FDA Reports on Risk of Lymphoma from Breast Implants

Although occurrence is rare, individuals who undergo breast implantation have an increased risk of developing breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)—a type of non-Hodgkin’s lymphoma.

Since this disease is not well-studied yet, the Food and Drug Administration (FDA) has provided medical device reports (MDRs), also known as adverse events reports, and medical literature estimates related to risk. In addition, the agency has released an update on its current understanding of the disease.

Since its last public update in March 2017, the FDA announced it is aware of 414 total cases of BIA-ALCL, for which studies estimate that the lifetime risk of developing the disease for those with textured breast implants ranges from 1 in 3817 to 1 in 30,000.

The FDA is not changing its recommendations regarding breast implants as of this report, but it will continue to track news and studies going forward.

"We’ve been working to gather additional information to better characterize and quantify the risk so that patients and providers can have more informed discussions about breast implants,” said Binita Ashar, MD, director of the division of surgical devices in FDA’s Center for Devices and Radiological Health, in the report.

Nurses who work with patients with breast cancer who are considering breast implants need to be aware of the risks of BIA-ALCL. Ashar shared that the FDA hopes the update “prompts providers and patients to have important, informed conversations about breast implants and the risk of BIA-ALCL.”

“We remain committed to working in partnership with all stakeholders to continue to study, understand and provide updates about this important public health issue," she wrote.

The FDA is updating the content and format of its breast implant post-approval studies web page to make current information about these important studies easier for patients to read and understand.

The report noted that “choosing to obtain a breast implant is a very personal decision that patients and their providers should make based on individual needs and with the most complete information about risks and benefits.”