Study: Women Who Use Contraceptive Implant 10 Times More Likely To Need Additional Surgery
According to the Wall Street Journal, Essure is the most recent challenge for the Food and Drug Administration, which did not require a randomized and controlled study before approving the intrauterine device.
The New York Times reported that a new study published in the BMJ found that women who used the birth control implant device “were 10 times as more likely to be back for surgery within a year than women who had their tubes tied.” The study, which analyzed the 52,326 women sterilized in hospitals and ambulatory surgery centers in the state of New York State from 2005 to 2013, found that 2.4% of the 8,048 women who used Essure returned for another surgery within a year, while only 0.2% of the 44,278 women “who had more traditional, minimally invasive sterilization” needed additional surgery.
And NBC News quoted the FDA who said “This is a high priority issue for the agency,” adding that it plans to “review the findings of this study, along with the latest medical literature on the Essure device and input from panel members and the public during our recent advisory committee meeting, to determine what future actions may be appropriate.”
In 2014, a lawsuit was filed against FDA-approved Essure permanent birth control product.