut of ADM consisting entirely of reticular dermis for ease of graft placement. Results of

case series and retrospective reviews in the peer-reviewed literature support the safety and

efficacy of FlexHD for use during postmastectomy breast reconstruction. FlexHD is an established

skin substitute for this indication (Lee, et al., 2018; Liu, et al., 2014; Seth, et al., 2013; Seth, et

al., 2012; Brooke, et al., 2012; Rawlani, et al., 2011; Cahan, et al., 2011; Topol, et al., 2008).

NeoForm

™

Dermis: Neoform Dermis (Mentor Corp., Santa Barbara, CA) is a solvent-dehydrated,

gamma-irradiated preserved human allograft dermis indicated for use as a soft tissue graft for

horizontal and vertical soft tissue augmentation of thickness and length, such as breast

reconstruction. NeoForm is classified as banked human tissue by the FDA. Although evidence in

the published, peer-reviewed scientific literature supporting the use of this product in breast

reconstruction is limited, Neoform Dermis is an established skin substitute used for tissue

expansion in breast reconstruction following a mastectomy. Neoform is no longer available for

distribution.

Other Skin Substitutes

Additional skin substitutes have been proposed as treatment options in breast reconstruction as

discussed below, but the evidence in the published peer-reviewed scientific literature does not

support the safety and efficacy of the use of these substitutes. The number of available studies is

limited and involves small, heterogeneous patient populations, short-term follow-ups, minimal

comparisons to the established treatment method for the condition, and/or lack of a control group.

In some cases, reported outcomes are inconsistent, and a consensus on patient selection criteria

and the appropriate surgical approach and techniques that should be used have not been

established.

ARTIA

™

Reconstructive Tissue Matrix: ARTIA Reconstructive Tissue Matrix (Artia Tissue

Matrix)/ ARTIA Tissue Matrix-Perforated (Allergan

™

, Parsippany, NJ [formerly LifeCell

™

Corporation, Branchburg, NJ]) is a surgical mesh that is derived from porcine skin that is

processed and preserved in a patented phosphate buffered aqueous solution containing matrix

stabilizers. ARTIA was originally developed by LifeCell Corporation and is currently distributed by

Allergan. According to the FDA 510(k) approval, ARTIA Tissue Matrix is intended for use as a soft

tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged

or ruptured soft tissue membranes which require the use of reinforcing or bridging material to

obtain the desired surgical outcome. The implant is intended for reinforcement in plastic and

reconstructive surgery (510(k) Number: K162752). There is insufficient evidence to support the

safety and efficacy of ARTIA Reconstructive Tissue Matrix as a skin substitute for breast

reconstructive surgery.

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Avance

Nerve Graft: Mastectomy can result in diminished or absent sensation which can lead

to a decreased sense of femininity and sexuality and potential thermal or mechanical injury.

Neurotization is a technique used to repair the loss of sensation and can be achieved through

autografts, allografts, or nerve conduit tubes depending on the length of the gap (Hamilton, et al.,

2021). Neurotization using allografts has been proposed as a means to bridge large nerve gaps

when nerve autografts are not feasible with the potential to recover sensation earlier and with

increased quality and quantity. Avance Nerve Graft (AxoGen, Inc., Alachua, FL) is an acellular,

processed human peripheral nerve tissue proposed for the surgical repair of severed peripheral

nerve discontinuities to support regeneration. The device maintains a 3-dimention scaffold that is

proposed to support cell migration and tissue regeneration. Avance is regulated by the FDA

Human Cellular and Tissue-based Products and the guidelines of the American Association of

Tissue Banks (AATB). The product is available in 16 sizes (Axogen, 2024).

Literature Review

There is insufficient evidence to support the safety and efficacy of neurotization with processed

nerve allografts (e.g., Avance Nerve Graft) after mastectomy either during immediate or delayed

breast reconstruction. Studies are in the form of a cohort studies and case reports limited by small

patient populations, short term follow-up and heterogeneity of surgical procedures. Studies were

also lacking safety outcomes (Peled, et al., 2023; Momeni, et al., 2021; Djohan, et al., 2020;

Peled and Peled, 2019).

Momeni et al., (2021) conducted a cohort study of individuals from a single institution to evaluate

sensation outcomes of the reconstructed breast following neurotization using a processed nerve

allograft. This study was an arm of the Registry study of Avance Nerve Graft utilization,

Evaluations, and outcomes in peripheral nerve Repair (RANGER). Patients (n=59; breasts=96)

ranged in age from 24–69 years old. A total of 33 patients were white, 14 were Asian, and 12

were Hispanic. Patients who underwent microsurgical breast reconstruction following mastectomy

with free abdominal flaps by a single surgeon with follow-up of ≥12 months were included in the

study. Patients who underwent autologous reconstruction using donor-sites other than the

abdomen, reconstruction with stacked flaps, and implant-based reconstruction were excluded.

There were two cohort groups: patients who underwent flap neurotization utilizing a 1-2mm x

50mm processed human nerve allograft (i.e., Avance, AxoGen, Alachua, FL) (n=39; breasts=59)

and those who did not undergo neurotization (n=20; breasts=37). The primary outcome

measured was cutaneous pressure threshold using the Semmes-Weinstein monofilaments test

(SWMF) at nine pre-defined locations on the breast. Follow-up took place at three, six, twelve, and

eighteen months. The majority of patients in both groups underwent bilateral immediate

reconstruction following nipple-sparing mastectomy for malignancy. However, procedures also

included areola-sparing, skin sparing, and simple mastectomy and reconstruction also included

delayed-immediate and delayed. A total of 22 patients (group 1=22 breasts; group 2=14 breasts)

had a complete data set at ≥12 months and were included in the final analysis. Compared to

those who did not undergo neurotization, group one was associated with a greater likelihood for

return of protective sensation in the majority of breast locations (p<0.01). Author noted

limitations of the study included: non-randomized study design, small sample size, and a lack of

secondary outcomes (e.g., impact of medical conditions, chemotherapy, radiotherapy on sensory

outcomes). Additional limitations of the study include short term follow-up, heterogeneity of

mastectomy procedures, and the lack of safety outcome measures. Additional long-term, high

quality studies are needed to evaluate the safety and efficacy of neurotization using processed

nerve allografts on sensation outcomes in patients who underwent mastectomy and breast

reconstruction.

BellaDerm

Acellular Hydrated Dermis: BellaDerm Acellular Hydrated Dermis (Musculoskeletal

Transplant Foundation, Edison, NJ) is human allograft skin minimally processed to remove

epidermal and dermal cells and is packaged in an ethanol solution. The process utilized preserves

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the extracellular matrix of the dermis. The resulting allograft serves as a framework to support

cellular repopulation and vascularization at the surgical site. BellaDerm is processed to remove

cells while maintaining the integrity of the matrix with the intent to address the issues of the

specific and nonspecific inflammatory responses. It is used for the replacement of damaged or

inadequate integumental tissue or for the repair, reinforcement or supplemental support of soft

tissue defects. Grafts of BellaDerm can range between 0.8mm and 1.7mm. It is used for breast

augmentation revision procedures, including correction of symmastia, capsular contracture,

bottoming out and malposition. There is insufficient evidence to support the safety and efficacy of

BellaDerm Acellular Hydrated Dermis as a skin substitute for breast reconstructive surgery.

