Health Canada has suspended a manufacturer’s licence for breast implants following a review that linked them to increased cancer rates.
On Tuesday, the federal agency announced it was suspending Allergan’s Biocell licences because the “the potential risks associated with the devices outweigh the potential benefits.”
Health Canada said the implants heightened the risk of BIA-ALCL, a type non-Hodgkin lymphoma, that could develop months or years after breast implant surgery.
The cancer usually presents as an accumulation of fluid between the implant and the surrounding tissue.
Health Canada had given Allergan two weeks at the start of April to prove that their implants did not cause more harm than good.
The agency said the proof the company provided was “insufficient.”
Health Canada found 26 Canadian cases of BIA-ALCL, with 85 per cent of those involving Allergan’s Biocell breast implants.
The agency estimates that the BIA-ALCL risk is 1 in 3,565 for Allergan Biocell macro-textured breast implants and 1 in 16,703 for Mentor Siltex micro-textured breast implants.
No Canadian cases of BIA-ALCL caused by smooth implants have been reported.
Although the review did not say why the implants seemed to lead to a higher rate of cancer, risk factors included the large surface area of the implants, genetic factors and chronic inflammation of the tissue around the implant.