Dive Brief:

• Bayer said it will no longer sell the Essure birth control device in the United States as of Dec. 31, citing falling sales. The company blamed “inaccurate and misleading publicity about the device” for the declining interest in the product among U.S. women, as well as decreased use of permanent birth control in favor of options such as long-acting reversible contraceptives.
• FDA, in its own statement, said numerous adverse events have been associated with the Essure implant, including “a significant collection of recent reports that have mentioned issues involving surgery to remove the device.”
• Amid thousands of lawsuits and pressure from some consumer groups, Bayer said it stands behind the product’s safety and efficacy. The company argued the device was supported by an extensive body of research involving more than 200,000 women over the past two decades. The German pharma had already halted sales outside the U.S.

Dive Insight:

Essure is a method of permanent birth control in which coils are inserted into the fallopian tubes to create a blockage that prevents the passage of an egg from the ovary. The device, approved by FDA in 2002, 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.

Bayer’s decision to discontinue U.S. sales of Essure comes after FDA in April ordered a restriction on sales of the product after determining that some women still were not receiving information about risks associated with the device before implantation, despite the addition of a boxed warning and patient decision checklist to the product’s labeling.

Bayer did not break out sales of the device in its most recent earnings report.

Essure is estimated to have been used by more than 750,000 patients worldwide since it was first approved by global regulatory authorities.

Bayer said the product’s safety profile has remained consistent over time. “We want to let the many women who have chosen Essure for their reproductive health know that our decision to discontinue sales is for business reasons, and not for any safety or efficacy concerns about Essure,” the company said. “Bayer will continue to support women with Essure and their healthcare providers.”

FDA said it will continue to evaluate reports of adverse events associated with the device and provide updates. Bayer also will continue to enroll patients in its post-market study of the device and report results to the agency.