NEW YORK (Reuters Life!) - Many heart devices are approved for use in the United States despite a lack of data on safety and effectiveness for women — even though the devices don’t work the same in the two genders, according to a study.
“We know the risks are different in women and men,” said study author Rita Redberg, a cardiologist at the University of California, San Francisco.
For example, women tend to bleed more when a device is implanted and appear to be at higher risk of dying due to the procedure, while some studies also indicate that women don’t see the same benefits as men.
For the study, published in Circulation: Cardiovascular Quality and Outcomes, Redberg and her team went through 78 summaries of U.S. Food and Drug Administration (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. So clearly there is a gap,” Redberg told Reuters Health.
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.
“Half the people that get heart disease are still women,” Redberg said.
“Men are on average 10 years younger than women when they get heart disease, but we catch up.”
Redberg 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.
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 view of the panel or the FDA.
Reporting by Frederik Joelving at Reuters Health; editing by Elaine Lies