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Study Finds FDA Needs To Do More to Protect Women

According to, a new study conducted by Northwestern University found that over the past fifteen years the Food and Drug Administration (FDA) has approved medical devices for use by women that posed serious and significant risks to women’s health but that were supported by weak clinical studies. More specifically, the study focused on eighteen medical devices approved for use between 2000 and 2015 designed for use by women and addressing a variety of women’s health concerns such as fetal monitoring, contraception, and uterine bleeding. The study found that, of those 18 medical devices approved by the FDA:

  • Four devices did not demonstrate any effectiveness whatsoever;
  • Six devices have not had any postmarketing safety studies conducted; and
  • Three devices have been taken off of the market due to safety concerns.

As a result, the FDA is facing calls to tighten up the standards it follows when approving high-risk medical devices designed to be used by women for public use.

Study Finds Regulatory Shortcomings

Under FDA’s approval guidelines, medical devices that present a “high-risk” of potential harm to patients must submit clinical data to the FDA showing that the device is both safe and effective. While these standards at first appear to be sufficient, the study points out significant deficiencies. For one thing, randomized clinical trials – considered to be the “gold standard” of clinical trials for determining effectiveness – are not required by the FDA. Not only this, but a medical device manufacturer need not have its results evaluated by the FDA’s experts before a device is approved. Finally, the FDA’s standards do not require any post-approval safety studies to ensure the approved device does not have any unintended side effects that make the product unsafe.

How the FDA’s Standards Endanger Women

The FDA’s practices in approving high-risk medical devices for women endanger women’s wellbeing. Without stringent approval standards designed to uncover the hidden dangers of a particular device, women can be lured into a false sense of security. They may believe that, because a particular medical device has been approved by the FDA, it will be both a safe and effective for them. They may use the device completely unaware that serious, even permanent, injuries can result from using the device (even if they use the device as directed). Unfortunately, the FDA may not recall the device or issue a warning until a sufficient number of women have been injured and reported these injuries to the FDA and/or device manufacturer.

Contact Us For Assistance

If you or a loved one have been injured by a medical device, the experienced Philadelphia medical device injury law firm of Cohen, Placitella & Roth, P.C. can assist you. We fight aggressively for women injured by dangerous medical devices and can help you recover compensation you need for your losses and pain. Contact our firm by telephone or online and discuss your case with our knowledgeable and compassionate legal team today.


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