Medical Devices Need Better Testing in Women

The FDA is approving heart valves, pacemakers, stents, and other heart-related devices without adequately testing them on women, a new study says.

Researchers from the University of California-San Francisco looked at 123 studies that were submitted to the FDA for 78 high-risk cardiovascular devices, including heart valves and implanted defibrillators. All were approved by the FDA between 2000 and 2007.

They found that FDA summaries of 28 percent of the studies made no mention of gender. Of those that did, men made up 67 percent of the study participants.

This is despite a 1994 FDA directive that required manufacturers of new medical devices to provide statements that the devices were tested in men and women in the same proportion as men and women experiencing the condition that the device would treat.

Less than half had statement

Only 41 percent of the studies examined by the California researchers included the required gender statement. Of these, 94 percent showed results by sex, and 26 percent found sex-related differences in the safety and effectiveness.

Only 11 percent of the studies without gender-bias statements included any performance data related to gender difference.

"We do not know if a lot of medical devices currently on the market are as safe and effective in women as they are in men," says lead researcher Rita F. Redberg, M.D., at UCSF and a member of the FDA Circulatory System Devices Panel.

Several errors

Among applications the FDA approved, device makers erroneously excluded women from studies, the researchers found. Some manufacturers understated the number of women with a specific heart condition. Other times, they said their study included an equivalent number of women as earlier studies, without acknowledging that those prior studies included only a token number of women.

The FDA says it is working to correct these shortcomings.

"The findings reported in this study are not new," says FDA spokeswoman Karen Riley. "FDA is aware of the under-representation of women in clinical trials."

The agency will issue guidance on gender this year, Riley says. "Interim policy improvements are already under way, intended to address the need for greater consistency in sex-specific analysis and availability of sex-specific information for approved medical devices," she says.

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