The Food and Drug Administration is now requiring the manufacturer of Essure, a contraceptive device, to place black box warning labels regarding the side effects of having this device implanted. Black box warnings are the FDA’s highest warning level and indicate that a product may cause serious injury or lead to death.
Essure is a device used for female sterilization, specifically, a type of tubal sterilization that requires no surgical incision. The device consists of two metal coils that are implanted into the fallopian tubes. The type of fibers used in the metal coil cause inflammation, so that ultimately scar tissue develops around the device and prevents contraception.
Essure was developed by Conceptus Inc., which is now a subsidiary of Bayer. Bayer, as the current maker of Essure, promotes the device as a non-invasive form of permanent birth control that is extremely effective and has a quick recovery time. However, since Essure’s FDA approval in 2002, the FDA has received over 5,000 reports of adverse reactions to the device. This includes 11 deaths, five of which were fetal deaths.
Furthermore, a 2015 study in the British Medical Journal found that women who went through Essure sterilization were more than 10 times more likely to require post-procedure surgery than those who underwent laparoscopic sterilization (tubal ligation).
Serious complications from Essure have been reported to the FDA and other sources. These complications include:
- Unintended pregnancies,
- Ectopic pregnancies,
- Severe pain and bleeding, and
- Migration of device and perforation of organs.
If you have suffered complications due to the implantation of an Essure device, contact the experienced attorneys at McDivitt Law Firm for a free consultation today by calling us at (877) 846-4878 or click here for a free and confidential case evaluation.