Breast Implant Removal

Number: 0142

Policy

Aetna considers the removal of breast implants medically necessary for members who meet the following selection criteria.

For members who have undergone either cosmetic augmentation mammoplasty or breast reconstruction following a medically necessary mastectomy (e.g., mastectomy for breast cancer or a prophylactic mastectomy (see CPB 0227 - BRCA Testing, Prophylactic Mastectomy, and Prophylactic Oophorectomy)), removal of a breast implant and capsulectomy or capsulotomy is considered medically necessary for any of the following indications:

1. Breast cancer in the implanted breast or remnant, or in the contralateral breast, where implant removal is necessary to excise the breast cancer; or
2. Breast implant-associated anaplastic large cell lymphoma; or
3. Extrusion of implant through skin, or
4. Implants complicated by recurrent infections, or
5. Implants with Baker Class IV contracture Footnotes^* (see Appendix) associated with severe pain, or
6. Implants with severe contracture Footnotes^* that interferes with mammography, or
7. Intra- or extra-capsular rupture of silicone gel-filled implants, or
8. Members who exhibit cutaneous hypersensitivity-like reactions associated with breast implants and who have failed conventional treatments (e.g., antibiotics, oral corticosteroids, and topical corticosteroids); or
9. Persons with textured implants that have been withdrawn from the market at the request of the FDA (Allergan Biocell); or
10. Persons with textured breast implants who exhibit persistent symptoms such as pain, lumps, swelling, or asymmetry that occur after the surgical incision has fully healed.
    

For members whose breast reconstruction followed a medically necessary mastectomy (i.e., mastectomy for breast cancer or a prophylactic mastectomy), removal of a breast implant and capsulectomy or capsulotomy is also considered medically necessary for these additional indications:

1. Baker Class III contracture Footnotes^* (see Appendix), or
2. Extra-capsular rupture of saline implant if the rupture compromises the cosmetic outcome of the implant.

Aetna considers removal of ruptured saline-filled breast implants not considered medically necessary for members who have previously undergone cosmetic breast augmentation mammoplasty.

If any of the above criteria for removal of a breast implant is met unilaterally, Aetna also considers medically necessary removal of the implant and capsulectomy or capsulotomy in the other breast if both implants are removed at the same time.

Requests for the removal of breast implants for any of the following indications is subject to medical review:

1. Baker Class III contracture Footnotes^* (see Appendix) that does not follow a medically necessary mastectomy; or
2. Implant removal for biopsy of breast mass that has not been proven to be cancerous; or
3. Implant removal for a mastectomy or lumpectomy that can be performed with the implant in place.

Footnotes^* Note on Documentation Requirements: Photographic documentation of contracture may be required.

Aetna considers autologous fat grafting (lipoaugmentation) following breast implant removal as cosmetic, where the implant was placed for cosmetic indications (i.e.,not for mastectomy for breast cancer or prophylactic mastectomy).

Silicone Implant Removal for Autoimmune Disease

Aetna does not consider either of the following medically necessary:

1. IgG testing in connection with silicone implants (the development of IgG antibodies is neither specific to silicone implants nor indicative of autoimmune disorders); or
2. Removal of silicone implants for autoimmune disease unless the member meets at least one of the selection criteria listed above (e.g., rupture of silicone-gel filled implant, etc.).

Reinsertion of Breast Implants

Although Aetna considers the removal of breast implants medically necessary for medical indications even if the implants were originally inserted for cosmetic purposes, Aetna considers the re-insertion of new breast implants cosmetic in this situation.  Aetna considers medically necessary the insertion of initial breast implants and the replacement of breast implants inserted following a medically necessary mastectomy (i.e., mastectomy for breast cancer or a prophylactic mastectomy) or for women with Poland's syndrome meeting the criteria in CPB 0272 - Pectus Excavatum and Poland's Syndrome: Surgical Correction.

See also CPB 0185 - Breast Reconstructive Surgery.

Background

At the time of the Food and Drug Administration (FDA) hearing on silicone breast implants in February of 1992, the FDA advised that ruptured silicone implants should be removed since the health risks of extruded silicone are not known.  At the same time, the FDA panel acknowledged that asymptomatic rupture may be present in up to 4 % of women with silicone implants, but the FDA specifically did not recommend screening for asymptomatic ruptures.

