Women’s Health Devices Being Approved With Insufficient Safety Data: Study

New research suggests that a number of medical devices for women have been approved based on flawed data, potentially causing severe adverse events, complications, injuries and deaths. 

In a study published in the June 2016 edition of the medical journal Obstetrics and Gynecology, researchers from Northwestern Medicine looked at the approval of obstetrics and gynecological devices approved over the last 15 years.

Researchers focused on 18 high-risk medical devices, which were approved after going before the FDA obstetrics and gynecology advisory committee between 2000 and 2015.

Of the dozen and a half devices reviewed, only 11 underwent randomized controlled trials before they were approved to establish they were safe and effective, and the manufacturers of only 12 of the devices were required to conduct post-market surveillance to examine problems that occurred once the products were approved and being used on women nationwide.

Three of the devices examined were subsequently removed from the market after the initial approval, including two that were never reviewed by FDA physician experts on its advisory committee the other device was approved by the FDA despite a recommendation by it’s advisory committee that the product not be allowed on the market in the United States.

“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,” Senior author Dr. Steve Xu said in a press release. “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.”

One of the devices the researchers noted was the controversial birth control implant Essure, which was approved by the FDA in 2002. In recent years, the device has been the focus of intense scrutiny within the medical community, after thousands of women suffered severe and debilitating problems following Essure procedures to have the bendable coils implanted into their fallopian tubes to prevent pregnancy.

Bayer Healthcare now faces a growing number of Essure lawsuits brought on behalf of women throughout the United States who have suffered an injury, each involving similar allegations that the manufacturer of the device failed to sufficiently research the device or adequately warn women, doctors and federal regulators about problems linked to Essure implants.

“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?”

Researchers indicate that pending legislation, known as the 21st Century Cures Act, may make it even easier for dangerous and defective medical devices to reach the market.

Consumer advocates have previously raised concerns that the FDA is not adequately protecting patients from dangerous drugs and medical devices, often failing to require stringent premarket studies to identify dangerous side effects or defects before the wide use of new treatments.

Despite questions about the latitude already provided to manufacturers, the 21st Century Cures Act would further loosen the approval process, allowing the agency to approve drugs and medical devices that have not had adequate clinical trials to ensure they are safe and effective, critics warn.