FDA’s new efforts to protect women’s health and help to ensure the safety of breast implants
There has been a growing discussion in recent months around the safety of certain breast implants, with regulatory agencies around the world weighing the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). It’s an issue that has been a priority for us at the U.S. Food and Drug Administration since 2011 when we warned women that the available information at the time indicated that there is a risk for women with breast implants, especially those with textured implants, for developing this disease.
In the pursuit of our mission to protect the public health, one of the most important things we do as regulators is to listen to the experiences and perspectives of patients, medical and scientific experts and other stakeholders related to medical products. The meeting covered a range of important topics on breast implant safety, including the use of surgical mesh in breast implant surgery, characterization of BIA-ALCL incidence and risk factors, and methods for assessing systemic symptoms. During the two-day meeting, we listened carefully to the insightful comments and personal stories from a broad range of public, scientific, medical and other stakeholders. These insights have been invaluable in growing our understanding of the potential risks associated with breast implants and the need for further efforts to help to ensure appropriate patient protections and improve breast implant safety.
The FDA would work with stakeholders, including patient groups, on the content and format of any labeling changes proposed or recommended by the FDA, which could include a boxed warning and a patient decision checklist, and would work with manufacturers on implementing any changes to the information they provide to health care professionals and patients, including labeling.
In an effort to promote greater public transparency, the FDA has ended all summary reporting of breast implant medical device reports and has notified breast implant manufacturers of this decision. 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. Alternative summary reports were not previously available in our public database for medical device reports, Manufacturer and User Facility Device Experience (MAUDE).
The information in medical device reports is important, but they are only one tool that contributes to our understanding of breast implants. Further, it is important that people understand that the reports are just that – a report by an outside party. The agency has not verified that they are accurate, nor that the issue was in fact caused by the device. For this reason, among others, these reports cannot be used alone to determine an incidence rate, causation or associations as many reports can be duplicative or incomplete.
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 health care 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.
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.