Rupture of silicone implants can be subdivided into 2 categories:

1. intra-capsular and
2. extra-capsular. 

After implantation, a reactive fibrous capsule is formed around the implant.  If the extruded silicone is contained by this fibrous capsule the rupture is termed intra-capsular.  If the silicone gel is extruded beyond the capsule, the rupture is termed extra-capsular.  Extra-capsular silicone can induce granulomatous reaction and can occasionally migrate to the axillary lymph nodes, producing a lymphadenopathy, which can mimic cancer.  Clinically, extra-capsular ruptures are often associated with a change in size and consistency of the breast.  Extra-capsular ruptures can usually be identified on mammography or other imaging studies.  Explantation of these implants is clearly indicated.

The health consequences of intra-capsular ruptures are uncertain since theoretically the silicone is contained within the fibrous capsule.  Furthermore it is known that intact implants routinely “bleed” microscopic silicone particles, which are also contained within the fibrous capsule.  Nevertheless, an intra-capsular rupture can evolve to an extra-capsular rupture and the FDA has indicated that ruptured implants, whether intra-capsular or extra-capsular, should be explanted as well.

Breast Implant-Associated Anaplastic Large Cell Lymphoma

Peters (2014) stated that since 1997, reports from the scientific community have suggested a possible association, without causation, between breast implants and anaplastic large cell lymphoma (ALCL).  Analysis of these patients has been challenging.  Many studies have been under-reported while others have been duplicated.  In 2011, a FDA “white paper” analyzed 34 of the 60 cases reported worldwide.  All 34 patients had undergone secondary surgery for breast swelling, firmness or pain; ALCL was an incidental finding.  Diagnosis of ALCL is made by hematoxylin and eosin histology and immunochemistry for the CD30 marker.  Anaplastic large cell lymphoma occurred with all types of implants.  Subsequent studies have suggested that textured implants may have a greater risk.  In all cases, ALCL cells were found in the capsule, in the seroma or within a mass adjacent to the implant.  There was no invasion of cells beyond the capsule into the breast parenchyma.  From the FDA study, the risk of developing ALCL after receiving implants appears to be approximately 1 in 1,000,000 per year.  All cases appear to be negative for the anaplastic lymphoma kinase marker; ALCL in most of these patients may represent a new entity with less aggressive behavior.  In most patients with capsule-confined disease, proper management may prove to be implant removal and capsulectomy.  Patients with a distinct mass adjacent to their implant may have a more aggressive clinical course that may become systemic.  They may require chemotherapy in addition to implant removal and capsulectomy.  All cases of ALCL should be referred to an appropriate specialist and reported to the FDA.

Hwang and colleagues (2015) noted that breast implant-associated ALCL is a rare new clinical entity.  The incidence is 0.3 % per 100,000 women per year.  Patients present with non-specific implant-related complications resulting in delayed diagnosis.  These investigators presented such a case to raise awareness and discussed management.  A 48-year old female presented with a 3-month history of left breast pain and swelling.  She had undergone multiple bilateral augmentations 8 years previously.  Triple assessment revealed a seroma, and a magnetic resonance imaging (MRI) scan excluded implant rupture.  Cytology showed a typical cells with mitotic activity that lead to removal of implants and a left capsulectomy.  Final histology revealed an anaplastic lymphoma kinase (ALK) negative ALCL confined to the capsule.  A CT scan and bone marrow biopsy excluded systemic disease, but due to later identified B symptoms, she received CHOP chemotherapy under the care of the hematologists.  ALK-negative ALCL is associated with breast implants, and any persistent late onset seroma or breast symptoms should raise the suspicion of ALK-negative ALCL as a differential diagnosis.  The authors stated that the recommended treatment is surgical removal of the implant including a full capsulectomy, highlighting the suspicion of ALCL to the pathologist.  Exclusion of systematic disease is also recommended in all patients, and the need for adjuvant therapy should be addressed on an individual case basis.  For disease confined to the capsule, adjuvant chemoradiotherapy is not needed.

