Medical Policy

This document addresses the following three areas: reconstructive breast surgery, cosmetic surgeries designed to enhance the appearance of the breast, and management of breast implants. Breast implant management includes conditions such as Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) and Breast Implant-Associated Squamous Cell Carcinoma (BIA-SCC).

Reconstructive breast surgery refers to surgical procedures to rebuild the contour of the breast, along with the nipple and areola if desired. Typically, breast reconstruction is performed following a mastectomy (that is, the breast has been removed because of breast cancer) or lumpectomy (that is, removal of the breast tumor and tissue surrounding it), but occasionally techniques of breast reconstruction are used to treat individuals who have an abnormal development of one or both breasts.

Note: Please see the following related document(s) for additional information:

• SURG.00011 Products for Wound Healing and Soft Tissue Grafting: Investigational
• CG-SURG-71 Reduction Mammaplasty
• CG-SURG-127 Products for Wound Healing and Soft Tissue Grafting: Medically Necessary Uses

Note: This document does not address gender affirming surgery or procedures. Criteria for gender affirming surgery or procedures are found in applicable guidelines used by the plan.

Note: For autologous fat grafting and other soft tissue augmentation procedures of the breast see:

• CG-SURG-123 Autologous Fat Grafting and Injectable Soft Tissue Fillers
• MED.00132 Autologous Adipose-derived Regenerative Cell Therapy

Note: The Women’s Health and Cancer Rights Act of 1998 (WHCRA) is federal legislation that provides that any individual with insurance coverage who is receiving benefits in connection with a mastectomy covered by their benefit plan (whether or not for cancer) who elects breast reconstruction, must receive coverage for the reconstructive services as provided by WHCRA. This includes reconstruction of the breast on which the mastectomy has been performed, surgery and reconstruction of the other breast to produce a symmetrical appearance and prostheses and treatment of physical complications of all stages of the mastectomy including lymphedema. If additional surgery is required for either breast for treatment of physical complications of the implant or reconstruction, surgery on the other breast to produce a symmetrical appearance is reconstructive at that point as well. The name of this law is misleading because: 1) cancer does not have to be the reason for the mastectomy; and 2) the mandate applies to all individuals regardless of gender. WHCRA does not address lumpectomies. Some states have enacted similar legislation, and some states include mandated benefits for reconstructive services after lumpectomy (WHCRA, 1998).

Medically Necessary: In this document, procedures are considered medically necessary if there is a significant functional impairment, and the procedure can be reasonably expected to improve the functional impairment.

Reconstructive: In this document, procedures are considered reconstructive when intended to address a significant variation from normal related to accidental injury, disease, trauma, treatment of a disease or congenital defect.

Note: Not all benefit contracts include benefits for reconstructive services as defined by this document. Benefit language supersedes this document.

Cosmetic: In this document, procedures are considered cosmetic when intended to change a physical appearance that would be considered within normal human anatomic variation. Cosmetic services are often described as those that are primarily intended to preserve or improve appearance.

Note: For a high-level overview of this document, please see Summary for Members and Families below.

Medically Necessary:

Removal of implants partially or completely filled with Silicone Gel is considered medically necessary when there is documented implant rupture (that is, using mammography, ultrasound, or MRI).

Removal of a Silicone Gel filled, Saline filled or “Alternative” implant is considered medically necessary for any of the following:

1. Infection of the implant or surrounding tissue; or
2. Implant exposure/extrusion; or
3. Pain related to Baker Class IV capsular contracture; or
4. Confirmed cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) or breast implant-associated squamous cell carcinoma (BIA-SCC); or
5. Elective removal in individuals with an increased risk of BIA-ALCL due to any of the following:
   1. Use of Allergan BIOCELL textured breast implants and tissue expanders; or
   2. Presence of a germline BRCA1 or BRCA2 pathogenic variant in an individual who underwent breast reconstruction using a textured breast implant after mastectomy performed for breast cancer; or
6. Prior to surgical treatment of breast cancer. (Note: Implant explantation is routinely performed at the time of mastectomy. In individuals treated with breast-conserving surgery [that is, lumpectomy], a breast implant may or may not interfere with subsequent treatment, and thus explantation at the time of lumpectomy is at the discretion of the treating physician and the treated individual).

Reconstructive:

Breast surgery is considered reconstructive to rebuild the normal contour of the affected and the contralateral unaffected breast to produce a more normal appearance following a mastectomy, lumpectomy, or other breast surgery for breast cancer.

Surgical procedures, such as reduction mammaplasty, may be considered reconstructive when done in advance of mastectomy or lumpectomy for breast cancer treatment or breast cancer risk-reduction in order to produce improved cosmesis and prevent postoperative complications.

Breast surgery of both breasts is considered reconstructive following the mastectomy of both breasts.

Breast surgery to alter the contour of the breast is considered reconstructive when there are significant abnormalities related to trauma, congenital defects, infection or other non-malignant disease. A specific example of this is Poland syndrome which may be diagnosed when all of the following are present:

1. Congenital absence or hypoplasia of pectoralis major and minor muscles; and
2. Breast hypoplasia; and
3. Congenital partial absence of the upper costal cartilage.

Removal of an implant (any type) with or without reimplantation is considered reconstructive when:

1. An implant, originally placed in an individual with a history of mastectomy, lumpectomy or treatment of breast cancer for reconstructive purposes as defined above; and
2. There has been development of a visible distortion (Baker Class III contracture).

Removal of a ruptured saline-filled or “Alternative” implant with or without reimplantation is considered reconstructive when originally placed in an individual with a history of mastectomy, lumpectomy or treatment of breast cancer for reconstructive purposes, as defined above.

Surgery on the contralateral breast to produce a symmetrical appearance after removal of an implant and reimplantation is considered reconstructive when the implant was originally placed for reconstructive purposes in an individual with a history of mastectomy, lumpectomy or treatment of breast cancer.

Not Medically Necessary:

Removal of a ruptured saline-filled or “Alternative” implant is considered not medically necessary since the potential adverse medical consequences of implant rupture are related to silicone gel implants only.

Removal of ANY TYPE of breast implant is considered not medically necessary for any of the following:

1. Systemic symptoms attributed to connective tissue disease, autoimmune diseases, etc.; or
2. Personal anxiety; or
3. Pain not related to contractures or rupture; or
4. The medically necessary or reconstructive criteria listed above have not been met.

Cosmetic and Not Medically Necessary:

Reimplantation of an implant inserted for cosmetic purposes only (that is, for reasons other than a history of mastectomy, lumpectomy, treatment of breast cancer, significant abnormalities related to trauma, congenital defects, infection or other non-malignant disease) and removed as part of a medically necessary or reconstructive surgery (see above) is considered cosmetic and not medically necessary.

Other breast procedures, (including augmentation mammaplasty/breast lift, implant repositioning, repair of inverted nipples, mastopexy) are considered cosmetic and not medically necessary except when performed as part of a covered breast reconstruction service.

This document describes clinical studies and expert recommendations, and explains when breast implant removal, breast rebuilding after surgery, and other breast procedures are clinically appropriate. The following summary does not replace the criteria or other information in this document. The summary may not contain all of the relevant criteria or information. This summary is not medical advice. Please check with your healthcare provider for any advice about your health.

