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 macro-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 Licenses for the five types of textured implants the company offers, in both saline and silicone models, have been revoked by Health Canada.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 other implant types are not affected by Health Canada’s ruling.
“We know that there’s an increased risk with these macro-textured implants, but there’s still research going on to find out what the cause of that cancer would be,” Health Canada’s chief medical advisor Dr. Supriya Sharma told HuffPost Canada.
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 ripples or ridges on the outside, with a rough adhesive surface that feels a bit like sandpaper, Sharma explained. 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.
Even if a macro-textured implant has the same volume as a smooth implant, its ridges mean that it covers a larger surface area, which Health Canada says could contribute to the risk.
Micro-textured implants, which have much smaller ridges than the macro, are still available in Canada. There have been a few cases of cancer in people with micro-textured implants, Sharma said, “but it’s a far, far lower risk than the macro.” There are no reported cases of cancer in people with the smooth implants, she added.
There are a few working theories, but Health Canada still doesn’t know the causes of ALCL. 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 U.S. joined the countries implementing a ban in late July. As recently as May, just weeks before Canada’s ban, the Food and Drug Administration put out a statement claiming that “the FDA does not believe that, on the basis of all available data and information, the device meets the banning standard.”
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.
“In all the cases that we’ve seen, people [with BIA-ALCL] have symptoms,” Sharma explained, usually a lump or a fluid-filled pocket near the implant. Anyone concerned about their implants should consult their doctor.
Health Canada is also conducting a safety review on more general systemic health symptoms that may be associated with a wide variety of types of breast implants. Sharma says that review will likely be finished by the end of the summer.
UPDATE 07/24/2019: This story has been updated to include the FDA’s decision to ban Allergan’s Biocell macro-textured breast implants.