DermaMatrix Acellular Dermis: DermaMatrix (formerly manufactured by Synthes Inc., West

Chester, PA) is an allograft derived from human skin and is classified by the FDA as banked

human tissue. DermaMatrix is proposed for use for breast reconstruction postmastectomy. Per the

manufacturer, as of June 2014, DermaMatrix is no longer available for distribution.

DuraSorb

Monofilament Mesh/ Polydioxanone Surgical Scaffold™: DuraSorb

Monofilament Mesh/ Polydioxanone Surgical Scaffold™ (Surgical Innovation Associates, Inc [SIA];

Philadelphia, PA) is a resorbable, colorless, monofilament knit surgical mesh made entirely of

uncolored and undyed polydioxanone (PDO) thread. Polydioxanone Surgical Scaffold is proposed

for use in reinforcement of soft tissue where weakness exists. On August 1, 2018, 510(k) approval

(510(k) Number: K181094) was given to Polydioxanone Surgical Scaffold™. It is manufactured in

two rectangular shapes: 6x16 cm and 10x25 cm. According to the manufacturer’s Instructions for

Use, DuraSorb has not been studied for use in the repair of direct inguinal hernias, intraperitoneal

use, contaminated and/or infected wounds or in breast reconstructive surgeries (Surgical

Innovation Associates, 2021). Evidence is lacking in the published peer-reviewed literature to

support the clinical effectiveness of DuraSorb Monofilament Mesh/ Polydioxanone Surgical Scaffold

for any indication.

GalaFLEX

Scaffold: This

surgical scaffold (Tepha, Inc., Lexington, MA) is a sterile, knitted,

resorbable mesh, constructed of non-dyed monofilament fibers made from poly-4-

hydroxylbutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed

into monofilament fibers and knitted into a surgical fold. It is provided in single sheets of varying

widths, lengths and shapes, and may also be cut to the shape or size desired for a specific

application. According to the FDA 510(k) approval GalaFLEX Scaffold is indicated for use “as a

transitory scaffold for soft tissue support and to repair, elevate and reinforce deficiencies where

weakness or voids exist that require the addition of material to obtain the desired surgical

outcome. This includes reinforcement of soft tissue in plastic and reconstructive surgery, and

general soft tissue reconstruction”. In November 2017, Hayes published a Clinical Research

Response for this product concluding that "Based on a review of published abstracts, there is

insufficient evidence to inform conclusions regarding the efficacy of GalaFLEX Surgical Scaffold for

use as reinforcement in soft tissue reconstruction”. There is insufficient evidence to support the

safety and efficacy of GalaFLEX Scaffold as a skin substitute for breast reconstructive surgery

(Hayes, 2017; Williams, et al., 2016) (510(k) Number: K140533).

GalaFLEX

™

3DR Scaffold: GalaFLEX

™

3DR Scaffold (Tepha, Inc., Lexington, MA) is a

bioresorbable surgical scaffold manufactured from P4HB. According to the FDA 510(k) approval,

GalaFLEX 3DR Scaffold (formerly known as GalaFORM 3D scaffold) is indicated for use as a

bioresorbable scaffold for soft tissue support and to repair, elevate and reinforce deficiencies

where weakness or voids exist that require the addition of material to obtain the desired surgical

outcome. This includes reinforcement of soft tissue in plastic and reconstructive surgery, and

general soft tissue reconstruction. GalaFLEX

™

3DR Scaffold is also indicated for the repair of fascial

defects that require the addition of a reinforcing or bridging material to obtain the desired surgical

result. The predicate device is GalaFLEX

™

Scaffold (510(k) Number: K162922). There is

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insufficient evidence to support the safety and efficacy of GalaFLEX

™

3DR Scaffold as a skin

substitute for breast reconstructive surgery.

GalaFLEX 3D Scaffold: GalaFLEX 3D Scaffold (formerly known as GalaSHAPE 3D) (Tepha, Inc.,

Lexington, MA) is a 3-dimensional monofilament scaffold made from poly-4-hydroxylbutyrate

(P4HB). After implantation, the scaffold is proposed to gradually bioresorb over 18-24 months

providing a lattice for new tissue ingrowth and regeneration. The FDA 510(k) approval indications

for use state that “GalaSHAPE™ 3D is indicated for use as a bioresorbable scaffold for soft tissue

support and to repair, elevate and reinforce deficiencies where weakness or voids exist that

require the addition of material to obtain the desired surgical outcome. This includes

reinforcement of soft tissue in plastic and reconstructive surgery, and general soft tissue

reconstruction. GalaSHAPE™ 3D is also indicated for the repair of fascial defects that require the

addition of a reinforcing or bridging material to obtain the desired surgical result” (Galatea

Surgical, 2024) (510(k) Number: K161092). The Galatea products are available in various sizes in

oval, rectangular, triangular, circular shapes and can be custom made. There is insufficient

evidence to support the safety and efficacy of Galatea products as a skin substitute for breast

reconstructive surgery.

hMatrix

: hMatrix Acellular Dermis (Bacterin International Holdings Inc., Belgrade, MT) is an

acellular dermal scaffold processed from donated human skin. The dermis is processed using a

proprietary method and the matrix is packaged and sterilized using low-dose gamma irradiation.

hMatrix is regulated by the American Association of Tissue Banks and the FDA guidelines for

banked human tissue. The product is stored and supplied frozen. Bacterin hMatrix PR for breast

augmentation (Bacterin, 2015). hMatrix is available in four sizes. There is insufficient evidence to

support the safety and efficacy of hMatrix as a skin substitute for breast reconstruction.

OviTex

: OviTex

(TELA Bio

, Inc., Malvern, PA) is a reinforced tissue matrix composed of

interwoven biologic material derived from ovine rumen and polymer reinforcement. The polymer

fiber is available in resorbable or permanent variations. It is proposed for use as a surgical mesh

to reinforce and/or repair soft tissue where weakness exists. Indications for use include the repair

of hernias and/or abdominal wall defects that require the use of reinforcing or bridging material to

obtain the desired surgical outcome. The OviTex portfolio of products includes: OviTex, a four

layer device not intended for intraperitoneal placement; OviTex 1S, a six layer device with smooth

external layers suitable for intraperitoneal placement; OviTex 2S, an eight layer device with two

smooth external layers suitable for intraperitoneal placement; OviTex LPR, a four layer device with

a smooth side suitable for laparoscopic and robotic-assisted intraperitoneal placement; and OviTex

PRS, a two or three layer device available in four shapes for plastic and reconstructive surgery. In

order to achieve better fluid management, tissue integration, and directional flexibility, OviTex

PRS was designed with micropores, macropores, and stents to address soft tissue repair in plastic

and reconstructive surgery (TelaBio

Inc., 2024). OviTex received FDA 510(k) (K141053) as

Ovine Tissue Matrix (OTM) in 2014 (FDA, 2022). It is available in various sizes. Evidence in the

published, peer-reviewed scientific literature supporting the use of this product in breast

reconstruction is lacking and its role is unclear.

