FDA provides updates on evaluating postmarket safety of Essure device
The Food and Drug Administration has updated its Essure website to include an analysis of medical device reports received in 2018. According to the announcement, FDA received approximately 6,000 medical device reports in 2018 related to Essure, which is a decrease from the nearly 12,000 medical device reports received by the FDA in 2017 but similar to the number received in 2015 and 2016.
As in 2017, FDA says most of the reports received in 2018 were submitted by Bayer and are related to litigation against the company, and most of the reports mention potential device removal. The agency also updated the Essure 522 study webpage with the number of participants enrolled in the postmarket surveillance study that the FDA ordered the company to conduct in 2016.
As of April 1, 2019, 891 patients have been enrolled in the study, with 307 enrolled in the group who elected Essure and 584 in the group who elected laparoscopic tubal ligation. The agency considers this to be adequate progress.
In light of Bayer’s decision to discontinue sales and distribution at the end of 2018, the FDA says that it recognized there would be challenges reaching the study’s initial sample size, because it relied on enrolling patients who were newly implanted with Essure until May 2020. To account for lower enrollment, the FDA says it worked with Bayer on a revised study plan to provide more long-term information regarding complications that may be experienced by patients, despite reduced enrollment. As part of the previously announced revised protocol for this study, participants will be followed for five years to provide longer-term information on the risks of the device, including issues that may lead women to have the device removed.
Bayer is required to continue enrolling new participants in its postmarket surveillance study as long as Essure is available in the U.S. Because healthcare providers may implant Essure up to one year from the date the device was purchased, the device will no longer be available after December 2019.
The FDA will post the interim study results once enrollment into the Essure arm of the study is completed. The data being collected is intended help the FDA to better understand the risks associated with Essure and compare them to laparoscopic tubal ligation.
Beginning in 2015, the FDA convened a public meeting to learn more about how the agency could better investigate patient complaints like pain, heavy bleeding and device migration; a year later, the FDA ordered the company to conduct a postmarket surveillance study and approved labeling changes including a boxed warning that highlighted the device’s risks. In April 2018, the agency issued an order restricting the sale and distribution of Essure; it was a unique type of restriction where the FDA used its authority to impose additional requirements to provide a reasonable assurance of the device’s safety and effectiveness. Bayer stopped selling and distributing the Essure permanent birth control device in the U.S. on December 31, 2018, and, at the end of this year, health care professionals and patients will no longer have access to the device.
