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Heart Devices Not Tested Enough in Women: Study
Date:3/1/2011

By Steven Reinberg
HealthDay Reporter

TUESDAY, March 1 (HealthDay News) -- On top of criticism that the U.S. Food and Drug Administration approves medical devices with too little oversight comes another troubling finding: Many heart-related devices win FDA approval without being adequately tested on women, despite an agency directive to do so.

This means that heart valves, pacemakers, defibrillators and stents get implanted in women without evidence that they benefit this population, researchers from the University of California, San Francisco say.

"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," said lead researcher Dr. Rita F. Redberg, a professor of medicine and director of Women's Cardiovascular Services at the university and a member of the FDA Circulatory System Devices Panel.

"The FDA needs to turn away device applications that don't have a gender-bias statement," said Redberg, senior author of the study, published online March 1 in Circulation: Cardiovascular Quality and Outcomes.

Differences in size and bleeding tendencies can affect the way these devices operate in men and women, and side effects can also vary by gender, Redberg said.

Recognizing those distinctions, in 1994 the FDA mandated that manufacturers of new medical devices 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, Redberg said.

The data is also supposed to include any safety or effectiveness problems seen in women using the device.

Redberg's team looked at 123 studies submitted with premarket approval applications for 78 high-risk cardiovascular devices, including heart valves and implanted defibrillators. All the devices were approved by the FDA between 2000 and 2007.

During that period, a time when women's heart
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