Permacol

™

: The Permacol Crosslinked Porcine Dermal Collagen Surgical Mesh (Tissue Sciences

Laboratories PLC, Hants, United Kingdom), a xenograft, is a fibrous flat sheet comprised of

acellular porcine dermal collagen and elastin. According to the FD) 510(k) approval, Permacol

™

intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the

surgical repair of damaged or ruptured soft tissue membranes (510(k) number: K992556). Breast

reconstruction is not specifically mentioned as an approved FDA indication. However, muscle flap

reinforcement is an FDA-approved indication for use. Permacol is available in multiple sizes.

Evidence in the published, peer-reviewed scientific literature supporting the use of this product in

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breast reconstruction is lacking and its role is unclear (Knabben, et al., 2017; Ramsden, et al.,

2009).

Phasix

™

Mesh: Phasix Mesh (Bard Davol, Inc. Warwick, RI), is a fully resorbable P4HB polymer

material proposed for use in breast reconstructive procedures. The P4HB is produced from a

naturally occurring monomer and is processed into monofilament fiber then knitted into a surgical

mesh. Phasix Mesh received FDA 510k approval on March 31, 2015 to reinforce soft tissue where

weakness exists in patients undergoing plastic and reconstructive surgery, or for use in

procedures involving soft tissue repair, such as the repair of hernia or other fascial defects that

require the addition of a reinforcing or bridging material to obtain the desired surgical result

(510(k) Number: K142818). The FDA approved indication for Phasix has no specific language

related to breast reconstruction. Phasix is available in multiple sizes as round, rectangular, and

square implants (Hayes, 2019, reviewed 2020). Evidence in the published, peer-reviewed

scientific literature supporting the use of this product in breast reconstruction is lacking and its

role is unclear.

Renuva

Allograft Adipose Matrix: Renuva

Allograft Adipose Matrix (MTF Biologics, Edison,

NJ) is an injectable allograft adipose matrix processed from human adipose tissue. It has been

proposed for use as part of a breast reconstruction procedure post mastectomy. According to the

manufacturer’s Instructions for Use, it is indicated for the replacement of damaged or inadequate

integumental adipose tissue matrix in areas of the body where native fat would exist and for the

reinforcement or supplemental support in underlying adipose tissue matrix as the result of

damage or naturally occurring defects (MTF Biologics, 2020). Renuva Allograft Adipose Matrix is

regulated by the FDA under 21 CFR Part 1271 Human Cells, Tissues and Cellular and Tissue-Based

Products (HCT/Ps). It is available in 1.5cc and 3cc. Evidence in the published, peer-reviewed

scientific literature supporting the use of this product in breast reconstruction is lacking and its

role is unclear.

Repriza

Acellular Dermal Matrix: Repriza (Promethean Lifesciences Inc., Pittsburg, PA) is a

human skin, acellular dermal matrix. The product is regulated by the American Association of

Tissue Banks and the FDA guidelines for banked human tissue. Repriza is membrane free and

proposed for implantation for reconstructive surgery including breast reconstruction, abdominal

wall reconstruct and augmentation of soft tissue irregularities. The matrix is provided in 4X12 cm

and 6X16 cm sheets. It can also be custom made. There is insufficient evidence to support the

safety and efficacy of Repriza for breast reconstructive surgery.

SERI

™

Surgical Scaffold: SERI Surgical Scaffold (Sofregen Medical Inc., Cambridge, MA formerly

Allergan, Medford, MA) has been proposed as a skin substitute for breast reconstruction (Jewell, et

al., 2015). Breast reconstruction is not specifically mentioned as an approved FDA indication. The

FDA 510(k) summary states that SERI is a “knitted, multi-filament, bioengineered, long-term

bioresorbable scaffold. It is derived from silk that has been BIOSILK™ purified to yield ultra-pure

fibroin. The device is a mechanically strong and biocompatible bioprotein” (FDA, 2013). The FDA

indications for use state, “SERI Surgical Scaffold is indicated for use as a transitory scaffold for

soft tissue support and repair to reinforce deficiencies where weakness or voids exist that require

the addition of material to obtain the desired surgical outcome. This includes reinforcement of soft

tissue in plastic and reconstructive surgery, and general soft tissue reconstruction” (510(k)

Number K123128). There is insufficient evidence in the published peer-reviewed scientific

literature supporting the efficacy of SERI Surgical Scaffold for breast reconstruction.

In May 2015 the FDA issued a warning letter to Allergan stating that the FDA approval of SERI

Surgical Scaffold did not include the use of SERI Surgical Scaffold for breast reconstruction. Per

the FDA, this indication falls outside of the intended use “because surgical mesh has not been

cleared or approved for use in breast reconstruction using a tissue expander or implant”. The FDA

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requested Allergan “immediately cease activities that result in the misbranding or adulteration of

the SERI Surgical Scaffold” for breast reconstruction” (FDA, 2015).

Sofregen Medical Inc., issued a statement indicating that as of Dec 31, 2021, Seri Surgical

Scaffold is no longer commercially available. Sofregen pointed to the fact that the remaining

inventory was approachign the end of the approved shelf life as the reason for discontinuation

(Sofregen Medical Inc., 2021).

SimpliDerm™: SimpliDerm™ (Aziyo Biologics, Silver Spring, MD) is a pre-hydrated human

acellular dermal matrix minimally processed to remove epidermal and dermal cells and then

preserved in an irradiation protection solution. The process utilizes a proprietary and patented

technology to preserve the remaining bioactive components and extracellular matrix of the

dermis. It is proposed for the repair or replacement of damaged or insufficient integumental tissue

and for the repair, reinforcement, or supplemental support of soft tissue defects or any other

homologous use of human integument (Alutia, 2024). The product is classified as a human tissue

and cell-based product regulated by the American Association of Tissue Banks (AATB) and in

compliance with U.S. FDA regulations (21 CFR 1271). It is available in both Ellipse

™

and

rectangular sizes. There is insufficient evidence in the published peer-reviewed scientific literature

to support the safety and efficacy of Simpliderm (Hydrated Acellular Dermal Matrix) for any

indication.

Strattice

™

Reconstructive Tissue Matrix or LTM Surgical Mesh: Strattice Reconstructive

Tissue Matrix or LTM Surgical Mesh (Allergan

™

, Parsippany, NJ [formerly LifeCell

™

Corporation,

Branchburg, NJ]) is an acellular, xenographic tissue matrix derived from porcine dermis (FDA,

2007). It is FDA 510(k) approved as LTM-RC surgical mesh “for use as a soft tissue patch to

reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft

tissue membranes. The implant is intended for the reinforcement of soft tissues repaired by

sutures or suture anchors, during rotator cuff surgery. Indications for use also include the repair

of hernias and/or body wall defects which require the use of reinforcing or bridging material to

obtain the desired surgical outcome” (FDA, 2007). Strattice is proposed for use during

postmastectomy breast reconstruction to support medial repair for breast pocket size and position.

