WASHINGTON — Breast implant maker Allergan (AGN) issued a worldwide recall Wednesday for certain textured models after regulators alerted the company to a heightened cancer risk with the devices.

The U.S. Food and Drug Administration said it called for the removal after new information showed Allergan’s Biocell breast implants with a textured surface were tied to the vast majority of cases of a rare form of lymphoma. The move follows similar action in France, Australia, and Canada.

The FDA is not recommending women with the implants have them removed because the cancer is so rare, but say they should check with their doctor if they have symptoms, which include pain and swelling.

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Biocell implants feature a textured surface designed to prevent slippage and to minimize scar tissue. The brand accounts for just 5% of the U.S. market. The vast majority of breast implants used in the U.S. have a smooth surface.

Wednesday’s recall does not affect Allergan’s smooth implants or a different Allergan textured implant sold under the Microcell brand.

Health authorities first linked breast implants to cancer in 2011. The disease is not breast cancer but lymphoma that grows in the scar tissue surrounding the breasts. It grows slowly and can usually be successfully treated by surgically removing the implants.

As recently as May, the FDA said that the danger did not warrant a national ban on the textured devices. But the FDA said Wednesday that new data show a direct link to cancer with Allergan’s implants not seen with other textured implants.

“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,” said FDA deputy commissioner Amy Abernethy, on a call with reporters.

The FDA said the latest figures show more than 80% of the 570 confirmed cases of the lymphoma worldwide have been linked to Allergan implants. Regulators estimate that the risk of the disease is six times higher with Allergan’s implants than textured implants made by other manufacturers.

FDA officials said they decided to act after receiving 116 new reports of the cancer. Those reports increased the number of deaths tied to the disease from 9 to 33, including at least 12 cases in women with Allergan breast implants.

FDA’s device director Jeffrey Shuren said the death increase played a significant role in their decision to seek a recall.

“Our team concluded action was necessary to protect the public health,” he said.

The new numbers still reflect a rare disease considering an estimated 10 million women globally have breast implants. The FDA estimates that hundreds of thousands of U.S. women have the Biocell implants.

There is no firm agreement on the exact frequency of the disease, known as breast implant-associated anaplastic large cell lymphoma. Published estimates ranging from 1 in 3,000 patients to 1 in 30,000 patients.

Researchers have offered different theories for why textured implants can trigger lymphoma, including that their surfaces causes an inflammatory response.

Allergan said in a statement it would no longer sell or distribute Biocell implants and tissue expanders, which are used to prepare patients for breast reconstruction. The company said it would direct surgeons to return unused implants.

Roughly 400,000 U.S. women get breast implants each year. The devices have a silicone outer shell and are filled with either saline or silicone. Silicone implants are more popular in the U.S. because they are considered more natural.

In the U.S., breast implants are also made by Johnson & Johnson, Sientra and Ideal Implant.

Diana Zuckerman, a researcher who has studied breast implant safety, called the Allergan removal inevitable.

“Either the company would voluntarily decide to withdraw them from the market to protect from lawsuits, or the FDA would persuade Allergan to do so,” Zuckerman said in an email.

— Matthew Perrone

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  • Yes, I have these implants in my body. It is my understanding that I am recommended to NOT get them removed as I currently have no side effects. However, once I am aware of any of the side effects (meaning I probably will already have BIA-ALCL cancer) then I am to have something done. This seems crazy!

  • I had the same reaction 11 years after reconstruction following breast cancer. My breast filled with fluid. The fluid was analyzed and determined to be cancer. Upon removal of implant the cancer was found meshed into the scar capsule. No mass located. Cancer cells only in the capsule surrounding the implant. Needless to say the next 2 years were torture.
    I am curious about a possible class action law suit. If anyone knows who I could contact, please advise

  • No one is saying how long these implants have been in existence. I had implants in about 1998 or so – were these implants being used then?

  • Should any one be surprise . this is just another ,example .evidence and concurrent results as to humans taking drugs and or medications . Is it not a known factor that every medication taken has side effects and with sides effects . the results in most cases are that the illness or ailment becomes or gets worst , rather than better . This the same with any forms or degrees of operations , minor or major . So once more as i have stated politicians and advocates for draining the swamps with health care ,more so to take and consume drugs often and regular will make you healthy is a fraud and complete false hood . These suggestions and or instructions are significantly responsible for the Pain killers death squads for example seventy two thousands [72, 000.00 over dose pain killers deaths in the year of 2017 in The United States Of America . please be reminded that the reports for the year 2018 has not being made public by The C.D.C more to come Trevor Merchant Bronx N.Y.C . Thursday . July . 25. 2019 at 4.21 p.m day light savings time

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