Data from the study was published in the journal Obstetrics and Gynecology.
“Devices are a huge part of the medical care that we provide women on a daily basis. We found that there’s an opportunity to increase the burden of proof required for a device to be approved for public use,” study author Dr. Jessica Walte of Northwestern University Feinberg School of Medicine said in a prepared statement.
Study investigators analyzed clearances for 18 high-risk devices approved between 2000 and 2015 and found that 4 devices, 22% of the total, were approved despite failing to demonstrate efficacy in clinical trials.
Another 6 devices, 33% of the total, were not required to undergo post-market studies, according to the report.
“We looked at the class of devices with the highest potential risk to patients — the devices that had to go through the most rigorous pre-market approval process. Despite this being the most stringent pathway, 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,” senior study author Dr. Steve Xu said in a press release.
A total of 3 devices were eventually withdrawn from the market after approval, 2 of which were not reviewed by the FDA’s obstetrics and gynecology advisory committee, the study claims. The 3rd was reviewed but not recommended by the committee.
Study authors highlighted controversial medical devices, such as a certain permanent contraceptive device approved in 2002, Bayer‘s (ETR:BAYN) Essure, which is now being evaluated for clearance based on numerous adverse event reports.
“There are no explicit requirements about conducting randomized-controlled trials or post-market surveillance for medical devices. Requirements are decided on a case-by-case basis. There are much higher standards for the approval of new drugs, whether oral, injectable or even topical. The important question to ask is: should we really be holding high-risk medical devices to a lower standard of evidence than drugs?” Xu said in prepared remarks.
The authors said that the 21st Century Cures Act could further deregulate medical devices, which could lead to clearances based on even less clinical evidence.
“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,” Walter said in a prepared release.