October 14, 2015 — The British Medical Journal has published a study linking Bayer’s Essure sterilization implant with a 10-fold increased risk of needing follow-up surgery compared to traditional “tube tying” surgery.
The conclusions of the study were based on an analysis of data on 52,326 women in New York who were sterilized between 2005 and 2013. During this time, 2.4% of Essure patients needed additional surgery, compared to 0.2% of patients who had laparoscopic (minimally-invasive) sterilization.
The researchers estimated that additional surgery was necessary for about 10,000 women who used Essure. According to the researchers:
“A more than 10-fold higher occurrence of reoperation during the first year following Essure-based surgery is a serious safety concern.”
Safety concerns have been growing in recent years. Since Essure was approved in 2002, the FDA has received over 5,000 complaints about debilitating side effects like chronic pain, heavy menstrual bleeding, allergic reactions, pain during intercourse, and more.
The New York Times reports that an FDA advisory panel blasted Bayer for failing to compile data that would have helped anticipate these risks.
The problem for victims is that lawsuits against Bayer are stymied by a federal preemption law. Public advocates like Erin Brokovich have taken up the cause and campaigned alongside women who were injured by Essure.