While the FDA currently has no plans to ban textured breast implants, the agency did outline steps to ensure providers and patients are educated on breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
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:
“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.