FDA announced that they are asking the medical device maker company Allergan Inc. to recall its texture implant after the agency found that it linked a rare form of cancer. FDA announces this on Wednesday.
Allergan said it was recalling BIOCELL breast implant and tissue expanders from all the market. They already recalled it from 38 countries because it linked to rare lymphoma. These devices have already banned in several countries.
FDA said on Wednesday that updated data shows that 573 cases and 33 deaths of lymphoma are linked to breast implants around the world. Among 573 cases 481 were using Allergan product, the agency said.
The agency said the data show that the risk of implant-related illness is about six times more if using Allergan BIOCELL textured implants than other manufacturers in the united state. But the Allergan devices make less than 5% of all implants in the US.
The FDA is not recommending women to remove devices if they are not experiencing problems.