Study questions FDA’s regulation of women’s health devices

Food and Drug Administration (FDA) approval of medical devices for women has been based on flawed data, according to a recent study conducted by Northwestern Medicine residents

Steve Xu, a resident in dermatology and Jessica Walter, a resident in obstetrics and gynecology, were the senior and first authors of the recent paper that assessed the approvals process for high-risk medical devices used in obstetrics and gynecology.

The investigators assessed the regulation of women’s health devices approved by the FDA in the last 15 years.

The authors suggest that their results, published in the journal Obstetrics and Gynecology, indicate that the agency’s approvals should be based on clinical studies more rigorous than currently required, both before and after the devices go to market.

Study first author, Walter, said: “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.”

The team identified 18 high-risk devices approved by the FDA from 2000 to 2015, most of them for endometrial ablation (reducing menstrual flow), contraception and fetal monitoring.

According to the report:

• Four of the devices were approved even though they failed to demonstrate efficacy in clinical trials.
• Six of the devices 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• Three devices were eventually withdrawn from the market after approval.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 and the other was reviewed but not recommended for approval by the committee.

Xu said: “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.”

“There are no explicit requirements about conducting randomised-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?”

The authors note in the paper that the 21st Century Cures Act – healthcare legislation passed in the House of Representatives in May 2015 – currently contains provisions that would reduce medical device regulation. The bill is  currently being considered by the Senate.

“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,” said Walter.