The U.S. Food and Drug Administration is the latest regulator to take action following a global investigation including Toronto Star, CBC News and Radio-Canada that revealed mounting safety concerns about the products.
In May, Health Canada banned the textured breast implants after a safety review found the products carry a rare but serious risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
At the time, Allergan stood steadfast behind the safety of its textured implants, which have a sandpaper-like surface. The company pointed to the U.S. FDA’s conclusion that the products’ risks did not warrant a ban.
More than 80 per cent of those 573 cases involved Allergan implants, the FDA said.
The continued distribution of Allergan’s Biocell breast implants “would likely cause serious, adverse health consequences and potentially death from BIA-ALCL,” the U.S. FDA said in a statement.
Health Canada said of the 26 confirmed Canadian cases of BIA-ALCL, 85 per cent involved Biocell implants. The estimated risk of developing the cancer for Biocell implants is 1 in 3,565, the regulator said.
In a statement, Allergan said health care providers worldwide should immediately stop using Biocell saline-filled and silicone-filled textured breast implants and tissue expanders.
“Patient safety is a priority for Allergan. Patients are advised to speak with their plastic surgeon about the risks and benefits of their implant type should they have any concern,” the company statement said.
BIA-ALCL is a rare cancer of the immune system, most often found in the scar tissue and fluid near the implant. It often occurs years after the device was implanted.
Women with Biocell implants who experience symptoms such as persistent swelling or pain near the implant are encouraged to speak with their doctor.
Health authorities do not recommend patients without symptoms get the implants removed.
Allergan’s other breast implant products are not affected by the ban.
The Toronto Star/CBC investigation was conducted with the International Consortium of Investigative Journalists, and included interviews with dozens of Canadian women who attributed serious health impacts to Biocell implants.
Jesse McLean is a Toronto-based investigative reporter. Follow him on Twitter: @jesse_mclean
Robert Cribb is a Toronto-based investigative reporter. Reach him via email: firstname.lastname@example.org