Locke and Lofts (2017) stated that ALCL has recently been reported in women with breast implants.  The incidence of breast implant-related ALCL is extremely rare and most surgeons would not expect to see this disease in their career.  However, the senior author has had 3 women present to his practice with ALCL over a 2-year period.  The 3 patients and their presentation were reviewed to establish the presenting complaint in each case of subsequently diagnosed ALCL.  Literature was reviewed to establish appropriate treatment protocols for any subsequent patients.  The average time between 1st implant placement and presentation with breast implant-associated ALCL was 13.3 years (range of 10 to 16 years) and age at presentation was 49 years (range of 45 to 53 years).  Each presentation was somewhat different, being a palpable mass, a painless seroma and a painful seroma.  Both patients with seroma underwent ultrasound-guided aspiration of fluid which confirmed ALCL.  All patients underwent implant removal and complete capsulectomy.  The patient with a mass at presentation initially declined adjuvant treatment, but subsequently developed an ALCL-associated seroma and was treated with surgery and post-operative chemotherapy.  The authors concluded that patients with breast implant-associated ALCL can present with different clinical signs and symptoms.  Late seroma is a relatively common presentation of breast implant-associated ALCL.  While firm guidelines for the management of breast implant-related ALCL are lacking, the authors suggested that any late seroma in the absence of infection should be managed with aspiration and cytological analysis of the fluid.

Laurent et al (2016) stated that ALK-negative ALCL associated with breast implant (i-ALCL) has been recently recognized as a distinct entity.  Among 4,3830 lymphomas registered in the French Lymphopath Network since 2010, 300 breast lymphomas comprising 25 peripheral T-cell lymphomas were reviewed.  Among peripheral T-cell lymphomas, ALK-negative ALCL was the most frequent and all of them were associated with breast implants.  Since 2010, all i-ALCL cases were collected from different institutions through the Lymphopath Network.  These researchers retrospectively analyzed immuno-morphologic features, molecular data and clinical outcome of 19 i-ALCLs.  The median age of the patients was 61 years and the median length between breast implant and i-ALCL was 9 years.  Most implants were silicone-filled and textured.  Implant removal was performed in 17/19 patients with additional treatment based on mostly CHOP or CHOP-like chemotherapy regimens (n = 10/19) or irradiation (n = 1/19); CHOP alone or ABVD following radiation without implant removal have been given in 2 patients.  The 2 clinical presentations , namely effusion and less frequently tumor mass correlated with distinct histopathologic features: in in-situ i-ALCL (anaplastic cell proliferation confined to the fibrous capsule) and infiltrative i-ALCL (pleomorphic cells massively infiltrating adjacent tissue with eosinophils and sometimes Reed-Sternberg-like cells mimicking Hodgkin lymphoma).  Malignant cells were CD30-positive, showed a variable staining for EMA and were ALK negative.  Most cases had a cytotoxic T-cell immunophenotype with variable T-cell antigen loss and pSTAT3 nuclear expression.  T-cell receptor genes were clonally re-arranged in 13/13 tested cases.  After 18 months of median follow-up, the 2-years OS for in-situ and infiltrative i-ALCL was 100 % and 52.5 %, respectively.  The authors concluded that in-situ i-ALCLs have an indolent clinical course and generally remain free of disease after implant removal.  However infiltrative i-ALCLs could have a more aggressive clinical course that might require additional therapy in addition to implant removal.

Clemens et al (2016) evaluated the effectiveness of different therapies used in patients with breast implant-associated ALCL (BIA-ALCL) to determine an optimal treatment approach.  These investigators applied strict criteria to pathologic findings, assessed therapies used, and conducted a clinical follow-up of 87 patients with BIA-ALCL, including 50 previously reported in the literature and 37 unreported.  A Prentice, Williams, and Peterson model was used to assess the rate of events for each therapeutic intervention.  The median and mean follow-up times were 45 and 30 months, respectively (range of 3 to 217 months).  The median overall survival (OS) time after diagnosis of BIA-ALCL was 13 years, and the OS rate was 93 % and 89 % at 3 and 5 years, respectively.  Patients with lymphoma confined by the fibrous capsule surrounding the implant had better event-free survival (EFS) and OS than did patients with lymphoma that had spread beyond the capsule (p = 0.03).  Patients who underwent a complete surgical excision that consisted of total capsulectomy with breast implant removal had better OS (p = 0.022) and EFS (p = 0.014) than did patients who received partial capsulectomy, systemic chemotherapy, or radiation therapy.  The authors concluded that surgical management with complete surgical excision is essential to achieve optimal EFS in patients with BIA-ALCL.

