FDA Won't Ban Sale of Textured Breast Implants Tied to Rare Cancer

Textured breast implants that have been linked to a rare type of cancer can still be sold in the United States, according to the FDA, which released a statement saying it does not have enough data to draw a clear link between the 2.

As of September 2018, there have been 457 reported cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) linked to certain textured breast implants. The issue has been on the radar of the FDA since 2011 when it alerted women that there was a risk for developing disease with the breast implants, especially those that are textured.

“At this time, the FDA does not believe that on the basis of all available data and information, the device meets the banning standard set forth by the Federal Food, Drug, and Cosmetic Act,” according to a statement from FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD, and Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health.

The announcement follows a 2-day public hearing in March where women with illnesses linked to implants spoke before plastic surgeons, regulators, and implant makers, demanding more information about the risks associated with the implants and urging a ban on the type associated with BIA-ALCL. The women also asked for implant makers to disclose the materials used in the implants and called for a black box warning.

In the statement, Abernethy and Shuren said that the FDA is looking into ways to incorporate ingredient information into the labeling in a way that is easy to understand and will work with stakeholders on labeling changes proposed or recommended by the agency, which could include a boxed warning and a patient decision checklist.

Other countries have moved to ban or restrict these implants from their markets based on concern over risk of BIA-ALCL. According to the FDA, there are textured implants in these markets that are not marketed in the United States and use of these implants is much higher, representing as much as 80% of market share. Meanwhile, textured implants represent less than 10% of breast implants sold in the United States.

The FDA also noted that although the majority of these cases have been associated with textured implants, there have also been cases among women with smooth-surface implants and many reports don’t identify the surface texture at the time of diagnosis.

Since the agency was made aware of this potential link in 2011, it has taken several measures to better understand the issue through an in-depth review of postapproval study data, medical device reports, scientific literature and breast implant-specific registries, and public discussions.

“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 of BIA-ALCL, including that the risk is higher with the use of textured implants, albeit still low,” according to the statement. “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 out evidence collected so that women and providers can be better informed about BIA-ALCL as they consider breast implants.”