Key Information

This document covers breast implant removal, breast restoration after surgery, and other breast procedures. Whether a service is clinically appropriate depends on the reason for the procedure, the type of implant, and the person’s health history.

What the Studies Show

Breast implants can cause problems over time. Some of these problems may require the implant to be taken out.

Silicone gel implants can break open. This is called a rupture. When this happens, silicone can spread to nearby tissues. Studies show that a broken silicone implant should be removed. Saline implants are filled with salt water. If a saline implant breaks, the salt water is absorbed by the body. This does not cause the same health risks.

Silicone or saline breast implants should be removed if certain problems occur. These include infection in the implant or nearby tissue, the implant breaking through the skin, or severe pain from hard scar tissue around the implant. Implants may also be removed before breast cancer surgery. They are usually taken out at the time of mastectomy. For people having a lumpectomy, the implant may or may not need to be removed, depending on whether it affects treatment, and this decision is made by the doctor and the individual together.

Removal is also recommended in confirmed cases of breast implant-associated cancer (anaplastic large cell lymphoma [BIA-ALCL] or squamous cell cancer of the breast). Breast implants with a rough surface (called textured implants) have been linked to a very rare type of cancer, although the risk is considered very low.

One brand of textured implant was recalled in 2019. The brand is Allergan BIOCELL. The recall was due to a higher risk of the cancer described above. People who still have this implant may choose to have it removed, even without symptoms.

Some people carry gene changes called BRCA1 or BRCA2. These gene changes increase the risk of breast cancer. Studies show that people with these gene changes who had a textured implant placed after breast cancer surgery face a higher risk of BIA-ALCL. One large study found they were about 15 times more likely to develop BIA-ALCL. A second study in a different country found a similar pattern.

Some people with breast implants develop symptoms throughout their body. These include joint pain, brain fog, tiredness, or immune system problems. Studies have looked at this closely. Some changes in the immune system have been found in people with implants. But no study has shown that these changes cause disease or symptoms. Better studies are needed to know if removing implants helps with these concerns.

After breast cancer surgery, the breast can be rebuilt. This can be done with implants, tissue from another part of the body, or both. Studies show that all of these methods can give good results. If radiation treatment is also needed, it can raise the chance of problems with implants. It does not raise the chance of problems when body tissue is used instead.

Some people choose not to rebuild the breast. This is called flat chest closure. Studies show that most people who choose this option are happy with the result. A small number later choose to have the breast rebuilt.

Surgery to reshape the breast may be covered when it is needed to correct a clear medical problem, such as changes caused by injury, a condition present at birth, infection, or another non-cancer illness. One example is Poland syndrome, a rare condition present at birth. It may be diagnosed when a person has underdeveloped or missing chest muscles, a smaller or underdeveloped breast on the same side, and partial absence of the upper rib cartilage.

All breast procedures carry some risks. These include infection, bleeding, scarring, and the need for more surgery. Implants can harden over time. Each type of procedure has its own risks. A healthcare provider can explain these in more detail.

When Are These Services Clinically Appropriate?

Removing a breast implant may be clinically appropriate when any of the following is true:

• A silicone gel implant has broken open. This must be shown on imaging, such as ultrasound or magnetic resonance imaging (MRI).
• The implant area is infected.
• The implant is pushing through or showing through the skin.
• The tissue around the implant has become very hard and painful. This is called Baker Class IV contracture.
• Cancer has been found in the tissue around the implant. This includes anaplastic large cell lymphoma or squamous cell carcinoma.
• The person has a recalled Allergan BIOCELL textured implant.
• The person has a BRCA1 or BRCA2 gene change and had a textured implant placed after breast cancer surgery.
• The implant needs to come out before breast cancer treatment.

Rebuilding the breast after cancer surgery is clinically appropriate. Options include a new implant, body tissue transfer, surgery on the other breast to match, or flat chest closure.

Rebuilding may also be clinically appropriate for people born with certain chest or breast differences, such as Poland syndrome.

An implant placed after breast cancer surgery may be removed or replaced if the tissue around it has hardened enough to change the breast shape. This is called Baker Class III contracture.

When Are These Services Not Clinically Appropriate?

Removing a breast implant is not clinically appropriate for:

• Body-wide symptoms blamed on the implant, such as joint pain, tiredness, or immune system problems. Studies have not shown that removal helps with these symptoms. Having a procedure that does not help can lead to needless worry or more treatment that is not needed.
• Worry or fear about the implant, without a medical problem.
• Pain that is not caused by hardening or a broken implant.

A broken saline or combination implant does not need to be removed for health reasons alone. Salt water does not cause the same risks as silicone gel. But if the implant was placed after breast cancer surgery, removal may still be clinically appropriate.

Breast procedures done only to change the look of a healthy breast are not clinically appropriate. This includes making the breast larger, lifting it, or changing the nipple shape. These may be clinically appropriate only when they are part of a covered breast reconstruction service.

(Return to Description/Scope)

Summary

The evidence supports a clear distinction between implant procedures performed for clinically significant complications, procedures performed to restore breast form after disease or deformity, and procedures performed primarily for aesthetic preference. Implant removal is strongly supported when there is silicone gel rupture, infection, extrusion, severe capsular contracture, implant-associated malignancy, or other findings that create meaningful clinical risk, pain, distortion, or functional interference. Restorative breast surgery is supported when needed to reestablish breast contour or symmetry after mastectomy, medically indicated lumpectomy, trauma, congenital anomaly, infection-related deformity, or failure of a prior reconstructive implant to achieve its intended result. In contrast, implant removal or replacement undertaken mainly to change appearance after cosmetic augmentation, without a defined clinical or restorative indication, is not supported by the evidence as treatment for disease or functional impairment.

Discussion

Regulatory and Legislative Framework

The Women’s Health and Cancer Rights Act of 1998 (WHCRA) mandated that reconstructive breast surgery for individuals who have undergone mastectomy be covered for those who have opted to have breast reconstruction. In individuals who have undergone a medically necessary lumpectomy, surgery to create a more normal anatomy is considered reconstructive.

Capsular Contracture

Contracture is the most common local complication of breast implants. Contractures are graded according to the Baker Classification:

Grade I: Augmented breast feels as soft as a normal breast.
Grade II: Breast is less soft and the implant can be palpated but is not visible.
Grade III: Breast is firm, palpable, and the implant (or its distortion) is visible.
Grade IV: Breast is hard, painful, cold, tender, and distorted.

Grade IV contractures interfere with adequate mammography screening and their presence has potential medical implications; therefore, removal may be considered medically necessary. Grade III contractures do not interfere with mammography and are not considered an absolute indication for removal. However, since Grade III contractures have an impact on the normal appearance of the breast, removal may be appropriate for implants originally placed for reconstructive purposes, since the goal of restoration of normal appearance is not achieved (Baker, 1978).

