Dive Brief:
- FDA will hold a public meeting of its General and Plastic Surgery Devices Panel on March 25-26 at the agency’s headquarters in Silver Spring, Maryland, to discuss issues and concerns related to the benefit-risk profile of breast implants.
- Commissioner Scott Gottlieb, in a series of tweets on Monday, said the meeting will gather input on benefit-risk considerations and possible measures to address some of those risks with breast implants. Members of the public are encouraged to provide comments to the panel and FDA on the subject.
- FDA plans to post more information and an agenda on the Advisory Committee Calendar web page 15 days prior to the meeting.
Dive Insight:
FDA noted in September its intent to convene the panel as part of its response to an MD Anderson Cancer Center study that brought back to the forefront a decades-long debate over the safety of silicone gel-filled breast implants.
MD Anderson’s research, based on FDA data from post-approval studies involving more than 100,000 breast implant patients, found an association between the devices and some autoimmune diseases and cancers. But the data did not establish a causative effect between silicone breast implants and those conditions.
The agency, in responding to the MD Anderson analysis, said it disagreed with the study’s conclusions and continues to believe scientific evidence does not conclusively demonstrate a link between breast implants and connective tissue diseases, breast cancer or reproductive problems. It defended its record of assessing, monitoring and communicating to the public about risks associated with the devices. The agency pointed to a 2011 Safety Update that found that approved silicone gel-filled implants from Allergan and Mentor had a "reasonable assurance of safety and effectiveness when used as labeled."
FDA had placed a moratorium on sales of silicone implants that lasted from 1992 to 2006, but the ban effectively ended when the agency approved new devices made by Allergan and Mentor in November 2006.
In November 2018, breast implant safety concerns came under renewed scrutiny as part of an extensive investigation by the International Consortium of Investigative Journalists (ICIJ) that took aim at both regulators and manufacturers for poor testing of medical devices and underreporting of injuries and deaths resulting from the implants.
In December 2018, Allergan lost its CE mark for its textured breast implants following a compulsory recall request from French regulators, prompting the company to suspend sales of the product throughout Europe. Allergan has said it plans to appeal the CE mark decision, noting the designation for its smooth implants was renewed. The company said it stands behind the benefit-risk profile of its breast implant products.
