Despite common belief, heart disease is not more prevalent in men than women. Coronary heart disease is the number one killer of both adult men and women, but when it comes to treatment, men and women are treated differently.
Women who seek emergency treatment with heart attack symptoms are more likely to be diagnosed with lesser conditions like acid reflux or anxiety than their male counterparts. But it’s not just treatment that shows a gender bias. In clinical studies of medical devices designed to treat cardiovascular disease, two men are enrolled for every one female participant.
However, not all cardiovascular medical devices are designed for use in women. The only FDA approved artificial heart is actually too large for most women. For women in need of new heart, receiving a transplant is the only option, but this is also problematic. Although heart disease affects men and women equally, women only account for 20% of patients waiting for heart transplants.
Even in clinical studies of obstetric and gynecological devices, data is far from perfect. Researchers at Northwestern University’s Feinberg School Of Medicine found several high-risk devices approved by the FDA for obstetric and gynecological procedures were studied significantly less thoroughly than other medical devices.
When women are underrepresented or misrepresented in clinical trials, the result is biased healthcare that puts women at an increased risk for injury or death.
Under current laws, healthcare providers are not required to report adverse events related to medical devices to the FDA. This voluntary system combined with an increased risk of dangerous medical devices for women can be a deadly combination.
This was the case with the laparoscopic power morcellator, which spread cancerous tumors throughout the body during procedures. However, because adverse event reporting is voluntary, it took years before the FDA identified the risk, at which time the device had already exposed thousands of women to cancer.