Study: Stronger Regulation Needed for Women's Health Devices

Women's health devices have been in the spotlight in recent years for all the wrong reasons. Laparoscopic power morcellators fell out of favor after being linked to spreading or advancing undetected gynecologic cancers, and Essure permanent birth control has drawn increased scrutiny as female patients have reported adverse events and called for regulatory action.

Now, a study by medical residents has found FDA requirements for obstetrics and gynecologic devices approved in the past 15 years have not been tough enough. 

The study, "Medical Device Approvals Through the Premarket Approval Pathway in Obstetrics and Gynecology from 2000 to 2015: Process and Problems," was published in the June issue of Obstetrics and Gynecology. Study authors found that of the 18 obstetrics and gynecology devices that received PMA approval between January 2000 and December 2015, only 14 met their primary clinical efficacy endpoint and that almost half of the approved devices had been studied with nonrandomized controlled trials.

Just 12 of the 18 devices were required to be followed with postmarket surveillance and one of the devices that was not subject to postmarket surveillance was later pulled from the market for patient safety. In all, there were three devices taken off the market. The researchers wrote that all three of these devices were not referred to or did not receive a recommendation for approval by an FDA advisory committee on obstetrics and gynecology devices. Two of these devices also did not show a benefit in pivotal trials. 

The study authors wrote, "Our results reveal significant weaknesses in the preapproval and postapproval regulation of high-risk obstetrics and gynecology devices. Greater specialty group involvement is necessary to ensure the development of safe and clinically effective devices."

The researchers focused on devices approved through FDA's PMA pathway, the toughest regulatory route for devices. Senior author Steve Xu, MD, a dermatology resident at Northwestern University Feinberg School of Medicine, said in a news release, "Despite this being the most stringent patheway, and despite the fact that we've had multiple safety issues connected to OB-GYN devices affecting millions of women worldwide, the evidence leading to approval has a lot of weaknesses."

The authors also discussed how potential changes to FDA regulation, via the 21st Century Cures Act that is making its way through Congress, might impact device approvals. Jessica Walter, MD, first author and a resident in Feinberg's obstetrics and gynecology department, referred to the legislation in the news release, "There are provisions that would broaden the definition of the 'valid scientific evidence' manufacturers need in order to prove medical benefit. Our concern is that this would lead to more devices getting approved with even less clinical evidence that they are both safe and effective."

Proponents of the 21st Century Cures Act say the legislation will make the device review process more efficient and allow faster access to highly innovative products without sacrificing safety. But the public's view hasn't been so rosy, with a recent poll showing half of respondents don't want to see changes to the process. 

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