Medical Coverage Policy: 0048

The following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make coverage determinations. References to standard benefit plan language and coverage determinations do not apply to those clients.

Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer’s particular benefit plan document [Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Policies are based. For example, a customer’s benefit plan document may contain a specific exclusion related to a topic addressed in a Coverage Policy. In the event of a conflict, a customer’s benefit plan document always supersedes the information in the Coverage Policies.

In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specific instance require consideration of 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable laws/regulations; 3) any relevant collateral source materials including Coverage Policies and; 4) the specific facts of the particular situation.

Each coverage request should be reviewed on its own merits. Medical directors are expected to exercise clinical judgment where appropriate and have discretion in making individual coverage determinations. Where coverage for care or services does not depend on specific circumstances, reimbursement will only be provided if a requested service(s) is submitted in accordance with the relevant criteria outlined in the applicable Coverage Policy, including covered diagnosis and/or procedure code(s).

Reimbursement is not allowed for services when billed for conditions or diagnoses that are not covered under this Coverage Policy (see “Coding Information” below). When billing, providers must use the most appropriate codes as of the effective date of the submission. Claims submitted for services that are not accompanied by covered code(s) under the applicable Coverage Policy will be denied as not covered.

Coverage Policies relate exclusively to the administration of health benefit plans. Coverage Policies are not recommendations for treatment and should never be used as treatment guidelines. In certain markets, delegated vendor guidelines may be used to support medical necessity and other coverage determinations.

This Coverage Policy addresses removal of silicone gel-filled or saline-filled breast implants and subsequent surgical implantation of a new U.S. Food and Drug Administration (FDA)-approved breast implant. Coverage for breast implant removal varies across plans and may be governed by federal and/or state mandates. Please refer to the federal mandate on breast reconstruction and the customer’s benefit plan document for coverage details. Removal of either a saline-filled OR silicone gel-filled breast implant when associated with breast reconstruction following mastectomy or lumpectomy is considered medically necessary for ANY indication, including for the purpose of producing a symmetrical appearance of the nondiseased breast.

The removal of a silicone gel-filled breast implant with or without capsulectomy is considered medically necessary when:

• rupture of the implant and/or extrusion of the implant contents have been confirmed on imaging studies (i.e., mammography, ultrasound, or magnetic resonance imaging [MRI]).

The removal of EITHER a silicone gel-filled OR saline-filled breast implant, with or without capsulectomy, is considered medically necessary for at least ONE of the following indications:

• The implant is interfering with EITHER of the following:
  • diagnostic evaluation of a suspected breast cancer
  • adequate treatment of known breast cancer (e.g., obstructing radiation therapy)
• ANY of the following:
  • acute, persistent or recurrent local or systemic infection secondary to a breast implant when there is failure, contraindication, or intolerance to medical management, including antibiotics
  • exposure of a breast implant
  • Baker Stage IV capsular contracture
  • tissue necrosis secondary to the implant
  • diagnosis of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)
  • current use of Allergan BIOCELL textured breast implants and tissue expanders
  • diagnosis of breast implant-associated squamous cell carcinoma (BIA-SCC)

Removal of an intact silicone gel-filled breast implant when performed solely for suspected autoimmune disease or connective tissue disease or breast cancer prevention is not covered or reimbursable.

Medical Coverage Policy: 0048

The following are considered not medically necessary and/or cosmetic unless associated with breast reconstruction following mastectomy or lumpectomy:

• removal of a ruptured saline-filled implant in the absence of one of the indications listed above
• removal of any type of breast implant when performed for ANY of the following:
  • solely to treat psychological symptomatology or psychosocial complaints
  • solely to improve appearance
  • solely because of shifting or migration of the implant
  • removal of the implant in the opposite/contralateral breast, unless criteria are otherwise met for that breast implant for any other indication not otherwise mentioned above as covered
  • replacement of an implant following removal

