Allergan has announced a global recall of textured breast implants that are linked to a rare type of cancer, at the request of the Food and Drug Administration.
“Biocell saline-filled and silicone-filled textured breast implants and tissue expanders will no longer be distributed or sold in any market where they are currently available,” according to a company statement Wednesday.
The FDA said in a statement that while the overall incidence of the cancer appears to be low, it asked Allergan to initiate the Biocell implant recall “once the evidence indicated that a specific manufacturer’s product appeared to be directly linked to significant patient harm, including death.”
The agency does not recommend that people who already have the textured implants get them removed unless there are symptoms or problems, but it is providing information for patients and providers to consider.
The FDA said it requested the recall after a “significant increase” in cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a type of non-Hodgkin lymphoma. Since its previous report in February, there have been 116 new cases and 24 deaths.
“Based on new data, our team concluded that action is necessary at this time to protect the public health,” said FDA Principal Deputy Commissioner Amy Abernethy.
Overall, according to the FDA, there have been 573 cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and 33 patient deaths worldwide. The agency said 481 of the cases are attributed to the Allergan implants, and that among the deaths “12 of the 13 patients for which the manufacturer of the implant is known, are confirmed to have an Allergan breast implant at the time of their BIA-ALCL diagnosis.”
