Allergan has issued a worldwide recall of its Biocell textured breast implants that have been associated with heightened risk of a rare form of cancer.
The company’s decision comes after an announcement made by the U.S. medical regulator, the Food and Drug Administration about the product, saying that its continuous use could result in serious health problems and even death.
Health Canada banned the textured breast implants in May after the products were found to be associated with the risk of developing the rare but serious breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) in a safety review.
Allergan maintained that its textured implants, which have a sandpaper-like surface, were safe to use. It also mentioned that the USFDA’s concluding report didn’t have enough grounds to call for a ban.
A statement by the USFDA said that the continued distribution of Allergan’s Biocell breast implants “would likely cause serious, adverse health consequences and potentially death from BIA-ALCL.”
The new safety data by the medical regulator showed that a total of 573 BIA-ALCL cases were reported globally, of which 33 resulted in patients’ death. Over 80 percent of these cases were linked to Allergan implants, mentioned the FDA.
Similar data was presented by Health Canada, which said there were 26 confirmed cases of BIA-ALCL in Canada, of which 85 percent were associated with Biocell implants.
The company then issued a statement suggesting healthcare providers to stop using these 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,” Allergan added.
BIA-ALCL is classified as a rare cancer of the immune system, which is most commonly found in the fluid near the implant and scar tissue. It takes years to develop after the implantation.