France, Canada Ban Textured Breast Implants Over Increased Cancer Risk
In terms of cosmetic surgery, breast implants are by far the most popular procedure. In 2018, over 313,000 breast augmentation surgeries were performed in the U.S. alone, a 48% increase from what was reported in 2000. But while these procedures are fairly routine, breast implant surgery may carry some unintended dangers. France and Canada are among the first countries to address these risks, as both nations have banned several types of textured breast implants that have been linked to a rare but serious form of cancer.
Textured breast implants manufactured by companies such as Allergan, Mentor World Wide, and Sientra feature a rough surface similar to sandpaper that adheres to the surrounding tissue like Velcro. Much like Essure permanent birth control, the tissue grows into this surface, stimulating an inflammatory reaction. The design prevents the implants from moving or shifting inside of the body once implanted.
But many healthcare professionals are advising that the risks outweigh the benefits, as textured breast implants have been linked to a rare immune-system cancer known as breast implant associated anaplastic large cell lymphoma (BIA-ALCL).
BIA-ALCL is a type of non-Hodgkin’s lymphoma. It is typically found in the scar tissue and fluid near the implant, but in some cases, it can spread throughout the body. According to the U.S. Food and Drug Administration (FDA), the chances of developing BIA-ALCL range from 1 in 3,000 women to 1 in 30,000 women. Despite the fact that the cancer is treatable with removal of the implants, nearly a dozen deaths have been reported.
In response to these concerns, countries have begun discontinuing the use of several types of textured breast implants. In April, 2019, France became the first country to enact a ban. The country’s National Agency for Safety of Medicines and Health Products informed manufacturers that it would be banning textured breast implants “as a precautionary measure.” To date, over 59 cases of BIA-ALCL have been recorded in France. Most of the women affected by the disease had textured breast implants.
One month later, Health Canada suspended the sale of Allergan’s Biocell breast implants, citing research showing that textured breast implants had a higher risk of BIA-ALCL than other implants.
Health Canada has been notified of 26 confirmed Canadian cases of BIA-ALCL, of which 22 (85%) involve Allergan’s Biocell breast implants. Based on Canadian confirmed case data and devices sales data provided by the manufacturers, Health Canada estimates that the risks of BIA-ALCL are 1 in 3,565 for Allergan Biocell macro-textured breast implants and 1 in 16,703 for Mentor Siltex micro-textured breast implants. No cases of BIA-ALCL have been reported in Canada with any smooth surface implants.
Patients in these countries are being advised not to have their textured breast implants removed if they have not experienced symptoms of BIA-ALCL, which include unexplained breast enlargement, fluid buildup, lumps, hardening of the breast, or an overlying skin rash.
But despite the actions of these and other countries, including a voluntary suspension through the Dutch Plastic Surgery Association at the request of the health minister, sales of textured breast implants continue in the U.S. The FDA has announced it would not ban textured breast implants, stating that it does not believe there is enough evidence to warrant a ban:
“At this time, the FDA does not believe that, on the basis of all available data and information, the device meets the banning standard set forth in the Federal Food, Drug, and Cosmetic Act,”
Instead, the FDA announced plans to work with patient’s groups and manufacturers to make label changes to textured breast implants, potentially including a black box warning – the agency’s strictest warning.
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Photo Credit: Docteur Spitalier Philippe