Textured Breast Implants Are Linked To More Cases Of A Rare Cancer, FDA Says

In a new report published on Wednesday, the Food and Drug Administration (FDA) announced a link between textured breast implants and lymphoma. Of reports received by the agency since September 2018, the FDA found there are 457 women in American diagnosed with the breast implant-associated anaplastic large cell lymphoma (shortened to BIA-ALCL), according to an agency statement. The agency's last report on the issue had found 414 cases, according to a statement.

NBC News reported that there have been more than 600 cases of BIA-ALCL around the globe, resulting in at least 16 deaths — nine of those were reported in the U.S.

"We hope that this information prompts providers and patients to have important, informed conversations about breast implants and the risk of BIA-ALCL," Dr. Binita Ashar, the director of the Division of Surgical Devices at the FDA's Center for Devices and Radiological Health, said in a statement on the updated case numbers.

In Wednesday's announcement the agency said it will communicate with doctors "who regularly treat patients, including primary care physicians and gynecologists, to learn about BIA-ALCL in patients with breast implants." The agency first told the public and doctors about the potential risk of cancer from textured breast implants back in 2011, according to NBC News.

In November 2018, the International Consortium of Investigative Journalists published an investigation into implants around the world and found many to be poorly tested. This led to an inquiry into breast implants in France. On Thursday, the inquiry recommended a ban on at least one type of breast implant that was linked to the BIA-ALCL — the same cancer from the FDA announcement.

While those steps to investigate breast implant safety in France continue, NBC News also reported that the FDA will meet next month for a safety review of implants used in U.S. The FDA reported that BIA-ALCL can occur in 1 in 3,000 to 1 in 30,000 women with implants, according to People.

The risk may be lower, but one doctor told Shape that women should still be aware of the link for this kind of non-Hodgkin’s lymphoma, or cancer in the immune system. "This is far greater than previously reported," Dr. Elisabeth Potter, a board-certified plastic surgeon and reconstruction expert, told Shape. "If a woman has textured implants in place, she needs to understand the risk of developing BIA-ALCL."

The agency said in a letter that it wants health care professionals to continue to report any possible cases of BIA-ALCL to the FDA for monitoring. Dr. William Maisel, the chief medical officer for the FDA's Center for Devices and Radiological Health, wrote in a Wednesday letter:

We want all healthcare providers to be aware of BIA-ALCL, particularly in patients with new swelling, lumps, or pain around breast implants, to expedite diagnosis of this malignancy. We are also asking health care providers to report to the FDA cases of BIA-ALCL in patients with breast implants. This includes reporting individual cases as well as rates you may have experienced during your practice.