A national register-based study using the Swedish Breast Implant Register identified severe capsular contracture requiring surgical intervention in 39 of 1095 breast reconstructions (3.6%) following risk-reducing mastectomy, with a cumulative incidence of 4.7% at 5 years. Eighty-two percent of contractures occurred within 2 years. Permanent tissue expanders carried a substantially higher risk of contracture than permanent fixed-volume implants (cumulative incidence at 5 years: 10.8% vs. 1.7%; adjusted hazard ratio [HR], 19.33; 95% confidence interval [CI], 3.92 to 95.43; p<0.001). No significant associations were found between capsular contracture and implant surface, placement, shape, volume, body mass index, drain use, acellular dermal matrix use, and staged versus single-stage approach, although these findings may be limited by sample size and model constraints (Hägglund, 2025).

In a retrospective per-breast analysis of 212 individuals (386 implant insertions) undergoing primary cosmetic breast augmentation with silicone implants, capsular contracture occurred in 31 of 386 insertions (8.0%). Independent predictors included smoking (odds ratio [OR], 2.95; 95% CI, 1.38 to 6.38), implant oversizing of greater than 20% above recommended volume (OR, 6.00; 95% CI, 2.44 to 14.80), and hematoma formation (OR, 14.60; 95% CI, 1.78 to 118.90). Implant surface type, surgical approach, age, body mass index, and implant brand were not significantly associated (Li, 2025).

Postmastectomy radiation therapy significantly increases capsular contracture risk in prosthetic breast reconstruction. In a multi-institutional Japanese cohort of 1138 individuals, Baker Grade III and IV capsular contracture (combined) occurred in 50.0% of individuals with prosthetic reconstruction who received postmastectomy radiation therapy, compared with 19.0% without radiation (p<0.001). Autologous reconstruction did not show a comparable increase with radiation (Sasada, 2025).

Tissue-level analysis of capsular contracture has identified interleukin-17A as elevated 3.44-fold in Baker Grade III/IV compared with Grade I/II contracture (p<0.001), providing mechanistic context for the inflammatory basis of severe contracture (Timmerman, 2025).

Silicone Implant Rupture, Immune Response, and Silicone Lymphadenopathy

The United States Food and Drug Administration (FDA) labeling of silicone implants recommends removal of ruptured silicone implants. The rationale for removal of ruptured silicone gel implant is mechanical and structural. Factors include physical device failure, silicone migration to surrounding tissues, and development of silicone lymphadenopathy.

Intact silicone implants are associated with leakage of small amounts of silicone, and there has been concern that this leakage is associated with various autoimmune diseases. A meta-analysis of studies examining the relationship between silicone breast implants and connective tissue diseases found inadequate evidence to support such an association (Janowsky, 2000). Subsequent studies have added biological context without altering this conclusion.

A Cochrane systematic review of five randomized controlled trials (202 participants) compared different implant types in reconstructive breast surgery and found that silicone-filled implants had a significantly higher rate of Baker Grade III/IV capsular contracture than saline-filled implants (risk ratio [RR], 3.25; 95% confidence interval [CI], 1.24 to 8.51; very low certainty; 50% vs. 16%). Saline implants had a significantly higher reintervention rate due to deflation (6 of 26 saline removed vs. 0 of 34 silicone). A single trial of 20 participants found no significant difference in capsular contracture between textured and smooth silicone implants. Comparison of variable-volume (single-stage) and fixed-volume (two-stage) implants found significantly better individual satisfaction and fewer reinterventions with the two-stage approach (RR for reintervention, 7.00; 95% CI, 1.82 to 26.89; very low certainty). All evidence was rated very low certainty. The review concluded that the available randomized trial evidence is insufficient to guide implant selection or to meaningfully inform individuals about comparative risks and complications (Rocco, 2016).

A pilot study of explanted periprosthetic capsular tissue from 43 individuals found significantly higher inflammation scores in tissue surrounding ruptured silicone gel implants compared with intact microtextured implants (4.9 vs. 1.6; p<0.0001). Histologic and transcriptomic analyses showed upregulation of genes involved with innate and adaptive immune responses, as well as pathways associated with autoimmune disease. However, all individuals in the study were clinically asymptomatic at the time of explantation, and no systemic inflammatory or clinical outcome measures were assessed, limiting the clinical interpretation of these findings (Pluvy, 2024).

A prospective cohort study of 188 individuals (71 implant-exposed, 117 implant-naive) found elevated serum antibodies to MUC-1 (p=0.018) and estrogen receptor (p=0.021) in implant-exposed individuals compared with implant-naive controls. These elevations were detectable within one month of first augmentation and sustained at six months. The authors framed these findings in the context of a cancer immunosurveillance hypothesis and did not link the elevations to autoimmune disease or systemic symptoms (Timmerman, 2025). A related analysis from the same research program found that implant rupture specifically does not further elevate serum antibody levels or alter breast parenchyma gene expression. Only 1 of more than 28,000 genomic features was differentially expressed, and it was immune-downregulated. The authors proposed that the immunological stimulus is the implant surface itself, not silicone gel release (Jagasia, 2025). These two studies share the same institutional review board protocol, RNA sequencing data repository, and overlapping participant populations at Northwestern University and cannot be cited as fully independent evidence.

Silicone lymphadenopathy is a clinically relevant complication of silicone breast implants. In a retrospective study of 52 individuals with silicone lymphadenopathy, rupture was present in 88.7% but the condition also occurred without rupture (11.3%), confirming that gel permeation through intact shells is sufficient. Most individuals (69.3%) were asymptomatic at detection. Lymph node involvement was predominantly axillary (86.5%). Of 8 individuals who underwent biopsy, all were found to have benign silicone lymphadenopathy with no malignancies. Management included implant exchange (40.4%), non-surgical management (34.6%), and implant explant (25.0%). The authors recommend against surgical excision of lymph nodes alone (Desai, 2025).

Breast Implant-Associated Malignancies

Anaplastic Large Cell Lymphoma: Epidemiology

Breast implant-associated anaplastic large cell lymphoma is a rare T-cell lymphoma arising most frequently around textured surface breast implants. No confirmed cases have been identified in individuals with only smooth surface devices (Clemens, 2019; American Society of Plastic Surgeons and the Plastic Surgery Foundation [ASPS/PSF], 2022). The disease typically presents as a delayed periprosthetic effusion developing more than one year after implantation, with an average onset of 7 to 10 years (Clemens, 2019). The condition occurs in both silicone and saline implant recipients and in both aesthetic and reconstructive populations (ASPS/PSF, 2022).

As of 2022, ASPS/PSF documented approximately 400 cases in the United States and 1227 cases worldwide. Lifetime risk estimates for textured implants range from 1 in 2207 to 1 in 86,029. For Allergan BIOCELL devices specifically, the estimated lifetime risk is 1 in 100 over 20 years (Cordeiro, 2020). A 2025 update from a Memorial Sloan Kettering Cancer Center prospective cohort reported an incidence of 0.311 cases per 1000 person-years (95% confidence interval [CI], 0.12 to 0.49) across 11 cases in 3546 women, superseding the previously reported preliminary figure of 0.294 per 1000 person-years (Ghione, 2025).

An international multicenter retrospective study across four institutions (Zurich, Linz, Salt Lake City, and Udine) identified six cases of breast implant-associated anaplastic large cell lymphoma among 92 breast lymphoma cases over 10 years. All six cases were classified as anaplastic large cell T-cell lymphoma, anaplastic lymphoma kinase-negative. The mean age at diagnosis was 47.5 years (range 31 to 69), with unilateral effusion as the presenting feature in half of cases (Maccio, 2025).

