FDA approved high-risk women's health devices without proper data: Study

Northwestern University researchers Steve Xu and Jessica Walter--Courtesy of Northwestern University

Some high-risk women's health devices were approved without proper data, according to a recent study. The findings point to a need for increased oversight from the agency, researchers said.

Scientists at Northwestern University looked at 18 high-risk devices approved by the FDA from 2000 to 2015, including those for menstrual flow reduction, contraception and fetal monitoring. Four of the devices were approved even though they did not show efficacy in clinical trials, according to results published recently in the journal Obstetrics and Gynecology.

Six of the devices included in the study were not required to undergo post-market studies to monitor their safety. Three devices were eventually withdrawn from the market, and of those three, two were not reviewed by experts on the FDA's obstetrics and gynecology advisory committee. The other product was reviewed but not recommended for approval by the panel.

"Devices are a huge part of the medical care that we provide women on a daily basis," study first author Dr. Jessica Walter, a resident in Northwestern University's Department of Obstetrics and Gynecology, said in a statement. "We found that there's an opportunity to increase the burden of proof required for a device to be approved for public use."

The team's findings show that the FDA's approval process for women's devices "has a lot of weaknesses," senior author Steve Xu, a resident in dermatology at Northwestern University, said in a statement. Researchers pointed to the example of Bayer's controversial birth control implant, Essure.

The device was approved in 2002, but has since come under scrutiny for causing serious problems in pregnant women. Regulators also got flak for approving the implant with only short-term evidence and insufficient post-market follow-up, study authors said.

The FDA said that it would reevaluate Essure after getting complaints of grave side effects and injuries. In February, the agency slapped the product with a black-box warning.

Fallout from approved devices such as Essure points to a need for more stringent medical device regulation, the team said, even as lawmakers are calling for opposite action.

The 21st Century Cures Act, which passed in the House of Representatives last May, would decrease medical device regulation. If approved by the Senate, the legislation would "broaden the definition of the 'valid scientific evidence' manufacturers need in order to prove medical benefit" for a device, Walters said. This could lead to more device approvals with less clinical safety evidence, she added.

The FDA should seek more advice from its expert advisory committees and use higher quality studies before approving products, the team said. "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. But that hasn't necessarily been shown in the literature," Walter said.

- here's the study abstract
- read the statement