The FDA yesterday said it won’t ban textured breast implants, which may be linked to a type of immune system cancer, after one of its advisory panels said there’s not enough evidence to support the move.
In March the federal safety watchdog’s General & Plastic Surgery Devices panel held two days of hearings before reaching its conclusion, over the protests of patient advocates and despite a surge in adverse event reports.
The FDA only in 2011 began reporting on the cancer, known as breast implant-associated anaplastic large cell lymphoma, and its link to implants. In February the federal watchdog said it has received 457 unique reports of the cancer, with 246 new reports logged since 2017. Textured breast implants accounted for less than 10% and macro-textured implants only 5% of the total sold in the U.S. last year, the agency said.
In March the FDA warned breast implant manufacturers Sientra (NSDQ:SIEN) and Johnson & Johnson (NYSE:JNJ) subsidiary Mentor Worldwide over failures to conduct appropriate post-approval studies of the devices. Allergan (NYSE: AGN) has already pulled its textured implants from the European market and France and Australia are considering outright bans.
“At this time, the FDA does not believe that, on the basis of all available data and information, the device meets the banning standard set forth in the Federal Food, Drug & Cosmetic Act,” the agency said yesterday. “The FDA believes regulatory action must be based on scientific data. While the majority of women who develop BIA-ALCL have had textured implants, there are known cases in women with smooth-surface breast implants and many reports do not include the surface texture of the implant at the time of diagnosis. We are focused on strengthening the evidence generated to help inform future regulatory actions and to assure that women and providers are adequately informed of the risk of BIA-ALCL, including that the risk is higher with the use of textured implants, albeit still low. We are still investigating the cause of the association and we will continue to monitor, assess and report our findings as we continue to strengthen our evidence collected so that women and providers can be better informed about BIA-ALCL as they consider breast implants.”
The FDA also said it’s ending summary reporting, in which device makers can submit adverse event reports in batches instead of individually, for breast implant manufacturers.
“Moving forward, breast implant manufacturers will be required to file individual medical device reports that will be publicly available in [the Manufacturer & User Facility Device Experience database]. For past data received through summary reporting, the agency will also be making this data, including alternative summary reports for all devices under the program, publicly available in the coming weeks,” principal deputy commissioner Dr. Amy Abernethy and CDRH director Dr. Jeffrey Shuren said in prepared remarks. “This is part of a larger effort to end the alternative summary reporting program for all medical devices, which we intend to complete in the coming weeks. This program was established in 1997 to more efficiently review adverse events for well-established risks but was not allowed for patient deaths and unusual, unique or uncommon adverse events, which, in the case of breast implants, included BIA-ALCL.
“Taken together, we believe these efforts to improve communication and focus on evidence generation will contribute significantly to improving the safety of breast implants and want to share that many of these efforts are already underway. We are committed to making a difference for women’s health and will continue working towards ensuring we understand the benefits and risks of these devices, and that women have the most complete information available to make important breast implant decisions,” they said.
