The federal watchdog said that it received approximately 6,000 medical device reports last year, a decrease from the nearly 12,000 it received in 2017 but close to the numbers it received in 2015 and 2016.
Most reports received by the agency last year were submitted by Bayer and were related to litigation against the company, with most reports mentioning device removal.
The FDA said that it also updated the Essure 522 study webpage, dedicated to a required post-market surveillance study of the device which was ordered by the federal watchdog in 2016.
As of April 1 this year, 891 patients have been enrolled in the study, with a total of 307 who elected to receive Essure and 584 who elected for laparoscopic tubal ligation. The FDA said that it “considers this to be adequate progress.”
The FDA said that Bayer is required to continue enrolling new participants in the study as long as it is available in the U.S., which is expected to end after December 2019 due to a one-year limit for use after purchasing the device.
The federal watchdog said that it plans to post interim study results once enrollment into the Essure arm of the study is completed.
“As part of the FDA’s continuing commitment to regularly communicate with stakeholders about the permanent birth control device Essure, today we are providing an update on our ongoing postmarket evaluation of Essure, so that patients and health care professionals have up-to-date information on this device to help them make more informed health care decisions. Even though this device is no longer sold, I want to reiterate the FDA’s commitment to regularly communicating with patients and health care professionals about Essure as more information is made available. Our work to continually monitor the long-term safety profile of Essure is part of our broader effort to assure device safety, which includes ongoing actions to enhance our post-market surveillance system to identify and address new safety concerns once a device is on the market and to encourage innovations that lead to safer medical devices,” FDA CDRH director Dr. Jeff Shuren said in a press release.
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