Following removal of a breast implant, the subsequent surgical implantation of a new U.S. Food and Drug Administration (FDA)-approved breast implant is considered medically necessary for EITHER of the following:

• breast reconstruction of a diseased or affected breast following mastectomy or lumpectomy
• creation of a symmetrical appearance in the contralateral/nondiseased breast following mastectomy or lumpectomy in the opposite breast

General Background

Breast implants vary in shell surface (e.g., smooth versus textured), shape (e.g., round or shaped), profile (i.e., how far it protrudes), volume (i.e., size) and shell thickness. The primary components of most breast implants are a shell, otherwise known as the envelope or lumen, filler (e.g., saline, silicone gel or alternative) and a patch to cover the manufacturing hole. While most breast implants are single lumen (i.e., shell only), some breast implants are double lumen (i.e., one shell inside the other). Some breast implants are manufactured with a fixed volume or filler; some are filled during surgery; and some allow for adjustments of the filler volume after implantation. Breast implants are typically inserted under local or general anesthesia in an outpatient setting. If the procedure is done for cosmetic reasons, the incision is most commonly made along the lower edge of the areola, in the axilla or in the inframammary fold.

For postmastectomy reconstruction, the surgical incision is used and the implant is placed either deep in the breast on the pectoral fascia (i.e., submammary) or beneath the pectoralis major. Surgical complications associated with breast implantation are similar to those encountered with other breast surgeries: infection, bleeding, change in nipple sensation (e.g., hypersensitivity or hyposensitivity), malposition, delayed healing, and anesthetic accidents. Although breast implants may be inserted for either reconstructive or cosmetic reasons, clinically significant post-implant complications may occur, necessitating removal of the implants.

Local complications associated with breast implants include: capsular contracture, acute or persistent infection, silicone implant extrusion, tissue necrosis and silicone implant rupture. These conditions, when they become clinically significant, may require removal of the implant. Additionally, the presence of an implant may interfere with the diagnosis or treatment of breast cancer. Infections that may occur in or around an implant include wound infections, as well as infections within a Medical Coverage Policy: 0048 capsular contracture or as a result of a ruptured implant.

Toxic shock syndrome is a rare complication with multiple systemic symptoms but usually does not have inflammation or purulence at the surgical site (Lalani, et al., 2022; Kim et al., 2021). Removal of the implant may be necessary when the infection does not respond to antibiotics. Unstable or weakened tissue and/or interruption in wound healing may result in the implant breaking through the skin (exposing it) or extrusion. Necrotic tissue may form around the implant, requiring implant removal. Silicone gel-filled implant rupture may cause the contents to leak into the surrounding tissues.

U.S. Food and Drug Administration (FDA) In the FDA labeling for approved breast implants, Mentor™ Corp., Santa Barbara, CA; Allergan™ Corp. (formerly Inamed™), Irvine, CA; Ideal Implant ®, Inc., Dallas, TX; and Sientra™, Inc., Santa Barbara, CA are listed as manufacturers of silicone and saline breast implants (FDA, 2022).

• FDA-approved saline-filled implants:
  • Allergan (formerly Inamed) Natrelle Saline Breast Implants (P020056 and P990074)
    • In July 2019, Allergan voluntarily recalled Natrelle BIOCELL textured breast implants and tissue expanders from the market to protect patients from breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Smooth surfaced implants are not affected by this recall (FDA, 2021).
  • Mentor Saline-Filled and Spectrum® Breast Implants (P990075)
  • Ideal Implant Saline-Filled Breast Implant (P120011)
  The FDA approved saline-filled breast implants for breast augmentation in women age 18 or older and for breast reconstruction in women of any age. They are also used in revision surgeries, which correct or improve the result of an original surgery.
• FDA-approved silicone gel-filled breast implants:
  • Allergan Natrelle® Silicone Gel-Filled Breast Implants (P990074 and P020056)
    • In July 2019, Allergan voluntarily recalled Natrelle BIOCELL textured breast implants and tissue expanders from the market to protect patients from BIA-ALCL. Smooth surfaced implants are not affected by this recall (FDA, 2021).
  • Allergan Natrelle® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implant (P040046)
    • In July 2019, Allergan voluntarily recalled Natrelle BIOCELL textured breast implants and tissue expanders from the market to protect patients from BIA-ALCL. Smooth surfaced implants are not affected by this recall (FDA, 2021).

