Sterilization device removed from sale with lawsuit pending

Washington D.C., Jul 20, 2018 / 16:30 pm

The Essure sterilization device is being withdrawn from sale, the pharmaceutical company Bayer announced today. This comes after more than 10,000 women filed a lawsuit saying they were seriously harmed by the device, and about three months after the FDA restricted sales and required patients be given additional information about risks.

The FDA added a "black box" warning to Essure in November of 2016, after numerous patient complaints about complications, such as abdominal pain and uterine perforation. 

Essure will be taken off the market in the United States as of December 31, 2018. Sales in every other country ceased as of September of last year, due to poor sales figures. The device was first approved for use in 2002.

The device is described as a "non-surgical permanent birth control," and consists of a pair of metal and polyester coils that are inserted into the fallopian tubes. These coils cause scarring in the tubes, blocking eggs from reaching the uterus. Bayer claims to have sold about 750,000 of these devices around the world. The device was preferred by some women as it purportedly had a much faster healing time than other sterilization techniques.

In a statement, Bayer said the decision to pull the device was was "based on a decline in U.S. sales of Essure in recent years and the conclusion that the Essure business is no longer sustainable," but that they "continue to stand behind the product's safety and efficacy."

The Food and Drug Administration has been monitoring Essure since September of 2015, after an "increase in adverse events" submitted to its official database.

The public outcry against Essure was in part driven by social media, which was able to bring women suffering similar symptoms together in one place.

In 2011, a Facebook group called "Essure Problems" was created for women to discuss various adverse reactions they had to the device. In some instances, women were required to have emergency hysterectomies after the devices broke and migrated throughout their bodies. Other suffered extreme allergic reactions to the metals in the device, developed headaches and mood disorders, and some even experienced ectopic pregnancies.

At least one woman was killed as a result of Essure, after her reproductive organs developed necrosis, and the device was blamed for at least 300 fetal deaths and stillbirths.

The Essure Problems group, which has grown to nearly 37,000 women, was responsible for some of the widespread media coverage about the device's dangers.

Responding to Friday's announcement, administrators of the Essure Problems group told CNA that "seven long years of fighting to get Essure removed from the United States market has finally paid off" and that the announcement "brought us to our knees in gratitude, relief and celebration."

"Women will not be harmed by this device any more. We have won, we have finally won!"

The FDA released a statement saying that they will continue to "remain vigilant in protecting patients" who have been implanted with Essure, and will work alongside Bayer to "best determine how to move forward to answer the critical questions we posed" regarding complications with the device.