New documentary called The Bleeding Edge brings attention to controversial medical devices such as Essure

Medical doctor speaking with woman about Essure

When we think of technology in the medical field, most people would agree that the noninvasive procedures used today are much better than the surgeries completed ten years ago or more. These changes are too often viewed as a better alternative than traditional medicine without asking many questions. After all, who wouldn’t want to have a shorter stay at the hospital, less pain, and faster recovery time? But what happens when the cutting edge of the medical field goes wrong and turns into “the bleeding edge”?

The Documentary

A recent documentary on Netflix called The Bleeding Edge has brought a lot of attention to Bayer’s controversial permanent birth control device, Essure. The documentary tells the heartbreaking stories of individuals who underwent procedures promising to be more helpful and less invasive. Unfortunately, for them, the procedure became a nightmare. The film quoted that “women with Essure experience sterilization failure seven times more often than women who had their tubes tied” (Bouillon, Bertrand, Bader, et al. 2018).

The individuals in this film talk openly about their struggles after having Essure implanted in their fallopian tubes. According to the documentary, “nearly 12,000 adverse events regarding Essure were reported to the FDA in 2017.” These adverse reactions caused many of the patients to need additional procedures/surgeries to remove the implants. Sadly, not only did these issues affect the women who had it done, but it heavily affected their families too.

The Approval Process

This documentary also explains how Bayer was able to get Essure on the market because of something called Pre-Market Approval (PMA) of the U.S. Food and Drug Administration (FDA). The film shows Dr. Diana Zuckerman as she discusses the PMA process. She explains that PMA is the most stringent pathway to get devise approval by FDA standards, however, the process of PMA can also only require one study which can be conducted with a smaller group; less than 100 people.

The documentary also points out that these companies are able to use previously approved devices as a pathway for approval on a new and moderately similar device with very little objection from the FDA – even when the previously approved device has been recalled. According to interviews in the film, the PMA process has become a loophole which allows companies to place devices on the market without being adequately tested.

The Bleeding Edge interviewed doctors and patients who claim that the FDA is not doing enough to protect them. They believe that the FDA approved Essure without conducting the appropriate testing.

What can you do?

If you had the Essure device implanted in your body and you later suffered complications, you may be able to file an Essure lawsuit. Please call Baron & Budd at 866-723-1890 or complete our contact form to schedule a consultation.

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