Worldwide recall launched for textured breast implants linked to rare cancer

The company that makes textured breast implants linked to a rare cancer announced Wednesday it would conduct a worldwide recall of the devices after the Food and Drug Administration reported a sharp increase in illnesses linked to their products and asked the company to remove them from the U.S. market.

Dublin-based Allergan said it was recalling BIOCELL textured breast implants and tissue expanders from any market on which they are currently sold. The devices have already been banned or recalled in several countries.

The FDA said Wednesday that updated data show that around the world 573 cases, and 33 deaths, of a rare lymphoma are 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. Of the 33 patient deaths, the identity of the manufacturer is known in only 13 cases. Of those, 12 are Allergan implants.

The agency said the new data indicates that the risk of implant-related illness with Allergan BIOCELL textured implants is about six times the risk of such illness with textured implants made by other manufacturers operating in the United States. The Allergan devices make up less than five percent of all implants sold in the United States.

The FDA’s new stance against the BIOCELL product is a change from just a few months ago, when it said it wasn’t taking any action against the devices.

Amy Abernethy, the FDA’s principal deputy commissioner, said that although the overall incidence of implant-linked disease “appears to be relatively low, once the evidence indicated that a specific manufacturer’s product appeared to be directly linked to significant patient harm, including death, the FDA took action to alert the firm to new evidence indicating a recall is warranted to protect women’s health.”

She added that, “Based on new data, our team concluded that action is necessary at this time to protect the public health.”