Anaplastic Large Cell Lymphoma: Risk Factors

Textured surface implants are the primary established risk factor.

Germline BRCA1 and BRCA2 pathogenic variants have been identified as a risk factor for breast implant-associated anaplastic large cell lymphoma in individuals with breast cancer who underwent reconstruction with textured implants. In a prospective cohort of 520 individuals from a prospectively followed cohort at Memorial Sloan Kettering Cancer Center who were tested for BRCA1/2, the age-adjusted rate of breast implant-associated anaplastic large cell lymphoma in BRCA1/2-positive individuals was 16 times the rate in BRCA1/2-negative individuals (95% confidence interval [CI], 3.6 to 76.1; p<0.0003). The multivariable Cox hazard ratio for BRCA1/2 carriers was 15.2 (95% CI, 3.2 to 71.4; p=0.0006), with no significant association observed for chemotherapy, radiotherapy, or bilateral implant status. The authors noted that the wide 95% CI reflects the rarity of the disease and that the association requires further characterization. The authors further stated that these findings will be useful in guiding decisions regarding textured implant placement in individuals with breast cancer and BRCA1/2 mutations after mastectomy, and potentially for individuals with these mutations who already have textured implants in place or who are considering prophylactic mastectomy (Ghione, 2025).

Independent corroboration was provided by a Dutch study that found BRCA1/2 pathogenic variants present in 4 of 15 individuals (26.7%) who developed breast implant-associated anaplastic large cell lymphoma after breast cancer reconstruction, compared with an expected prevalence of approximately 5.1% in the Dutch breast cancer population (de Boer, 2018).

On July 24, 2019, the United States Food and Drug Administration (FDA) announced a Class I device recall of Allergan BIOCELL textured breast implant and tissue expander products from the United States market due to the risk of breast implant-associated anaplastic large cell lymphoma. The recall encompassed Natrelle saline-filled, silicone-filled, Inspira silicone-filled, and 410 highly cohesive anatomically shaped silicone-filled breast implants. However, the FDA recommended against removal of breast implants in individuals who have no symptoms due to the low risk of developing breast implant-associated anaplastic large cell lymphoma (FDA, 2019).

On September 29, 2020, the FDA issued its final Guidance for Industry and Staff for saline, silicone gel, and alternative breast implants, which guides implant manufacturers about labeling requirements and includes instructions for post-approval core studies to be conducted for 10 years, with data about complications and implant extractions to be reported (FDA, 2020).

On October 27, 2021, the FDA issued new labeling requirements for all legally marketed breast implants. The requirements include a boxed warning, a decision checklist to be reviewed with the prospective individual by the health care provider, updated silicone gel-filled breast implant rupture screening recommendations, a device description listing specific materials, and a device card for the individual. The sale and distribution of breast implants is now restricted to health care providers and facilities that provide information using the decision checklist (FDA, 2025).

Squamous Cell Carcinoma

Breast implant-associated squamous cell carcinoma has been identified as a second implant-associated malignancy. American Society of Plastic Surgeons and the Plastic Surgery Foundation (ASPS/PSF) recognized breast implant-associated squamous cell carcinoma in a 2022 position statement and indicated that complete en bloc capsulectomy with explantation is the treatment approach when the condition is confirmed, noting that incomplete resection can result in early and aggressive recurrence. Breast implant-associated squamous cell carcinoma presents with extracapsular spread in approximately 80% of cases at diagnosis, compared with 28% for breast implant-associated anaplastic large cell lymphoma, and carries a reported six-month mortality of 43.8%, compared with 2.8% one-year mortality for breast implant-associated anaplastic large cell lymphoma (ASPS/PSF, 2022). Breast implant-associated squamous cell carcinoma has been reported in individuals with both smooth and textured implants, and the average time from implantation to presentation is approximately 22 years. However, the number of reported cases remains too small to determine what factors increase individual risk (ASPS/PSF, 2022; National Comprehensive Cancer Network [NCCN] Breast Cancer, 2026). The American College of Radiology (ACR) Appropriateness Criteria^®, updated in 2025, apply the same initial imaging evaluation to suspected breast implant-associated malignancy regardless of histologic type, rating ultrasound and magnetic resonance imaging without and with contrast as usually appropriate for any individual with a suspected implant-associated malignancy of any implant type (Bennett, 2026).

Clinical Practice Guidelines

The National Comprehensive Cancer Network (NCCN) T-Cell Lymphomas guidelines (Version 2.2026) recommend total capsulectomy with removal of the breast implant and excision of any associated mass, with biopsy of suspicious lymph nodes, for all individuals with confirmed breast implant-associated anaplastic large cell lymphoma. Complete surgical excision alone is the optimal treatment for localized disease (stages IA through IC). The guidelines note that breast implant-associated anaplastic large cell lymphoma is not a disease of the breast parenchyma and that there is no role for mastectomy or sentinel lymph node biopsy. Immediate or delayed breast reconstruction with autologous tissue or smooth surface breast implants may be considered following treatment. Regarding prophylactic explantation, the guidelines state that prophylactic explantation of textured implants is not routinely recommended but may be reasonable for risk reduction in select individuals following an informed discussion regarding the benefits and risks of surgery. The guidelines also identify BRCA1/2 mutations as a risk factor for breast implant-associated anaplastic large cell lymphoma in individuals with breast cancer and textured implants. Surveillance following treatment includes history and physical examination every 3 to 6 months for 2 years, then as clinically indicated, with imaging not more often than every 6 months for 2 years (NCCN T-Cell Lymphomas, 2026).

The NCCN Breast Cancer guidelines (Version 2.2026) address breast reconstruction following both breast-conserving surgery and mastectomy. The guidelines recognize both implant-based and autologous reconstruction approaches and describe 14 named autologous flap types. Delayed reconstruction or implant exchange should occur at least 6 months after completion of radiation therapy. Tissue expansion through radiation therapy with delayed conversion carries a Category 2B designation when radiation therapy status is unknown. The guidelines identify smoking and World Health Organization Class 2 or Class 3 obesity as relative contraindications for all reconstruction types and poorly controlled diabetes as a risk factor for complications. Regarding breast implant-associated malignancy, the guidelines note that breast implant-associated squamous cell carcinoma is associated with either smooth or textured implants (NCCN Breast Cancer, 2026).

In 2022, the American Society of Plastic Surgeons and the Plastic Surgery Foundation (ASPS/PSF) issued a position statement with nine formal recommendations covering informed consent, preoperative workup, diagnostic evaluation, surgical specimen collection, and registry reporting for breast implant-associated malignancies. The position statement recommends bilateral explantation with complete en bloc capsulectomy as the surgical standard for confirmed breast implant-associated anaplastic large cell lymphoma, noting that bilateral removal is recommended due to the risk of incidental contralateral disease (ASPS/PSF, 2022).

