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
"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,
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 disease was
gaining unprecedented attention, there was no increase in the
proportion of women participating in studies or the number of
applications with gender-bias statements, Redberg said.
FDA summaries of 28 percent of the studies made no mention of
gender. Of those that did, men made up 67 percent of the study
participants, the researchers found.
In addition, only 41 percent of the studies included the
required gender statement. Of these, 94 percent showed results by
sex, and 26 percent found sex-related differences in the safety and
effectiveness, the researchers found.
Only 11 percent of the studies without gender-bias statements
included any performance data related to gender difference. Studies
of fewer than 50 patients were not included in the sex-based
analysis, the authors noted.
Among applications the agency approved, device makers
erroneously excluded women from studies, the researchers found.
Some manufacturers understated the number of women with a specific
heart condition. Other times, they said their study included an
equivalent number of women as earlier studies, without
acknowledging that those prior studies included only a token number
Since data are not available about devices that the FDA didn't
approve, Redberg's team couldn't determine how many of these
included gender data.
The FDA, meanwhile, says it is working to correct these
"The findings reported in this study are not new," said FDA spokeswoman Karen Riley. "FDA is aware of the under-representation of women in clinical trials," she added.
Recently, the FDA division that approves medical devices has
come under fire from the medical community for approving devices
too fast without proper data, while device manufacturers complain
it doesn't approve devices fast enough and over-complicates the
The agency's own 2009 study found that women, children and
minorities were underrepresented in premarket cardiovascular
clinical trials. "Women were less often enrolled in the studies
than men (33.9 percent versus 66.1 percent)," Riley said.
The agency will issue guidance on gender this year, Riley added.
"Interim policy improvements are already under way, intended to
address the need for greater consistency in sex-specific analysis
and availability of sex-specific information for approved medical
devices," she said.
Commenting on the study, Dr. Nieca Goldberg, director of the
Women's Heart Program at NYU Langone Medical Center in New York
City, said more must be done on women's behalf.
"There has to be greater oversight," Goldberg said. "We have to meet the needs and expectations of women."
A woman needs to ask her doctor about the risks and benefits of
these devices, Goldberg said.
"But we can't stop women from having these procedures if they really meet the indications," she said.
Redberg, who was speaking independently of her role with the
FDA, says stricter enforcement of guidelines is needed.
For more information on women and heart disease, visit the
American Heart Association.
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