Health Canada has banned the sale or importation of macro-textured breast implants after a health review determined that they increase the risk of a “rare but serious” form of cancer.
Only one company, Allergan, manufactures the Biocell textured breast implants that are currently available in Canada. Licenses for the five types of textured implants the company offers, in both saline and silicone models, have been revoked by Health Canada. Allergan has agreed to recall its unused products from the Canadian market. The company’s non-textured implants are not affected by Health Canada’s ruling.
In a 2017 review, Health Canada reported only five cases of the rare type of non-Hodgkin lymphoma. But this January, the agency announced it would update its review of breast implants, as that number had risen to 26. The findings, released Wednesday, determined that 22 of those 26 patients had received Allergan’s textured breast implants.
Breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL, is a rare cancer of the immune system that can develop in the scar tissue around a breast implant, sometimes years after a procedure. Textured implants have an adhesive surface that has been described as similar to sandpaper or Velcro.
One of the purported advantages of textured implants over smooth ones is that they stick to the body and develop scar tissue, and so they’re less likely to move around inside the breast.
Health Canada still doesn’t know the causes of ALCL, but in addition to this kind of breast implants, genetic factors and chronic inflammation are thought to be factors.
In April, France also banned several types of textured breast implants as a “precautionary measure” again BIA-ALCL. The Netherlands has also temporarily halted their sale as they investigate further.
The Food and Drug Administration in the U.S., on the other hand, decided earlier this month not to ban the implants. “The FDA does not believe that, on the basis of all available data and information, the device meets the banning standard,” the agency said.
Health Canada says people who currently have textured breast implants but don’t have implant-related health problems shouldn’t worry about getting them removed, stressing that the risk of developing BIA-ALCL is still relatively rare. Anyone concerned about their implants should consult their doctor.
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