Approval of medical devices for women based on flawed data: Study

The FDA's review process for obstetric and gynecological devices is not rigorous enough, as several devices approved since 2000 have caused serious adverse health events.
By Stephen Feller  |  May 20, 2016 at 3:48 PM
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CHICAGO, May 20 (UPI) -- The U.S. Food and Drug Administration has approved several high-risk devices for obstetric and gynecological procedures in the last 15 years that underwent less than rigorous, if not poor, trials before receiving approval, according to a recent study.

Researchers at Northwestern University's Feinberg School of Medicine found the devices -- which range in use from contraception and fetal monitoring to endometrial ablation -- were approved based on flawed data from studies that were too small or too short, and many have not been followed up with after approval despite reports of significant adverse health events.

The 18 devices researchers focused on represented those with the highest potential risk to patients, and should have been subjected to the most rigorous pre- and some post-approval scrutiny.

"There are no explicit requirements about conducting randomized-controlled trials or post-market surveillance for medical devices," Dr. Steve Xu, a researcher at Northwestern University, said in a press release. "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?"

For the study, published in the journal Obstetrics and Gynecology, the researchers reviewed trial data and approval process records for the 18 devices approved by the FDA between January 2000 and December 2015. The median approval time for the devices was 290 days, ranging from 178 to 1,399.

Of the devices, 11 were put through randomized controlled trials, one had a randomized crossover study, five had nonrandomized prospective studies and two were human factor studies. Of these, 14 met efficacy goals set for the trials, though just 12 out of 18 were required to conduct postmarket surveillance.

Since approval of the 18 devices, three have been withdrawn from the market, two of which had failed to show efficacy in their clinical trials and one was not required to be monitored after approval and removed from market because of patient safety concerns.

The researchers say more rigorous testing is clearly needed for all devices, and in the case of implant-type devices meant to last a lifetime, such as intra-uterine devices for birth control, longer trials are needed. In the case of IUDs, the FDA is reviewing new data and patient reports of the devices not working or causing other health issues.

"Devices are a huge part of the medical care that we provide women on a daily basis," said Dr. Jessica Walter, a researchers at Northwestern. "We found that there's an opportunity to increase the burden of proof required for a device to be approved for public use."

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