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Women’s Cardiovascular Health at Risk

The medical industry needs to do a better job of protecting the hearts of American women. One of the many health challenges women have had to deal with was the scam of Hormone Replacement Therapy. Marketed by pharmaceutical companies as a cure-all for aging, HRT also claimed to protect against heart disease. In 2002 it was revealed that not only was this claim false, but in fact HRT increased risk of heart disease. Women were tricked into using a product that caused the very thing it claimed to prevent.

Another blow to women’s heart health came when researchers at University of California, San Francisco discovered that many heart-related medical devices have not been adequately tested on women. Although women constitute just over 50% of the population, many devices are tested overwhelmingly on men before getting FDA approval.

After looking through 123 studies for 78 different high-risk medical devices that were approved by the FDA, researchers found significant gender bias. The devices looked at were all for cardiovascular health, including heart valves, implanted defibrillators, pacemakers and stents. Since heart disease is the number one cause of death among women in the US, it is important that these devices perform safely and effectively on women as well as men.

28% of the studies analyzed made no mention of gender. Men constituted 67% of the participants in the other studies. Due to differences in bleeding tendencies and size, men and women may have different reactions or side effects with these devices. “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,” researcher Dr. Rita Redberg said.

The results from their analysis should be surprising given that in 1994, the FDA released a mandate that manufacturers issue a gender-bias statement with each new product application, guaranteeing that the devices were tested in appropriate proportions of men and women. However, under half of the studies reviewed included that required statement. Of those that did, 26% actually showed sex-linked differences in safety and effectiveness.

Since the 1980s, women’s health groups have been advocating for closer analysis of medication and medical devices and their effects on women. Men have been given preference as test subjects because they lack some of the hormonal variables that make women more “challenging.” This is an unacceptable excuse for sexist practices that endanger women. They deserve the same assurance that approved medical devices and equipment will be safe and effective when used on them, and the FDA needs to crack down and make this happen.

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