On July 20, 2018, the drug manufacturer Bayer announced that by the end of the year it will no longer sell its Essure birth control implant. This tiny coil-like device is implanted in the fallopian tubes to be used as a form of permanent birth control. Despite being advertised by Bayer as a safe and permanent birth control method, there have been as many as 30,000 reports of injury or illness potentially related to the use of Essure since its approval by the FDA in 2002. Its use has already been discontinued elsewhere around the world, and the U.S. is the only market in which Essure is still sold, despite strong evidence of it potential for serious harm.
Studies have shown strong evidence of potential serious side effects related to use of Essure including, but not limited to:
- Movement of the device from the fallopian tubes and into the abdomen or pelvis;
- Perforation of internal organs, including the bowels, bladder, uterus, and fallopian tubes;
- Hypersensitivity and allergic reactions to nickel and other components of the device;
- Chronic pain;
- Severe bleeding;
- Ectopic pregnancies (where the fetus forms outside the uterus, a potentially deadly condition);
- Miscarriage or stillbirth; and
Removal of the device often requires surgery, which may involve hysterectomy or other extremely invasive procedures. One medical study showed that Essure patients required follow-up surgery ten times more frequently than patients using other permanent birth control methods such as tubal ligation.
The product received a “black box” warning from the FDA in 2016 (the strongest type of FDA warning) due to the known risks of the device. There have been over 16,000 lawsuits filed due to injuries resulting from Essure use.
Despite long knowing of the potentially serious consequences of its use, Bayer only recently started a program to ensure patients were receiving the necessary information before undergoing such a potentially dangerous procedure. Prior to that, many patients were not warned about these risks and underwent the procedure without fully understanding the potential consequences. For many, Bayer’s warnings and now removal of the device from the market is too little, too late. Many have been injured, and those with Essure may still become injured in the future.
Berman, Sobin, Gross, Feldman & Darby LLP serves individuals who have used Essure and have had complications as a result. If you or someone you know have used Essure, call us at the toll-free number or email us at firstname.lastname@example.org to make sure you are protected. We will contact you with several follow-up questions to determine if you qualify for inclusion into the ongoing litigation.