Here's something scary: According to a new study in Obstetrics and Gynecology, many of the women's health devices that the FDA has approved for ob-gyn use are not proven to be safe. These include devices to reduce menstrual flow, monitor fetuses, and provide contraception.
For the study, researchers examined 18 medical devices approved between 2000 and 2015 and found that four were not proven to be effective, six weren't studied after they hit the market, and three were withdrawn. Those three devices weren't even approved by doctors—one was not recommended, and two weren't reviewed at all.
The birth control implant Essure, for example, was FDA-approved in 2002 but was not subject to any follow-up research. Now, there are lawsuits against the brand with allegations that Essure causes autoimmune diseases, pelvic injuries, and a number of other complications. There's currently a Facebook group of nearly 30,000 women who say they've suffered unexpected side effects due to Essure.
The authors of the study recommend much more rigorous guidelines for regulating women's health devices. For example, there are currently no standards requiring follow-up studies after a device is put on the market or ensuring that the initial studies are as rigorous as possible. It doesn't appear we're headed in the direction of stricter guidelines, though. The paper points out that the 21st Century Cures Act currently under consideration in the Senate would actually reduce the standards set for medical devices.
“There are much higher standards for the approval of new drugs, whether oral, injectable, or even topical," study author Steve Xu told Futurity. "The important question to ask is: Should we really be holding high-risk medical devices to a lower standard of evidence than drugs?” Um...no.
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