The NCCN consensus guideline (Clemens, 2019) recommends en bloc resection as the standard treatment for confirmed breast implant-associated anaplastic large cell lymphoma and states that complete excision is associated with prolonged overall survival (p=0.001) and event-free survival (p=0.001). The guideline also recommends a minimum of 50 milliliters of fluid collection for fine-needle aspiration and introduced the tumor, node, metastasis (TNM) staging system (stages IA through IV) to predict survival more accurately than Ann Arbor staging (p=0.01) (Clemens, 2019).

The Breast Surgery Collaborative Community published a consensus statement on capsulectomy terminology, defining en bloc capsulectomy (removal with a margin of uninvolved tissue for suspected or established breast implant-associated cancers), total intact capsulectomy (complete removal as a single unit), total capsulectomy (complete removal, not necessarily as a single unit), and partial capsulectomy (removal where some capsule is left behind). The statement specifies that the only indication for en bloc capsulectomy is established or suspected breast implant-associated cancer after appropriate medical workup (Breast Surgery Collaborative Community, 2024).

A systematic review including 17 studies and 254 cases of breast implant-associated anaplastic large cell lymphoma found a mean time from implantation to diagnosis of 13 years (range 1 to 29 years). In a pooled analysis of 14 studies with 525,475 individuals with breast implants, the risk ranged from 0 to 1 per 1000 cases, and individuals with breast implants had a 28.86 times higher risk of developing the condition compared with the general population (Elameen, 2024). Risk estimates vary widely, and the rising incidence may reflect both increased use of textured implants and increased recognition of the disease (Kinslow, 2022).

Saline and Alternative Implants

Saline-filled implants have been associated with infection, implant exposure, and pain related to capsular contracture, all requiring implant removal.

Capsular tissue inflammation scores for textured saline-filled implants (1.8) are similar to those of intact microtextured silicone implants (1.6) and substantially lower than ruptured silicone gel implants (4.9) (Pluvy, 2024). A comparison of ruptured saline (n=4) and ruptured silicone (n=12) implants found no significant difference in any serum antibody measured, though the saline subgroup was severely underpowered (Jagasia, 2025).

Systemic Symptoms Attributed to Breast Implants

Published evidence is insufficient to support the removal of breast implants for systemic symptoms attributed to connective tissue disease, autoimmune diseases, personal anxiety, or pain not related to contractures or rupture. While recent studies have identified measurable immune responses at both the capsular tissue level (Pluvy, 2024) and the systemic serum level (Timmerman, 2025) in individuals with breast implants compared with individuals without implants, no study has established a clinical link between these biological changes and autoimmune disease diagnosis, connective tissue disease, or symptom causation.

Breast Reconstruction: Technique, Timing, and Radiation Therapy

Breast reconstruction following mastectomy or lumpectomy can be accomplished through implant-based approaches, autologous tissue transfer, or a combination. The choice and timing of reconstruction depends on factors including personal preference, degree of resection, prior surgeries or radiation treatments, body habitus, ongoing cancer treatment plans, and coexisting medical conditions.

A retrospective comparison of hybrid deep inferior epigastric perforator flap plus implant reconstruction (n=26), implant-only reconstruction (n=59), and deep inferior epigastric perforator flap-only reconstruction (n=60) found that the hybrid approach had a lower overall complication rate (18.4%) than implant-only (41.1%; p=0.014) and a significantly lower infection rate (2.6% vs. 22.2%; p=0.006) (Wang, 2025).

A prospective comparison of pedicled muscle-sparing transverse rectus abdominis myocutaneous flap, free deep inferior epigastric perforator flap, and delayed free deep inferior epigastric perforator flap (n=12 per group) found no significant differences in satisfaction with breast appearance, psychological well-being, sexual well-being, or physical well-being at 12 months across all three techniques (all p>0.05) (Amr, 2025).

A Cochrane systematic review of 35 nonrandomized studies (57,555 women) comparing implant-based with autologous tissue-based breast reconstruction following mastectomy found that implant-based reconstruction may reduce psychosocial well-being (mean difference -4.26 points on the BREAST-Q; 95% confidence interval [CI], -4.91 to -3.61; low certainty), sexual well-being (mean difference [MD], -6.63; 95% confidence interval [CI], -7.55 to -5.72; low certainty), and satisfaction with reconstruction (MD, -5.96; 95% CI, -10.24 to -1.68; low certainty) compared with autologous reconstruction. Physical well-being showed no clear difference (MD, -1.92; 95% CI, -4.44 to 0.60; very low certainty). Implant-based reconstruction may increase long-term complications (RR, 1.56; 95% CI, 1.09 to 2.22; very low certainty) but showed no significant difference in short-term complications (RR, 0.80; 95% CI, 0.63 to 1.03; very low certainty). All 35 included studies were nonrandomized, all GRADE ratings were low or very low certainty, and substantial heterogeneity was present across multiple outcomes. The review concluded that neither approach is universally superior and called for a tailored and algorithmic method when deciding on the most appropriate type of breast reconstruction (Rocco, 2024).

A matched-pair study of minimally invasive deep inferior epigastric perforator flap harvest (fasciotomy less than 3 centimeters, n=11) compared with conventional harvest (fasciotomy 10 to 12 centimeters, n=11) found comparable operative times but significantly faster time to first mobility (1.18 vs. 2.09 days; p=0.001), reduced opioid requirement (18 vs. 42 milligrams hydromorphone equivalent; p<0.001), and shorter hospital stay (5.2 vs. 9.1 days; p<0.0001) with no increase in complications (Bucher, 2025).

Radiation Therapy and Reconstruction Method

Postmastectomy radiation therapy significantly affects reconstruction outcomes, particularly for prosthetic approaches. In a multi-institutional cohort of 1138 individuals, prosthetic breast reconstruction with postmastectomy radiation therapy carried a complication odds ratio (OR) of 2.01 (95% confidence interval [CI], 1.29 to 3.13; p=0.002), while autologous reconstruction did not show increased complications with radiation (OR, 0.78; 95% CI, 0.42 to 1.47; p=0.444). In multivariate analysis, autologous reconstruction was independently associated with lower overall complication risk compared with prosthetic (OR, 0.69; 95% CI, 0.50 to 0.94; p=0.024) (Sasada, 2025).

Neoadjuvant chemotherapy compresses the mastectomy-to-radiation interval (median 2.07 months vs. 7.47 months for adjuvant chemotherapy; p<0.001) and independently predicts tissue expander-based reconstruction failure (multivariate hazard ratio [HR], 2.73; p=0.003). The tissue expander-based reconstruction failure rate was 44.6% in the neoadjuvant group compared with 26.9% in the adjuvant group (Padilla, 2025).

Reconstruction Timing

A prospective multicenter cohort compared immediate autologous deep inferior epigastric perforator flap reconstruction followed by postmastectomy radiation (n=56) with delayed reconstruction after radiation (n=32). At long-term follow-up (median 37 to 46 months post-reconstruction), no differences in satisfaction with breasts, physical well-being, or adverse effects of radiation met established clinically meaningful thresholds (all p>0.77). Short-term body image and physical functioning were better preserved with immediate reconstruction, but these differences resolved after completion of delayed reconstruction (Jansen, 2025).

