Looking Ahead: FDA Actions on Breast Implant-Associated Cancer

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) has been a hot-button topic in the world of cancer, lately.

In a March 25 hearing, the FDA declared that they have no plans to ban the implants. However, the agency did say that it is looking into ways to continue to safeguard individuals and ensure that they are well-educated before making a decision regarding breast implants.

Breast cancer survivor Renee Ridgeley wishes that she was presented with more information to make an informed decision after undergoing reconstruction for breast cancer.

“I wanted the textured [implants] because they looked so good. And nobody ever gave me any reason to not want that. I think later, when I was having so many complications and pain from the surgery, [and was] doing my own research, I realized there was a big difference between textured and smooth — and not just on the surface,” she told CURE, a sister publication of Oncology Nursing News, in the “CURE Talks Cancer” podcast.

FDA Takes Action

On May 2, 2019, FDA principal deputy commissioner Amy Abernethy, MD, PhD, and Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, published a statement on the steps the agency will take to ensure the safety of breast implants, especially when it comes to BIA-ALCL. They included:

• Improving information available to the general population and healthcare providers about the risk of BIAALCL. This would include incorporating product ingredient information in an easyto-read format, and potentially a boxed warning and/or patient decision checklist. The FDA also seeks to educate the medical community on potential health risks of textured implants.
• Regularly communicate information. The FDA has been conducting regular BIAALCL—related updates on global medical device reports since 2011. They recently said that they will also communicate information about systemic symptoms experienced by those with the implants.
• Changing how breast implant manufacturers file medical device reports. Alternative summary reporting of breast implant medical device reports will officially be ending. Previously, these types of reports did not allow for patient deaths and unusual, unique, or uncommon adverse events to be reported. Looking ahead, manufacturers will need to file individual medical device reports that will be publicly available through the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database.
• Partnering with registries. To continuously gather data on BIAALCL, the FDA will partner with registries such as the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma Etiology and Epidemiology and the National Breast Implant Registry.

“We are focused on strengthening the evidence generated to help inform future regulatory actions and to assure that women and providers are adequately informed on the risk of BIA-ALCL, including that the risk is higher with the use of textured implants, albeit still low,” the FDA’s statement said.