FEATURED , Industry , News

Alan Stolier/

FDA Reports on Risk of Lymphoma from Breast Implants

Though rare, anaplastic large cell lymphoma (BIA-ALCL) has been reported in individuals who have undergone breast implant surgery. BIA-ALCL is a type of T-cell non-Hodgkin’s lymphoma which was first described in 1997 (Ovid_ External Link ). Though there is no consensus on the implant substance contributing to the disease, more cases have been reported in textured compared to smooth implants. It is theorized that BIA-ALCL cells arise because of a sustained T-cell immune response to bacterial antigens in biofilm though there is little supportive evidence. The most common presenting symptom is a swollen breast due to a late (> 1yr) unilateral seroma between the implant surface and capsule. There is less commonly, a mass or thickening or severe capsule contraction.  The diagnosis is made by histologic analysis of the implant capsule or the finding of CD30-positive cytokeratin negative, ALK negative malignant cells in the fluid aspirate from around the implant. Treatment generally consists of implant removal, capsulectomy and systemic therapy, with or without radiation.

In March 2017 the FDA announced that it was aware of 414 cases with an estimated lifetime risk of 1 in 3817 to 1 in 30,000 for women with textured implants. At this point the FDA is not changing its recommendations regarding breast implants but continues to track studies going forward. The FDA also recommends that all patients should have informed conversations with their physicians regarding the risk of BIA-ALCL. The FDA keeps a webpage which is available for reporting all cases of BIA-ALCL (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma_pas.cfm?c_id=73&t_id=90235 )

Leave A Comment