Flat Chest Closure

Aesthetic flat chest closure is a reconstructive option following mastectomy. A retrospective study of 252 individuals who underwent flat closure at a single institution reported a 17.5% overall complication rate. Satisfaction with breasts scored a median of 58 (interquartile range 47 to 71) and psychosocial well-being of the chest scored a median of 72.5 (interquartile range 58 to 82.3) on the BREAST-Q instrument. Overall, 66.0% of respondents reported being happy with their outcome. The delayed reconstruction rate after flat closure was 2.8%. The most commonly reported reasons for choosing flat closure were lower complication rate (76.0%), shorter recovery time (70.0%), and avoiding implantation of foreign objects (70.0%) (Soroudi, 2025).

Description of Technology

Reconstructive breast surgery is a surgical procedure that is designed to restore the normal appearance of a breast after a medically necessary mastectomy for breast cancer or other medical condition, injury or congenital abnormality. In contrast, cosmetic breast surgery is defined as surgery designed to alter or enhance the appearance of a breast that has not undergone a medically necessary surgery, an accidental injury/trauma, congenital defect, infection or other non-malignant disease.

Breast reconstruction following a mastectomy can be begun before, immediately after, or some time following a procedure to remove a breast. In an immediate procedure, the surgeon will place a breast implant in the location where the breast was removed during the same operative session. This is referred to as a one-stage procedure and has no impact on the outcome of any chemotherapy treatments. A delayed reconstruction procedure may be necessary if radiation therapy is needed following the surgery, since implants may interfere with such treatment. In some circumstances, it is necessary to do a two-stage procedure. This involves the initial placement of a tissue expander to stretch the skin. An implant is later inserted as the second-stage procedure. A two-stage procedure may be begun either in the same operative session as the mastectomy or at a later date. In some situations involving breast cancer or the need to reduce breast cancer risk, reduction mammaplasty is performed before the mastectomy or lumpectomy in order to prevent postoperative complications and to improve the cosmetic outcome.

Another technique used in breast reconstruction involves a two-phase procedure. In the first phase, the breast mound is created, using either an implant with or without a tissue expander, or an autologous tissue reconstruction procedure with a transverse rectus abdominis musculocutaneous flap (that is, TRAM flap), and allowed to heal. In the second phase, which begins 3 to 6 months after the first stage is completed, the breast shape is refined and the nipple-areola is created. Tattooing of the nipple and/or areola is the final stage of reconstruction, and in some cases may be delayed up to 2 years.

Another surgical option that has gained some favorable feedback from individuals who have had a mastectomy is called aesthetic flat chest closure. This involves contouring of the chest wall after mastectomy without traditional breast reconstruction. The surgeon removes extra skin, pockets of fat or excess tissue, and tightens and smooths out the remaining tissue to create a flat chest wall contour. This procedure is considered reconstructive following a mastectomy for breast cancer and can be done immediately following the mastectomy or delayed until a few months later. In most cases individuals opt for removal of the contralateral breast and flat closure of that side also, in order to create a symmetrical appearance. A team of plastic surgeons from New York University noted that, to date, "There is no plastic surgery literature on specific techniques to achieve an aesthetic flat closure after mastectomy" (Morrison, 2022).

The National Cancer Institute (NCI) defines aesthetic flat closure as the following:

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 is removed. The remaining tissue is then tightened and smoothed out so that the chest wall appears flat (NCI, 2011).

Baker and colleagues described results of a satisfaction survey of 931 women who had a history of uni- or bilateral mastectomy for treatment of breast cancer or elevated breast cancer risk without current breast mound reconstruction. Satisfaction with outcomes and surgeon support for the individual’s experience were characterized using 5-level scaled scores. Mastectomy alone was the first choice for 73.7% of the respondents. The top two reasons for choosing flat closure were a desire for a faster recovery and avoidance of foreign body placement. Overall, the mean scaled satisfaction score was 3.72 ± 1.17 out of 5. In the multivariable analysis, low levels of surgeon support for the choice of flat closure were the strongest predictor of having a satisfaction score lower than 3 (odds ratio [OR], 3.85; 95% confidence interval [CI], 2.59-5.72; p<0.001). The authors noted that dissatisfaction was more likely among respondents reporting a body mass index (BMI) of 30 kg/m2 or higher (OR, 2.74; 95% CI, 1.76-4.27; p<0.001) and those undergoing a unilateral procedure (OR, 1.99; 95% CI, 1.29-3.09; p=0.002). Greater satisfaction was associated with a perception of having received adequate information about surgical options (OR, 0.48; 95% CI, 0.32-0.69; p<0.0001) and having a surgeon with a specialized breast surgery practice (OR, 0.56; 95% CI, 0.38-0.81; p=0.002). The authors concluded that the majority of individuals who had undergone a mastectomy alone were satisfied with their surgical outcome. They noted that surgeons may optimize the individual’s experience by recognizing and supporting the choice of flat closure (Baker, 2021).

Description of Chest Wall Deformities

Congenital chest wall deformities include, but are not limited to, Poland syndrome, pectus excavatum (also referred to as sunken chest or funnel chest), and pectus carinatum (referred to as pigeon breast or chicken breast). Poland syndrome is a rare, congenital disorder which is associated with a wide range of malformations of the ribs on one or both sides of the sternum. This condition is characterized by absence or hypoplasia of the pectoralis major and minor muscles, absence of costal cartilages, hypoplasia of the breast and subcutaneous tissue, and a variety of hand and upper-extremity anomalies. In general, the severity of congenital chest wall deformities is dependent upon the depth, symmetry and width of the deformity which is evaluated by chest radiographs. In more severe cases where cardiac and/or pulmonary compression and cardiac displacement may be involved, the clinical evaluation may include chest computed tomography (CT) or magnetic resonance imaging (MRI), in addition to echocardiography and pulmonary function testing. Surgical repair may be necessary in some severe cases where cardiopulmonary function is impaired.

Concepts of Medical Necessity, Reconstructive and Cosmetic

The coverage eligibility of medical and surgical therapies to treat breast conditions is often based on a determination of whether repair of the abnormality is considered medically necessary, reconstructive, or cosmetic in nature. In many instances, the concept of reconstructive overlaps with the concept of medical necessity. For example, breast surgery to address pain related to Baker Class IV capsular contracture will be considered medically necessary and thus eligible for coverage, regardless of the contract language pertaining to reconstructive services, unless some other exclusion applies. Generally, reconstructive is often taken to mean that the service “returns the person to whole” as a result of a congenital anomaly, disease, or other condition, including post trauma or post therapy. Cosmetic generally describes changing a physical appearance that would be considered within normal human anatomic variation. Categories of conditions without associated functional impairment that may be included as reconstructive definitions, include or may be due to the following: surgery, accidental trauma or injury, diseases, congenital anomalies (including Poland syndrome), severe anatomic variants, and chemotherapy or radiation therapy.

