November 9, 2015 — A lawsuit has been filed against Bayer HealthCare by a woman who was seriously injured by the Essure sterilization implant.
The lawsuit (PDF) was filed by plaintiff Danielle Patterson in the U.S. District Court for the Northern District of California (San Francisco) in November 2015 (Case No. 3:15-cv-05088).
Patterson had the Essure procedure in May 2009. After the procedure, she experienced “severe constant daily pain.” In September 2013, she had a uterine ablation to control severe bleeding. She did not realize Essure was causing her problems until 2015, when she learned of other women having similar issues.
In her lawsuit, Patterson accuses Bayer of negligence for “actively and fraudulently concealing adverse reports of migrations and perforations.” According to the complaint:
“Defendants were concealing adverse reactions, not using conforming material approved by the FDA, not using sterile cages, operating out of an unlicensed facility, and manufacturing medical devices without a license to do the same.”
Essure received Conditional Pre-Market Approval (CPMA), which shields Bayer from product liability lawsuits. Attorneys argue that Essure’s approval is invalid because the manufacturer failed to report adverse events. The FDA issued a citation after eight perforations were not reported during clinical trials.
Marketing materials for Essure also claim “There were zero pregnancies in the clinical trial.” However, the lawsuit states that there were actually four pregnancies during the clinical trials and five pregnancies during the first year of commercial experience.
Other materials state that “Once your doctor confirms that your tubes are blocked, you never have to worry about unplanned pregnancy.”
According to the lawsuit, at least 30 women have gotten pregnant after a doctor confirmed their tubes were blocked. Studies have also found a 10X increased risk of getting pregnant after one year compared to women who get their “tubed tied” laparoscopically.