Essure Premarket Approval Modified by The FDA

Essure Premarket Approval Modified by The FDA

Introduction

After receiving nearly 12,000 adverse event reports related to the Essure birth control implant last year, the FDA decided to restrict the sales and distribution of the device to ensure that every woman who decides to receive the implant is first made fully aware about the associated risks. This move was fuelled by the fact that some women were not being adequately informed about the potential risks and complications, even after the addition of the black-box label warning and a patient checklist.

The new change makes it illegal for doctors to implant patients with the birth control device without both parties signing off that they have discussed the potential health risks. Essure lawsuits are filed against Bayer Healthcare in various federal and state courts throughout the nation, with the recent addition of another lawsuit filed by at least fifty plaintiffs from Texas, Florida, Illinois, and other states alleging that Essure birth implant caused severe injuries.

Thousands of Essure lawsuits are filed nationwide. In 2016, Judge Winifred Y. Smith, coordinated 55 cases before a single judge in Alameda County Superior Court under Judicial Council Coordination Proceeding No. 4887. Apart from this, several groups of Essure cases have been consolidated in other courts. At least 18 federal lawsuits are currently consolidated in the U.S. District Court for the Eastern District of Pennsylvania as of November 2016. However, Essure lawsuits are filed individually by each plaintiff and are not class actions.