Reconstructive breast surgery is defined as procedures to restore normal breast appearance after surgery, accident, or trauma and is distinguished from cosmetic procedures that are performed primarily to improve appearance. The policy emphasizes reconstruction is typically performed after mastectomy and includes related services such as nipple/areola reconstruction, tattooing, autologous tissue flaps, and contralateral procedures to achieve symmetry.
Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is described as a rare T-cell lymphoma occurring around textured implants (not a breast cancer), diagnosed by CD30-positive large anaplastic T cells in aspirated fluid with histologic confirmation. The registry and epidemiology context note FDA-reported totals of 1380 confirmed cases worldwide with 64 deaths (as of June 30, 2024) and PROFILE registry reporting (458 US suspected/confirmed cases as of May 30, 2025). Management includes explantation and capsulectomy per guideline recommendations.
Regulatory history referenced includes the 2019 Allergan (Natrelle Biocell) recall of certain textured implants and the FDA's October 2021 orders strengthening implant labeling (boxed warning, patient decision checklist, updated rupture screening). The FDA has not recommended removal of textured implants in asymptomatic individuals, but regulatory actions and professional society statements have informed surveillance and management recommendations.
Federal mandates are summarized: the Women's Health and Cancer Rights Act of 1998 requires coverage for reconstruction following mastectomy, including reconstruction of the affected breast, surgery to achieve symmetry, and prostheses and treatment of complications. State mandates (examples cited) also require coverage in some jurisdictions.
The rationale supporting reconstructive surgery and explantation criteria includes clinical benefit evidence (case series supporting psychosocial improvements from reconstruction; case series supporting explantation for local complications) and pragmatic considerations: local complications (contracture, rupture, infection, extrusion) commonly necessitate removal, and BIA-ALCL requires complete surgical excision when diagnosed. The policy also notes insufficient evidence that prophylactic explantation reduces ALCL risk, while professional consensus recognizes circumstances where prophylactic removal of high-risk textured implants may be considered reasonable after shared decision-making.