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Weekly Column –  Is it true that women are more negatively affected by medical devices than men?

When it comes to clinical trials of new drugs and medical devices, all too often, it’s still a man’s world. For decades, most biomedical research focused on men, including research on medical devices intended for both men and women.

According to the Food & Drug Administration, a medical device is “…an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article” that is “intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in man or other animals.”

Note its very definition is focused on “man”.

For decades, most biomedical research focused on white men—so much so that finally in 1993, Congress ordered the National Institutes of Health (NIH) to include women and people of color in all its clinical trials. Yet medical device manufacturers and drug companies are not required to comply with that rule, so progress has been slow.  Women are now included in most trials of new drugs, but they are less likely to be included in sufficient numbers in trials of medical devices. This leads to problems when devices like hip replacements and certain heart devices just aren’t the right size or shape for women. For example, it took until 2010 for device manufacturers to create a smaller ventricular assist device designed for women.  

In 2014 the FDA came up with recommendations for the medical device industry regarding using women in research. Not mandates, they are careful to say, but guidelines, because: “Certain medical products elicit different responses in women compared to men.”

Also according to the FDA, some medical devices can be more dangerous for women than men:

  1. Ventricular Assist Devices (VADs) provide mechanical circulatory support for patients with heart failure. One study of a next-generation VAD showed that in subjects treated with the investigational device, there was a higher rate of stroke in women as compared to men (18% vs. 6%). There were also trends toward increased rates of bleeding and infection in women compared to men… the strength of these conclusions is somewhat limited by the sample size (150 men and 44 women).
  2. Women are more at risk from metal on metal hips: “From this information, FDA recommendations for orthopedic surgeons include that women may be at risk for increased device wear and/or adverse local tissue reactions and should be followed more closely.”

So when it comes to medical devices, how can women protect themselves?

Here are some suggestions from Consumer Reports:

Consider alternatives. Ask your doctor what will happen if you don’t get the implant. Many women who received transvaginal mesh for prolapse repair, for example, probably never even needed surgery.

Research the device. The Food and Drug Administration’s website, FDA.gov, has a wealth of information about device safety warnings, complaints, and recalls, easily accessible by typing the name of the device into the site’s search box. It’s also worth searching Google. If the results include a lot of law firms looking for clients injured by the device, that’s a sign to ask your doctor some hard questions. For an optional device like a Lap-Band or breast implant, look around the Internet for patient forums. Though the information there isn’t validated, you’ll get a sense of whether patients are reporting trouble with the device.

Write down what you got. If your doctor doesn’t give you information about the brand name, model, and serial number (if it exists) of your device, ask for it. If you learn of a warning or safety recall, from the FDA or elsewhere, you’ll know whether yours is one of the problem models.

Stay alert—but don’t panic. If you learn that there are problems with your device, contact your doctor and ask what warning signs to watch for. Also go to the FDA website to read up on official warnings and find out whether it’s safe to keep the device in your body.

In addition to those tips, you can search for any financial relationship between your surgeon and the device manufacturer by checking Open Payments Data.  

To learn more about about medical device safety watch The Bleeding Edge documentary, now streaming on Netflix.

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