Multiple lawsuits were filed last year against Bayer Healthcare, the current owner of Essure, a permanent birth control device. The lawsuits alleged Conceptus, the original manufacturer of the device breached its warranty and committed fraud in the clinical trials to get the device approved by the Food and Drug Administration (FDA). Patients allege evidence of certain health risks posed by Essure was hidden from the FDA to get the approval. Bayer also failed to warn patients or their physicians about risks such as migration where the device can move through the tubes into the lower abdomen and pelvis, perforation where the device can puncture the uterus or tubes, rash and itching from possible metal allergies, unintended pregnancies including ectopic pregnancies, and continued pelvic pain. Had they known the risks or been warned, many women say they would have chosen a different method. If Essure moves, separates, breaks, or punctures the tubes or uterus multiple surgeries can be required to remove the device and, in some cases, the entire uterus had to be removed.
Essure was approved by the FDA in 2002 with premarket approval, shielding it from product liability and litigation. The lawsuits allege Conceptus violated the conditions of premarket approval, however, and should no longer be able to claim the protected status. Essure is an alternative to women who want to have their tubes tied. A doctor inserts a small, metal coil into each Fallopian tube then the body forms scar tissue around the coils, blocking the tubes and preventing pregnancy.
On February 29, 2016 the FDA mandated a clinical study on Essure to determine heightened risks for certain women. The FDA has also required Essure put labels on packaging to physicians and patients including a ‘patient decision checklist’ so women can have more informed conversations with their doctors before deciding to undergo the Essure implant. A ‘black box' warning is the most stringent warning the FDA issues, indicating serious injury or death could result from the product – a warning now mandated on Essure devices.
Essure patient lawsuits are ongoing. If you have suffered complications from the use of Essure or other medical devices call The Poppe Law Firm at 502-895-3400.