Essure is a device inserted into each fallopian tube to prevent pregnancy. This is a permanent form of birth control that does not require surgery. On November 4, 2002, Essure was approved by the FDA as a PMA (premarket approval) device. During that same year, the 2002 instructions for use (IFU) reported between 1.1% and 2.9% rate of perforation of the uterus or the fallopian tubes. The IFU warns of the increased risk of hypervolemia during the insertion procedure and an increased risk of ectopic pregnancy if the patient becomes pregnant.
Common adverse reactions to Essure within 15 months of device placement include:
If you have suffered severe pain and adverse side effects after being fitted with Essure, you are not alone. While Essure has not been recalled by the FDA, the FDA has observed a dramatic increase in adverse events in relation to the Essure device in recent years. Furthermore, in February 2016, the FDA ordered the Essure manufacturer to conduct a clinical study to investigate the risks associated with the device. The Agency also issued a proposed language for a black box warning to be added to Essure labeling in order to ensure that women are properly informed of the potential serious complications.
We recommend that you speak to our product liability lawyers at Kaiser Gornick LLP to learn more about your remedies.
There have been legal claims surrounding the violations of conditions for receiving PMA by the makers of Essure (parent company Bayer Pharmaceuticals). The allegations involve fraud in clinical trials, questionable studies and actively concealing negative reports about the device from the FDA. Further, the company is also accused of underreporting adverse events and using deceptive marketing. There are lawsuits consolidated in the U.S. District Court for the Eastern District of Pennsylvania regarding these claims.
Our Essure lawyers at Kaiser Gornick LLP are a team of nationally recognized attorneys ready to explore your right to compensation. Learn more about Essure lawsuits and what we can do to help.