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# Bayer Removes from Market 99% of Essure Devices
- URL: https://www.fdaweb.com/bayer-removes-from-market-99-of-essure-devices/
- Published: 2020-01-10T12:00:00.000Z
- Updated: 2026-09-14T15:58:17.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5145819

A year after Bayer [stopped selling and distributing](http://email.prnewswire.com/wf/click?upn=zySGXW1QLHU8t7wSbPI8iADmwAaKTbie2jeFmcdktodsJP9oiqZLP8VtzTKz6CpDsLFOU4WNVs6whnzTyj20gb8EL3J27Y5s-2FsNEqF1OZLAvEOcdu6VGXQsJcuHUrgpCQ8tafFefpXR6Iyy0fVqqz8VOsp6D55c1MSiPTDBVgH8nruuME-2FPw5hqhZG0P-2FbDLZjgfpur90JCywmN9cNY27ltytcZ0tbVJIcg2jWHq1KSHm50pygL8XId-2B3PSeduat2DRZ9LQ6oH-2BGrTQvG5a1mRFSaGUR3aTSaB5R4ULxzfw1ZPyopVO-2BqC29oPU12eVcxsJjt-2FBmyUc-2FyN57BlNwIVH7PBWsnLYeXAxyChrdHRE-3D%5FnE9rxSXA5G4kxsTVkgv43tTJnmhvULg8vMtvbdZHwXEle6c6tqdvw12Z3skft0RuTHbGqoZe4bD2UAolVeWLZLj0lqDgzd6cPGmmFX5vxv8U8K1btin8zuycokrv2w5jNxdqFom959kg6wkV14RTFzMaP-2BRp-2BsvtpLlvBI308OomEnk2yaeQ08xbLM4xP3WXSnk37GNvv5nHoouuPpwjIoSkT2oh4-2Fm-2FUY6zQmVMrfSJ-2BOjKvtFtqJB4-2B5g36n8k4SCpPL9-2BrXC5uKrU1cFwAj6FLHXufcCh3RMLM6QE2wVoDhVqTnorVTCmeXdYRbIb4TxdkPYG4gCI9-2BHdPBt2JFmTG29yZIpu57r-2FZt6Auw0-3D&ref=fdaweb.com) Essure, an implantable contraceptive device, CDRH director **Jeff Shuren** says the company has repossessed 99% of unused devices in the market. “Additionally, postmarket safety monitoring for women who have Essure implanted remains a top priority for the agency, and today we are announcing that enrollment in Bayer’s required postmarket surveillance study has ended,” he said in an [agency update](http://s2027422842.t.en25.com/e/es?s=2027422842&e=292407&elqTrackId=376c7bc788024cd5a73d955f2e3dcbdc&elq=43619e7a490d4f05a0991a9d98696013&elqaid=10878&elqat=1&ref=fdaweb.com). “Follow-up of patients in the study is ongoing, and the FDA is committed to sharing new information with the public about the postmarket safety of this device as it becomes available.”

As of this month, 1,128 patients have been enrolled in the postmarket study, with 340 enrolled in the group who elected Essure and 788 in the group who elected laparoscopic tubal ligation. [As previously announced](http://email.prnewswire.com/wf/click?upn=zySGXW1QLHU8t7wSbPI8iADmwAaKTbie2jeFmcdktodsJP9oiqZLP8VtzTKz6CpDmleqNYQD4iW5XNAbYFKBsDfUXAGj6FcdHTjWJnooGdIeW9yxTUcjT7RyJlDc8QcOeLKvKkksynToqKycuqO5HDQZs3yU0Gm-2FQnmgFjxqWgPchkM2Yl-2FKojk-2FgjoJqm9AuPC5D0UhNYOZUIcNWc7VJegTBU33zQKmNG5EEwXYMu3MWkYTEYxHe2SO-2FW29IwNWBx4STD60yjjcKL3dGfD2W-2Bfetoy5WIw3yHRSLkr-2FImWOLxC5tvjnYBBOkbK0iOzDt9yxAMPY-2B1s5HnVAJJapjA-3D-3D%5FnE9rxSXA5G4kxsTVkgv43tTJnmhvULg8vMtvbdZHwXEle6c6tqdvw12Z3skft0RuTHbGqoZe4bD2UAolVeWLZLj0lqDgzd6cPGmmFX5vxv8U8K1btin8zuycokrv2w5jNxdqFom959kg6wkV14RTFzMaP-2BRp-2BsvtpLlvBI308OomEnk2yaeQ08xbLM4xP3WXSnk37GNvv5nHoouuPpwjIrOHKqPiVIgA-2BqkChXyzHsne201bfo3dK2fUX80bwWfKm5nw6MA8WDAKauWvW1dTUpcOuyND60ZnhEj5H1Fighsdm4RaUmoGvjJN-2BaB0Kb0sZDfkXPXQ-2BcSeF5DZOXtybFojInHAhYrAGSVn0iW-2B0h0-3D&ref=fdaweb.com), FDA instructed Bayer to extend the study from three years to five years to better understand the device’s long-term safety profile. The agency will post interim study results, including information about device removal, once the data are analyzed.