Breast implants linked to an emerging cancer are being recalled at FDA request

Following the lead of other countries, the U.S. Food and Drug Administration reversed itself Wednesday and asked Allergan to recall textured breast implants that have been linked to a rare form of lymphoma.

In response, Dublin-based Allergan on Wednesday announced a global recall of its Biocell line of saline-filled and silicone-filled implants, as well as tissue expanders used in implant surgery.

The FDA also updated its worldwide tally of breast implant-associated anaplastic large cell lymphoma (ALCL), noting a “significant increase" since the agency’s last update earlier this year. There are now 573 cases and 33 deaths — a jump of 116 new cases and 24 deaths since the earlier count. Of these, 481 cases and 12 deaths are attributed to Allergan’s rough-surfaced products.

“Although the overall incidence of BIA-ALCL appears to be relatively low, once the evidence indicated that a specific manufacturer’s product appeared to be directly linked to significant patient harm, including death, the FDA took action to alert the firm to new evidence indicating a recall is warranted to protect women’s health,” Amy Abernethy , FDA principal deputy commissioner, said in a statement issued Wednesday.

In May, following a meeting of its expert advisory committee, the FDA declined to ban the implants. Meanwhile, at least 38 countries, including Canada, France, and Australia, have taken action to get Allergan’s textured products off the market.

Jamee Cook, 41, of Dallas, who cofounded a Facebook group dedicated to ALCL patients, emailed that she was “ecstatic” about the announcement. “But the FDA should have stepped in before now," she added. “Either way, lives will be saved and this will spark questions from breast implant patients about their overall safety. It’s a win-win.”

The FDA is not advising women without symptoms of ALCL to remove their textured implants.

First recognized in 1997, ALCL is an immune cell cancer — not breast cancer — that typically starts with swelling around the breast implant. Texturing, introduced in the early 1990s by Allergan and some other implant makers, is believed to trigger chronic inflammation that activates the immune blood cells that multiply and turn malignant in implant lymphoma.

If promptly treated by removing the implant and surrounding capsule of scar tissue, ALCL is highly curable. However, misdiagnoses and sub-optimal surgery remain common — and some women don’t have symptoms.

Terri McGregor, 54, of North Bay, Ontario, who almost died in 2015 of asymptomatic ALCL that spread before it was accidentally detected, said in an email that too many plastic surgeons are still not ordering recommended ALCL lab tests after removing implants.

“Our current patient crisis continues,” McGregor emailed. “There is resistance to ALCL testing by too many plastic surgeons who are not following protocols.”

This month, AbbVie, maker of autoimmune disease therapy Humira, announced it would pay $63 billion to acquire Allergan, best known for its anti-wrinkle product Botox. Investment analysts were quick to question the merger, with one commenter on Seeking Alpha calling Allergan “a company in decline with glaring concerns in its drug portfolio.” Allergan’s stock price closed Wednesday on the New York Stock Exchange at $160.98, down $0.91 a share (0.56%).

Implant makers may also face litigation over ALCL. Philadelphia law firm Ross Feller Casey last year filed what it believed to be the first such lawsuit, on behalf of a woman who developed ALCL eight years after getting Mentor textured implants. The firm says it “is actively pursuing lawsuits across the U.S."