FDA announces new initiatives on breast implant safety
A month after hearing from plastic surgeons, patients and other stakeholders on the topic of breast implant safety, the FDA has announced its first steps toward improving the flow of safety information to patients and physicians.
On Thursday, the FDA issued a statement outlining new steps the agency is taking to protect women considering breast implants and said it will continue to study the array of health conditions and symptoms referred to by some patients and health care professionals as breast implant illness. The agency added that it would also continue to take steps to better characterize the condition and its risk factors.
The FDA also noted that although some of its international counterparts have opted to ban or restrict sales of textured breast implants based on concerns tied to BIA-ALCL, the small U.S. market share of textured implants does not necessitate a national ban.
The FDA added that it has ended all summary reporting of breast implant medical device reports and, moving forward, breast implant manufacturers will now be required to file individual medical device reports that will be publicly available in the Manufacturer and User Facility Device Experience database.
The agency said that continuing its partnership with ASPS and The PSF through the PROFILE and the National Breast Implant Registry (NBIR) databases will further help garner greater insight and more comprehensive information about women's experiences with breast implants.
"We expect that both breast implant registries will greatly contribute to helping us evaluate data from providers regarding their patients with breast implants," the statement reads. "The data already made available to us from the PROFILE registry provides additional information about patients diagnosed with BIA-ALCL. However, more needs to be done to increase the number of healthcare professionals contributing to the registries and types of information collected by the registries."
"The FDA continues to encourage stakeholders that have organized these registries to take steps to expand provider participation; request additional information from providers, such as the patient's family history of autoimmune disorders and details of past operations; and seek ways to make the data collected more public and transparent, so that patients and researchers can access and analyze the information."
Beginning immediately, monthly data summary updates of the PROFILE registry will be publicly posted on the ASPS website at PlasticSurgery.org/ALCL.
The agency reports that it is considering ways to incorporate product-ingredient information into labeling in a way that would be easy for patients to understand. This could include working with patient groups on labeling changes, which might include a boxed warning and/or patient-decision checklist and collaboration with manufacturers to implement these changes or any other information they provide to healthcare professionals and patients.