In April, the FDA said some women were not being properly informed of the risks associated with Essure before getting implanted and it limited its sale to healthcare facilities providing full information about its risks and benefits.
Since Bayer will not be able to meet its expected enrollment numbers for this study that relied on enrolling patients who were newly implanted with Essure, we'll be working with the company to best determine how to move forward to answer the critical questions we posed concerning certain patient complications that may be experienced by patients who have Essure.
In 2015, the FDA investigated the increasing number of complaints from Essure users, including punctured organs, ectopic pregnancies, serious allergic reactions, and other problems.
Essure consists of two sets of small metal coils that are inserted through the vagina and cervix into the fallopian tubes.
Bayer in a statement said the decision was not related to safety concerns. At the time of the approval, Essure was manufactured and marketed by Conceptus, Incorporated, a company Bayer acquired in June 2013. Last year, Bayer stopped selling the device in Europe.
Dr. Christopher M. Zahn, vice president of the American College of Obstetricians and Gynecologists, said in a statement Friday that the safety data on hysteroscopic sterilization, the fallopian tube procedure by which Essure works, "has not changed". The Company states that the decision to discontinue Essure was based on declining U.S. sales and not on any changes to the benefit-risk profile of the product.
I want to stress that, even when Essure is no longer sold, the FDA will remain vigilant in protecting patients who've already had this device implanted.
The majority of those sales were in the United States, he said, where the company has seen an average 40 percent annual sales decline in the device since its introduction. That includes monitoring "adverse event" reports and holding Bayer to its promise to conduct further safety studies.
And earlier this year, the agency restricted sales of the device to healthcare providers who agreed to have patients sign paperwork acknowledging the device's risks and benefits. It also ordered the company to give doctors a three-page "patient decision checklist" to inform women about the risks.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.