FDA Declines to Ban Breast Implants, Will Require Full MDR Reporting by Manufacturers
Following a two-day meeting by a Food and Drug Administration (“FDA”) advisory committee on breast implant safety earlier this year, FDA on May 2, 2019, released a statement announcing that no breast implant models will be banned from the U.S. market at this time. Also described in the statement are a number of measures the agency is undertaking in order to assist women in making more informed decisions regarding breast implants.
The March 26, 2019, meeting of the General and Plastic Surgery Devices Panel was convened to discuss issues and concerns related to the benefit-risk profile of breast implants, including a potential link between textured breast implants and breast-implant associated anaplastic large cell lymphoma (“BIA-ALCL”). The panel heard testimony from nearly 40 member surgeons of the American Society of Plastic Surgeons as well as from a number of women who stated that they suffered adverse health consequences after receiving breast implants. The panel recommended that health care providers implement stronger informed consent practices for breast implant surgeries, including disclosure of information regarding the signs and symptoms of breast implant illness (“BII”) and BIA-ALCL as well as the increased risk of BIA-ALCL with textured implants.
According to the May 2 statement, which was jointly issued by FDA Principal Deputy Commissioner Amy Abernethy and Center for Devices and Radiological Health Director Jeff Shuren, FDA concluded after reviewing available data and information that textured breast implants do not meet the legal standard for imposing a ban under the Food, Drug, and Cosmetic Act. The statement points out that 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.”
The statement also announced a change of policy with respect to adverse event reporting. Manufacturers of breast implants will no longer be permitted to submit summary reports of adverse events and instead will be required to file individual medical device reports (“MDRs”) that will be publicly available in the Manufacturer and User Facility Device Experience (“MAUDE”) database. FDA will also make the previously submitted summary reports public in the coming weeks. Additionally, FDA will work with primary stakeholders on developing the content and format of possible boxed warnings or patient checklists for breast implants in order to communicate significant health concerns and risks associated with breast implants.
According to the statement, FDA also is undertaking new efforts to improve the characterization of, and risk factors for, BII and to increase information available to women to enable more informed decision-making about “whether to obtain breast implants or to remove existing breast implants in an effort to reverse systemic symptoms.” The agency also plans to examine whether device materials may cause immune or inflammatory reactions among certain predisposed individuals, and may require disclosure of breast implant ingredient information to be included in product labeling.
Shortly before the March 26 meeting, FDA sent warning letters to two manufacturers of breast implants for failing to adequately comply with post-market commitments to study the long-term safety of their products. These actions, coupled with FDA’s recent statement, signal that breast implant safety is a high-priority issue for the agency. Manufacturers, providers, payors, and other stakeholders should carefully evaluate the potential impact of FDA’s announced initiatives on their activities.