FDA Lax in Essure Risk Warnings: Advocates

Members of a 37,000-member advocacy group say that the number of women harmed by Bayer Healthcare’s Essure sterilization coil continue to grow while FDA efforts to inform them of the risks are not working. The Philadelphia Inquirer reports that the Essure Problems Facebook group says that in the first quarter of this year, the agency received about 2,000 reports of women undergoing operations, usually hysterectomies, to remove coils that were causing complications such as pain and bleeding.

More than 9,000 removals have been reported since 2009, the article says, in addition to miscarriages, fetal deaths, and other problems.

Essure Problems co-founder Angie Firmalino, who needed a hysterectomy to get rid of broken coil fragments, told the newspaper, “We feel like FDA needs to step in and take action. How much harm is acceptable for a non-lifesaving device?”

An FDA spokesperson told the Inquirer the agency “continues to review the available information about Essure, including reports of problems submitted to FDA.” And a Bayer spokesperson said, “We take all adverse events seriously…. We have reached out to many women who have reported complications … and provided any guidance we can. There are risks with all medical procedures.”

The article reports that last year FDA ordered Bayer to add label warnings that Essure can cause chronic pain, organ perforation, and allergic reactions, and to create a “patient decision checklist.” But some 200 women have contacted Essure Problems in the last six months to say that doctors did not tell them about the label warnings or use the three-page checklist.

The Facebook group emailed FDA 6/5 saying, “Unfortunately for many women, they are being implanted without informed consent.” They say the agency responded, “We understand your frustration. We assure you, Essure is a high-priority issue for the agency and we continue to take feedback like yours into consideration.”

Meanwhile, a separate group of women have asked FDA why a 2016 agency-ordered postmarket surveillance study (see story) on the device’s safety has not yet been started by Bayer. In a 6/5 query to FDA by the Essure Problems Admin Team and Women Harmed by Essure, the group complained that after several Freedom of Information Act requests about the study protocol there have been no responses from the agency to date. Additionally, they said they are “disturbed” by the increasing number of women implanted with Essure “who were given NO information or informed consent concerning the Black Box Warning or the Patient Decision Checklist.”

In response to a request for comment, FDA told FDA Webview 6/8 that it approved the study plan 9/2/2016, and Bayer has since begun the postmarket study. “As of 5/3, 60 sites had been selected for participation, 31 sites had submitted IRB applications, 24 sites had central IRB approval and three sites had been enrolled, it said. As of 5/3, one patient had been enrolled in the study. Site and patient enrollment is a continuous process.”

The agency noted that a publicly available Web page has been set up to keep all stakeholders informed of the progress of each postmarket surveillance study. It displays general information and the status of each study (based on protocol-driven timelines and adequacy of the data). A one-year study report is due 9/2, and FDA intends to provide an update after the next interim report.