Bayer Ending Sales Of Essure Birth Control Device
Bayer said that it will stop selling the Essure birth control implant device in the U.S. at the end of the year due to weak sales. The United States was the only country where the device was still being sold. The company has already ended sales of the device in England, Brazil, Canada, France and several other countries.
Bayer said its decision to halt sales of the device was not related to any litigation or safety issues. The company is currently facing lawsuits by more than 16,000 U.S. women over Essure. Many of the lawsuits have been consolidated or merged from states across the country.
Essure, marketed as a permanent contraceptive implant, has been subject to thousands of injury reports from women. According to the US Food and Drug Administration, nearly 27,000 reports of adverse events had been received between 2002, when Essure was approved, and the end of 2017. Several deaths have also been attributed to the device or to complications from it.
The Essure device consists of two nickel-titanium coils that are inserted into the fallopian tubes. There, the device sparks the formation of scar tissue that blocks sperm from fertilizing a woman’s eggs. Since the release of the device, women have complained of allergic reactions, pain, bleeding, and numerous cases where the implant punctured the uterus or shifted out of place. The FDA estimates that Essure has been used by more than 750,000 patients gloobally since it was first approved.
The FDA has placed multiple restrictions on the device, including adding its most serious warning to the device in 2016. According to FDA commissioner Dr. Scott Gottlieb, sales of the device in the United States had declined by about 70 percent since the warning was added. Even though the device will no longer be sold, the FDA will continue to evaluate reports filed about injuries related to the device, as well as reports of surgeries required to remove it.