Choice of Breast Reconstruction Procedure

Breast reconstruction can play a pivotal part in recovery from breast cancer surgery. Reconstruction has been shown to improve quality of life in several domains including psychological, emotional, sexual, and social well-being. The choice and timing of breast reconstruction depends on a variety of factors that may be unique to each individual. Such factors include personal preference, degree of resection, prior surgeries or radiation treatments, body habitus including the amount of tissue available from donor sites, ongoing cancer treatment plans, and coexisting medical conditions. Common reconstructive techniques may include, but are not limited to, implant insertion, revision or removal of pre-existing implants (including implants placed for cosmetic purposes), reduction mammaplasty, surgery to the contralateral breast to achieve symmetry (which may include reduction mammaplasty, augmentation mammaplasty, mastopexy, or other procedures), tissue transfer, or chest wall reconstruction with flat chest closure.

Timing of Procedures

The number and timing of reconstructive breast procedures varies, depending on the individualized treatment plan developed by the treating physician(s) and the individual. These plans may be impacted by the overall treatment plan for the breast cancer itself.

Capsulectomy Procedures

The Breast Surgery Collaborative Community published a consensus statement on capsulectomy (BSCC, 2024).

The consensus terminology for capsulectomy procedures is as follows:

En Bloc capsulectomy: Removal of the breast implant capsule with a margin of uninvolved tissue for treatment of suspected or established breast implant-associated cancers after appropriate medical workup.

Total intact capsulectomy: Complete removal of the breast implant capsule as a single unit.

Total capsulectomy (also called total precise capsulectomy): Complete removal of the breast implant capsule, not necessarily done as a single unit or in one piece.

Partial capsulectomy: Removal of the breast implant capsule where some capsule is left behind.

The BSCC states that “the absolute and only indication for an en bloc capsulectomy is for an established or suspected breast implant-associated cancer after appropriate medical workup”.

Additionally, they state:

“Possible indications for capsulectomy include:

1. Capsular contracture
2. Ruptured implant
3. Any abnormality or suspected abnormality of the capsule”

Alternative breast implants (also called combination implants): A type of breast implant that has two compartments that contain both silicone and saline. Some of these implants have silicone as the inner compartment and saline as the outer compartment. The saline compartment is filled at the time of surgery. Other implants in this category contain saline in the inner compartment and silicone in the outer compartment.

Augmentation mammaplasty (also referred to as augmentation mammoplasty): A surgical procedure in which the purpose is to enlarge the breast or breasts.

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL): This is a rare form of T-cell lymphoma (that is, a non-Hodgkin lymphoma) that is associated with breast implants. ALCL is characterized by abnormal growth of T-lymphocytes (T-cells) and strong expression of a protein, cytokine receptor CD30. ALCL can involve many parts of the body, including the lymph nodes and skin. There are currently two major variants of ALCL recognized in the literature, one of which expresses the protein anaplastic lymphoma kinase (ALK-positive) and a second which does not (ALK-negative). Reports in the scientific community have suggested a possible association between ALK-negative ALCL and silicone- and saline-filled breast implants. Optimal treatment is complete removal of the breast implants.

Breast implant-associated squamous cell carcinoma (BIA-SCC): A rare, potentially aggressive epithelial malignancy that arises from the fibrous capsule surrounding a breast implant. BIA-SCC is distinct from breast cancer and from BIA-ALCL; it is characterized by sheets of squamous cells with features ranging from metaplasia to frank carcinoma. First reported in 1992, BIA-SCC has been identified with both silicone and saline implants. The recommended treatment is complete surgical excision, including bilateral implant removal and total capsulectomy.

Capsulectomy: A surgical procedure that removes thick hardened tissue, known as the capsule, that forms around a breast implant.

Contracture: A condition where scar tissue forms internally around the breast implant, tightens and makes the breast round, firm, and possibly painful. This excessive firmness of the breasts can occur soon after surgery or years later.

Contralateral: Pertaining to the opposite side which, in the case of breasts, refers to the breast not being medically treated.

Extrusion: A condition in which inadequate tissue coverage, infection, or other weakening of the skin results in exposure of the implant through the skin.

Mastectomy: The surgical removal of a breast.

Mastopexy: A surgical procedure designed to elevate sagging breasts to a normal position, often with some improvement in shape.

Poland syndrome: A condition where an individual is born missing some of their chest muscles and cartilage and did not develop a breast on one side of the chest during puberty.

Prophylactic mastectomy: A surgical procedure to remove a breast or both breasts with the purpose of reducing the risk of breast cancer in women determined to be at intermediate or high risk for developing breast cancer.

Reconstructive breast surgery: Surgical procedures performed to correct or repair abnormal structures of the breast that are designed to restore the normal appearance of one or both breasts.

Reduction mammaplasty (also referred to as reduction mammoplasty): A surgical procedure to decrease breast size.

Rupture: A condition where a liquid or gel-filled breast implant bursts, allowing leakage of its contents into the surrounding tissue.

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

Reconstructive Breast Procedures before or after Breast Surgery
When services may be Reconstructive when criteria are met:

Reconstructive Breast Procedures for Other Indications:
When services may also be Reconstructive when criteria are met:
For the procedure codes listed above; for the following diagnoses:

When services are Cosmetic and Not Medically Necessary:
For the procedure codes listed above when criteria are not met, or when the code describes a procedure indicated in the Position Statement section as cosmetic and not medically necessary.

Breast Implant Removal or Revision
When services may be Medically Necessary or Reconstructive when criteria are met:

When services are Not Medically Necessary:
For the procedure and diagnosis codes listed above when criteria are not met, for all other diagnoses not listed; or when the code describes a procedure indicated in the Position Statement section as not medically necessary.

Peer-Reviewed Publications:

