Allergan Plc said on Wednesday it was recalling its Biocell textured breast implants and tissue expanders across markets, citing concerns over a rare form of cancer, after the U.S. health agency asked the drugmaker to pull the products.
The Food And Drug Administration found the use of these breast implants was tied to increased risk of a rare type of cancer known as breast-implant associated anaplastic large cell lymphoma (BIA-ALCL).
“Once the evidence indicated that Allergan’s product appeared to be directly linked to significant patient harm … the FDA took action to alert the firm to new evidence and that the recall is warranted,” Amy Abernethy, FDA’s principal deputy commissioner, said on a media call.
Allergan has already stopped selling the Biocell textured implants in Europe and Canada.
Breast implants come in both textured and smooth formats, with the former resembling sandpaper, making it less likely to move around inside the breast and change position.
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Textured breast implants are more commonly used in Europe than in the United States, with it accounting for only 10% of all breast implants sold in the country.
Demand for Allergan’s smooth implants may be impacted and litigation claims may rise due to the recall, Stifel analyst Annabel Samimy said, but added that a direct impact from the recall was negligible for the company, which is being bought by AbbVie Inc for $63 billion.
Other textured implants sold in the United States are made by Sientra Inc and Johnson & Johnson’s Mentor unit.
The FDA has warned in the past that risk of BIA-ALCL is higher in textured implants, but the risk with Allergan’s Biocell textured implants is about six times compared with textured implants from other manufacturers marketing in the United States, according to the health agency.
The FDA said 573 cases of BIA-ALCL were recorded globally as of July 6, out of which 481 patients had Allergan implants at the time of diagnosis.
Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said the FDA is still assessing if the risk of developing BIA-ALCL is limited to specific models of textured, or all textured breast implants.
Allergan said the recall, however, does not affect its Natrelle smooth or Microcell breast implants and tissue expanders.