According to a recent study by Northwestern Medicine residents, certain medical devices used in obstetrics and gynecology were approved by the FDA on the basis of flawed data.
After assessing the regulation of women’s health devices approved by the FDA in the last 15 years, the study authors say their results indicate that the agency’s approvals should be based on more rigorous clinical studies than is currently required, including before and after the devices go on the market.
Study first author Jessica Walter, a resident in obstetrics and gynecology at Northwestern University Feinberg School of Medicine, stated:
“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.”
22% Failed to Show Efficacy
The team identified 18 high-risk devices approved by the FDA from 2000 to 2015, most of them for fetal monitoring, contraception, and endometrial ablation.
Four of the devices (22%) were approved even though they failed to demonstrate efficacy in clinical trials. Six of the devices (33%) were not required to undergo post-market studies to survey ongoing safety.
Three devices were eventually withdrawn from the market after approval. Of those three, two were not reviewed by physician experts on the FDA’s obstetrics and gynecology advisory committee.
The other was reviewed but not recommended for approval by the committee.
“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,” said senior author Steve Xu, a resident in the department of dermatology. “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.”
The researchers single out controversial medical devices like a permanent contraceptive device, Essure, approved by the FDA in 2002 that is now being evaluated after numerous reports of adverse events including pain, organ damage, and unintended pregnancy.
According to the U.S. F.D.A. adverse events database and other studies in the medical literature, there have been a large number of adverse events, including tubal perforations, intractable pain and bleeding leading to hysterectomies, possible device-related deaths, and hundreds of unintended pregnancies.
The device, meant to last a lifetime, was approved based on short-term evidence and insufficient post-market follow-up, explain the study authors.
Case-by-case Requirements Basis
“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,” Xu says. “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?”
Walter and Xu maintain that clinicians, in all specialties that use medical devices, not just obstetrics and gynecology, have a responsibility to understand how FDA regulation works and to take a more active role collecting and reporting data about the complications and unintended outcomes that result from devices. They also recommend that the FDA seek more input from expert advisory committees and rely on higher quality studies.
“I think some stakeholders believe that increasing regulation means stifling innovation, and that if we make it harder for these devices to be approved, potentially life-changing devices will have a higher barrier to actually getting to market,” Walter says. “But that hasn’t necessarily been shown in the literature.”
Walter, Jessica MD; Tsai, Shelun BA; Ghobadi, Comeron MD; Hayman, Emily MD; Xu, Shuai MD
Retrospective Study of the FDA Database for High Risk Medical Device Approvals in Obstetrics & Gynecology
Obstetrics & Gynecology: May 2016 doi: 10.1097/01.AOG.0000483836.35314.b1