• Mentor MemoryGel® Silicone Gel-Filled Breast Implants (P030053)
• Mentor MemoryShape® Silicone Gel-Filled Breast Implant (P060028)
• Sientra Silicone Gel Breast Implant (P070004)

The FDA labeling for silicone and saline breast implantation states breast implant surgery should not be performed in women with: an active infection, existing cancer or precancer of a breast that has not been adequately treated, or who are pregnant or nursing. On September 8, 2022, updated Mar 22, 2023, the FDA issued a safety communication about reports of cancers, including squamous cell carcinoma (SCC) and various lymphomas, in the scar tissue (capsule) that forms around breast implants. The various lymphomas are different than the previously reported Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). The safety communication states that the FDA believes the occurrence of SCC or various lymphomas in the capsule are rare, however the incidence rate and risk factors for are unknown. Reported signs and symptoms included swelling, pain, lumps or skin changes. The FDA does not recommend the removal of breast implants because of this safety communication.

Medical Coverage Policy: 0048

On October 27, 2021, the FDA issued new labeling requirements for all legally marketed breast implants due to ongoing concerns about the possible risk of systemic illness or anaplastic large cell lymphoma in patients with silicone gel-filled breast implants. Additionally, the sale and distribution of breast implants will be restricted only to health care providers and facilities that provide information to patients using the "Patient Decision Checklist." The manufacturers are required to post the following updated device labeling to their websites:

• Patient decision checklist, which must be reviewed with the prospective patient by the health care provider to help ensure the patient understands the risks, benefits and other information about the breast implant device. The patient must be given the opportunity to initial and sign the patient decision checklist and it must be signed by the physician implanting the device.
• “Boxed warning. Updated silicone gel-filled breast implant rupture screening recommendations.”
• Device description with a list of specific materials in the device.
• Patient device card.

In June 2011 (updated 2018), the FDA released a report updating the clinical and scientific information for silicone gel-filled breast implants, including preliminary safety data from studies conducted by the manufacturers as a condition of their November 2006 approval. The conclusion in the report states that, “Based on the totality of the evidence, the FDA believes that silicone gel- filled breast implants have a reasonable assurance of safety and effectiveness when used as labeled. Despite frequent local complications and adverse outcomes, the benefits and risks of breast implants are sufficiently well understood for women to make informed decisions about their use. Manufacturers and physicians should continue to provide balanced and up-to-date information to women considering breast implants to help inform their decisions” (FDA, 2018).

Implant Rupture and Deflation

Breast implants are not considered lifetime devices. Trauma is a common cause of rupture. Some implants will spontaneously deflate or rupture immediately after implantation; some will deflate over time, while others may remain intact for 10 or more years following surgery.

Silicone Gel-Filled Implant Rupture

Silicone gel-filled implants may rupture as the result of the age of the implant, the presence of a capsular contracture, or trauma.

When silicone gel-filled implants rupture, a patient may experience the following symptoms:

• decreased breast size
• nodules
• asymmetrical appearance of the breasts
• pain, tenderness
• swelling
• tingling or numbness

Other ruptures may be completely asymptomatic (i.e., silent ruptures). Silicone gel that extrudes beyond the reactive fibrotic capsule (i.e., extracapsular rupture) that forms surrounding the implant may migrate away from the breast. The free, migrated silicone may result in the formation of granulomas in the breast or other areas such as the chest wall or axillae. Some granulomas can migrate to lymph nodes in the axillae and may even mimic cancer. Extruded silicone gel that is contained within the fibrotic capsule is referred to as an intracapsular rupture.

