The reports of problems with Essure started almost as soon as the device was approved nearly 14 years ago. Essure, a device implanted in the fallopian tube, was hyped as a revolution in female sterilization. Up until its development and release, the only option a woman had to permanently terminate her ability to have children was surgical sterilization. Essure was supposed to have the same effect with no surgery in a procedure that could be completed in 15 minutes.
Reports of complications in women implanted with Essure began almost immediately. The trickle soon turned into a flood and, soon after, women across the country began organizing in an effort to trigger a re-evaluation of the device. Complaints ranged from pelvic pain and difficulty during sex to perforation of the fallopian tube itself. Additionally, rather than sterilizing the women it was implanted into, one doctor believes that up to 10% of women implanted with Essure would become pregnant within 10 years.
Up until recently, the only studies involving Essure were conducted using relatively small sample numbers. And, in many cases, those samples grew even smaller. Many women were not followed throughout the entirety of the study period. However, a new study has been released and the sample size, and its data, are significant.
Dr. Art Sedrakyan of Weill Cornell Medicine in New York and his colleagues looked at data from a sample of over 8,000 women implanted with Essure devices. That data was then compared to the data from 44,000 women who had the standard procedure commonly referred to has “having your tubes tied.”
The research concluded that women using Essure had 10 times the number of operations to repair issues with that device than woman who chose to have the standard surgery.
Dr. Sedrakyan’s report states that a “more than 10-fold higher occurrence of re-operation during the first year following Essure-based surgery is a serious safety concern.” He adds that this “translates to one in 49 or 50 women getting this surgery again.”
The FDA has finally engaged on the Essure issue. The agency has scheduled public hearings about the device and acknowledged the growing number of complaints from all corners of the country. Still, no plans have been made to pull the device from the market. Rather, the FDA is seeking to enhance the warnings regarding Essure and determine whether or not further warnings are necessary.
An enhancement of the warnings on the device is little consolation to the women around the country whose lives have been negatively impacted by Essure. The last time we wrote about Essure here on the Lopez McHugh blog, the largest Essure awareness group on Facebook, Essure Problems, had around 19,000 members. Today, that number has swollen to 23,000.
One has to wonder how many more studies have to be released and women must be injured before the FDA takes serious, concrete action on Essure.