No Recall Yet for Essure Coils; FDA awaits a safety study report

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Early February, a group of five women who manage the ‘’Essure Problems’’ Facebook group comprising more than 35,000 women who experienced painful and debilitating injuries when the coils migrated, perforated the uterus or fallopian tubes, caused allergic reactions, infections or other complications, met with FDA chief Scott Gottlieb, demanding removal of Essure from the market.

The group presented data and photos of broken coils, stillbirths, injuries and other problems linked to the Essure coils to support the recall; however, the FDA chief put their request on hold until the safety study, designed to examine the side effects of Essure coils is completed by Bayer which involves 2,800 women (it is not expected to be completed until 2023).

Although the product is banned in countries like Australia and Brazil and suspended across Europe, in the U.S. it still continues to be available though with a black-box warning and a patient checklist to be completed prior the implant.

Hundreds of Essure lawsuits are filed against Bayer by women across the country, each raising similar allegations that the birth control device maker failed to adequately warn the medical community and women despite knowing about the serious risks.

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