It would seem fairly intuitive that women and men would react differently to medical devices?even a non-medical professional (like myself) could guess that size, hormones, past pregnancies, and the use of oral contraceptives could mess with clinical outcomes. Yet women remain underrepresented in clinical trials. For example, one opinion piece mentioned how among trials examining 78 high-risk cardiovascular devices approved between 2000 and 2007, approximately 67% of the patients were men, even though women represent nearly half of all cardiovascular disease patients. And there are real risks involved in this underrepresentation. The same article discussed how although implantable cardioverter-defibrillators were approved for both men and women, a more recent meta-analysis showed that the devices do not reduce mortality when used for primary prevention in women?knowing this little tidbit would have definitely been helpful for physicians recommending these devices.
The Food and Drug Administration (FDA) recognizes this shortfall; in fact, the organization published a draft guidance for medical device manufacturers called ?Evaluation of Sex Differences in Medical Device Clinical Studies?, which discussed the need to gather gender-specific data and enrol more women participants. But skeptics argue that simply publishing these guidelines won?t change anything?FDA trial sponsors still won?t have clear financial motives to enrol more women in trials. Also, it's been observed that women in general are more reluctant to participate in trials, so it might not be an issue of them being excluded intentionally.
Although nothing concrete is being implemented yet, this is definitely something for manufacturers to keep in the back of their minds as they launch clinical trials for new devices. And as a woman, I?m definitely a proponent of making sure that devices work just as well for us as for men!