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# Medical Device Reports Updated on Bayer’s Essure
- URL: https://www.fdaweb.com/medical-device-reports-updated-on-bayers-essure/
- Published: 2021-03-15T12:00:00.000Z
- Updated: 2026-09-14T16:50:44.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5148883

FDA has [updated its Web site](http://email.prnewswire.com/ls/click?upn=3slWLw94I3jq-2B-2FedjFNgZH-2F-2BdT2Hfvce-2B9YoPQjyr3Mkq8wsSim17zLEufiGecLsGGCp5ypRJxZQv78-2FZenVymx4a-2FbCYgrdTx89VKtBaaqGHdviU0L2kFV5PdbeAEoGbZyKYXYnGEsuZ35hUnD5FQ-3D-3DpX-B%5Ff0D7hj0BJ4b-2F7NuVqzPDs7FGiq8VLIwAX0sPSotqoLJejYqb1dmQHyCXe45PgGWV-2BM5DAuliV1oILi8CIaeAoDm3EApRdguKIQMIoM2uxidzH3caIEQPVURX844TM7SdkoNr3FZRdnGOkpPKGUxpkxXav7nZBBanGls-2FKOCPmTAXo2-2FNHG5e5piIzTanJkH7d0xML4RMmUCbU0fZJBHMvHKy26UteB896zZyoRNsiN1Y-2Blas3IZZoS70h3St1UD1pIwIpGKKkTrwFEaQdnZscOTCB1Cc8fjENvXAgy627-2B1TiRPD8kFOZcWrQJb4JrX0pPMrI98kWt9JDup9paDzT2MZqclhKD8Bs9ozu1oaB-2Fk-3D&ref=fdaweb.com) to include an annual analysis of medical device reports involving Bayer’s now-withdrawn Essure contraceptive implant that were received from 11/4/2002 to 12/31/2020\. Last year, the agency received 16,086 medical device reports related to Essure, an 6.6% increase from the 15,083 medical device reports received in 2019, according to the report. “As in 2019 and recent years, most of the reports received by the FDA in 2020 were submitted by Bayer (the company that manufactured Essure) and more than 90% are related to litigation against the company,” the agency says. “Litigation reports may reference information previously submitted to the FDA.”

Additionally, as part of an ongoing update on variance reports, the agency posted the seventh spreadsheet of adverse event reports received by Bayer as required in a [4/24/2020 variance](http://email.prnewswire.com/ls/click?upn=3slWLw94I3jq-2B-2FedjFNgZAmdierth9sDznGHUIlSHO9mXt7iii-2BH0OUJjOqLHEXGzYi8%5Ff0D7hj0BJ4b-2F7NuVqzPDs7FGiq8VLIwAX0sPSotqoLJejYqb1dmQHyCXe45PgGWV-2BM5DAuliV1oILi8CIaeAoDm3EApRdguKIQMIoM2uxidzH3caIEQPVURX844TM7SdkoNr3FZRdnGOkpPKGUxpkxXav7nZBBanGls-2FKOCPmTAXo2-2FNHG5e5piIzTanJkH7d0xML4RMmUCbU0fZJBHMvNS44j2Kv5zK-2B9bEjBFD3hSbF0RI5oC-2BPptJxMZp9Tnq33UJ-2BZVPfpzKgJfnA4JBhZMU6pw6FTs8GRX7RRM0mX0L8kpDT7F-2BLsWh-2BnZo-2BmW2L4AsCfBH1mU4niilL0KhQw5pwu5NIIRfutGpoJl0BmA-3D&ref=fdaweb.com) from MDR reporting requirements. These are from social media as a result of litigation and may reference information already reported to FDA. And Bayer has posted its [second quarterly analysis report](http://email.prnewswire.com/ls/click?upn=3slWLw94I3jq-2B-2FedjFNgZL9wWbWvwp-2F6la7BXM80N83Vb0yjlurh8Qzd-2F7GpL5skG30S7Ux8DMvOu8D3v2u0fhp-2BZxkML01WhS0mA7dZVt9TIwoxHop4EqFyToMWtOl7kcsy%5Ff0D7hj0BJ4b-2F7NuVqzPDs7FGiq8VLIwAX0sPSotqoLJejYqb1dmQHyCXe45PgGWV-2BM5DAuliV1oILi8CIaeAoDm3EApRdguKIQMIoM2uxidzH3caIEQPVURX844TM7SdkoNr3FZRdnGOkpPKGUxpkxXav7nZBBanGls-2FKOCPmTAXo2-2FNHG5e5piIzTanJkH7d0xML4RMmUCbU0fZJBHMvDS4I4m4rmdnrQb6T-2FpHh-2FDuzaALfNfHYJn8Ny-2FSOl9S9jfwTR5eZJTgJMIXb480dJsYSu5A4TWxbBYvqMKj3WX-2BcQXCWDYjIVwS6CXSm-2FXQNxizHEn9gq5guyfdm13g-2F9KT7BMBSOmW-2BD6i00gtW60-3D&ref=fdaweb.com) of the adverse event information included in [the variance](http://email.prnewswire.com/ls/click?upn=3slWLw94I3jq-2B-2FedjFNgZJQlqERpxMcPvAzrI43L5palQ5xkNqR8cpy5jgYYGXzJEGYbEUSR0Ig-2FLqP2-2B1DjKSvZUUSwx4ynAffGZpaYyYyhQoALJjDCbi6ZWYKVGGgwy3aw40pcPRkbYrC7Zhzb686srgJD-2Fx3Wj7mTEi3bHxI6gMJfv4C9KB9LT87ErKODxi0ASe1jfSMYvgB4J0epog-3D-3DRupe%5Ff0D7hj0BJ4b-2F7NuVqzPDs7FGiq8VLIwAX0sPSotqoLJejYqb1dmQHyCXe45PgGWV-2BM5DAuliV1oILi8CIaeAoDm3EApRdguKIQMIoM2uxidzH3caIEQPVURX844TM7SdkoNr3FZRdnGOkpPKGUxpkxXav7nZBBanGls-2FKOCPmTAXo2-2FNHG5e5piIzTanJkH7d0xML4RMmUCbU0fZJBHMvIXIJo11snC1LQhCqZ4Jsn3M6Aln3IavT5GKHjHbUhOMvdfRPCQsba8vLYyPD1l-2FB3EcBndDVUtikNwlZbL1SEG1hhJJiQiGFCG-2BKIwQQg9xn22bh-2FoKEWqLPju8Ft2iYDG5aYlbcIBurfxuW6eqV1w-3D&ref=fdaweb.com) reporting spreadsheets, reported between 9/2020 through 11/2020.