FDA: Textured implants to remain on the market

Amy Abernethy

The FDA issued a statement maintaining that textured breast implants do not meet the banning standard of the Federal Food, Drug and Cosmetic Act, despite an association between the implants and anaplastic large cell lymphoma.

The agency will take other steps to improve patient and provider education about the risks of implants and to strengthen warnings on the product labeling.

This statement — issued by FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD, and Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health — follows a 2-day meeting in March, during which the FDA heard from implant manufacturers, clinicians and women concerned their implants led to a range of illnesses, such as chronic fatigue, cognitive issues, and joint and muscle pain.

“While the FDA doesn’t have definitive evidence demonstrating breast implants cause these symptoms, the current evidence supports that some women experience systemic symptoms that may resolve when their breast implants are removed, referred to by some patients and health care professionals as breast implant illness,” Abernethy and Shuren said in the statement. “We believe women considering a breast implant should be aware of these risks. ... We are taking steps to better characterize the condition and its risk factors, and are considering ways to help to ensure women have all of the information they need to make informed decisions about whether to obtain breast implants or to remove existing breast implants in an effort to reverse systemic symptoms.”

The FDA plans to take steps to:

Improve information available to women and health care professionals about the risks associated with breast implants, including addressing the risk for breast-implant associated anaplastic large cell lymphoma (BIA-ALCL), the greater risk for BIA-ALCL with textured implants, and the risk for systemic symptoms;

Incorporate product ingredient information into the labeling in a way that is easy for patients to understand;

Educate the medical community about BIA-ALCL and other risks associated with breast implants and to educate pathologists about testing for this lymphoma specific to breast implants;

Update the public about any new information related to breast implant risks, as well as update and improve the communication tools for women on the FDA’s website; and

Change how breast implant manufacturers file medical device reports with the FDA, ending all summary reporting of breast implant medical device reports. Breast implant manufacturers will be required to file individual medical device reports that will be publicly available in the Manufacturer and User Facility Device Experience, or MAUDE, database.

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Ultimately, the statement did not include a ban on textured implants.

“The FDA believes regulatory action must be based on scientific data,” Abernethy and Shuren wrote. “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 [for] BIA-ALCL, including that the risk is higher with the use of textured implants, albeit still low,” the statement continues. “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.”