Women left behind in heart device tests

Many heart devices get approved by the U.S. Food and Drug Administration (FDA) despite a lack of data on safety and efficacy in women, researchers said Tuesday.

That could have serious consequences, say the authors of the new study, because the devices, which include pacemakers, defibrillators and blood vessel stents, don’t work the same in the two genders.

“We know the risks are different in women and men,” said study author Dr. Rita F. Redberg, a cardiologist at the University of California, San Francisco.

For instance, women tend to bleed more when a device is implanted and appear to be at higher risk of dying due to the procedure.

And some studies indicate women don’t see the same benefits as men from the devices, Redberg added.

Redberg is a member of the FDA Circulatory System Devices Panel, but her work on this study was done independently and her report doesn’t reflect the views of the panel or the FDA.

She and her team went through 78 summaries of FDA approvals for high-risk heart devices.

“Only 41 percent of all the studies had a gender bias statement which the FDA has required since 1994,” Redberg told Reuters Health. “So clearly there is a gap.”

The study, published in Circulation: Cardiovascular Quality and Outcomes, also found that more than a quarter of the premarket approval applications didn’t report on the sex of study participants. And in those that did, two-thirds of the participants were men.

And it’s not due to different disease risks between men and women, according to Redberg.

“Half the people that get heart disease are still women,” she said. “Men are on average 10 years younger than women when they get heart disease, but we catch up.”

She said 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 recommends that women ask about the data on a given heart device before they consider having it implanted.

According to a 2009 study by Redberg’s team, nearly 500,000 Americans had pacemakers or defibrillators implanted in 2008, and more than 1.2 million got stents to keep their coronary arteries from collapsing.

SOURCE: Circulation: Cardiovascular Quality and Outcomes, online March 1, 2011.