Medical policy: Reconstructive Breast Surgery Including Management of Breast Implants, External Breast Prosthesis and Post Mastectomy Bras

Policy number: MP 1.103

Effective date: 4/1/2026

Policy

Augmentation mammoplasty may be considered reconstructive and medically necessary when there is documented clinical evidence of one of the following:

• Surgery for benign disease when a subcutaneous mastectomy is performed with immediate or delayed prosthesis; OR
• Following previous mastectomy for benign or malignant disease including the unaffected breast to provide symmetry with the breast on which the radical or modified radical mastectomy was performed. (Act 51 of 1997); OR
• Unilateral or bilateral breast aplasia; OR
• Unilateral breast hypoplasia with significant breast asymmetry when associated with abnormalities of the chest wall. Examples include, but are not limited to, Poland syndrome, Jeune syndrome, pectus excavatum, pectus carinatum, or trauma; OR
• Gender affirmation in accord with MP 1.144 Gender Affirming Surgery

Augmentation mammoplasty performed for any other reason is considered cosmetic and is investigational as there is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure.

Reconstruction may be performed by an implant-based approach or through the use of autologous tissue.

Explantation of a silicone gel-filled breast implant may be considered medically necessary for any of the following indications:

• Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL);
• Documented implant rupture;
• Infection;
• Extrusion;
• Baker Class IV contracture; or
• As adjunct to current surgical treatment of breast cancer

Explantation of a saline-filled breast implant may be considered medically necessary for any of the following indications:

• Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL);
• Infection;
• Extrusion;
• Baker Class IV contracture;
• As adjunct to current surgical treatment of breast cancer;
• A ruptured implant if the original breast implantation was for reconstructive purposes; or
• A ruptured implant if a recalled textured product

Explantation of a breast implant associated with a Baker Class III contracture may be considered medically necessary only in those individuals who had originally undergone breast implantation for reconstructive purposes.

Reconstructive breast surgery after explantation of an implant may be considered medically necessary only in those patients who had originally undergone breast implantation for reconstructive purposes.

Mastopexy or reduction mammoplasty may be considered reconstructive and medically necessary only when performed on the unaffected breast following previous mastectomy when the purpose is to provide symmetry with the breast on which the mastectomy has been performed.

The use of adipose-derived stem cells, alone or in conjunction with autologous fat grafting for reconstructive breast surgery, is considered investigational as there is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure.

Individuals who have originally undergone implantation of a cosmetic breast implant are not candidates for additional reconstructive surgery or replacement implantation following surgery.

The following indications for explantation of implants are considered investigational as there is insufficient evidence concerning the health outcomes or benefits associated with this procedure:

• Systemic symptoms, attributed to connective tissue diseases, autoimmune diseases;
• Anxiety;
• Baker class III contractures in individuals with implants for cosmetic purposes;
• Rupture of a saline implant in individuals with implants for cosmetic purposes;
• Pain not related to contractures;
• Preventive explantation in asymptomatic individuals to reduce remote risk of anaplastic large cell lymphoma;
• Preventive explantation in asymptomatic individuals to reduce remote risk of B cell lymphoma

External breast prosthesis/post-mastectomy bras

Two (2) to four (4) post-mastectomy bras are considered medically necessary and may be replaced once every 12 months. A maximum of four bras may be provided within a rolling 12-month period.

External breast prosthetic devices are considered medically necessary for a patient who has had a mastectomy.

One (1) off-the-shelf breast prosthesis and one (1) custom fabricated breast prosthesis, per affected side, is considered medically necessary following a mastectomy for the useful lifetime of the prostheses. Custom-fabricated breast prosthetic devices are considered medically necessary following a mastectomy when ordered by the patient’s physician.

For purposes of this medical policy, “useful lifetime” means two (2) years for silicone breast prostheses, and six (6) months for foam breast forms.

Subsequent replacement(s) of a prosthetic device is considered medically necessary when its useful life has passed, when it becomes damaged or when there is a change in the medical condition. Reference MP 6.026 Durable Medical Equipment and Supplies for information regarding repair, adjustment or replacement.

Policy guidelines

Application of the above policy regarding explantation of implants requires documentation of the original indication for implantation and the type of implant, either saline- or silicone gel- filled, and the current symptoms, either local or systemic. The following chart should facilitate determination of the medical necessity of explantation. Yes indicates that the explantation would be considered medically necessary, given the symptoms, type of implant, and original indication for implantation.