MRI may be used to view the prosthesis in the breast and assist in determining if leakage of the materials has occurred. MRI may be medically necessary to confirm suspected silicone gel-filled breast implant rupture when this diagnosis cannot be confirmed by mammography or breast ultrasound.

In 2001 (reviewed 2018), the FDA completed a study on the health effects of ruptured silicone gel breast implants. The goal of this study was to determine if a correlation exists between loose silicone that migrates into the tissue and the development or progression of collagen vascular disease. A total of 343 women volunteered to participate in this study via a questionnaire concerning joint pain, swelling or stiffness, rash on the breasts and chest, and fatigue. These participants were also questioned about being diagnosed with any illnesses such as scleroderma, fibromyalgia, chronic fatigue syndrome or lupus. All participants underwent MRI to determine if their implants were intact or ruptured with extruded silicone gel. This study concluded that, for women who reported fibromyalgia, MRI did confirm that silicone gel had consistently extruded outside of the fibrous scar.

Saline-Filled Implant Rupture

Saline-filled breast implants may deflate or rupture when saline solution leaks through an unsealed or damaged valve or through a break in the implant shell. Implant deflation may occur in the immediate postoperative period or slowly develop over a period of time. An alteration in the appearance of the breast may result; however, the presence of a ruptured or leaking saline-filled implant does not lead to any medical complications that require intervention, such as removal of the implant. The leakage or rupture of a saline-filled breast implant, in the absence of other signs or symptoms (e.g., significant capsular contracture or persistent infection), is not a medically necessary indication to undergo capsulectomy and breast implant removal.

Periprosthetic Capsular Contracture

When a breast implant is inserted, a scar capsule forms around it as part of the natural healing process. Capsular contracture occurs when the scar tissue or capsule that normally forms around the implant tightens, ultimately squeezing the implant. Significant contracture may result in severe pain or may be associated with subclinical infection. The presence of a contracture may also interfere with the ability to diagnose or treat breast cancer.

The degree of periprosthetic contracture is often classified by using the Baker grading system. The four Baker grades are as follows (American Society of Plastic Surgeons [ASPS], 2018): Grade 1: Grade one capsular contracture is asymptomatic (producing or showing no symptoms). The formation of scar tissue around the implant does not interfere with the size, shape or texture of the breasts. The breasts look natural and remain soft to the touch. Grade 2: Grade two capsular contracture usually presents itself with only minor cosmetic symptoms.

The breasts will usually appear normal in shape but feel somewhat firm to the touch.

Grade 3:

Grade three capsular contracture presents itself with obvious cosmetic symptoms. The breasts will be firm to the touch and appear abnormal, e.g., they will be overly round, hard-looking and the nipples may be misshapen. However, this grade of capsular contraction often doesn't cause much (if any) pain.

Grade 4:

Like grade three capsular contracture, grade four capsular contracture causes the breasts to become hard and misshapen. Patients with grade four capsular contracture also experience breast soreness; their breasts will often be tender and painful to the touch.

Treatment of clinically significant contractures (i.e., Baker grade IV) can range from removing the capsular tissue (e.g., capsulectomy) to removal of the implant itself. Infections that occur due to the presence of a breast implant rupture and/or capsular contracture are typically treated with antibiotics.

The pathogenesis of fibrous capsular contracture after breast augmentation with implants is still under debate and varies from patient to patient. In a prospective study by Pajkos et al. (2003), biofilm, in particular, S. epidermis biofilm, was found in a significant proportion of patients with capsular contracture. This thin layer of bacteria can develop around the implant(s) after a type of bacteria (e.g. staph bacteria) is introduced to the breast cavity during surgery.

Other theories regarding the development of capsular contracture include genetics, hematomas and seromas (ASPS, 2018).

Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)

Individuals with breast implants have a risk of developing breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). BIA-ALCL is not breast cancer rather it is a rare type of non-Hodgkin’s lymphoma (cancer of the immune system). Symptoms are persistent swelling, presence of a mass or pain in the area of the breast implant. These symptoms can occur years after the implantation. In most cases, BIA-ALCL is found in the fluid surrounding the implant (seroma) or contained within the fibrous scar capsule, but in some cases, it can spread throughout the body.

BIA-ALCL is diagnosed by pathology/cytology testing of the seroma fluid or mass, with Wright Giemsa stained smears and cell block immunohistochemistry/flow cytometry testing for cluster of differentiation (CD30) and Anaplastic Lymphoma Kinase (ALK) markers. Precise risks are difficult to determine due to lack of information about how many patients have received breast implants in the U.S. and worldwide (FDA, 2019).

FDA recommendations state that BIA-ALCL has generally only been identified in patients with symptoms such as pain, lumps, persistent swelling, or breast asymmetry that occur years after implantation. Implant removal in patients without signs or symptoms for prophylactic reasons is not recommended. The FDA recommends reporting all BIA-ALCL cases to MedWatch, the FDA Safety Information and Adverse Event Reporting program and case reports to the PROFILE Registry.

The PROFILE Registry was developed in 2012. On July 24, 2019, the FDA requested that Allergan, the manufacturer of a specific type of textured implant, recall specific models of its textured breast implants from the U.S. market due to the risk of BIA-ALCL. The FDA's analysis in 2019 was attributed to a worldwide reported total of 573 unique BIA-ALCL cases including 33 patient deaths. Of the 573 cases of BIA-ALCL, 481 are reported to have Allergan breast implants at the time of diagnosis. (FDA, 2019; FDA, 2019).

As of April 1, 2022, there have been 1,130 unique BIA-ALCL cases combined in the United States and globally with 59 deaths (FDA, 2022).

The National Comprehensive Cancer Network^® (NCCN) Clinical Guidelines in Oncology^™ T Cell Lymphomas

The NCCN reports that in recent years the instances of BIA- ALCL has increased. Initial workup for BIA-ALCL includes ultrasound of the breast and axilla or breast MRI in selected cases or PET/CT scan in selected cases. If ultrasound is inconclusive, breast MRI is recommended. Cytology with cell block preparation and flow cytometry immunophenotype are essential to confirm the diagnosis of BIA-ALCL. A biopsy is useful if there is a solid mass associated with the implant.

Referral to a plastic surgeon for management of an implant seroma is recommended if the pathologic diagnosis is negative for lymphoma. A second pathology consultation is recommended in a tertiary cancer center if the pathologic diagnosis is indeterminate of lymphoma. Individualized management by a multidisciplinary team is recommended for histologically confirmed BIA-ALCL.

The NCCN treatment recommendations for patients with BIA-ALCL include total capsulectomy with removal of the breast implant and excision of any associated mass with a biopsy of suspicious lymph nodes for all patients (NCCN, 2023).

According to the American Society of Plastic Surgeons (ASPS) statement titled \

The American Academy of Neurology, the American College of Surgeons, the American College of Rheumatology, the American Medical Association, the American Society of Plastic Surgeons and the American Society of Clinical Oncology all agree with the findings of a 2000 study of 13,500 women researched by the National Cancer Institute.

This study found no correlation between breast implants and the development of connective or autoimmune disease or an increase in breast cancer risk (Nelson, 2000). McLaughlin et al. (2007) summarized the epidemiologic evidence regarding the safety of silicone gel-filled breast implants. The topics included in this report included CTD, suicide, offspring effects, neurologic disease, implant rupture, and local perioperative complications requiring the need for additional surgery.

Based on the review of the published epidemiologic literature on the safety of breast implants, through September 2007, the authors reported that \