Strattice is available in seven sizes with various shapes. There is insufficient evidence in the

published peer-reviewed scientific literature supporting the efficacy of Strattice. Studies are

primarily in the form of retrospective reviews (Dikmans, et al., 2016; Barber, et al., 2015; Lardi,

et al., 2014; Kilchenmann, et al., 2014; Maxwell, et al., 2014; Glasberg and Light, 2012).

In June 2015 the FDA issued a warning letter to LifeCell Corporation stating that the FDA approval

for Strattice did not include the use of Strattice for breast reconstruction. Per the FDA, this

indication falls outside of the intended use “because surgical mesh has not been cleared or

approved for use in breast reconstructive surgery applications”. The FDA requested that LifeCell

“immediately cease activities that result in the misbranding or adulteration of the Strattice

Reconstructive Tissue Matrix” for breast reconstruction.

SurgiMend

Collagen Matrix: SurgiMend or SurgiMend Collagen Matrix (Integra

LifeSciences

Corp., Plainsboro, NJ formerly TEI Biosciences Inc., Boston, MA) is an acellular dermal tissue

matrix derived from fetal or neonatal bovine dermis. The matrix acts as a scaffold that is

progressively integrated, remodeled, and replaced by the functional host tissue. Approved as a

Class II, FDA 510(k) device, SurgiMend is “intended for implantation to reinforce soft tissue where

weakness exists and for the surgical repair of damage or ruptured soft tissue membranes”

specifically for plastic and reconstructive surgery, muscle flap reinforcement, and hernia repair

(e.g., abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, incisional) (510(k) Number:

K083898). SurgiMend is available in multiple sizes and thicknesses. SurgiMend PRS, a pure

collagen product, is designed for plastic and reconstructive surgery and is available in multiple

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shapes, sizes and thicknesses (Integra LifeSciences Corp, 2023; Butterfield, et al., 2013, Gaster,

et al., 2013, Ohkuma, et al., 2013; Endress, et al., 2012; Craft, et al., 2011; Cromwell, et al.,

2009).

TEI has historically marketed SurgiMend for breast reconstruction. In May 2015, the FDA issued

TEI a warning letter stating that TEI did not have FDA clearance or approval to market SurgiMend

for breast reconstruction. Per the FDA, this indication falls outside of the intended use “because

surgical mesh has not been cleared or approved for use in breast reconstructive surgery

applications”. The FDA requested that TEI “immediately cease activities that result in the

misbranding or adulteration of SurgiMend” for breast reconstruction (FDA, 2015).

Veritas Collagen Matrix: Veritas Collagen Matrix (Synovis

Surgical Innovations, St. Paul, MN)

is an implantable noncrosslinked biologic mesh made from bovine pericardium. Veritas is FDA

approved as a surgical mesh under the 510(k) process for use as an implant for surgical repair of

soft tissue deficiencies including: muscle flap reinforcement. There is also a Veritas Collagen

Matrix Dry product that is FDA approved as a predicate device for the conventional Collagen Matrix

(FDA, 2008; FDA, 2006). There is insufficient evidence to support the use of Veritas Collagen

Matrix. The limited number of published studies investigating is primarily in the form of

retrospective reviews.

Systematic Review and Meta-Analysis: Ho et al. (2012) conducted a systematic review and

meta-analysis to determine an aggregate estimate of risks associated with acellular dermal matrix

(ADM)-assisted breast reconstruction. AlloDerm was used in the majority of studies. ADMs other

than AlloDerm were used in one study (i.e., FlexHD, Strattice). Seven complications were studied

including seroma, cellulitis, infection, hematoma, skin flap necrosis, capsular contracture, and

reconstructive failure. Sixteen studies met the inclusion criteria. The pooled complication rates

were seroma 6.9%, cellulitis 2.0%, infection 5.7%, skin flap necrosis 10.9%, hematoma 1.3%,

capsular contracture 0.6% and reconstructive failure 5.1%. Five studies reported findings for both

the ADM and non-ADM patients and were used in the meta-analysis to calculate pooled odds ratio

(OR). ADM-assisted breast reconstructions had a higher likelihood of seroma, infection, and

reconstructive failure than breast reconstructions without the use of ADM. The relation of ADM use

to hematoma, cellulitis, and skin flap necrosis was inconclusive. In the studies evaluated, ADM-

assisted breast reconstructions exhibited a higher likelihood of seroma, infection, and

reconstructive failure than prosthetic-based breast reconstructions using traditional musculofascial

flaps. ADM is associated with a lower rate of capsular contracture. The authors reported that given

the relatively low-quality evidence that currently exists in the literature, additional randomized-

controlled studies are needed to further evaluate the safety and efficacy of ADM in implant-based

breast reconstruction.

Kim et al. (2012) conducted a systematic review and meta-analysis to evaluate complication

outcomes from human acellular dermal matrix (ADM) used as an adjunct to traditional

submuscular tissue expander/implant breast reconstruction. Forty-eight uncontrolled cohort

studies met inclusion criteria. Thirteen studies had information only on human ADM matrix-based

reconstruction, 29 had information only on submuscular-based reconstructions, and six reported

complications on human ADM and submuscular techniques. A total of 2037 human ADM

reconstructions and 12,847 submuscular reconstructions were included in the meta-analysis. A

total of 877 human ADM and 3464 muscular reconstructions from six studies were used to

calculate relative risks. Average follow-up time was 13.8 months in the human ADM group and

28.3 months in the submuscular cohort There was an increased rate of total complications, 15.4%

vs. 14.0%; seroma, 4.8% vs. 3.5%; infection, 5.3% vs. 4.7%; and flap necrosis, 6.9% vs. 4.9%

in the human ADM cohort compared to the submuscular reconstruction cohort. The rate of

hematomas was greater in the submuscular cohort 1.5% vs. 1% in the human ADM. Meta-

analysis revealed an increase in the risk of total complications (relative risk, 2.05; 95 percent

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confidence interval, 1.55 to 2.70), seroma (relative risk, 2.73; 95 percent confidence interval,

1.67 to 4.46), infection (relative risk, 2.47; 95 percent confidence interval, 1.71 to 3.57), and

reconstructive failure (relative risk, 2.80; 95 percent confidence interval, 1.76 to 4.45) in the

human ADM cohort. There was a trend toward increased risk of hematoma (relative risk, 2.06; 95

percent confidence interval, 0.86 to 4.95) and flap necrosis (relative risk, 1.56; 95 percent

confidence interval, 0.85 to 2.85) in the human acellular dermal matrix cohort, but the results

were not statistically significant. Most pooled complication analyses showed significant

heterogeneity. The meta-analysis suggested that the use of human ADM increases complication

rates compared to submuscular approach.

