Newly Published Study on Essure Reignites Longstanding Controversies
Jan. 22, 2019
The results of a medical study published this month concluded that women undergoing hysteroscopic sterilization have a significantly higher risk of receiving an additional tubal resection or ligation than those undergoing laparoscopic sterilization. In fact one older New York study found that nearly 10,000 patients with Essure impanted required a reoperation from complications from the device. "We found tenfold higher risk of repeat surgery after Essure when compared to laparoscopic surgery. This means that nationally more than 10,000 women likely underwent additional surgery in the past five years," said Dr. Art Sedrakyan, a professor of healthcare policy and research at Weill Cornell Medicine. These more recent findings which looked at 7-year outcomes following sterilization, again begs the questions of how safe is the Essure device? Despite Bayer ceasing sales of the device on December 31, 2018, women are still at risk as doctors can still implant any remaining inventory until December 31, 2019. This travesty is rendered even more serious as many doctors who are continuing to implant the device are failing to give the mandated black box warnings and/or adequately discuss and explain the patient decision checklist.
There have been over 25,000 adverse event reports filed with the FDA pertaining to Essure and over 18,000 lawsuits filed by women suffering injuries from the device. The device hasn't even proved to be the most effective in preventing pregnancy, with researchers estimating that nearly 10% of women could get pregnant within 10 years of being implanted with the device. With so many complications one wonders how it was initially approved by the FDA and why it was allowed to remain on the market for so long. Many experts believe that the injuries are grossly underreported to the FDA and the actual injuries caused by the device may be far greater that we realize. