Medical Policy

Policy Num:       07.001.015
Policy Name:     Reconstructive Breast Surgery/Management of Breast Implants
Policy ID:          [07.001.015]  [Ac / B / M+ / P+]  [7.01.22]

Last Review:       July 10, 2024
Next Review:      July 20, 2025
 

Related Policies:

07.001.114 Bioengineered Skin and Soft Tissue Substitutes

07.001.066 Risk Reducing Mastectomy

07.001.119Surgical Treatment for Breast Cancer Related Lymphedema 

Reconstructive Breast Surgery/Management of Breast Implants

Summary

Description

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.

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 epidemiologic 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.

Additional Information

Not applicable.

Objective

The objective of this evidence review is to evaluate the evidence of the effectiveness of reconstructive breast surgery and indications for explantation of breast implants. It also establishes criteria for the explantation of breast implants based on whether the original implant was cosmetic or reconstructive in nature, and whether the implant is silicone gel-filled or saline-filled.

Policy Statements

Coverage eligibility of breast implants for the purposes of augmentation may depend on contract language. After reconstructive breast surgery on one side, insertion of an implant on the contralateral, normal side is rarely necessary to achieve symmetry.

Reconstructive breast surgery may be considered medically necessary after a medically necessary mastectomy, accidental injury, or trauma. Medically necessary mastectomies are most typically done as treatment for cancer. 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 in all cases for a documented implant rupture, infection, extrusion, Baker class IV contracture, or as an adjunct to current surgical treatment of breast cancer.

Explantation of a ruptured saline-filled breast implant may be considered medically necessary only in those individuals who had originally undergone breast implantation for reconstructive purposes. Otherwise, indications for the explantation of a saline-filled implant are similar to those of a silicone-filled implant.

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 is considered medically necessary only in those individuals who had originally undergone breast implantation for reconstructive purposes.

The following indications for explantation of implants are considered investigational:

• 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 (see Policy Guidelines);

• Preventive explantation in asymptomatic individuals to reduce remote risk of B cell lymphoma.

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.

In 2023, The American Association of Plastic Surgeons published a consensus statement on BIA-ALCL.^1, The statement notes, "The final decision for explantation with or without capsulectomy should be shared between patient and surgeon following an evaluation of the patient’s goals balanced against the perceived benefits of the surgery and an individual surgical risk assessment." Plans might locally consider coverage of prophylactic explantation of textured breast implants to reduce remote risk of anaplastic large cell lymphoma based on this recommendation.

Coding

See the Codes table for details.

Benefit Application

BlueCard/National Account Issues

State or federal mandates (eg, Federal Employee Program) may dictate that certain U.S. Food and Drug Administration‒approved devices, drugs, or biologics may not be considered investigational, and thus these devices may be assessed only by their medical necessity.

Benefits are determined by the group contract, member benefit booklet, and/or individual subscriber certificate in effect at the time services were rendered. Benefit products or negotiated coverages may have all or some of the services discussed in this medical policy excluded from their coverage.

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 mammaplasty 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.

The following 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.

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)."^2, 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.^3,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 include the following components:

• Breast implants are not considered lifetime devices;

• The chance of developing complications increases over time;

• Some complications will require more surgery;

• 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

Rationale

This evidence review was created in December 1995 and archived in January 2012. It was re-activated in June 2022 with a search of the PubMed database. The most recent literature update was performed through April 30, 2024.

Evidence reviews assess the clinical evidence to determine whether the use of a technology improves the net health outcome. Broadly defined, health outcomes are length of life, quality of life, and ability to function including benefits and harms. Every clinical condition has specific outcomes that are important to patients and to managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of a technology, 2 domains are examined: the relevance and the quality and credibility. To be relevant, studies must represent 1 or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. Randomized controlled trials are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

Promotion of greater diversity and inclusion in clinical research of historically marginalized groups (e.g., People of Color [African-American, Asian, Black, Latino and Native American]; LGBTQIA (Lesbian, Gay, Bisexual, Transgender, Queer, Intersex, Asexual); Women; and People with Disabilities [Physical and Invisible]) allows policy populations to be more reflective of and findings more applicable to our diverse members. While we also strive to use inclusive language related to these groups in our policies, use of gender-specific nouns (e.g., women, men, sisters, etc.) will continue when reflective of language used in publications describing study populations.

Population Reference No. 1

Breast Reconstruction Surgery

Clinical Context and Therapy Purpose

The purpose of breast reconstruction surgery in individuals who have undergone breast surgery or who have experienced injury or trauma to the breast is to provide a treatment option that is an alternative to usual treatment without reconstructive breast surgery.

The following PICO was used to select literature to inform this review.

Populations

The relevant population of interest is individuals who have undergone breast surgery or who have experienced injury or trauma to the breast.

Interventions

The therapy being considered is reconstructive breast surgery.

There is a broadening array of surgical approaches to breast reconstruction. The most common is insertion of a breast implant, either a silicone gel-filled or saline-filled prosthesis. The implant is either inserted immediately at the time of mastectomy or sometime afterward in conjunction with the previous use of a tissue expander (19342, 19357).

The breast may also be reconstructed using autologous tissues, such as a free flap, a latissimus dorsi flap, or more commonly, using a transverse rectus abdominis flap. Nipple areola reconstruction or nipple tattooing may also be considered reconstructive breast surgery. Since the purpose of reconstructive breast surgery is to restore the normal appearance of the breast, on some occasions procedures are performed on the contralateral, normal breast to achieve symmetry, such as mastopexy and reduction mammaplasty. These procedures fall into the category of reconstructive breast surgery only when performed in conjunction with a contralateral mastectomy for cancer with associated reconstruction. Except for medically necessary reduction mammaplasty, these procedures are considered cosmetic in other circumstances.

Comparators

The comparator of interest is usual care without breast reconstructive surgery.

Outcomes

The general outcomes of interest are overall survival, disease-specific survival, morbid events, functional outcomes, health status measures, quality of life, treatment-related mortality, and treatment-related morbidity.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;

• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies;

• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought;

• Consistent with a 'best available evidence approach,' within each category of study design, studies with larger sample sizes and longer durations were sought;

• Studies with duplicative or overlapping populations were excluded.

Review of Evidence

Complications of breast implants are common and may require explantation.^4, Determining the medical necessity of explantation requires documentation of the type of implant and its original indication, i.e., whether reconstructive or cosmetic. The basic underlying principle is that cosmetic implants require explantation only for absolute medical indications that pose significant health consequences, while the criteria for explantation of reconstructive implants are broader. Since the purpose of reconstructive implants is the restoration of normal breast appearance, in a small subset of patients explantation may be warranted in cases of unsatisfactory aesthetic outcome.

Complications can be subdivided into local or systemic complications. Local complications include implant contracture, rupture, extrusion, or infection. Extrusion or infection are considered absolute medical indications for explantation in all cases, whether the implant was originally cosmetic or not. Documented rupture of a silicone gel-filled implant is considered an absolute indication for explantation in all cases. However, explantation of a ruptured saline implant is considered medically necessary only in the setting of prior reconstruction. Since normal saline is physiologic, rupture poses no health threat, and thus explantation would not be considered medically necessary in patients with cosmetic implants.

However, a ruptured saline implant compromises the aesthetic outcome and thus explantation may be considered appropriate in cases of reconstructive implants.

Rupture of the breast implant may be difficult to document, but physical exam, mammography, ultrasonography, or magnetic resonance imaging has been used. There is no consensus on which method affords the best sensitivity and specificity.^5,6,7, Although it has been suggested that older implants are associated with a higher incidence of rupture, there is no consensus that screening implants for rupture is warranted. Specifically, in the hearings on breast implants by the U.S. Food and Drug Administration (FDA), held in 1992, the FDA did not recommend screening for asymptomatic ruptures.

Instead, workup for a potential rupture is typically initiated at the onset of local symptoms, such as sudden change in the size or consistency of an implant, or the development of local pain.

Section Summary: Breast Reconstruction Surgery

Breast reconstruction is intended for patients undergoing mastectomy for breast cancer, or who have an injury or trauma to the breasts. For the general population of women undergoing mastectomy, the evidence supports the conclusion that breast reconstruction improves psychosocial outcomes, such as anxiety, social functioning, and perception of body image.

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.

Population Reference No. 2 

Breast Implant Explantation in Individuals with Implant Rupture, Infection, Extrusion, Baker Contracture, or Surgical Treatment of Breast Cancer

Clinical Context and Therapy Purpose

The purpose of breast explantation in individuals with implant rupture, infection, extrusion, Baker contracture, or surgical treatment of breast cancer is to provide a treatment option that is an alternative to usual treatment without expantation.

The following PICO was used to select literature to inform this review.

Populations

The relevant population of interest is individuals with breast implants and documented implant rupture, infection, extrusion, Baker contracture, or surgical treatment of breast cancer.

Interventions

The therapy being considered is breast implant explantation.

Comparators

The comparator of interest is usual care without breast implant explantation.

Outcomes

The general outcomes of interest are overall survival, disease-specific survival, morbid events, functional outcomes, health status measures, quality of life, treatment-related mortality, and treatment-related morbidity.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;

• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies;

• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought;

• Consistent with a 'best available evidence approach,' within each category of study design, studies with larger sample sizes and longer durations were sought;

• Studies with duplicative or overlapping populations were excluded.

Review of Evidence

Local complications of breast implants are frequent and may require removal of the implant. Contracture is the most common local complication of breast implants. Contractures are somewhat subjective findings, and can be graded according to the Baker classification as follows:^8,

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 are the cause of local symptoms, and thus their presence constitutes a health risk.^9, Therefore, explantation may be considered medically necessary in all cases, regardless of whether the implant was originally inserted for cosmetic or reconstructive purposes. Grade III contractures, which describe firm, palpable implants, do not interfere with mammography; therefore, explantation of these implants is not considered an absolute indication for explantation. However, since Grade III contractures have an impact on the normal appearance of the breast, explantation may be appropriate in implants inserted for reconstructive purposes, since the goal of restoration of the normal appearance of the breast is not achieved.

Potential systemic complications of implants, most prominently various connective tissue diseases or chronic fatigue syndrome, have been controversial in the past. In particular, it had been hypothesized that leakage of silicone, due either to an implant rupture or to “bleeding” of silicone through an intact capsule, may incite an autoimmune response with the development of systemic symptoms. However, large epidemiologic studies have not demonstrated that women with breast implants are overrepresented among all those with connective tissue disease.^10,11,12,13, In addition, there are inadequate empiric studies to demonstrate that removal of breast implants is associated with resolution of systemic symptoms. As a result of this evidence, there is not considered to be a relationship between silicone breast implants and systemic disease, particularly connective tissue disease.

Patients with cosmetic implants may develop breast cancer. While lumpectomy can be accomplished without removal of the implant, in general, explantation as an adjunct to surgical treatment for breast cancer would be considered medically necessary. However, explantation is not necessary in patients who are undergoing chemotherapy or radiation therapy for breast cancer.

Once an implant has been removed, patients who have originally undergone reconstructive implantation are candidates for additional reconstructive breast surgery, either insertion of another breast implant, or for autologous reconstruction of the breast, as described here. Patients who have originally undergone implantation of a cosmetic breast implant are not candidates for additional reconstructive breast surgery after explantation.

Section Summary: Breast Implant Explantation in Individuals with Implant Rupture, Infection, Extrusion, Baker Contracture, or Surgical Treatment of Breast Cancer

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.

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.

Population Reference No. 3

Preventive Breast Implant Explantation to Reduce Remote Risk of Anaplastic Large Cell Lymphoma

Clinical Context and Therapy Purpose

The purpose of breast implant explantation in asymptomatic individuals is to reduce remote risk of anaplastic large cell lymphoma (ALCL).

Anaplastic large cell lymphoma is a form of T-cell, non-Hodgkin lymphoma. According to National Comprehensive Cancer Network (NCCN) Consensus Guidelines published in 2019, breast implant-associated ALCL (BIA-ALCL) is commonly indolent and slow-growing, with an excellent prognosis (overall survival rate 94% and 91% at 3 and 5 years, respectively), especially when treated with surgery.^14, The most common presentation is a large spontaneous periprosthetic fluid collection occurring at least 1 year and on average 7 to 10 years following implantation.

The following PICO was used to select literature to inform this review.

Populations

The relevant population of interest is asymptomatic individuals with breast implants without documented implant rupture, infection, extrusion, Baker contracture, or surgical treatment of breast cancer.

Interventions

The therapy being considered is breast implant explantation.

Comparators

The comparator of interest is usual care without breast implant explantation.

NCCN consensus guidelines recommend that symptomatic effusions greater than 1 year after implantation should be tested for BIA-ALCL, but do not address screening in asymptomatic individuals.^14,

Outcomes

The general outcomes of interest are overall survival, disease-specific survival, morbid events, functional outcomes, health status measures, quality of life, treatment-related mortality, and treatment-related morbidity.

Specific outcomes include the incidence of ALCL and complications of explantation surgery.

Follow-up of 8 to 12 years following implantation is preferred.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;

• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies;

• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought;

• Consistent with a 'best available evidence approach,' within each category of study design, studies with larger sample sizes and longer durations were sought;

• Studies with duplicative or overlapping populations were excluded.

Review of Evidence

Systematic Reviews

Lynch et al (2021) conducted a systematic review of epidemiological studies of the risk of BIA-ALCL.^15, In addition to published literature, the study authors collected regulatory agency epidemiologic data, including from the FDA’s Manufacturer User Facility Device Experience (MAUDE) database and the American Society of Plastic Surgeons (ASPS) Patient Registry and Outcomes For breast Implants and Anaplastic large cell lymphoma (ALCL) etiology and Epidemiology (PROFILE) registry.

Eight studies met inclusion criteria (Table 1). The heterogeneity of reported data prevented meta-analysis and limited the calculation of combined risk estimates. The authors presented estimates by geographic location and by device. Two studies conducted in the US provided data to calculate the incidence rate, with estimates ranging from 1.46 per 100,000 person-years to 0.203 per 100,000 person-years (2.03 per million). The patient-specific cumulative risk within the US market ranged from 1.79 per 1,000 to 2.82 per 1,000. In the US, FDA estimates ranged from 1 in 3,817 to 1 in 30,000.

The authors concluded that population-based cohort studies and government databases consistently revealed an association between textured-surface breast implants and the incidence of BIA-ALCL. There was significant global geographic and manufacturer-specific variation in the risk of disease, but the data confirmed that Allergan textured devices carry substantially higher risk profiles than other devices regardless of population studied. No cases occurred solely in the context of a smooth surface breast implant. The evidence was limited by incomplete clinical data and a lack of long-term follow-up. The authors recommended greater standardization of reporting outcomes, and improving long-term follow-up to help establish more robust data.

Table 1. Epidemiological Studies Included in Lynch et al (2021)^15,

ALCL: anaplastic large cell lymphoma; NR: not reported.

Additional systematic reviews have similarly concluded that while rare, the incidence of BIA-ALCL is increasing, but limitations in the evidence base preclude an accurate estimation of its incidence.^24,25,26,

Regulatory Epidemiologic Database

In 2023, McCarthy et al published an updated report from the PROFILE registry.^27, From August 2012 to August 2020, a total of 330 suspected or confirmed cases of BIA-ALCL were reported to the registry, including 144 cases newly reported since the 2018 publication included in the systematic reviews discussed above. All cases occurred in individuals with a history of a textured device; there were no cases reported in an individuals with a confirmed smooth-only device history.

Section Summary: Preventive Breast Implant Explantation to Reduce Remote Risk of Anaplastic Large Cell Lymphoma

Systematic reviews of epidemiological studies and government regulatory epidemiologic databases have evaluated the risk of BIA-ALCL. Estimates varied widely, with the highest incidence associated with textured implant products that are no longer marketed in the US. 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.

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 epidemiologic 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.

Population Reference No. 4 

Preventive Breast Implant Explantation to Reduce Remote Risk of B Cell Lymphoma

Clinical Context and Therapy Purpose

The purpose of breast implant explantation in asymptomatic individuals is to reduce the remote risk of B cell lymphoma.

The following PICO was used to select literature to inform this review.

Populations

The relevant population of interest is asymptomatic individuals with breast implants without documented implant rupture, infection, extrusion, Baker contracture, or surgical treatment of breast cancer.

Interventions

The therapy being considered is breast implant explantation.

Comparators

The comparator of interest is usual care without breast implant explantation.

Outcomes

The general outcomes of interest are overall survival, disease-specific survival, morbid events, functional outcomes, health status measures, quality of life, treatment-related mortality, and treatment-related morbidity.

Specific outcomes include the incidence of B cell lymphoma and complications of explantation surgery.

Follow-up of 8 to 12 years following implantation is preferred.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;

• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies;

• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought;

• Consistent with a 'best available evidence approach,' within each category of study design, studies with larger sample sizes and longer durations were sought;

• Studies with duplicative or overlapping populations were excluded.

Review of Evidence

Case Reports

Recent case reports and small case series (N=3 to 8 cases) have described B cell lymphomas occurring in individuals with breast implants.^28,29,30, More data are needed to determine if breast implants are associated with an increased risk of B cell lymphoma.

Section Summary: Preventive Breast Implant Explantation to Reduce Remote Risk of B Cell Lymphoma

The evidence is limited to case reports and small case series describing occurrences of B cell lymphoma in individuals with breast implants.

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.

SUPPLEMENTAL INFORMATION

The purpose of the following information is to provide reference material. Inclusion does not imply endorsement or alignment with the evidence review conclusions.

Practice Guidelines and Position Statements

Guidelines or position statements will be considered for inclusion in ‘Supplemental Information' if they were issued by, or jointly by, a US professional society, an international society with US representation, or National Institute for Health and Care Excellence (NICE). Priority will be given to guidelines that are informed by a systematic review, include strength of evidence ratings, and include a description of management of conflict of interest.

American Association of Plastic Surgeons

In 2023, The American Association of Plastic Surgeons published a consensus statement on BIA-ALCL.^1, Recommendations were based on a systematic review of the literature and focused on textured-surface breast implants. Recommendations releveant to this evidence opinion included the following:

• "Use of macrotextured breast implants should be discontinued and surveillance of patients who received breast implants, smooth and textured surface, should be employed."

• "Implant manufacturers should disclose publicly or for independent academic analysis, their internal surveillance data, detailing both the number of BIA-ALCL cases reported to them and their country-specific and global sales and implantation figures for their respective breast implants."

• "No change in the use of smooth-surface breast implants is warranted at this time based upon BIA-ALCL."

• "Currently available evidence is sufficient to determine that the association of textured breast implants to BIA-ALCL does meet the definition of causation based on the Bradford Hill criteria."

• "An en bloc capsulectomy with explantation, resection of associated masses and excision of involved lymph nodes is recommended for patients with BIA-ALCL, when deemed appropriate as part of a multidisciplinary evaluation."

• "Based on the potential for risk reduction, prophylactic explantation of macrotextured surface implants can be deemed reasonable. Furthermore, after implementing a risk stratification and surveillance plan, coupled with an informed discussion about the benefits of surgery, it may also be considered reasonable for explantation of any type of textured implant...It’s important to differentiate between the notion of a procedure being reasonable—referring to the potential to mitigate risk—and it being advisable. While we acknowledge the reasonableness of these procedures, the determination of their advisability rests solely with the discretion of the surgeon in consultation with the patient." The panel further noted, "The final decision for explantation with or without capsulectomy should be shared between patient and surgeon following an evaluation of the patient’s goals balanced against the perceived benefits of the surgery and an individual surgical risk assessment. Importantly, this was based on a consensus recommendation as evidence remains limited on risk reduction. Different textured implants carry very different risks for BIA-ALCL, and patients differ in their comorbidities and risk tolerance. The final decision for explantation with or without capsulectomy should be shared between patient and surgeon following an evaluation of the patient’s goals balanced against the perceived benefits of the surgery and an individual surgical risk assessment."

• "Prophylactic explantation of the contralateral textured breast implant is recommended in patients with a confirmed BIA-ALCL diagnosis due to the risk of unrecognized or occult bilateral disease."

• "Preemptive notification of the risk of developing BIA-ALCL is recommended for all patients with textured breast implants."

American College of Radiology

In 2023, the American College of Radiology published Appropriateness Criteria for initial imaging in asymptomatic and symptomatic individuals with breast implants.^31, The document includes the following statements:

• "For asymptomatic patients with saline implants, no imaging is recommended. If concern for rupture exists, ultrasound is usually appropriate though saline rupture is often clinically evident."

• "There is no relevant literature to support the role of [breast ultrasound] in the evaluation of an asymptomatic patient with silicone implants that have been in place less
  than 5 years. Note that in the updated FDA recommendations for asymptomatic patients with silicone implants, the first US or MRI should be performed at 5 to 6 years
  postoperatively, then every 2 to 3 years thereafter."

• "In a patient with unexplained axillary adenopathy with current or prior silicone breast implants, ultrasound and/or mammography are usually appropriate, depending on age."

• "In a patient with concern for silicone implant rupture, ultrasound or MRI without contrast is usually appropriate."

• "In the setting of a patient with breast implants and possible implant-associated anaplastic large cell lymphoma, ultrasound is usually appropriate as the initial imaging."

National Comprehensive Cancer Network

The 2024 National Comprehensive Cancer Network (NCCN) guidelines ( v.2.2024) included a section in their breast cancer guidelines that was titled “Principles of Breast Reconstruction Following Surgery” which included the following relevant statements:^32,

• Breast reconstruction is elective and patients may choose to not have breast reconstruction. Individual patients present preoperatively with a variety of factors that may impact the choice of reconstruction, the risk of complications, donor site morbidity, and aesthetic result. Each of these factors must be taken into account, along with patient desire, to choose the optimal method of reconstruction.

• Selection of reconstruction option is based on an assessment of cancer treatment, patient body habits, obesity, smoking history, comorbidities, and patient concerns.

• The patient may have a strong feeling towards one form of reconstruction after being given the options. Breast reconstruction should be a shared decision.

In 2019, NCCN published consensus guidelines on the diagnosis and treatment of breast implant-associated ALCL but these guidelines did not address preventive explantation of implants to reduce risk.^14,

U.S. Preventive Services Task Force Recommendations

Not applicable

Medicare National Coverage

There is no national coverage determination. In the absence of a national coverage determination, coverage decisions are left to the discretion of local Medicare carriers.

Ongoing and Unpublished Clinical Trials

Some currently unpublished trials that might influence this review are listed in Table 2.

Table 2. Summary of Key Trials

NA: not applicable; NCT: national clinical trial.

References

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2. Allergan. Biocell Product Safety Alert. 2019. https://www.biocellinformation.com/. Accessed May 13, 2024.
3. Food and Drug Administration. 2021. FDA Strengthens Safety Requirements and Updates Study Results for Breast Implants. https://www.fda.gov/news-events/press-announcements/fda-strengthens-safety-requirements-and-updates-study-results-breast-implants. Accessed May 13, 2024.
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7. Samuels JB, Rohrich RJ, Weatherall PT, et al. Radiographic diagnosis of breast implant rupture: current status and comparison of techniques. Plast Reconstr Surg. Sep 1995; 96(4): 865-77. PMID 7652061
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12. Sánchez-Guerrero J, Colditz GA, Karlson EW, et al. Silicone breast implants and the risk of connective-tissue diseases and symptoms. N Engl J Med. Jun 22 1995; 332(25): 1666-70. PMID 7760867
13. Silverman BG, Brown SL, Bright RA, et al. Reported complications of silicone gel breast implants: an epidemiologic review. Ann Intern Med. Apr 15 1996; 124(8): 744-56. PMID 8633836
14. 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. Jan 31 2019; 39(Suppl_1): S3-S13. PMID 30715173
15. Lynch EB, DeCoster RC, Vyas KS, et al. Current risk of breast implant-associated anaplastic large cell lymphoma: a systematic review of epidemiological studies. Ann Breast Surg. 2021; 5. PMID 35415602
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17. McGuire P, Reisman NR, Murphy DK. Risk Factor Analysis for Capsular Contracture, Malposition, and Late Seroma in Subjects Receiving Natrelle 410 Form-Stable Silicone Breast Implants. Plast Reconstr Surg. Jan 2017; 139(1): 1-9. PMID 27627058
18. 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. May 2020; 73(5): 841-846. PMID 32008941
19. Nelson JA, Dabic S, Mehrara BJ, et al. Breast Implant-associated Anaplastic Large Cell Lymphoma Incidence: Determining an Accurate Risk. Ann Surg. Sep 01 2020; 272(3): 403-409. PMID 32694446
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21. Campanale A, Boldrini R, Marletta M. 22 Cases of Breast Implant-Associated ALCL: Awareness and Outcome Tracking from the Italian Ministry of Health. Plast Reconstr Surg. Jan 2018; 141(1): 11e-19e. PMID 29280858
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28. Medeiros LJ, Marques-Piubelli ML, Sangiorgio VFI, et al. Epstein-Barr-virus-positive large B-cell lymphoma associated with breast implants: an analysis of eight patients suggesting a possible pathogenetic relationship. Mod Pathol. Dec 2021; 34(12): 2154-2167. PMID 34226673
29. Evans MG, Miranda RN, Young PA, et al. B-cell lymphomas associated with breast implants: Report of three cases and review of the literature. Ann Diagn Pathol. Jun 2020; 46: 151512. PMID 32315816
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Codes

Applicable Modifiers

N/A

Policy History

Date

Action

Description