Nguyen et al (2011) conducted a systematic review of the literature to assess the quality and

quantity of evidence regarding the use of acellular dermal matrices (ADM) (e.g., AlloDerm) in

prosthetic breast reconstruction. Eighteen articles in the form of case reports, prospective cohort

studies and retrospective reviews met inclusion criteria. The authors analyzed the evidence for the

following proposed advantages of ADM: decrease or eliminate the need for expanders to create a

tissue pocket for an implant; reduction in postoperative pain; decrease in operative time;

increased initial fill volumes; fewer expansions; precise control of over the lateral and

inframammary fold; ability to use more of the mastectomy skin flaps; faster time to completion of

reconstruction; improved lower pole expansion; decreased incidence of capsular contractures;

decreased rate of revisions; improved aesthetic outcome of the breast. The authors concluded that

there was insufficient data to support any of the above proposed benefits of ADM for breast

reconstruction due to the paucity of actual data and conflicting data. Some studies did not

formally quantify or report applicable data; evidence was inconsistent due to the variations in size

of the matrix, type of mastectomy, size and viability of the mastectomy flaps and surgeon

judgment; and data was conflicting due to variations in surgical technique, patients’ physical

characteristics, and number of expansions used.

Use Outside of the US

Skin substitutes are offered outside the US by several companies. Several products have received

CE Mark approval (e.g., Integra

SurgiMend PRS Meshed, Strattice, Veritas Collagen Matrix).

Products approved in the US may not be approved for use outside of the US and products

approved outside the US may not be approved for use in the US. Also, the approved indications

for the products may not be the same within and outside of the US. Integra LifeSciences has CE

Mark approval for Surgimend PRS Mesh for pre- and sub-pectoral breast reconstruction in Europe.

Strattice has CE Mark approval by the Netherlands-based notified body, KEMA, for its Strattice

Reconstructive Tissue Matrix. The CE Mark allows Strattice to be marketed in 27 Europena Union

member states. Strattice is proposed for use in breast reconstruction. Native

(mbp, Germany)

porcine acellular dermal matrix is proposed for use in Europe for breast reconstruction.

Autologous Fat Transplant (Lipoinjection, Lipofilling, Lipomodeling)

Despite various techniques of reconstruction with autologous tissues or prostheses, autologous fat

transplant (i.e., lipoinjection, lipofilling, lipomodeling) has been proposed to replace volume after

breast reconstruction or to fill defects in the breast following breast conservation surgery. It has

been proposed as a stand-alone procedure or as an adjunct to other breast reconstruction

techniques. The use of autologous fat transplant for primary breast augmentation is controversial

due to a lack of clarity regarding its safety and efficacy. It has been proposed that injection of fat

into a previous tumor site may create a new environment for cancer and adjacent cells.

Additionally, fat transplant to the breast has been discouraged since it has been reported that

calcifications secondary to fat necrosis may mimic breast cancer or that radiological changes post

fat grafting would obscure and delay the diagnosis of subsequent breast cancer. In breast

reconstruction, unlike elsewhere in the body, fat is implanted in a poorly vascularized and loose

space which may attribute to the poor results.

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Autologous fat transplant generally involves the transfer of fat from the abdomen or thighs into

the breast under local anesthesia. The harvested fat is injected into the breast, usually in small

parcels and thin strips, at different levels in the subcutis. It has been reported that a certain

amount of fat resorption is expected in all cases of fat grafting. Clinically, volume loss has been

reported between 40%-60% and usually within the first 4-6 months. Patients usually have 2-4

sessions of lipomodelling depending on their condition. The proposed benefit of the procedure is

that it can restore volume to the breast without the morbidity associated with other reconstruction

techniques. Although refinement in technique has aided reproducibility of favorable results, a

standardized method of fat harvest, preparation, and injection is needed. Results are dependent

on technique and surgeon expertise. It is recommended that breast reconstruction using

autologous fat transfer be carried out by surgeons with specialist expertise and training in the

procedure.

Literature Review: The available literature consists mostly of case reports, case series and

expert opinion and describes autologous fat transplant for various breast indications, both

cosmetic and reconstructive. Although the published evidence supporting the role of autologous

fat transplant as a breast reconstruction procedure is not robust, limited data from several small

studies indicate that autologous fat transplant raises no major safety concerns and may improve

outcomes in a carefully selected subset of patients. Additionally, autologous fat transplant is

widely used and accepted in clinical practice as a breast reconstruction procedure (Tukiama, et al.,

2022; Hayes, 2020; De Decker, et al., 2016; Claro, et al., 2012; Parikh, et al., 2012; Saint-Cyr,

et al., 2012; Rosing, et al., 2011; de Blacam, et al., 2011; Losken, et al., 2011; Petit, et al.,

2011a; Petit, et al., 2011b; Illouz, et al., 2009; Hyakusoku, et al., 2009; Kanchwala, et al., 2009;

Chan, et al., 2008; American Society for Dermatologic Surgery (ASDS); 2008; Coleman, et al.,

2007; Spear, et al., 2005). Research is ongoing to distinguish benign from malignant lesions after

fat grafting (Parikh, et al, 2012).

Professional Societies/Organizations:

The 2008 American Society for Dermatologic Surgery

(ASDS) guidelines of care for injectable fillers states that, “One significant concern is the safety of

fat transfer into the female breast. Calcifications and nodularity may develop and require the

patient to undergo numerous tests and repeated evaluations to rule out an underlying

malignancy” (Alam, et al., 2008).

Australian Safety and Efficacy Register of New Interventional Procedures –Surgical

(ASERNIP-S): ASERNIP-S published a systematic review on autologous fat transfer for cosmetic

and reconstructive breast augmentation. The authors concluded that “the evidence base in this

review is rated as poor, limited by the quality of the available evidence. Specific limitations of the

evidence include absence of studies comparing autologous fat transfer to the nominated

comparator procedures, as well as a lack of standardized reporting of outcomes. Autologous fat

transfer for cosmetic and reconstructive breast augmentation is considered to be at least as safe

as the nominated comparator procedures. It is important to note that this rating is based on

indirect comparisons that have been made using overall complication rates. Important safety data

examining the effect of microcalcifications following autologous fat transfer on subsequent breast

cancer detection were not reported in the studies included in this review; therefore, safety in

regards to this outcome cannot be determined. The efficacy of autologous fat transfer cannot be

determined from the literature included in this review. Efficacy outcomes reported in the included

autologous fat transfer studies varied from those reported for the nominated comparator

procedures; therefore, it was not possible to compare efficacy. However, the inability of

autologous fat transfer to achieve a volume increase comparable to that of prostheses or

autologous tissue augmentation suggests that it is less efficacious than these comparator

procedures. There is a need for controlled trials (ideally randomized), assessing the effects of

microcalcifications following autologous fat transfer on immediate and long-term breast cancer

detection, to be conducted. Studies to determine the maximal breast volume increase reliably

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achieved by autologous fat transfer would also be useful in order to define the patient population

who would benefit most from the procedure, as well as which breast indications should be treated

using autologous fat transfer” (Leopardi, et al., 2010).

