Bayer said Friday it will stop selling its Essure birth control system in the United States at the end of the year, citing a decline in U.S. sales of the device and the conclusion that the Essure business is no longer sustainable.
Although the controversial product is the subject of nearly 30,000 adverse event reports to FDA and thousands of patient lawsuits, Bayer insisted in a statement Friday that its decision to discontinue sales of the product is for business reasons only, "not for any safety or efficacy concerns about Essure."
The company added that the benefit-risk profile of Essure has not changed and that Bayer continues to stand behind the product's safety and efficacy.
Regardless of the reasons behind Bayer's decision to stop selling Essure in the United States, the patient advocacy group known as the E-Sisters is certainly considering the move a victory.
"So proud of my wife and the work the Essure Problems teams has done over the many years to stop Bayer from selling this harmful product. Mission accomplished," Tweeted Jeremy Schulman, the husband of one patient advocate.
FDA turned up the heat on Bayer in April to make sure women considering the implantable contraceptive device are adequately informed of its risks.
Now, patients must be given the opportunity to sign an acceptance of risk and informed decision acknowledgment, and the same "patient-doctor discussion checklist" must be signed by the physician implanting the device. The agency said Bayer will be required to implement the restrictions immediately and ensure that the process going forward results in healthcare provider compliance with the sales restriction.
FDA added a boxed warning to Essure in 2016 and ordered Bayer to run a new postmarket surveillance study on the device, as well as provide a patient decision checklist to ensure that women considering the permanent birth control option were fully informed of the procedure's risks and benefits. It seems some women, however, never received that information before having the Essure implanted.
In March, FDA reported that it received 12,000 medical device reports about Essure in 2017.
FDA Commissioner Scott Gottlieb acknowledged that Bayer's decision to halt Essure sales follow a series of earlier actions that FDA took to address the reports of serious adverse events associated with the device.
"For women who have received an Essure implant, the postmarket safety of Essure will continue to be a top priority for the FDA. We expect Bayer to meet its postmarket obligations concerning this device," Gottlieb said.
The Essure method of permanent birth control involves coils that are inserted into the fallopian tubes to create a blockage that prevents the passage of an egg from the ovary.