Bayer (Leverkusen, Germany) announced on Friday, July 20, that it would cease the sale and distribution of its Essure permanent birth control device on Dec. 31, 2018, in the United States. This follows an order issued by FDA in April 2018 restricting the sale and distribution of the device following numerous complaints from users and an announcement by Bayer in September 2017 that it would discontinue sale of the device in all countries except the United States. However, said Bayer in a statement, withdrawal of the device in the United States was not related to safety concerns. Rather, the decision to stop selling the birth control device was predicated on plummeting sales.
Essure is the only implanted birth control device for women on the market that does not require a surgical incision. A flexible metal coil with polyester fibers is placed in each fallopian tube through the vagina, where it causes scar tissue to build up and form a barrier that prevents sperm from reaching the eggs. The device is reportedly 99.3% effective at preventing pregnancy, according to Bayer.
Essure is estimated to have been used by more than 750,000 patients worldwide since it was first approved by global regulatory authorities, writes FDA on its website. “The device has been associated with serious risks including persistent pain, perforation of the uterus and fallopian tubes, and migration of the coils into the pelvis or abdomen. As the FDA learned more from patients about the serious adverse events associated with this device, we took a series of important actions to better understand the benefits and risks, and to address patient safety concerns,” said the statement.
In February 2016, FDA issued a mandatory clinical study to determine heightened risks for particular women and in November 2016 the agency required Bayer to add a boxed warning to the product’s label stating information about adverse events associated with the device. Since that time, sales of Essure in the United States have declined by approximately 70%, according to FDA.
In its 2017 financial report, Bayer said that more than 16,000 lawsuits had been filed by Essure patients in the United States and that more were expected.
FDA Commissioner Scott Gottlieb, MD, stressed that, even after Essure is no longer sold in the United States, the agency will continue to monitor adverse events involving the product and will communicate any new findings. In the statement, he also sought to reassure women who are currently using Essure successfully to prevent pregnancies that they “can continue to do so. Those with Essure who suspect they may be having symptoms related to the device, such as persistent pain, should consult with their doctor on what steps may be appropriate for them to take. Device removal has its own risks,” added Gottlieb.
Sister brand MD+DI has published a timeline recounting the “brief history of Essure,” starting in 2002 when FDA approved the device developed by Conceptus, which was bought by Bayer in 2013 for $1.1 billion.