Autologous Fat Transplant with the use of Adipose-Derived Stem Cells

Research has indicated that subcutaneous fat contains many stem and regenerative cells including

cells important in tissue survival and vascularization. It is proposed that autologous adipose-

derived regenerative cells (ADRCs) may increase graft survival. With the growing use of

autologous fat grafting, published preclinical and clinical data describing cell enriched adipose

tissue transplants in breast defect repairs and breast augmentation are increasing. After adipose

harvesting using syringe liposuction, the tissue is processed with a system such as the Celution

800 System

, (Cytori Therapeutics, Inc., San Diego, CA) which washes the graft and isolates

ADRCs (Kamakura, et al., 2011).

Literature Review: The available literature is limited and consists mostly of case reports and

case series, both cosmetic and reconstructive (Ito, et al., 2017; Pérez-Cano, et al., 2012;

Kamakura, et al., 2011). Optimal patient selection criteria have not been established through well-

designed comparative clinical trials with long-term outcomes data (Kamakura, et al., 2011;

Yoshimura, et al., 2008).

Pérez-Cano et al. (2012) conducted a single-arm, prospective, multicenter clinical trial of 71

women who underwent breast conserving surgery for breast cancer and autologous adipose-

derived regenerative cell (ADRC)-enriched fat grafting for reconstruction of defects =150 mL (the

RESTORE-2 trial). Endpoints included patient and investigator satisfaction with functional and

cosmetic results and improvement in overall breast deformity at 12 months post-procedure.

Females presenting with partial mastectomy defects and without breast prosthesis were eligible.

The RESTORE-2 protocol allowed for up to two treatment sessions and 24 patients elected to

undergo a second procedure following the six-month follow-up visit. Of the 67 patients treated, 50

reported satisfaction with treatment results through 12 months. Sixty-one patients underwent

radiation therapy as part of their treatment; two patients did not receive radiation and the status

of radiation treatment was not known for the other four patients. Using the same metric,

investigators reported satisfaction with 57 out of 67 patients. There were no serious adverse

events associated with the ADRC-enriched fat graft injection procedure. There were no reported

local cancer recurrences. The investigators reported improvement from baseline through 12

months in the degree of retraction or atrophy in 29 out of 67 patients, while 34 patients had no

change and four patients reported worse symptoms. Post-radiation fibrosis at 12 months was

reported as improved in 29 patients, while 35 patients had no change and three patients had

worse symptoms. Management of atrophy was reported as improved in 17 patients, with 48

patients having no change and two patients reporting worse symptoms. The authors reported that

future comparative studies are needed to determine the benefit of ADRC-enriched fat grafting as

compared to traditional fat grafting in various clinical circumstances.

In a case series study, Kamakura et al. (2011), reported on the use of autologous adipose-derived

stem cell (ADSC) enriched fat grafting for breast augmentation (n=20). After the adipose tissue

was harvested by liposuction, it was processed in the Celution 800 System

to wash and isolate

the adipose-derived regenerative cells and produce a fat graft enriched with the regenerative cells.

The average number of cells per gram of harvested adipose tissue was 3.4 x 10

, and the mean

cell viability as measured with an automated cell counting system before graft delivery was 85%.

Clinical outcomes measured included improvement in circumferential breast measurement from

baseline state. There was improvement in circumferential breast measurement in all patients, and

breast measurements were stable by three months after grafting. At nine months, the mean

breast measurement had increased 3.3cm from preoperative measurements. Through nine

months, overall patient satisfaction was 75%, and physician satisfaction 69%. The procedure was

Page 27 of 49

Medical Coverage Policy: 0178

well-tolerated without any serious adverse events. Postoperative cyst formation was seen in two

patients. This study was limited by small sample size, no control group and lack of long-term

outcomes. The authors reported that to date a, a randomized, controlled study has not been

performed to compare the outcomes of cell-enriched fat transfer with those of traditional fat

transfer.

Suction-Assisted Lipectomy and Excision of Redundant Skin

Suction-assisted lipectomy of the trunk or extremity area is a procedure in which excess fat

deposits are removed using a liposuction cannula. Excision of redundant skin is a procedure in

which excess skin and/or subcutaneous tissue (e.g., dog ear, standing cone) is removed. Both

procedures have the goal of recontouring the body, thereby improving appearance. These

procedures may be performed alone or as one component of the flap breast reconstruction

procedure. Suction-assisted lipectomy and excision of redundant skin, when performed alone and

not as part of a medically necessary flap breast reconstruction procedure are considered cosmetic

in nature. When these procedures are performed as part of a medically necessary flap breast

reconstruction procedure, they are considered incidental to the primary procedure.

External Breast Prostheses and Mastectomy Bras Following Mastectomy or Lumpectomy

Breast reconstruction has become an integral component of the treatment of patients with breast

cancer who have undergone a mastectomy or lumpectomy. External breast prostheses are

available for women who have uneven- or unequal-sized breasts and who decide not to, or are

waiting to, undergo surgical breast reconstruction. They may choose to wear a breast prosthesis

and mastectomy bra, or elect to wear a mastectomy garment that has the prosthesis already

inserted in it.

Prostheses can attach to the skin with a fabric backing and adhesive or may be worn unattached

with a mastectomy bra. Prefabricated prostheses come in various shapes, sizes and skin tones.

Custom-fabricated breast prostheses are custom-designed and special ordered for the individual,

based on an impression of the chest wall. In general, prefabricated prostheses can adequately

meet the external prosthetic needs of most individuals. Reusable external nipple prostheses are

available to cover flat or missing nipples.

U.S. Food and Drug Administration (FDA)

The FDA classifies external aesthetic restoration prostheses as Class I devices that are exempt

from premarket notification (FDA, 2023).

Federal Mandate

The Women’s Health and Cancer Rights Act of 1998 (WHCRA) was enacted as a federal mandate

in October 1998. The federal mandate defines coverage for breast reconstruction following

mastectomy as:

• reconstruction of the breast on which the mastectomy was performed

• surgery and reconstruction on the other breast to produce symmetrical appearance

• prostheses and treatment of physical complications in all stages of mastectomy, including

lymphedemas

Under this mandate, benefits for breast reconstruction services following mastectomy or

lumpectomy must be provided to both men and women; a diagnosis of breast cancer cannot be

required; and timing of breast reconstruction services is not a factor in coverage. In addition, the

mandate prohibits any limitations to the number of prostheses or the length of time from the date

of the mastectomy.

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Medical Coverage Policy: 0178

Medicare Coverage Determinations

Contractor

Determination Name/Number

Revision Effective

Date

NCD

National

Breast Reconstruction Following Mastectomy

(140.2)

1/1997

LCD

CGS

External Breast Prostheses (L33317)

1/2020

LCD

Novitas

Cosmetic and Reconstructive Surgery

(L35090)

7/2021

LCD

First Coast

Cosmetic and Reconstructive Surgery

(L38914)

7/2021

LCD

Palmetto

Cosmetic and Reconstructive Surgery

(L33428)

7/2021

LCD

Noridian

Plastic Surgery (L37020)

10/2019

Note: Please review the current Medicare Policy for the most up-to-date information.

