FDA Reports on Breast Implants and Anaplastic Lymphoma

As of the most recent medical device reports update, the FDA received 660 MDRs of BIA-ALCL, of which 457 were unique and confirmed by a physician or testing. This number is an increase of 246 from the previous year and includes the death of nine patients that could be attributed to BIA-ALCL.

To relay this information, the FDA issued a statement from Binita Ashar, MD, of the FDA’s Center for Devices and Radiological Health, as well as a letter to health care providers urging them to be aware of BIA-ALCL, educate patients on the risk, and report all confirmed cases.

“We hope that this information prompts providers and patients to have important, informed conversations about breast implants and the risk of BIA-ALCL,” Ashar said in the statement. “At the same time, we remain committed to working in partnership with all stakeholders to continue to study, understand and provide updates about this important public health issue.”

According to the American Society of Plastic Surgeons (ASPS), an estimated 550,000 breast implants are used in the U.S. each year, and of these, 70,000 are textured. The FDA first identified a possible association between breast implants and ALCL in 2011. They've since been met with criticism from health advocates on the grounds of poor regulation and failure to raise awareness of the risks associated with breast implants.

In response, the FDA will hold an advisory committee panel meeting on breast implant safety in March. Members of breast implant victim advocacy groups fighting for public awareness of this issue will be in attendance.

Advocates Fight to Inform Women of Breast Implant Risks

One particular advocacy leader on this issue, Michelle Forney, was diagnosed with BIA-ALCL in January 2018. She, along with three other advocates, launched biaalcl.com later that year as a resource for women seeking answers regarding potential risks, signs, symptoms, and resources for support.

Forney and eight others diagnosed with BIA-ALCL will attend the FDA public hearing in hopes of the chance to speak and provide more context for the issue.“When you look at a connection between a medical device and a cancer, and you know that (breast implants are) one of the number one medical devices sold on the market, then it should’ve been a no-brainer that this is going to be emerging and that we’re going to need to get this out in front of everybody quickly,” Forney says.

“Everyone was hung up on the fact that it’s rare — it’s only rare because it’s unknown.”

Dr. Eric Swanson, a Kansas-based plastic surgeon, will also be attending the FDA hearing and has written extensively on the topic. He points to manufacturers and their profitability margin for surgeons as reasoning for why textured implants are still available on the market. Swanson hopes the FDA will consider banning, if not all textured implants, at least the types of implants associated with the highest cancer risk.

“Really the answer should be obvious, which is if you’ve got a defective product, not only do you not implant it, you remove it from the marketplace so that women’s health is protected,” Swanson says.

At the hearing, advocates hope to discuss plans to increase awareness of BIA-ALCL  and effective methods for testing and treatment. It’s important health care providers of various disciplines know how to diagnose BIA-ALCL, as symptomatic women will most likely visit their gynecologist or primary care physician first, rather than their plastic surgeon.

The concern, however, expands beyond physicians and labs. Forney urges women who have undergone both cosmetic and reconstructive surgery to take their health and safety seriously.