SAN FRANCISCO, March 2 (UPI) -- Medical device makers are required to include women in studies they submit to the U.S. government for approval, but only a few do, U.S. researchers say.
Senior author Dr. Rita F. Redberg, a professor of medicine and director of Women's Cardiovascular Services at the University of California, San Francisco, says in 1994 it was required 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 and differences in the safety and effectiveness of the device in women.
Researchers reviewed 123 studies contained in the pre-market approval applications for 78 high-risk cardiovascular devices including heart valves and implanted defibrillators that gained FDA approval from 2000 to 2007.
The study, published in Circulation: Cardiovascular Quality and Outcomes, found 41 percent of the studies had the required gender-bias statement. Of those studies, 94 percent discussed examining their results by sex and 26 percent reported differences in device safety or effectiveness between men and women.
"Women and men differ in their size, bleeding tendencies, and other factors that are directly relevant to how the devices will work," Redberg says in a statement. "It is likely that the benefits and risks of devices are different in women."