Indication/Type of implant

*Rupture of implants requires documentation with an imaging study, such as mammography, magnetic resonance imaging, or ultrasonography. Lack of imaging confirmation of rupture in association with persistent local symptoms is considered case by case.

** Pain as an isolated symptom is an inadequate indication for explantation. The pain should be related to the Baker classification or a diagnosis of rupture.

Cross-references

• MP 1.004 Cosmetic and Reconstructive Surgery
• MP 1.013 Reduction Mammoplasty for Breast-Related Symptoms
• MP 1.036 Risk Reducing Mastectomy and Bilateral or Salpingo-Oophorectomy
• MP 1.144 Gender Affirming Surgery
• MP 1.158 Bio-Engineered Skin, Soft Tissue Substitutes and Amniotic Membranes
• MP 6.026 Durable Medical Equipment and Supplies

Product variations

This policy is only applicable to certain programs and products administered by Capital Blue Cross and subject to benefit variations. Please see additional information below.

FEP PPO - Refer to FEP Medical Policy Manual.

Description/background

Reconstructive breast surgery

Reconstructive breast surgery is defined as a surgical procedure that is designed to restore the normal appearance of the breast after surgery, accidental injury, or trauma. Breast reconstruction is distinguished from purely cosmetic procedures by the presence of a medical condition, e.g., breast cancer or trauma, which leads to the need for breast reconstruction.

The most common indication for reconstructive breast surgery is a prior mastectomy; in fact, benefits for reconstructive breast surgery in these individuals are a mandated benefit in many states. In contrast, cosmetic breast surgery is defined as surgery designed to alter or enhance the appearance of a breast that has not undergone surgery, accidental injury, or trauma. Reduction mammoplasty is a common example of cosmetic breast surgery, but surgery to alter the appearance of a congenital abnormality of the breasts, such as tubular breasts, would also be considered cosmetic in nature.

This policy describes different types of reconstructive breast surgery and reviews the evidence on efficacy for the different approaches. It also establishes criteria for the explantation of breast implants based on indication, whether the original implant was cosmetic or reconstructive in nature, and whether the implant is silicone gel-filled or saline-filled.

Augmentation mammoplasty is the surgical enlargement of the breast, either to increase breast size or to replace a full or partial breast that has surgically been removed or congenitally absent. Surgeries are designed to restore the normal appearance of the breast. The augmentation is done by utilizing autogenous tissue such as a muscle flap graft or by inserting a gel or saline filled prosthesis.

Fat grafting to the breast

Following a mastectomy, patients often experience pain and irradiated skin; as an adjunct to reconstructive breast surgery, surgeons will sometimes graft autologous fat to the breast. Adipose-derived stem cells (ADSCs) have been proposed as a supplement to the fat graft in an attempt to improve graft survival; however, whether ADSCs play a role in tumorigenesis is still relatively unknown. Autologous fat grafting is a procedure where the patient’s fat cells are collected from other parts of the body, processed, and then reinserted into the breast area. Autologous fat grafting to the breast has been proposed for indications that include breast augmentation following oncologic surgery. Grafting would be performed as an adjunct to reconstruction after mastectomy or lumpectomy, and it would be of benefit in the following areas: for contouring purposes, improving breast shape and volume; and for alleviating post-mastectomy syndrome (neuropathic pain) and irradiated skin (thereby reducing complication and failure rates of implant reconstruction). Variability in long-term results and oncologic concerns have limited application of autologous fat grafting in the breast.

Adipose-derived stem cells

Stem cell biology and the related field of regenerative medicine involve multipotent stem cells that exist within a variety of tissues, including bone marrow and adipose tissue. A single gram of adipose tissue yields approximately 5000 stem cells; this is 100 to 500 times the number of mesenchymal stem cells found in an equivalent amount of bone marrow. Stem cells, because of their pluripotentiality and unlimited capacity for self-renewal, offer promise for tissue engineering and advances in reconstructive procedures. In particular, adipose tissue represents an abundant and easily accessible source of adipose-derived stem cells (ADSCs), which can differentiate along multiple mesodermal lineages. ADSCs may allow for improved graft survival and the generation of new fat tissue after transfer from another site.

