Medical devices for treating heart problems can affect male and female patients differently. But according to a new study by a University of California, San Francisco, research team, federal regulators often approve the products without knowing their potential impact on women.
The study, published in Circulation: Cardiovascular Quality and Outcomes, reviewed the approval process of 78 heart devices deemed high risk that were approved by the Food and Drug Administration from 2000 to 2007. The researchers’ conclusion: trials on the devices, including implantable defibrillators and heat valves, either failed to take gender into account or missed out on the impact on women because two-thirds of the test subjects were men.
As a result, “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,” lead researcher Dr. Rita F. Redberg told the news service HealthDay.
Redberg, a cardiologist, noted that the FDA since 1994 officially has required gender-bias statements in approval applications, which are supposed to include information on a device’s varying effects on men and women. Her research team found, however, that only 41 percent of the FDA-approved devices they reviewed had such statements.
Among the problems women face, Reuters reports, is their tendency to bleed more when a device is implanted. Women also seem to have a higher risk of deadly complications. And some studies show that, even after a device is safely implanted, women appear to benefit less than men.
The lack of attention to women may stem from the common, but mistaken, idea that heart problems primarily afflict men. “Half the people that get heart disease are still women,” Redberg said. “Men are on average 10 years younger than women when they get heart disease, but we catch up.”
An FDA spokeswoman said the agency “is aware of the under-representation of women in clinical trials” and is working on correcting the problem.