Breast implant-associated large cell lymphoma (BIA-ALCL) is a type of non-Hodgkin’s lymphoma (NHL). The FDA does not recommend removal of textured breast implants unless the patient exhibits symptoms. When BIA-ALCL occurs, it has been identified most frequently in patients undergoing implant revision operations for late onset, persistent seroma.  Because it has generally only been identified in patients with symptoms such as pain, lumps, swelling, or asymmetry that occur after the surgical incision has fully healed, Breast implant removal in patients without symptoms or other abnormality is not recommended.

The FDA (2019) notes that in most cases, BIA-ALCL is found in the fluid and scar tissue near the breast implant, but in some cases, it can spread throughout the body.  In most patients, BIA-ALCL is treated successfully with surgery to remove the implant and surrounding scar tissue, and in some patients, also treatment with chemotherapy and radiation therapy.  The main symptoms of BIA-ALCL are persistent swelling or pain in the area of the breast implant.  These symptoms may occur well after the surgical incision has healed, often years after implant placement.  Evaluation for BIA-ALCL usually entails a physical examination, imaging, and/or assessment of the fluid or tissue around the breast implant.  The FDA states that patients with confirmed BIA-ALCL should undergo implant removal with removal of the surrounding scar capsule, which is a more extensive operation than implant removal alone.

Cutaneous Hypersensitivity-Like Reactions Associated With Breast Implants

Labadie and colleagues (2018) noted that breast implantation is an increasingly common procedure for both cosmesis and reconstruction.  Risk of cutaneous reactions to breast implants is low and typically described in post-surgical settings.  Adverse skin hypersensitivity-like reactions to implants have also been reported but are not well-described.  These investigators reviewed the scientific literature on cutaneous hypersensitivity-like reactions to breast implants.  They carried out a systematic literature review using PubMed. Articles pertaining to breast implants and cutaneous hypersensitivity-like reactions in humans.  A total of 10 studies on hypersensitivity-like reactions from breast implants were included in the review.  Potential allergenic compounds in breast implants include silicone, polyurethane texturing, and acellular dermal matrix.  Peri-vascular lymphocytic infiltrate was a common finding on histopathology.  Patch testing and pre-operative silicone cube implantation were used to determine sensitivity.  Attempted treatments included topical and oral corticosteroids, and antibiotics.  Most cases required implant removal for resolution of symptoms.  The authors concluded that cutaneous hypersensitivity-like reactions to breast implants appeared to be rare complications, sometimes necessitating implant removal.

Autologous Fat Grafting (Lipoaugmentation) following Breast Implant Removal

Chiu (2016) noted that patients who were diagnosed with symptomatic capsular contracture or with safety concerns for the implant would be often reluctant to accept the operation of implant exchange, choosing instead removal without exchange or taking other options to rebuild their breasts.  These patients may benefit from augmenting the overlying soft tissue of the breasts with autologous fat grafting after removing the prosthesis.  This investigators carried out a retrospective analysis of the patients receiving fat grafting for breast augmentation after implant removal.  Between March 2011 and November 2013, a total of 27 patients received autologous fat grafting after breast implant removal.  Objective evaluation was made by measuring the change in breast thickness with ultrasonography (US) taken before and after the treatment.  Aesthetic evaluation was performed using a 5-point Likert scale for patient satisfaction and comparing pre-operative and post-operative digital photographs for physician satisfaction.  The mean breast thickness change was 13.1 mm (SD = 3.3) which was an increment by 154 % in comparison to the averaged breast thickness of 8.5 mm after implant removal.  The results of patient satisfaction and physician satisfaction were 16.3 (SD = 1.2) and 16.7 (SD = 1.6).  Complications included recipient site infection, fat necrosis, and small areas of induration.  The overall complication rate was 22.2 % (6 of 27).  The author concluded that autologous fat grafting was beneficial for the correction of deformed breasts after implant removal; with its preferential fill qualities, the wide cleavage and excessive upper pole fullness associated with existing implants could also be corrected.

