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.
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