The Food and Drug Administration said Wednesday it has asked Allergan to recall its textured breast implants after discovering the devices are linked to a higher risk of a rare type of cancer.
The FDA said that there has been a significant increase in known cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a type of cancer that affects the immune system.
FDA Principal Deputy Commissioner Amy Abernethy said that "overall incidence" of this type of cancer is low, Allergan's textured implants "appeared to be directly linked to significant patient harm, including death," prompting the regulatory agency to request the company recall the devices.
Allergan, based in Dublin, Ireland, said it has agreed to removed its Biocell textured implants from the market.
The FDA held hearings in March but did not move to recall the devices, even though more than two dozen countries, including France, Canada and Australia, already had done so.
The FDA said it has identified 573 cases of this type of large cell lymphoma, including 116 cases identified since February. Of these known cases, 481 are attributed to Allergan implants, the FDA says.
The agency says 33 women have died of this type of cancer. Of the 13 deaths in which officials identified a manufacturer, 12 had Allergan implants when they were diagnosed with this rare cancer, according to the FDA.
"Based on new data, our team concluded that action is necessary at this time to protect the public health," Abernethy said.
The FDA does not recommend women have textured breast implants removed if they show no symptoms. Such an operation might bring unnecessary risk to patients.
Textured implants represent about 5% of implants sold in the United States, according to the FDA.
Allergan says it is recalling Biocell saline-filled and silicone-filled textured breast implants and tissue expanders. These products will no longer be distributed and sold, and the company says surgeons should no longer implant Biocell textured breast implants and tissue expanders and return unused products to the company.
Dr. Elisabeth Potter, a plastic surgeon in Austin, Texas, has cared for women with cancer after receiving textured implants. She says the recall is an important step to protect women from the potential risks of textured implants.
"It was influenced by folks speaking up when the FDA didn’t act quickly enough," Potter says. "The power is now back in a woman’s hands, and the FDA is backing her up. "
Potter says women with textured implants should talk with their doctors and monitor for any symptoms such as pain, swelling, redness or anything abnormal.
FDA officials said the agency will continue to monitor safety and share updates with patients and the medical community.
Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement that the agency will "continually evaluate any new information and may, as a result, take action regarding other breast implants, if warranted."
He says the agency will assess whether the risk of this type of large cell lymphoma is limited to specific models of textured implants, or whether the risk applies to all textured breast implants.
Michele Carpenter is breast program director at St Joseph’s Hospital in Orange, California.
Carpenter says she expects the FDA to follow with voluntary recalls of textured implants made by other manufacturers.
"We can't say it’s the product as much as it is the type," of implant, Carpenter says.
To see the article in USA Today, click here.