Breast implant maker Allergan issued a worldwide recall for certain textured models after the FDA alerted the company to heightened cancer risk with the devices.
The U.S. Food and Drug Administration (FDA) announced that 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 FDA is not suggesting that women with the implants have them removed because the cancer is so rare, but be cautious and visit their doctor if they experience any symptoms like swelling or pain.
The vast majority of 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. The disease is not breast cancer but lymphoma that grows in the scar tissue surrounding the breasts and which can be successfully treated by removing the implants.
The FDA said that the danger does not warrant a ban but the data shows a direct link to cancer by the use of Allergan’s textured implants. The figures show that more than 80% of the 570 confirmed cases of the lymphoma worldwide have been linked to Allergan implants. The estimated risk of the disease is six times higher with Allergan’s implants than textured implants made by other manufacturers.