ESSURE Still Causing Problems
We blogged about the debilitating problems some women have experienced from using ESSURE in August of 2015, and unfortunately it’s still on the market causing harm to women. Since its FDA approval in 2002, thousands of women implanted with the device have complained of autoimmune disease, pain, bleeding, unintended pregnancies, miscarriages, abscesses, and tumors.
ESSURE, now manufactured by Bayer, is a soft, flexible metal spring inserted into each fallopian tube. Over the course of several months, scar tissue forms around the coils, blocking the tubes to prevent eggs from releasing into the uterus. It is currently the only approved alternative to surgical sterilization.
A lawsuit was filed in November 2016 in California on behalf of dozens of women all over the country claiming the company who manufactured ESSURE didn’t warn women of serious complications. The lawsuit also alleges that Bayer didn’t provide all the complaints they received to the FDA. The FDA found over 15,000 adverse event reports were never turned over to the FDA resulting in federal violations. If doctors and women had this information about all the adverse events women were experiencing, I doubt that many women would have chosen to have ESSURE device implanted.
Recently, due to pressure from a Facebook group called “Essure Problems,” the FDA held a hearing on ESSURE which resulted in a black box warning for the device, which is the highest level of warning before a device is removed from the market. It was a small victory for this Facebook group with over 32,000 members who call themselves the “E-Sisters” who say their ultimate goal is to get the device banned from the market.
While there is a great need for safe, effective birth control, it does not need to come at such a high cost and endanger the safety and health of women. We will keep following this story and any updates from the lawsuit in California.
If you or a loved one has suffered due to the Essure device, contact us. We want to help!