Plastic surgeons alert patients after Health Canada finds increased cancer risk in certain breast implants
Allergan is considering appealing Health Canada’s ban on its Biocell macro-textured implants
Plastic surgeons across B.C. are informing some of their patients their breast implants have been linked to an increased risk of a rare form of cancer.
The office of Vancouver-based plastic surgeon Dr. Nick Carr has contacted at least 500 patients and told them what symptoms to watch out for.
"It's created a worry. There is a certain concern and anxiety around it that's here now, that wasn't there six months ago," he said.
On May 28, Health Canada suspended the sale of Allergan's Biocell breast implants, citing research that, compared to other implants, found patients with textured implants had a higher risk of breast implant-associated large cell lymphoma (BIA-ALCL), a rare cancer that affects the immune system.
The health authority updated its safety review following an increase in reports of Canadian cases. It received reports of 26 confirmed cases of the rare cancer — an increase from its initial safety review in 2017 where it knew of only five confirmed Canadian cases.
Allergan is no longer allowed to sell its Biocell macro-textured implants in Canada, and all unused implants are to be sent back to the manufacturer.
The company's other breast implant products are not affected.
In a statement on its website, the company says, "Allergan continues to stand firmly behind the benefit / risk profile of its breast implant products," and it plans to explore options to appeal the Canadian health regulator's decision.
Links to cancer
When textured implants hit the Canadian market in 2006, their more natural, teardrop shape made them popular, particularly for reconstructive surgery.
Textured breast implants have a rough surface, similar to sandpaper. Because of their textured surface they adhere to the tissue around them and prevent the implants from moving around, unlike smooth-surfaced implants.
Dr. Nancy Van Laeken, a plastic surgeon with Providence Health Care says many of the patients she has contacted are breast cancer survivors.
"They've been through a difficult time only to find out that what has been used to help them get through their breast cancer may, in fact, cause another type of cancer," she said.
There is no recommendation to remove the implants if patients don't have any symptoms associated with BIA-ALCL.
Patients are told to contact their plastic surgeons and watch out for swelling, lumps and pain in the breast.
Some patients have decided to keep their implants and continue to monitor their symptoms, others are too anxious and want them removed as soon as possible.
"I think the important thing is that everybody is following and watching, because if the diagnosis is made early, the disease can be cured by removal of the implant," said Van Laeken.
Issues with textured breast implants
Allergan took its textured breast implants off the market in Europe in December, after a French regulatory body ordered a recall.
The U.S. Food and Drug Administration (FDA), however, said in May that it would not ban textured breast implants pending an investigation.
Some surgeons say they began noticing inflammatory problems around the implants, including pain and swelling, long ago.
Dr. Nick Carr stopped using textured implants several years ago.
"I realized, perhaps five years ago, a lot of women that had these textured implants were coming back and were having a variety of different problems," he said.
In a study he published last September in the Journal of Plastic and Reconstructive Surgery, he found that of the 539 implants he had removed from patients, Biocell textured implants had the shortest shelf life.
"There was a very high number that had pain specific to their implants," said Carr, and once the implants were removed the pain was gone.
But surgeons say they didn't know of the links to cancer.
"Were women warned? No, because most of the women that had these implants had them put in 10 years ago, when nobody really knew that the disease even existed," said Carr.
Previously, Carr says the risk was perceived as one in 300,000 to a million. But as more cases accumulated, it became evident that it wasn't as rare as once thought.
Recent estimates by Health Canada found the risks of BIA-ALCL are one in 3,565 for Allergan Biocell macro-textured breast implants and one in 16,703 for Mentor Siltex micro-textured breast implants, a different manufacturer which has not been recalled.
Health Canada knows of 26 confirmed Canadian cases of BIA-ALCL. Of those cases, 22 involved Allergan's Biocell breast implants.
Van Laeken worries the number of cases might go up in the future.
"The disease seems to develop not immediately but many years after patients had the implant," she said.