FDA Panel: Too early to pull textured breast implants over cancer risk, need more data

A panel of experts convened by the FDA yesterday said that there’s not enough data to pull textured breast implants from the market over concerns that they may be linked to a type of immune system cancer, according to an AP News report. The recommendation comes from the first day of a two-day panel meeting discussing the risks associated with breast implant devices, reviewing current study data and exploring how to best track and treat the cancer, and other issues, the devices have been tied to. The FDA only began reporting on the cancer, known as breast implant-associated anaplastic large cell lymphoma, and its link to implants in 2011. Last month, the federal watchdog said it has received 457 unique reports of the cancer, with 246 new adverse event reports related to it since 2017. Estimates of the frequency of the disease range greatly, from one in 3,000 to one in 30,000, according to the AP News report. The disease has also been reported to the FDA by patients with smooth implants, and other research has indicated that silicone that leaks from the implant could possibly trigger or exacerbate immune system disorders. Despite the increased visibility of the cancer and its link to implants, the panel did not recommend any immediate restrictions on the devices, according to the report. The majority of the 19 panelists said that it was too soon to pull the products from the shelves. Consumer advocates, and the panel’s consumer representative, did not agree, according to AP...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cosmetic/Aesthetic Food & Drug Administration (FDA) Oncology Women's Health Source Type: news