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Women Get Short Shrift in Many Heart Device Studies, Despite Requirement
Date:3/1/2011

DALLAS, March 1, 2011 /PRNewswire-USNewswire/ -- Despite a long-standing requirement for medical device makers to include women in studies they submit to the Food and Drug Administration for device approval, only a few include enough women or analyze how the devices work specifically in women, according to research reported in Circulation: Cardiovascular Quality and Outcomes.

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"Women and men differ in their size, bleeding tendencies, and other factors that are directly relevant to how the devices will work," said Rita F. Redberg, M.D., M.Sc., senior author of the study and professor of medicine and director of Women's Cardiovascular Services at the University of California, San Francisco.

"It is likely that the benefits and risks of devices are different in women. Despite the directive to find out, it isn't happening."

In 1994, the Center for Devices and Radiological Health instituted a policy that all FDA submissions seeking new device approval must contain:

  • A gender-bias statement explaining whether the proportion of men and women in the study reflects the proportion of men and women who have the condition being treated.
  • Differences in the safety and effectiveness of the device in women.

  • In their analysis, researchers reviewed 123 studies contained in the pre-market approval applications for 78 high-risk cardiovascular devices (the category that includes heart valves and implanted defibrillators) that gained FDA approval between 2000 and 2007.

    In 28 percent of the studies, FDA summaries of the evidence didn't report the gender of study participants. In those that did, men made up an average of 67 percent.

    The investigators found that the required gender-bias statement was present in only 41 percent of the studies. Of studies that included the statement, 94 perce
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    SOURCE American Heart Association
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