Mess (2018) stated that breast implant removal followed by fat transfer to the breast (lipoaugmentation) is a newer procedure and as such there is a need for empirical aesthetic comparisons between breast augmentation with implants versus fat transfer.  A survey was created using standardized before and after photographs of 12 patients who underwent implant removal and lipoaugmentation; 4 photographs of breasts that had no surgery were used as controls, with identical before/after photographs.  The survey was administered to 96 respondents from the general population and 10 plastic surgeons.  Respondents were asked to rate the breasts using a 5-point Likert scale without procedural knowledge.  The responses were evaluated using parametric statistical t-tests to compare responses to implants versus fat transfer in terms of their respective attractiveness, naturalness, size, symmetry, and femininity.  Fat transfer was significantly preferred to implants on all 5 measures; attractiveness, naturalness, size, symmetry, and femininity.  Fat transfer was significantly preferred to implants by a margin of +0.36 average on 1-5 scale, which was approximately 1/3 of a Likert interval on all measures.  Plastic surgeons took significantly longer than the general population to complete the survey and preferred fat transfer over implants to a higher degree.  The author concluded that lipoaugmentation could provide a favorable aesthetic outcome in women seeking implant removal.  The general public could be conveniently surveyed via crowd sourcing, and their aesthetic judgments largely mirrored those of trained and experienced plastic surgeons.  The author noted that patients weighing breast implant removal or breast implant revision could consider this study in their decision-making.

Furthermore, an UpToDate review on “Complications of reconstructive and aesthetic breast surgery” (Nahabedian and Gutowski, 2018) does not mention autologous fat grafting / lipoaugmentation as a management option.

Appendix

Table: Baker Classification

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

Table: CPT Codes / HCPCS Codes / ICD-10 Codes

Code	Code Description
Information in the [brackets] below has been added for clarification purposes.   Codes requiring a 7th character are represented by "+":
CPT codes covered if selection criteria are met:
19328	Removal of intact mammary implant
19330	Removal of mammary implant material
19370	Open periprosthetic capsulotomy, breast
19371	Periprosthetic capsulectomy, breast
CPT codes not covered for indications listed in the CPB:
15769	Grafting of autologous soft tissue, other, harvested by direct excision (eg, fat, dermis, fascia)
15771	Grafting of autologous fat harvested by liposuction technique to trunk, breasts, scalp, arms, and/or legs; 50 cc or less injectate
+15772	each additional 50 cc injectate, or part thereof (List separately in addition to code for primary procedure)
15773	Grafting of autologous fat harvested by liposuction technique to face, eyelids, mouth, neck, ears, orbits, genitalia, hands, and/or feet; 25 cc or less injectate
+15774	each additional 25 cc injectate, or part thereof (List separately in addition to code for primary procedure)
20926	Tissue grafts, other (eg, paratenon, fat, dermis) [when the implant was placed for cosmetic indications]
Other CPT codes related to the CPB:
19120 - 19126	Breast, excision of cyst, fibroadenoma, or other benign or malignant tumor, aberrant breast tissue, duct lesion, nipple or areolar lesion (except 19300), open, male or female, one or more lesions
19316 - 19380	Breast, repair and/or reconstruction procedures
Other HCPCS codes related to the CPB:
L8020 - L8039	Breast prostheses
L8600	Implantable breast prosthesis, silicone or equal
ICD-10 codes covered if selection criteria are met:
C50.011 - C50.929	Malignant neoplasm of breast
C84.60 - C84.69	Anaplastic large cell lymphoma, ALK-positive
C84.70 - C84.79	Anaplastic large cell lymphoma, ALK-negative
N63.0 - N63.42	Unspecified lump in breast
N64.4	Mastodynia
R52	Pain, unspecified
T85.41x+ - T85.49x+	Mechanical complication of breast prosthesis and implant
T85.79x+	Infection and inflammatory reaction due to other internal prosthetic devices, implants, or grafts

The above policy is based on the following references: