FDA forces Allergan to recall possible cancer-causing breast implants

On Wednesday, the medical device maker Allergan announced a worldwide recall of its Biocell breast implants which are linked to a rare form of cancer. (Richard Drew / AP)

Anyone who has had breast implants or might be considering them needs to be aware of a recall from one of the largest manufacturers.

Allergan, the company that makes textured breast implants and tissue expanders, issued a worldwide recall of the devices on Wednesday after the Food and Drug Administration identified a sharp increase in the number of deaths from a rare lymphoma associated with the products.

Dublin-based Allergan said it was recalling BIOCELL textured breast implants and tissue expanders from all markets in which they are sold. The devices already have been banned or recalled in several countries including France, Canada and Australia. The FDA said the international recall helps ensure that unused products are removed from suppliers’ and doctors’ offices.

The agency also issued an advisory for patients with breast implants, patients considering breast implants, and their health care professionals outlining the known risks and the steps patients should consider when monitoring for symptoms of implant-associated anaplastic large cell lymphoma, including swelling and pain in their breasts.

The FDA said the risk of large cell lymphoma from Allergan’s textured breast implants is six times higher than other brands. However, the agency said it will evaluate any new information and also could take action regarding other breast implants, if warranted.

Updated FDA data shows that 573 cases, and 33 deaths, of the rare lymphoma were linked to breast implants, a significant increase since earlier this year. Of the 573 cases, 481 are attributed to the Allergan product, the agency said.

“The FDA does not recommend removal for patients without symptoms due to potential risks, but we provide helpful information for patients and providers to consider when discussing next steps,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health.

The agency said it also is considering recommendations for changes to the labeling of all breast implants, which could include a boxed warning and a patient decision checklist to help women consider the benefits and risks.

NBC6 South Florida news anchor Jen Herrera has published her story of how breast implants affected her health. Herrara, author of Are Your Fake Boobs Making You Sick? said she attributes her saline implants to joint pain and other issues with her health.

“I have met hundreds of women with similar stories,” she said. “While I did not have the textured implants or cancer, and no doctor said my implants caused my health issues, it was not until I had them removed that my health went back to normal.”

West Palm Beach health attorney Dean Xenick said whenever the FDA recommends a product be recalled, that should cause concern. “For those women who have undergone procedures where breast implants have been used, the prudent course of action is to discuss the recall with their physicians to determine the best course of action," said Xenick, of Reid Burman Lebedeker Xenick, which handles cases involving defective medical devices and drugs.