(NCD = National Coverage Determination; LCD = Local Coverage Determination)

Appendix

Appendix A

Product

CPT

Code

HCPCS Code

Considered Medically Necessary

AlloDerm

15777

Q4116

AlloMax

™

15777

C1781, Q4100

Cortiva

™

15777

C9399,Q4100

Dermacell™

15777

Q4122

FlexHD

15777

Q4128

Considered Not Medically Necessary

ARTIA

™

Reconstructive Tissue Matrix

15777

C1763

Avance® Nerve Graft

64912, 64913

C9399, Q4100

BellaDerm

Acellular Hydrated Dermis

15777

C1781,

C9399,Q4100

Biodesign

Nipple Reconstruction Cylinder

19350

C1763

DermaMatrix Acellular Dermis

15777

C1781,

C9399,Q4100

DuraSorb

Monofilament Mesh/ Polydioxanone

Surgical Scaffold™

15777 C1781

GalaFLEX

Scaffold

15777

C1781,

C9399, Q4100

GalaFLEX 3DR Scaffold

15777

C1781,

C9399 Q4100

GalaFLEX 3D Scaffold

15777

C1781,

C9399,Q4100

Juvederm

19350, 11950

C9399

OviTex®

15777

C1781

Permacol

™

15777

C9364

Phasix

™

Mesh

15777

C1781

Radiesse

11950, 19350

Q2026

Renuva

Allograft Adipose Matrix

No specific code

J3590

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Medical Coverage Policy: 0178

SERI

™

Surgical Scaffold

15777

C1781,Q4100

SimpliDerm™

15777

C9399, Q4100

Strattice

™

Reconstructive Tissue Matrix

15777

Q4130

SurgiMend

Collagen Matrix

15777

C9358, C9360

Veritas Collagen Matrix

15777

C9354

Coding Information

Notes:

1. This list of codes may not be all-inclusive since the American Medical Association (AMA)

and Centers for Medicare & Medicaid Services (CMS) code updates may occur more

frequently than policy updates.

2. Deleted codes and codes which are not effective at the time the service is rendered may

not be eligible for reimbursement.

Breast Reconstruction

Considered Medically Necessary when criteria in the applicable policy statements listed

above are met:

CPT

Codes

Description

11920

Tattooing, intradermal introduction of insoluble opaque pigments to correct color

defects of skin, including micropigmentation; 6.0 sq cm or less

11921

Tattooing, intradermal introduction of insoluble opaque pigments to correct color

defects of skin, including micropigmentation; 6.1 to 20.0 sq cm

11970

Replacement of tissue expander with permanent implant

11971

Removal of tissue expander without insertion of implant

13100

Repair, complex, trunk; 1.1 cm to 2.5 cm

13101

Repair, complex, trunk; 2.6 cm to 7.5 cm

13102

Repair, complex, trunk; each additional 5 cm or less (List separately in addition to

code for primary procedure)

15734

Muscle, myocutaneous, or fasciocutaneous flap; trunk

15771

†

Grafting of autologous fat harvested by liposuction technique to trunk, breasts,

scalp, arms, and/or legs; 50 cc or less injectate

15772

†

Grafting of autologous fat harvested by liposuction technique to trunk, breasts,

scalp, arms, and/or legs; each additional 50 cc injectate, or part thereof (List

separately in addition to code for primary procedure)

15777

Implantation of biologic implant (eg, acellular dermal matrix) for soft tissue

reinforcement (eg, breast, trunk) (List separately in addition to code for primary

procedure)

19316

Mastopexy

19318

Breast reduction

19325

Breast augmentation with implant

19328

Removal of intact breast implant

19330

Removal of ruptured breast implant, including implant contents (eg, saline, silicone

gel)

19340

Insertion of breast implant on same day of mastectomy (ie, immediate)

19342

Insertion or replacement of breast implant on separate day from mastectomy

19350

††

Nipple/areola reconstruction

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CPT

Codes

Description

19357

Tissue expander placement in breast reconstruction, including subsequent

expansion(s)

19361

Breast reconstruction; with latissimus dorsi flap

19364

Breast reconstruction; with free flap (eg, fTRAM, DIEP, SIEA, GAP flap)

19367

Breast reconstruction; with single-pedicled transverse rectus abdominis

myocutaneous (TRAM) flap

19368

Breast reconstruction; with single-pedicled transverse rectus abdominis

myocutaneous (TRAM) flap, requiring separate microvascular anastomosis

(supercharging)

19369

Breast reconstruction; with bipedicled transverse rectus abdominis myocutaneous

(TRAM) flap

19370

Revision of peri-implant capsule, breast, including capsulotomy, capsulorrhaphy,

and/or partial capsulectomy

19371

Peri-implant capsulectomy, breast, complete, including removal of all intracapsular

contents

19380

Revision of reconstructed breast (eg, significant removal of tissue, re-advancement

and/or re-inset of flaps in autologous reconstruction or significant capsular revision

combined with soft tissue excision in implant-based reconstruction)

19499

†††

Unlisted procedure, breast

†

Note: Considered experimental/investigational/unproven when used to report

autologous fat transplantation using adipose-derived stem cells

††

Note: Considered Not Medically Necessary when used to report nipple reconstruction

with Juvederm, Radiesse, or Cook Biodesign® Nipple Reconstruction Cylinder.

†††

Note: Considered medically necessary when used to report thoracodorsal artery

perforator (TDAP) flap with a breast reconstruction procedure performed on the

diseased/affected breast. Considered experimental/investigational/unproven when

used to report adipose-derived stem cell autologous fat transplantation.

HCPCS

Codes

Description

C1789

Prosthesis, breast (implantable)

L8600

Implantable breast prosthesis, silicone or equal

S2066

Breast reconstruction with gluteal artery perforator (GAP) flap, including harvesting

of the flap, microvascular transfer, closure of donor site and shaping the flap into a

breast, unilateral

S2067

Breast reconstruction of a single breast with "stacked" deep inferior epigastric

perforator (DIEP) flap(s) and/or gluteal artery perforator (GAP) flap(s), including

harvesting of the flap(s), microvascular transfer, closure of donor site(s) and

shaping the flap into a breast, unilateral

S2068

Breast reconstruction with deep inferior epigastric perforator (DIEP) flap or

superficial inferior epigastric artery (SIEA) flap, including harvesting of the flap,

microvascular transfer, closure of donor site and shaping the flap into a breast,

unilateral

Not covered when used to report intraoperative assessment of tissue perfusion as it

considered integral to the primary procedure and not separately reimbursable:

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Medical Coverage Policy: 0178

CPT

Codes

Description

15860

Intravenous injection of agent (eg fluorescein) to test vascular flow in flap or graft

Considered Not Medically Necessary: /Cosmetic in nature when used to report

correction of surgically-induced donor site asymmetry or excess tissue that results from

flap breast reconstruction procedures. Considered incidental to the primary procedure

when used to report suction-assisted lipectomy of the trunk as part of a medically

necessary flap breast reconstruction procedure:

CPT

Codes

Description

15839

Excision, excessive skin and subcutaneous tissue (includes lipectomy); other area

15877

Suction assisted lipectomy; trunk

Skin/Tissue Substitutes/Fillers (see Appendix A)

Considered Medically Necessary when criteria in the applicable policy statements listed

above are met:

