Appeal type: Medical Necessity
Decision: Upheld Decision of Health Plan

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for surgery to remove and replace bilateral implants with smooth silicone implants.The present best medical opinion is that prophylactic replacement of textured breast implants with smooth implants to reduce the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is not medically necessary, and replacement of textured breast implants with smooth implants for the treatment of capsular contracture is not medically indicated. Regarding textured breast implants and BIA-ALCL with risk of lymphoma, the U.S. Food and Drug Administration (FDA) stated in 2019 that current literature reports various estimates for the incidence of BIA-ALCL. These estimated incidence rates range from a high of 1 per 3,817 patients to a low estimate of 1 in 30,000. The FDA stated that while the majority of patients who develop BIA-ALCL have had textured implants, and most cases reported in the literature describe individuals who have had textured implants, there have been reports of BIA-ALCL in patients with smooth-surfaced implants and many reports do not include the surface texture of the implant at the time of diagnosis. At this time, the European Society of Breast Cancer Specialists (EUSOMA) also recommends that textured implants can safely continue to be used with fully informed consent, and that women who have these type of implants already in place do not need to remove or substitute them. In this case, the patient was examined and was reported to have soft breasts, Baker Grade II, with no report of pain or tenderness. After a discussion about textured breast implants and BIA-ALCL, the patient decided to replace her textured silicone reconstructive breast implants with smooth breast implants. A subsequent MRI showed no evidence of capsulitis. On a return visit six months later, the patient was reported to have hard and tender breasts with Grade IV capsular contractures and severe tenderness. The provider diagnosed capsular contracture and proposed removing the textured implants and replacing them with smooth implants without capsulectomies. Textured breast implants, however, are not a cause of capsular contracture, and they are often used to try to reduce the risk of capsular contracture. Replacing textured implants with smooth implants is not a treatment for capsular contracture. Accordingly, the requested surgery to remove and replace bilateral implants with smooth silicone implants is not medically necessary to treat the patients condition.The California reconstructive surgery statute requires health insurers to cover reconstructive surgeries, defined as surgery performed to correct or repair abnormal structures of the body caused by congenital defects, developmental abnormalities, trauma, infection, tumors, or disease to do either of the following: (1) to improve function; or (2) to create a normal appearance, to the extent possible. In this case, the patients reconstructed breasts constitute abnormal structures of the body caused by a tumor. The present request to remove and replace bilateral implants with smooth silicone implants, however, will not improve function and will not improve appearance in the absence of confirmed significant capsular contraction. MRI showed intact implants with minimal fluid bilaterally which was not significant, and there was no suggestion of significant active capsulitis. In addition, the submitted photographs of the patient show well healed implant breast reconstructions that are consistent with Grade II capsular contracture. Under these circumstances, the requested procedure would not provide more than a minimal improvement in the appearance of the patient. Therefore, the requested surgery to remove and replace bilateral implants with smooth silicone implants is not reconstructive in nature.Final Result: The reviewer determined that the requested services are not medically necessary to treat the patients condition and are not reconstructive in nature. Therefore, the Health Plans denial should be upheld.Credentials/Qualifications: The reviewer is board certified in plastic surgery and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.