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Study shows many heart devices receive FDA approval without adequate testing on women


Despite longstanding requirements by the U.S. Food and Drug Administration, women are still underrepresented when it comes to the development and approval of cardiovascular devices such as implantable defibrillators, according to findings published yesterday in Circulation.

In the study (subscription required), researchers analyzed 123 studies of 78 heart-related devices that were granted pre-market approval by the FDA for men and women between 2000 and 2007. Overall, the results showed only 41 percent of studies reviewed by the FDA included a gender bias statement. Reuters reports:

The study also found that more than a quarter of premarket approval applications didn't report on the sex of study participants. In those that did, two-thirds of the participants were men...

[Study author Rita Redberg, MD,] added that manufacturers were clearly ignoring the FDA's requirements for testing in women as well, but that it didn't appear to have any consequences for whether a device is approved by the agency.

As a result, she advised women to ask for data on a given heart device before they consider having it implanted.

Previously: Women underrepresented in heart studies, A new target-heart-rate formula for women, by women and Understanding and preventing women's heart disease
Photo by Steve Winton

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