Netflix is releasing a documentary called, The Bleeding Edge this week. It is described as revealing “how the rush to innovate can lead to devastating consequences for patients.” It includes a discussion of medical devices and the problems they cause. One such device is Essure.
The Filmmakers, Kirby Dick and Amy Ziering, issued a statement after Bayer announced it is discontinuing sales of Essure in the United States saying, “This is exactly why we do this work: This film has already changed policies and changed history.” While we haven’t seen a direct link between the Netflix release and Bayer’s decision, the timing is interesting.
As of January 2018, over 16,000 women have sued Bayer.
These lawsuits have been going strong for several years now around the country. The Food and Drug Administration and Bayer have been very active regarding Essure in the last few years after thousands of complaints and adverse events came to light through FDA inspections, grassroots efforts of women who alleged they’ve been hurt by the device, and ongoing litigation.
This past April, the FDA restricted sales of the tubal ligation device and reinforced the need for medical facilities and doctors to use a specific checklist to more explicitly inform patients of the risks associated with the device. This was significant because Bayer had to add a black box warning to its label in 2016. It had engaged in several postmarket surveillance initiatives to Essure’s the safety and effectiveness, including conducting longer term (3 year follow up) clinical studies.
Despite discontinuing sales, the study will continue. It will not likely hit its goal of enrolling 2,000 women participants. FDA Commissioner Scott Gottlieb issued a statement that FDA will continue working with Bayer on the study.
In the meanwhile, women will not have Essure as a birth control option, which may be a double edged sword, at least if you listen to Bayer and some Essure supporters. Bayer isn’t likely redesigning the device and after its experience with Essure and it’s Mirena medical device, Bayer may not jump into this sector in the near future, but we shall see.
In the meanwhile, the the attorneys at KBA continue fighting for clients impacted by the Essure device. Partner Justin Browne serves on the Plaintiffs’ Steering Committee in California where over 10,000 cases are pending. He will provide updates as the litigation unfolds, so be sure to check back.