Wednesday, July 24, 2019
WASHINGTON (AP) — Breast implant maker Allergan Inc. issued a worldwide recall today for certain textured models after regulators alerted the company to a heightened cancer risk with the devices.
The U.S. Food and Drug Administration said it called for the removal after new information showed Allergan's Biocell breast implants with a textured surface were tied to the vast majority of cases of a rare form of lymphoma. The move follows similar action in France, Australia and Canada.
The FDA is not recommending women with the implants have them removed because the cancer is so rare, but say they should check with their doctor if they have symptoms, which include pain and swelling.
Biocell implants feature a textured surface designed to prevent slippage and to minimize scar tissue. The brand accounts for just 5 percent of the U.S. market. The vast majority of breast implants used in the U.S. have a smooth surface.
The recall does not affect Allergan's smooth implants or a different Allergan textured implant sold under the Microcell brand.
Health authorities first linked breast implants to cancer in 2011. The disease is not breast cancer but lymphoma that grows in the scar tissue surrounding the breasts. It grows slowly and can usually be successfully treated by surgically removing the implants.