Bayer on Friday announced that in 2019 it will no longer sell its implanted contraceptive device Essure in the United States, citing declining sales of the device.
The announcement comes after Bayer in September 2017 said it was discontinuing sales of Essure in all countries except the United States in response to a "lack of interest in the product," according to the Wall Street Journal.
FDA approved Essure—a nickel-titanium coil inserted into the fallopian tubes to prevent pregnancy—in 2002. Bayer acquired Essure in 2013 and has since faced several lawsuits and received more than 5,000 reports of complications related to the implant, including abdominal pain, abnormal uterine bleeding, and device migration.
Since the device's approval, FDA has required updates to Essure's labeling, including risk disclosures for a chance of pregnancy after implantation and for chronic pain, as well as a warning to women with sensitivity to nickel. FDA in 2016 released final guidance requiring a "black box" warning for certain permanent contraceptive implants, including Essure. FDA also asked Bayer to conduct a post-market study to evaluate the device's safety.
FDA Commissioner Scott Gottlieb in March announced the agency was investigating thousands of new adverse event reports concerning Essure, noting that FDA in 2017 received nearly 12,000 adverse event reports related to the device. FDA in April issued an order that limited the sale and distribution of Essure to health care providers that give women information about the device's risks and benefits.
According to Reuters, Bayer currently is facing about 16,000 lawsuits in the United States related to Essure and expects to see more.
Bayer to discontinue US sales of Essure
Bayer on Friday said it will discontinue the distribution and sale of Essure in the United States after Dec. 31, 2018. Bayer said its decision to stop selling Essure in the United States did not relate to safety concerns. The company said, "Our decision to discontinue sales is for business reasons, and not for any safety or efficacy concerns about Essure." It added, "The benefit-risk profile of Essure has not changed, and we continue to stand behind the product's safety and efficacy, which are demonstrated by an extensive body of research."
Bayer spokesperson Steven Immergut said the company had sold about one million Essure devices around the world since the device came on the market in 2002. He said the majority of those sales occurred in the United States, where Bayer has seen an average 40% decline in annual device sales since 2002.
Bayer cited the declines in U.S. sales, saying it is no longer sustainable for the company to continue selling the device in the United States. The company said "[s]everal factors have contributed to declining interest in Essure among women in the [United States], including decreased use of permanent contraception overall, increased reliance on other birth control options, such as long-acting reversible contraceptives … , and inaccurate and misleading publicity about the device."
Bayer said it informed FDA of its decision to phase out U.S. sales of Essure by the end of 2018, and said it is directly informing health care providers of the company's decision. Physicians will be able to continue implanting Essure until the end of 2019, at which time physicians will be asked to return any unused Essure devices, Reuters reports.
Bayer said it will continue to enroll patients in a post-market surveillance studies to examine Essure's safety and will "continue to fully comply with its other regulatory responsibilities regarding Essure." Bayer said it is working closely with FDA "to ensure appropriate follow up."
Gottlieb in a statement said FDA will continue to monitor the safety of Essure. He said FDA "expect[s] Bayer to meet its postmarket obligations concerning this device" (Bellon, Reuters, 7/20; Mohan, Wall Street Journal, 7/20; McGinley, "To Your Health," Washington Post, 7/20; AP/Modern Healthcare, 7/20; Bayer release, 7/20).
Just updated: Your cheat sheets for understanding health care's legal landscape
To help you keep up with the ever-changing regulatory environment, we recently updated our cheat sheets on some of the most important—and complicated—legal landmarks to include a brand new one-pager on the new tax law.
Check out the cheat sheets now for everything you need to know about MACRA, the new tax law, antitrust laws, fraud and abuse prevention measures, HIPAA, and the two-midnight rule.
Get the Cheat Sheets
Next in the Daily Briefing
Weekly review: How Americans diet, in 6 charts