The potentially therapeutic properties of ADSC have led to novel techniques of fat grafting in conjunction with ADSC therapy for breast fat grafting. Differentiation of ADSC into adipocytes may provide a reservoir for adipose tissue turnover. Differentiation of ADSC into endothelial cells, with the release of angiogenic growth factors by ADSC, may decrease the rate of graft resorption by increasing blood supply to the grafted fat tissue. Further, ADSC may serve to accelerate wound healing and protect the graft from ischemia reperfusion injury. Current methods for isolating ADSC can involve various processes, which may include centrifugation and enzymatic techniques that rely on collagenase digestion, which in turn is followed by centrifugal separation to isolate the stem cells from primary adipocytes. Isolated ADSCs can be expanded in a monolayer on standard tissue culture plastic surfaces with a basal medium containing 10% fetal bovine serum. Newly developed culture conditions provide an environment in which the study of ADSCs can be done without the interference of animal serum and may also allow rapid expansion of autologous ADSCs in culture for use in human clinical trials. A standard expansion method has not yet been established.

To address the problems of unpredictability and low rates of fat graft survival, Yoshimura et al. (2008) developed a technique known as cell-assisted lipotransfer, which produces autogenous fat rich in ADSCs. In cell-assisted lipotransfer, half of the lipoaspirate is centrifuged to obtain a fraction of concentrated ADSCs; meanwhile, the other half is washed, enzymatically digested, filtered, and spun down to an ADSC-rich pellet. The latter is then mixed with the former, converting a relatively ADSC-poor aspirated fat to ADSC-rich fat.

A point-of-care system is available for concentrating ADSC from mature fat. The Celution™ System is designed to transfer a patient’s adipose tissue from one part of the body to another in the same surgical procedure.

External breast prosthesis

External Breast Prosthesis is an artificial breast either worn inside a bra or attached directly to the chest wall after breast surgery. Mastectomy bras are designed with a pocket to hold a prosthesis, or the prosthesis is assimilated into the bra itself. Manufacturers make a wide selection of types, shapes, sizes, and colors. They may be made from silicone gel, foam, fiberfill, or other materials that yield similar to natural tissue. They can be asymmetrical (designed only for the left or right side) or symmetrical (designed to be used on either side). A custom fabricated prosthesis is molded specifically to the patient’s chest by making an impression of the chest wall. In general, prefabricated prostheses can adequately meet the external prosthetic needs of most patients.

Regulatory status

In July 2019, Allergan voluntarily recalled Natrelle Biocell textured breast implants and tissue expanders from the market. The recall notice stated, “Allergan is taking this action as a precaution following notification of recently updated global safety information concerning the uncommon incidence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) provided by the U.S. Food and Drug Administration (FDA). Smooth surfaced implants are not affected by this recall.” FDA and other health authorities have not recommended removal or replacement of textured breast implants or tissue expanders in asymptomatic individuals.

In October 2021, FDA issued additional orders restricting the sale and distribution of breast implants. The orders required new labeling including a boxed warning, a patient decision checklist, updated silicone gel-filled breast implant rupture screening recommendations, a device description with a list of specific materials used in the device, and a patient device card.

FDA recommended that the boxed warning includes the following components:

• Breast implants are not considered lifetime devices;
• The chance of developing complications increases over time;
• Breast implants have been associated with the development of a cancer of the immune system called BIA-ALCL;
• BIA-ALCL occurs more commonly in patients with textured breast implants than smooth implants and deaths have occurred from BIA-ALCL; and
• Breast implants have been associated with systemic symptoms.

The orders apply to the following devices:

• IDEAL IMPLANT Structured Saline Breast Implants
• Mentor Saline-Filled and Spectrum Breast Implants
• Inamed (now Allergan) Natrelle Saline Filled Breast Implants
• Inamed (now Allergan) Natrelle Silicone Filled Breast Implants
• Mentor MemoryShape Silicone Gel-Filled Breast Implants
• Mentor MemoryGel Silicone Gel-Filled Breast Implants
• Sientra OPUS Silicone Gel Breast Implants

In September 2006, Celution Cell Concentration System (Cytori Therapeutics; San Diego, CA) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process as a cell saver device. The system is cleared for the collection, concentration, washing, and reinfusion of a patient’s cells for applications that may include, but are not limited to, cardiovascular, plastic and reconstructive, orthopedic, vascular, and urologic surgeries and procedures. In 2007, Cytori Therapeutics received the FDA 510(k) clearance to market the Autologous Fat Transfer system, which transfers a patient’s own adipose tissue from one part of the patient’s body to another.

