Dive Brief:
- FDA Commissioner Scott Gottlieb spelled out changes to Bayer's Essure postmarketing study due to challenges reaching the initial study's sample size goal after Bayer announced it would stop selling and distributing the device in the U.S. at the end of 2018.
- Originally, the postmarketing study planned to enroll 1,400 women in both an Essure arm and laparoscopic tubal sterilization arm. But as of Dec. 3, only 293 patients were enrolled in the Essure arm and 498 in the laparoscopic tubal ligation arm.
- In an effort to collect long-term safety information in spite of the lower enrollment, FDA instructed Bayer to lengthen the postmarketing study from three years to five years, conduct additional blood testing to monitor certain inflammatory markers and require enrollment all patients receiving the device prior to discontinuation.
Dive Insight:
The permanent birth control device, approved by FDA in 2002, has been the subject of numerous adverse event reports. Though Bayer contended low sales led to ceasing U.S. sales in July, the move came amid a barrage of lawsuits and negative publicity over the device's safety record. The company at the time said it stood behind the device's safety and efficacy.
Between January 2017 and June 2018, FDA received more than 15,000 reports, which FDA's Center for Devices and Radiological Health used to inform its changes to the postmarketing study, according to the agency.
The decision to cease sales followed an April action by FDA to restrict sale and distribution of Essure to providers who gave information to patients about the risks and benefits of the device and an opportunity to sign an acknowledgment. The physician implanting the device is required by FDA to sign the checklist. The agency had earlier added a boxed warning explaining adverse events including persistent pain and abnormal bleeding were associated with the device.
Gottlieb said women with the device implanted should continue to use it, noting removal comes with its own risks.
"Women who suspect the device may be related to symptoms they are experiencing, such as persistent pain, should talk to their doctor on what steps may be appropriate," Gottlieb said.
He pointed to the Women's Health Technologies Coordinated Registry Networks, an effort to link real-world data to create more clinical evidence to supplement postmarketing studies.
"In addition to the post-market surveillance study, the agency will continue its efforts to monitor Essure's safety and effectiveness since its approval in 2002 by reviewing the medical literature, clinical trial information, post-approval study data and medical device reports submitted to the agency," Gottlieb said in a statement.
Bayer did not respond to an interview request from MedTech Dive in time for publication.
