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By Peter Loftus 

This article is being republished as part of our daily reproduction of WSJ.com articles that also appeared in the U.S. print edition of The Wall Street Journal (July 25, 2019).

Allergan PLC recalled certain textured breast implants from the market after U.S. health regulators said there was an increase in cases of a rare type of cancer and deaths among women receiving the implants.

The U.S. Food and Drug Administration said Wednesday it asked Allergan to recall the implants because their continued sale "would likely cause serious, adverse health consequences and potentially death" from a cancer known as breast-implant-associated anaplastic large cell lymphoma, which develops in the body's immune system.

The FDA noted that the type of textured implants in question are a small portion of implants sold in the U.S., but that the risk associated with Allergan's implants was about six times the risk with similar types of implants from other manufacturers, including Johnson & Johnson. Hundreds of thousands of women have received the recalled Allergan implants, an FDA official said.

"While the overall incidence appears to be relatively low, once the evidence indicated the Allergan product was linked to patient harm including deaths, the FDA took action," Amy Abernethy, the FDA's principal deputy commissioner, said on a conference call with reporters. "We know that today's news will be alarming to patients with breast implants."

The move came two months after the FDA said it didn't plan to ban any breast implants over various safety issues it had examined, saying there wasn't sufficient evidence. Instead, the FDA at that time tightened the requirements for implant manufacturers to report health problems in patients receiving them.

The FDA for years has been monitoring the safety of implants used for breast augmentation or reconstruction, and in 2011 first warned of the potential risk of anaplastic large cell lymphoma from implants.

Dublin-based Allergan said Wednesday it is globally recalling its Biocell textured breast implants, which have a rougher surface designed to adhere to surrounding tissue and make them less likely to become repositioned than smooth breast implants. The recall also includes products known as tissue expanders that are used in breast-implant surgery. Allergan said surgeons should no longer use the recalled implants or expanders.

Shares of Allergan fell 0.6% Wednesday to $160.98.

The FDA said it has now received reports of 573 cases of the implant-associated lymphoma and 33 deaths of such patients. The FDA attributed some 84% of the 573 cases to Allergan implants. Among the deaths, 12 of the 13 patients for which the implant's manufacturer was known were patients with Allergan textured implants at the time of diagnosis, the FDA said. The manufacturer or texture is unknown for the remaining 20 reported deaths, the FDA said.

The FDA's new tally of lymphoma cases and deaths is up significantly from an FDA update in February, when the agency said there were 457 cases including nine deaths.

The FDA said the recall will ensure that unused implants are removed from suppliers' and doctors' offices. The FDA isn't recommending removal of implants in patients without symptoms because the risk of developing lymphoma is low, and there are safety risks associated with removal.

Patients with confirmed cases of lymphoma should undergo implant-removal surgery and removal of the surrounding scar tissue, the FDA said. Patients with the recalled implants should talk to their doctor if they experience symptoms, which include persistent swelling or pain near the implant.

FDA officials said they haven't ruled out the possibility that smooth implants could increase the risk of lymphoma because some of the reported lymphoma cases include women with smooth implants. But in some of those cases, the women previously had textured implants, so it was less clear that the smooth implants were increasing risk, said Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health.

Health regulators in some countries including France have banned or restricted sales of textured implants. Allergan suspended sales of its textured breast implants in Europe and withdrew the remaining textured breast implants then on the market in Europe in the fourth quarter of 2018. Textured implants are used more commonly in Europe than in the U.S.

Allergan posted a list of the recalled breast implants and tissue expanders online.

More than a dozen lawsuits have been filed against Allergan in the U.S. and Canadian courts alleging the company's textured breast implants caused women to develop lymphoma. The suits also allege Allergan failed to properly warn against this risk and failed to promptly and properly report the results of certain studies relating to these products, Allergan said in a securities filing in May.

An Allergan spokeswoman said the company declines comment on pending legal matters.

Allergan's total breast implant sales were $263 million in 2018.

Allergan, which also makes the cosmetic product Botox, has agreed to be acquired by AbbVie Inc. for about $63 billion. Completion of the deal is pending.

Write to Peter Loftus at peter.loftus@wsj.com

(END) Dow Jones Newswires

July 25, 2019 02:47 ET (06:47 GMT)

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