Heart devices on the market often don’t have adequate data on safety and effectiveness in women.
Devices like pacemakers, defibrillators, heart valves, and stents may act differently in women than in men, and there is a stunning lack of information about how safe or effective these devices are for women.
In spite of requirements for medical device makers to include women in studies submitted to the Food and Drug Administration (FDA) for device approval, most do not include enough women, nor do they adequately analyze how the devices work in women, according to according to research reported in Circulation: Cardiovascular Quality and Outcomes.
A news release from the American Heart Association quotes 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:
“Women and men differ in their size, bleeding tendencies, and other factors that are directly relevant to how the devices will work. It is likely that the benefits and risks of devices are different in women. Despite the directive to find out, it isn’t happening.”
FDA submissions for device approval are required to include a gender-bias statement, including such information as whether the proportion of men and women in the study corresponds to the proportion of men and women who have the condition, as well as information on differences based on gender.
Researchers found studies that didn’t bother to report gender of participants at all. For those who did, men made up an average of 67 percent.
A gender-bias statement was included in 41 percent of the studies. Of that 41 percent, 94 percent said they examined results by gender, and only 26 percent reported on differences in safety or effectiveness for women. There is no information available on applications which were not approved by the FDA.
About Heart Disease in Women
- Heart disease is the number one cause of death among women 20 and older, killing about one woman every minute.
- More women die of heart disease than the next four causes of death combined — including all forms of cancer.
- Ninety percent of women have one or more risk factors for developing heart disease.
American women are being seriously shortchanged — giving our number one killer the upper hand.
The FDA mandated manufacturers of new medical devices to include gender statements in 1994. Why is this requirement not being enforced? And why are manufacturers, for the most part, still excluding women from important studies?
We deserve better than that.
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