New, stronger FDA warning for Essure birth control implant

Monday’s announcement comes after more than 5,000 women filed grievances with the FDA between November 2002 and May 2015, complaining of unintended pregnancies, miscarriages, stillbirths and severe pain and bleeding after an Essure implantation.

The U.S. Food and Drug Administration is requiring the maker of the Essure birth control device to add “black box” warnings and conduct new trials amid concerns about the safety of its use.

The FDA said on Monday that while it continued to believe that Essure was an appropriate option for most women seeking a permanent form of birth control, some may be at risk of serious complications.

More than 5000 adverse events involving Essure have been reported, according to the FDA’s website, although the role of the device is not always clear. More than a decade after the government approved the use of Essure to block conception, thousands of women have registered complaints about discomfort and internal injuries they say are related to the device. The women who spoke detailed harms they attributed to the device, including unplanned pregnancies when it failed and surgeries to remove it after suffering painful side effects.

“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 pushed the agency to halt the device’s use, said in a statement Monday.

If you have a complaint about Essure, you can file it online.

Bayer will be permitted to keep the device on the market for now-a decision that has drawn criticism from some-but will be required to study the device’s efficacy and complications in a real-world environment.

Essure is a permanent and nonsurgical form of birth control for women.

The study also will evaluate how complications affect a patient’s quality of life, and identify reasons why women don’t come back for follow-up testing three months after insertion to make sure that Essure has been properly placed.

“The actions we are taking today will encourage important conversations between women and their doctors”, said Dr. William Maisel, chief scientist at the FDA Center for Devices and Radiological Health. “While conducting a post-market study and issuing labeling recommendations are positive developments, these actions mean nothing unless the FDA is able to take action…”

The FDA issued a new, mandatory clinical study for Essure to determine heightened risks for particular women.

The draft FDA guidance also includes proposed language for the “patient decision checklist”, for doctors to discuss with patients to better communicate risks and help to ensure an informed decision-making process. Women have reported painful side effects but Bayer says that the majority of patients are satisfied with the device.