HCPCS

Codes

Description

Q4116

Alloderm, per square centimeter

Q4122

Dermacell, per square centimeter

Q4128

Flex hd or allopatch hd, or matrix hd per square centimeter

Considered Medically Necessary when used to report AlloMax

™

HCPCS

Codes

Description

C1781

Mesh (implantable)

Q4100

Skin substitute, not otherwise specified

Considered Medically Necessary when used to report Cortiva

™

HCPCS

Codes

Description

C9399

Unclassified drugs or biologicals

Q4100

Skin substitute, not otherwise specified

Considered Not Medically Necessary:

HCPCS

Codes

Description

C9354

Acellular pericardial tissue matrix of nonhuman origin (Veritas), per sq cm

C9358

Dermal substitute, native, nondenatured collagen, fetal bovine origin (SurgiMend

Collagen Matrix), per 0.5 sq cm

C9360

Dermal substitute, native, nondenatured collagen, neonatal bovine origin

(SurgiMend Collagen Matrix), per 0.5 sq cm

C9364

Porcine implant, Permacol, per sq cm

Q2026

Injection, Radiesse, 0.1 ml

Q4130

Strattice TM, per sq cm

Page 32 of 49

Medical Coverage Policy: 0178

Considered Not Medically Necessary when used to report ARTIA

™

Reconstructive Tissue

or Matrix, Biodesign® Nipple Reconstruction Cylinder:

HCPCS

Codes

Description

C1763

Connective tissue, nonhuman (includes synthetic)

Considered Not Medically Necessary when used to report when used to report Phasix

Mesh and OviTex®:

HCPCS

Codes

Description

C1781

Mesh (implantable)

Considered Not Medically Necessary when used to report BellaDerm® Acellular

Hydrated Dermis, DermaMatrix Acellular Dermis, GalaFLEX® Scaffold, GalaFLEX 3DR

Scaffold, GalaFLEX 3D Scaffold:

HCPCS

Codes

Description

C1781

Mesh (implantable)

C9399

Unclassified drugs or biologicals

Q4100

Skin substitute, not otherwise specified

Considered Not Medically Necessary when used to report SERI™ Surgical Scaffold:

HCPCS

Codes

Description

C1781

Mesh (implantable)

Q4100

Skin substitute, not otherwise specified

Considered Not Medically Necessary when used to report Juvederm:

HCPCS

Codes

Description

C9399

Unclassified drugs or biologicals

Considered Not Medically Necessary when used to report Avance® Nerve Graft and

SimpliDerm™:

HCPCS

Codes

Description

C9399

Unclassified drugs or biologicals

Q4100

Skin substitute, not otherwise specified

Experimental/Investigational/Unproven when used to report the injection of a non-

covered product listed in the policy statement above or when used to report autologous

fat transplant using adipose-derived stem cells or xenograft cartilage grafting:

Page 33 of 49

Medical Coverage Policy: 0178

CPT

Codes

Description

11950

Subcutaneous injection of filling material (eg, collagen); 1 cc or less

11951

Subcutaneous injection of filling material (eg, collagen); 1.1 to 5.0 cc

11952

Subcutaneous injection of filling material (eg, collagen); 5.1 to 10.0 cc

11954

Subcutaneous injection of filling material (eg, collagen); over 10.0 cc

Considered Not Medically Necessary when used to report Biodesign

Nipple

Reconstruction Cylinder:

HCPCS

Codes

Description

C1763

Connective tissue, non-human (includes synthetic)

Considered Not Medically Necessary when used to report ARTIA

™

Reconstructive Tissue

Matrix, BellaDerm

Acellular Hydrated Dermis, DermaMatrix Aceullular Dermis,

GalaFLEX

Surgical Scaffold, GalaFORM

™

3D, Juvederm

, Phasix

™

Mesh, or SERI

™

Surgical Scaffold:

HCPCS

Codes

Description

C1781

Mesh (implantable)

C9399

Unclassified drugs or biologicals

Q4100

Skin substitute, not otherwise specified

Considered Not Medically Necessary when used to report Renuva

Allograft Adipose

Matrix:

HCPCS

Codes

Description

J3590

Unclassified biologics

Considered Not Medically Necessary when used to report Strattice

™

HCPCS

Codes

Description

Q4130

Strattice

™

, per square centimeter

Experimental/Investigational/Unproven when used to report breast reconstruction

procedures using adipose-derived stem cells in autologous fat transplantation or

xenograft cartilage grafting:

CPT

Codes

Description

19366

Breast reconstruction with other technique

19499

Unlisted procedure, breast

Cosmetic in nature/Not Medically Necessary when used to report correction of

surgically induced donor site asymmetry that results from flap breast reconstruction

procedures:

Page 34 of 49

Medical Coverage Policy: 0178

CPT

Codes

Description

15877

†††††

Suction assisted lipectomy; trunk

15879

†††††

Suction assisted lipectomy; lower extremity

†††††

Note: Considered incidental to the primary procedure when used to report suction-

assisted lipectomy of the trunk as part of a medically necessary flap breast

reconstruction procedure

External Breast Prostheses and Mastectomy Bras Following Mastectomy or Lumpectomy

Considered Medically Necessary when criteria in the applicable policy statements listed

above are met:

HCPCS

Codes

Description

L8000

Breast prosthesis; mastectomy bra, without integrated breast prosthesis form, any

size, any type

L8001

Breast prosthesis, mastectomy bra, with integrated breast prosthesis form,

unilateral, any size, any type

L8002

Breast prosthesis, mastectomy bra, with integrated breast prosthesis form,

bilateral, any size, any type

L8015

External breast prosthesis garment, with mastectomy form, post mastectomy

L8020

Breast prosthesis, mastectomy form

L8030

Breast prosthesis, silicone or equal, without integral adhesive

L8031

Breast prosthesis, silicone or equal, with integral adhesive

L8032

Nipple prosthesis, prefabricated, reusable, any type, each

L8033

Nipple prosthesis, custom fabricated, reusable, any material, any type, each

L8035

Custom breast prosthesis, post mastectomy, molded to patient model

L8039

Breast prosthesis, not otherwise specified

*Current Procedural Terminology (CPT

Chicago, IL.

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60.

Revision Details

Type of Revision

Summary of Changes

Date

Annual Review

• Revised policy statement for areolar and

nipple reconstruction.

• Added policy statement for “flat closure

chest wall reconstruction”.

• Revised policy statement for oncoplastic

reconstruction.

• Added policy statement for “DuraSorb®

Monofilament Mesh/ Polydioxanone Surgical

Scaffold™” to the list of EIU products.

• Removed policy statement for hMatrix and

Repriza.

• Revised policy statement for lipectomy or

excision of redundant skin statement.

3/15/2024

Page 49 of 49

Medical Coverage Policy: 0178

“Cigna Companies” refers to operating subsidiaries of The Cigna Group. All products and services

are provided exclusively by or through such operating subsidiaries, including Cigna Health and Life

Insurance Company, Connecticut General Life Insurance Company, Evernorth Behavioral Health,

Inc., Cigna Health Management, Inc., and HMO or service company subsidiaries of The Cigna