On July 20, 2018 Bayer announced that it would stop selling Essure, a hysteroscopic sterilization procedure for women. Bayer’s decision to pull Essure from the market comes on heels of an FDA black box warning for the device. A black box warning is the FDA’s highest warning that a drug or device may cause death or serious injury.
Essure is a metal spring like device with synthetic fibers that is implanted into a woman’s fallopian tubes in order to prevent eggs from fertilization. The device was marketed as a form of tubal sterilization that did not involve a surgical procedure.
Since its approval by the FDA in 2002, the agency received more than 27,000 adverse event reports related to Essure. In addition to death, complications from the Essure procedure include; chronic pelvic pain, fetal death, organ puncture, ectopic pregnancies, device migration, expulsion, and perforation of pelvic organs requiring hysterectomies.
In the United States, more than 16,000 women are suing Bayer over the adverse effects of Essure. That number has increased by nearly 460 percent since 2016. The largest group of these cases have been consolidated before a state court judge in Oakland, California. In a statement, Bayer said it anticipates more lawsuits.
If you or a family member are the victim of Essure complications contact an experienced attorney at the Naumes Law Group for a free consultation at 844-826-8445 or online at www.naumeslaw.com to help you understand and fight for your rights.