Product News and Recalls

As Women Call for Action, FDA Continues “Assessment” of Breast Implant Cancer Risk

FDA continues assessment of breast implant cancer riskA growing number of women are being diagnosed with a form of breast cancer linked to breast implants, and the calls for lawsuits and legislative action or regulation are rising.

16 deaths may already be associated with the condition known as BIA-ALCL or breast-implant associated anaplastic large cell lymphoma. U.S. diagnoses of the cancer are now up to 457 from a previous high of 414. Over 600 cases have been documented around the world.

The stories told by women who discuss their diagnoses all seem to have a common thread: a complete failure to receive any sort of notification about a risk of developing breast cancer as a result of their implants. “If someone said ‘By the way, you could get a cancer’ your ears would prick up and it would be more of a thoughtful process you’d go through,” says Irene Kennedy in an interview with The Guardian. Kennedy received her implants eight years ago and has since had them, along with the surrounding scar tissue that formed, removed. She has undergone a full recovery but remains anxious at the prospect of the cancer returning.

A group of more than 200 women who have been diagnosed with ALCL are considering a lawsuit against Allergan; the company that made their implants. They too say they were not notified or sufficiently warned about the possibility of developing breast cancer prior to receiving the implants.

While much of the concern over BIA-ALCL resides in European markets where textured breast implants were significantly more common, evidence indicates that the condition is not exclusive to that type and that patients receiving smooth implants like those used in the U.S. may also be susceptible.

To that end, the FDA is acknowledging the public’s alarm over the issue but is refusing to institute any bans or take significant action to prevent the use of breast implants until it gathers more data. In a statement released on its website, the agency says that it is “evaluating the body of available evidence regarding the safety and risks of breast implants, including concerns specific to textured implants and the risk of BIA-ALCL.” It is changing the way implant manufacturers file device reports with the agency and increasing its involvement with several international registries to improve its ability to track global cases of ALCL but does not currently believe that implants meet “the banning standard set forth in the Federal Food, Drug, and Cosmetic Act.”