FDA product code: CAC

Rationale

Summary of evidence

For individuals who have undergone breast surgery or who have experienced injury or trauma to the breast who receive breast reconstruction surgery, the evidence includes case series. Relevant outcomes are overall survival, disease-specific survival, morbid events, functional outcomes, health status measures, quality of life, treatment-related mortality, and treatment- related morbidity. The evidence supports the conclusion that breast reconstruction improves psychosocial outcomes, such as anxiety, social functioning, and perception of body image. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with breast implants and documented implant rupture, infection, extrusion, Baker contracture, or surgical treatment of breast cancer who receive breast implant explantation the evidence includes case series. Relevant outcomes are overall survival, disease-specific survival, morbid events, functional outcomes, health status measures, quality of life, treatment-related mortality, and treatment-related morbidity. Local complications of breast implants are common and may require explantation. The medical necessity of implant explantation is dependent on the type of implant, the indication for removal, and the original indication for implantation. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For asymptomatic individuals with breast implants without documented implant rupture, infection, extrusion, Baker contracture, or surgical treatment of breast cancer who receive preventive breast implant explantation to reduce remote risk of anaplastic large cell lymphoma (ALCL), the evidence includes prospective and retrospective epidemiological cohort studies, case series, and systematic reviews. Relevant outcomes are overall survival, disease-specific survival, morbid events, functional outcomes, health status measures, quality of life, treatment-related mortality, and treatment-related morbidity. Systematic reviews of epidemiological studies and government regulatory epidemiological databases have evaluated the risk of breast implant- associated ALCL (BIA-ALCL). Estimates varied widely, with the highest incidence associated with textured implant products that are no longer marketed in the United States. The certainty of the evidence is limited by insufficient follow-up duration to assess risk and lack of standardization of clinical outcome data collection. Additionally, there is no evidence evaluating whether removal of implants reduces ALCL risk, and there are known risks of explantation surgery. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with breast implants without documented implant rupture, infection, extrusion, Baker contracture, or surgical treatment of breast cancer who receive preventive breast implant explantation to reduce remote risk of B cell lymphoma, the evidence includes case reports. Relevant outcomes are overall survival, disease-specific survival, morbid events, functional outcomes, health status measures, quality of life, treatment-related mortality, and treatment-related morbidity. Recent case reports and small case series (N=3 to 8 cases) have described B cell lymphomas occurring in individuals with breast implants. More data are needed to determine if breast implants are associated with an increased risk of B cell lymphoma. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have breast cancer who receive autologous fat grafting to the breast with ADSC enrichment of the graft, the evidence includes small single-arm studies, some of which are retrospective. Relevant outcomes are symptoms, morbid events, functional outcomes, quality of life, resource utilization, and treatment-related morbidity. The observational studies were heterogeneous in the patient selection, methods in harvesting stem cells, number of procedures, and outcomes measured. Studies have mainly reported patient and investigator satisfaction and cosmetic results. One small, prospective study found that use of ADSC enrichment with autologous fat grafting was superior to autologous fat grafting alone by improving the retention rate of fat graft postoperatively at 6 and 12 months. Larger clinical trials are needed to confirm this benefit. Limitations of the data include small sample sizes, short-term follow-up, and uncertainty about the possible oncologic influence ADSC may have on the fat grafting procedure. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Disclaimer

Capital Blue Cross’ medical policies are used to determine coverage for specific medical technologies, procedures, equipment, and services. These medical policies do not constitute medical advice and are subject to change as permitted by law or applicable clinical evidence from independent treatment guidelines. Treating providers are solely responsible for medical advice and treatment of members. These policies are not a guarantee of coverage or payment. Payment of claims is subject to a determination regarding the member’s benefit program and eligibility on the date of service, and a determination that the services are medically necessary and appropriate. Final processing of a claim is based upon the terms of contract that applies to the member’s benefit program, including benefit limitations and exclusions. If a provider or a member has a question concerning this medical policy, please contact Capital Blue Cross’ Provider Services or Member Services.

Coding information

Note: This list of codes may not be all-inclusive, and codes are subject to change at any time. The identification of a code in this section does not denote coverage as coverage is determined by the terms of member benefit information. In addition, not all covered services are eligible for separate reimbursement.

Covered when medically necessary

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