Tag Archives: Essure Postmarket Study

FDA Releases Statement on Essure Review

On March 7, 2018, FDA Commissioner Scott Gottlieb released a statement regarding the agency's ongoing monitoring and investigations into issues related to Bayer‘s controversial birth control device Essure. More than 750,000 women have received the implant since Essure’s approval in 2002. As of December 31, 2017, the FDA has received 26,773...
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Essure Postmarket Study to be conducted in Wake of Reported Injuries

After thousands of problems associated with permanent contraceptive device Essure were reported to the FDA, the device regulator ordered the device’s manufacturer Bayer to submit plans for a postmarket surveillance study. The FDA requires these kinds of studies for devices that have posed significant adverse health problems or are permanent implants.Read more

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