Flawed Data on High-Risk Women's Health Devices
Some high-risk medical devices used in obstetrics and gynecology were approved by the FDA based on flawed data, according to a study from Northwestern Medicine in Chicago, published in the journal Obstetrics and Gynecology in May 2016.
A release from the university explains that 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 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.
The release quotes study first author Dr. Jessica Walter, a resident in obstetrics and gynecology at Northwestern University Feinberg School of Medicine, as saying, “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. Four of the devices — 22 percent — were approved even though they failed to demonstrate efficacy in clinical trials. Six of the devices — 33 percent — 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Three devices were eventually withdrawn from the market after approval.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 Dr. Steve Xu a resident in 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 authors point to controversial medical devices like a permanent contraceptive device approved by the FDA in 2002 that is now being evaluated after numerous reports of adverse events including pain, organ damage and unintended pregnancy. The device, meant to last a lifetime, was approved based on short-term evidence and insufficient post-market follow-up, explain the study authors.
“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 said. “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?”