Study Cites Flaws in Approvals Of High-Risk OB-GYN Devices

A number of high-risk women’s health devices gained FDA approval based on inadequate data, according to a new study from Northwestern Medicine.

The researchers call on regulators and physician organizations to create and support more rigorous approval standards and stricter postapproval tracking requirements for these devices. Physicians should also be more proactive about postmarketing monitoring and adverse event reporting, they said.

The study, published in Obstetrics and Gynecology, looked at 18 high-risk devices and found:

• Four were approved despite failing to show efficacy in clinical trials;
• Six were not required to undergo postmarket studies;
• Three were taken off the market after approval; and
• Of those three, two were not reviewed by the FDA’s Obstetrics and Gynecology Advisory Committee. The other was reviewed by the committee but not recommended for approval.

Most of the devices were approved between 2000 and 2015 for endometrial ablation, contraception and fetal monitoring. The study highlighted Bayer’s Essure device, which was approved in 2002 with short-term evidence and not enough postmarket follow-up, the authors say. The device is now being evaluated in light of numerous adverse event reports (IDDM, March 7).

Implications of the Study

Senior author Steve Xu questioned the logic of holding high-risk medical devices to a lower standard of evidence than drugs. “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,” he noted.

The researchers also raised concerns that the House-passed 21st Century Cures Act would weaken medical device regulation, broadening the definition of “valid scientific evidence” that can 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 author Jessica Walter. The bill is now pending in the Senate.

Walter and Xu are calling on clinicians to improve their understanding of FDA regulation and become more proactive about collecting and reporting data on device complications and adverse events. “Given that post-marketing surveillance is often passive voluntary reporting, physicians need to be more than mere end-users,” said Xu.

The study also points out that almost all the obstetrics and gynecology devices approved via the PMA pathway had subsequent supplements. “A high number of supplements increases the risk of device creep where small incremental changes become additive and substantial over time,” it says. “Thus, the number of supplement applications is another important consideration of postmarketing regulation.”

In addition to higher-quality studies and greater emphasis on supplement applications, the study recommends more input from expert advisory committees and increased use of device-specific registries. — Joya Patel