FDA

FDA Issues Update on Adverse Event Reports Related to Essure

By MedTech Intelligence Staff
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FDA

Bayer’s second quarterly analysis report of adverse event information includes nearly 12,000 serious injuries, 45 malfunction reports and nine deaths.

Although Bayer stopped selling its Essure permanent birth control device mid-2018, FDA has continued to monitor product safety via postmarket surveillance study data.

FDA recently announced the publication of Bayer’s second quarterly analysis report of adverse events for September 2020 through the end of November 2020. According to FDA, these events are from social media posts and may be connected to litigation, but they are not necessarily new adverse events.

“Reports do not necessarily represent unique cases, but rather events identified in comment threads from social media posts, sometimes by the same individual. The most common patient problems reported were pain, perforation, foreign body/device fragment in patient, pregnancy (including ectopic), heavier periods (menses/hemorrhage), and hypersensitivity. The majority of reports (94%) are related to potential device removal, which is consistent with the MDRs for Essure since 2017. For the 9 death reports, the social media posting dates (when provided) ranged from the year 2013 to 2015. None of the death reports provided a date for the reported death event… The limited information prevents the ability to draw any conclusions as to whether the device, or its removal, caused or contributed to any of the reported deaths or other events in the reports.” – FDA, “Problems Reported With Essure

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