Regulators in two countries acted this month to protect women from breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a rare form of cancer that has been linked to textured breast implants.
Health Canada suspended Allergan’s license to market Biocell breast implants on April 4th, after a review found that 24 of 28 Canadian women with BIA-ALCL had received the textured devices.
A day later, France’s National Agency for Safety of Medicines and Health Products announced a ban on Biocell implants and five other polyurethane or textured breast implants due to ALCL concerns. Allergan actually withdrew Biocell breast implants from the European market last December, after their certification expired.
The regulators emphasized that they had not established a causal connection between textured breast implants and cancer, and both characterized their respective actions as a “precautionary measure.”
At least 457 women in the United States have developed BIA-ALCL, including 9 who died. Six hundred cases, including 17 deaths, have been reported worldwide. Most victims received textured breast implants, which feature a Velcro-like surface that adheres to the breast tissue and prevents slippage.
The U.S. Food & Drug Administration (FDA) convened a two-day advisory panel meeting last month to address BIA-ALCL and other breast implant safety concerns. While several cancer victims called for a ban on textured breast implants, many panel members asserted it was premature to consider such drastic action. The FDA has promised to issue a decision in the coming weeks.
According to The Washington Post, textured devices account for just 12% of the breast implants sold in the United States. However, they make up nearly 99% of the worldwide market.
ALCL is slow-growing form of non-Hodgkin’s lymphoma that develops in the scar capsule that eventually develops around breast implants. Signs and symptoms of the disease include:
ALCL is highly treatable when detected early. Women who have the disease undergo surgery to remove their breast implants and any masses, but may also require chemotherapy and radiation if the cancer has spread beyond the scar capsule.
Roughly 93% of patients who undergo treatment remain disease free three years later. When patients have died, diagnosis and treatment were delayed an average of two years after symptoms first appeared.
The FDA only began investigating BIA-ALCL in 2011. As a result, many patients and doctors weren’t even aware of the disease until recently.
Michelle Forney, for example, had breast implants for about 16 years when she noticed swelling, asymmetry of her breasts and intense itching in 2015. The symptoms continued for three years, while her doctors tried to pinpoint the cause.
It wasn’t until she opted to have the implants removed that a biopsy found ALCL.
“I had four mammograms and two ultrasounds in that three-year window” the 47-year-old Sacramento woman told The Washington Post. “Nothing showed up.”