FDA Orders New Essure Warnings, As Critics Press for Recall

Published on March 2, 2016 by Sandy Liebhard

Federal regulators have ordered new label warnings for the Essure birth control implant, a system of permanent contraception that has been the subject of thousands of patient complaints. For many women, however, the new warnings do not go far enough, and they have vowed to continue their fight for an Essure recall.

The Essure Permanent Birth Control System is now marketed by Bayer, and has been implanted in thousands of women since its launch in 2002 by Conceptus, Inc. The nickel-titanium coils are inserted into the fallopian tubes via the vagina. Once in place, they promote the formation of scar tissue that blocks sperm from reaching any unfertilized eggs released by the ovaries The end result is similar to a tubal ligation, but without the need for general anesthesia.

Essure Named in 5,000+ FDA Complaints

According to the U.S. Food & Drug Administration (FDA), more than 5,000 complaints involving Essure were logged with the agency between November 2002 and March 2015. They detailed instances of unintended pregnancies, miscarriages, stillbirths and severe pain and bleeding that persisted long after Essure was implanted. Many of the women who received the coils said they were forced to undergo removal surgery because of the severe side effects they experienced.

On February 29th, the FDA announced that it was ordering a new Black Box Warning – the strongest safety alert possible – for the Essure label so that doctors and patients are aware of its risks. The agency is also working on a “checklist” for doctors to discuss potential complications with patients.

In addition, the FDA has orderd Bayer to conduct a new study  designed to “provide important information about the risks of the device in a real-world environment.” The study must follow at least 2,000 women for at least 3 years, and monitor Essure recipients for problems such as unwanted pregnancy, pelvic pain and other symptoms. Finally, it must assess how these complications impact quality of life

Essure to Remain on the Market

In the meantime, Essure will remain on the market, something that is not sitting well with many.

“Anything less than a recall is just unacceptable. It’s like we’re not being heard,”Jennie Fisher, a member of the Essure Sisters Facebook Group, told USAToday. “I just hate to see more women being implanted every day when we know it’s not safe.”

“It’s unbelievable that it took the FDA since September to make just two recommendations with no enforcement measures and [to] ask the manufacturer to perform another study while leaving Essure on the market,” Rep. Mike Fitzpatrick (R-Pa.), who has long pushed for an Essure recall, said in a statement issued on Monday.

“Essure should be off the market until the requested studies are completed,” Rep. Rosa DeLauro (D-Conn.) told The Washington Post.

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