1. Amr SG, Khater AA, El Fahar MH, et al. Impact of immediate unilateral breast reconstruction with abdominal flaps on quality of life: a single-center prospective interventional study in Egypt. Aesthetic Plast Surg. 2025; 49(15):4316-4331.
2. Baker JL, Attai DJ. ASO author reflections: patients who go flat after mastectomy deserve an aesthetic flat closure. Ann Surg Oncol. 2021; 28:2493-2505.
3. Bucher F, Tamulevicius M, Dastagir N, et al. Comparing minimally invasive and conventional approaches to DIEP flap harvest: a matched-pair analysis from a high-volume center. Aesthetic Plast Surg. 2025; 49(23):6623-6631.
4. Clemens MW, Jacobsen ED, Horwitz SM. 2019 NCCN consensus guidelines on the diagnosis and treatment of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Aesthet Surg J. 2019; 39(S1):S3-S13.
5. Cordeiro PG, Ghione P, Ni A, et al. Risk of breast implant associated anaplastic large cell lymphoma (BIA-ALCL) in a cohort of 3546 women prospectively followed long term after reconstruction with textured breast implants. J Plast Reconstr Aesthet Surg. 2020; 73(5):841-846.
6. de Boer M, van Leeuwen FE, Hauptmann M, et al. Breast implants and the risk of anaplastic large-cell lymphoma in the breast. JAMA Oncol. 2018; 4(3):335-341.
7. Desai A, Smartz T, Tabibi O, et al. Presentation and management of silicone lymphadenopathy: a single institutional retrospective cohort study. Aesthetic Plast Surg. 2025; 49(12):3417-3424.
8. Elameen AM, AlMarakby MA, Atta TI, et al. The risk of breast implant-associated anaplastic large cell lymphoma; a systematic review and meta-analysis. Aesthetic Plast Surg. 2024; 48(24):5315-5328.
9. Ghione P, Mandelker D, Arcila ME, et al. BRCA1/2 impact on the development of implant-associated lymphoma in women with breast cancer and textured implants. Blood Adv. 2025; 9(17):4436-4443.
10. Hägglund S, et al. Capsular contracture after implant-based breast reconstruction following risk-reducing mastectomy: a national register-based study. BJS Open. 2025; 9(4):zraf080.
11. Jagasia P, Timmerman R, Dolivo D, et al. Rupture of breast implants does not cause systemic or local immune changes. Aesthetic Surg J. 2025; 45(5):463-469.
12. Janowsky EC, Kupper LL, Hulka BS. Meta-analyses of the relation between silicone breast implants and the risk of connective-tissue diseases. N Engl J Med. 2000; 342(11):781-790.
13. Jansen BAM, Bargon CA, Bouman MA, et al. Patient-reported outcomes after immediate and delayed DIEP-flap breast reconstruction in the setting of post-mastectomy radiation therapy. Breast Cancer Res Treat. 2025; 210:759-769.
14. Kinslow CJ, Kim A, Sanchez GI, et al. Incidence of anaplastic large-cell lymphoma of the breast in the US, 2000 to 2018. JAMA Oncol. 2022; 8(9):1354-1356.
15. Li XY, et al. Analysis of risk factors for capsular contracture after breast augmentation: a retrospective study. Front Surg. 2025; 12:1596993.
16. Maccio U, et al. Clinical and pathological features of lymphomas in the breast: a comprehensive multicentric study. Sci Rep. 2025; 15:29032.
17. Morrison KA, Karp NS. Not just a linear closure: aesthetic flat closure after mastectomy. Plast Reconstr Surg Glob Open. 2022; 10(5):e4327.
18. Padilla O, Jairam M, Yen A, et al. Tissue expander breast reconstruction outcomes following postmastectomy radiation therapy in the era of neoadjuvant chemotherapy. Front Oncol. 2025; 15:1636472.
19. Pluvy I, Randrianaridera E, Tahmaz I, et al. Immunological characterization of periprosthetic capsular tissue in women with breast implants. Biomaterials. 2024; 317:123025.
20. Sasada S, Tsuji W, Watanabe N, et al. Breast reconstruction-related complications from postmastectomy radiation therapy in stage II-III breast cancer. Breast Cancer. 2025; 33(1):243-250.
21. Soroudi D, Parmeshwar N, Gozali A, et al. Post-mastectomy flat closure: a mixed-methods analysis of patient outcomes and perspectives. Ann Surg Oncol. 2025; 32(8):5827-5837.
22. Timmerman R, Allison S, Dolivo D, et al. Breast implants elicit local and systemic immune response: evidence for breast cancer immunosurveillance. Plast Reconstr Surg. 2025; 155(5):797-809.
23. Wang C, Roy N, Montalmant KE, et al. Deep inferior epigastric perforator flap with implant placement has a favorable complication profile compared with implant-only or flap-only reconstruction. J Reconstr Microsurg. 2025; 41(7):631-640.

Government Agency, Medical Society, and Other Authoritative Publications:

1. American Society of Plastic Surgeons and the Plastic Surgery Foundation (ASPS/PSF). Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and breast implant-associated squamous cell carcinoma (BIA-SCC). ASPS/PSF position statement. September 2022. Available at: https://www.plasticsurgery.org/for-medical-professionals/publications/psn-extra/news/asps-statement-on-breast-implant-associated-squamous-cell-carcinoma.  Accessed on April 13, 2026.
2. Baker JL. Augmentation mammaplasty. In: Owsley JG, Peterson RA, eds. Symposium on aesthetic surgery of the breast. St. Louis: Mosby; 1978.
3. Bennett DL, Brown A, Freer PE, et al. ACR Appropriateness Criteria breast implant evaluation: update 2025. J Am Coll Radiol. 2026; 23(4):658-680.
4. Breast Surgery Collaborative Community (BSCC). Consensus Statement from the Breast Surgery Collaborative Community (BSCC) on capsulectomy terminology and management. 2024. Available at: https://www.plasticsurgery.org/documents/medical-professionals/BSCC-Capsulectomy-Terminology-Management-Consensus-Statement.pdf.  Accessed on April 13, 2026.
5. National Cancer Institute (NCI). Dictionary of cancer terms: aesthetic flat closure. 2026. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/aesthetic-flat-closure.  Accessed on April 13, 2026.
6. NCCN Clinical Practice Guidelines in Oncology™. © 2026. National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology. For additional information visit the NCCN website: https://www.nccn.org/. Accessed on April 13, 2026.
   • Breast Cancer (V2.2026). Revised February 19, 2026.
   • T-Cell Lymphomas (V2.2026). Revised January 17, 2026.
7. Rocco N, Rispoli C, Moja L, et al. Different types of implants for reconstructive breast surgery. Cochrane Database Syst Rev. 2016; (5):CD010895.
8. Rocco N, Catanuto GF, Accardo G, et al. Implants versus autologous tissue flaps for breast reconstruction following mastectomy. Cochrane Database Syst Rev. 2024; (10):CD013821.
9. U.S. Food and Drug Administration (FDA). Guidance for industry and FDA staff: saline, silicone gel, and alternative breast implants. Current as of September 29, 2020. Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/saline-silicone-gel-and-alternative-breast-implants.  Accessed on April 13, 2026.
10. U.S. Food and Drug Administration (FDA). Information on breast implants and anaplastic large cell lymphoma. Current as of October 23, 2019. Available at: https://www.fda.gov/medical-devices/breast-implants/questions-and-answers-about-breast-implant-associated-anaplastic-large-cell-lymphoma-bia-alcl.  Accessed on April 13, 2026.
11. U.S. Food and Drug Administration (FDA). Labeling for approved breast implants. Current as of February 6, 2025. Available at: https://www.fda.gov/medical-devices/breast-implants/labeling-approved-breast-implants.  Accessed on April 13, 2026.
12. Women’s Health and Cancer Rights Act (WHCRA), §713; October 21, 1998. Available at: https://www.govinfo.gov/content/pkg/PLAW-105publ277/pdf/PLAW-105publ277.pdf.  Accessed on April 13, 2026.

Aesthetic flat chest closure
Augmentation Mammaplasty
BIOCELL Textured Implants
Breast Implant-Associated Squamous Cell Carcinoma (BIA-SCC)
Breast Implants
Breast Lift
Breast Procedures
Mammaplasty
Mastopexy
Natrelle Saline-Filled breast implants
Natrelle Silicone-Filled breast implants
Natrelle Inspira Silicone-Filled breast implants
Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants
Reconstructive Breast Surgery
Reduction Mammaplasty

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Federal and State law, as well as contract language, including definitions and specific contract provisions/exclusions, take precedence over Medical Policy and must be considered first in determining eligibility for coverage. The member’s contract benefits in effect on the date that services are rendered must be used. Medical Policy, which addresses medical efficacy, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and we reserve the right to review and update Medical Policy periodically.

No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electronic, mechanical, photocopying, or otherwise, without permission from the health plan.

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