Canada said Thursday it aims to soon suspend the sales in this country a type of breast implant that has been linked to a rare form of cancer.
The announcement comes after France banned the types of implants with a textured surface or polyurethane coating, and after the US Food and Drug Administration (FDA) last month held two days of hearings on their risks.
Health Canada said it was a “precautionary measure” following a safety review triggered by a spike in cases of anaplastic large cell lymphoma (BIA-ALCL), a rare type of cancer that attacks the immune system, linked to the implants.
The agency noted 28 cases in Canada — out of 457 recorded worldwide, according to the FDA.
The only distributor of textured implants in this country, US manufacturer Allergan, has 15 days to provide new evidence to support their continued use.
Otherwise its licenses will be suspended and “the product will no longer be permitted to be sold in Canada,” said a statement.
Silicone implants are used in breast enhancements, or for reconstructive purposes after a mastectomy for breast cancer. They can either be smooth, textured or coated in polyurethane.
The popular textured implants are designed to stick to the breast tissue to avoid slipping out of position.
Some studies suggest that inflammation caused by the textured implants rubbing against breast tissue could cause BIA-ALCL.
Several implant wearers have already launched legal action against Allergan, accusing it of “deliberately endangering the lives of others.”
Polyurethane-coated implants are not sold in Canada./AFP
amc/ia
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