FDA Investigating Essure Birth Control Device for Related Health Issues
Written By: Rheingold, Giuffra, Ruffo & Plotkin LLP
The Food and Drug Administration (FDA) has recently announced it will be opening an investigation into Essure, a permanent non-surgical birth control device manufactured by Bayer HealthCare. The device consists of coils which are inserted into the fallopian tubes to prevent conception. Thousands of complaints have been submitted to the FDA including reports of severe pain, pelvic pain, painful sex, organ perforation, device migration, metal allergies, unplanned pregnancies, and ectopic pregnancies (pregnancy outside the uterus).
A recent petition to the FDA alleges the "original manufacturer of the device, Conceptus, Inc., perpetrated fraud during the clinical trials, violated the terms of the FDA's pre-market approval of the device and violated several federal laws in the manufacturing and marketing of" Essure. The FDA is set to announce in February its decision about what action it will take regarding Bayer's Essure device.
Before Essure was put on the market it received pre-market approval (PMA) from the FDA. PMA shields pharmaceutical companies from lawsuits because of the rigorous testing process. However, women hope to get around or revoke the PMA shield by alleging fraud in the approval process. According to Amanda Dykeman, an Essure Problems administrator, Bayer falsified clinical trial records to get Essure approved. Amanda spoke at a September 2015 FDA panel on Essure.
If you were injured by Essure, contact the lawyers at Rheingold, Giuffra, Ruffo & Plotkin LLP, today to protect your rights. Call us today at 800-349-0004, to speak with an experienced medical device litigation team. We have handled hundreds of medical device lawsuits and we are available to help clients with Essure claims.