Black Box Warning And More Studies Of Essure Ordered By The FDA

Serious Side Effects, Essure Litigation

Essure is a small, flexible coil insert made from a nickel and titanium alloy. Essure was originally manufactured by Conceptus and was subsequently bought by Bayer and has been marketed as the only permanent both control that can be provided without a surgical procedure. While convenient, this form of birth control has given rise to an array of side effects, including perforation of the uterus and/or fallopian tubes, intra-abdominal or pelvic device migration, persistent pain and allergy or hypersensitivity reactions, among other complications.

These complications have led to a slew of litigation against Conceptus and Bayer for claims such as:

  • Negligent manufacture
  • Negligent risk management
  • Breach of express warranty
  • Negligent training and fraudulent manufacture

A Black Box Warning

Because of the number and extent of injuries caused by Essure, in March 2016, the U.S. Food and Drug Administration announced that it would require a black box warning on the device and called for more safety studies to be conducted. This announcement came after more than 5,000 women filed grievances with the FDA between November 2002 and May 2015. A black box warning is the strictest warning put in the labeling of prescription drugs or drug products by the FDA when there is reasonable evidence of an association of a serious hazard with the drug. This warning label would include a list of adverse effects caused by Essure, including those listed above.

Injured By Essure? Call For Help.

If you or a loved one has been injured by Essure, the dedicated attorneys at Reich & Binstock are here to help. Our Houston attorneys have over 30 years of experience and will help you get the recovery you deserve. For your free initial consultation, call 713-352-7883 or 877-643-3099 toll free, or send us an email to get in touch. We represent clients nationwide in defective medical device cases.