An Irish medical manufacturer voluntarily withdrew its textured breast implant and related tissue expanding devices from markets after the federal Food and Drug Administration tracked a spike in a rare cancer and deaths tied to the products and asked that they be recalled.
U.S. regulators, the New York Times reported, lagged their European counterparts by almost a year in acting to protect women seeking cosmetic and reconstructive procedures involving the Allergan implant:
“Worldwide, 573 cases and 33 deaths from the cancer have been reported, with 481 of the cases clearly attributed to Allergan Biocell implants, the F.D.A. said. Of the 33 deaths, the agency said its data showed that the type of implant was known in 13 cases, and in 12 of those cases the maker was Allergan.”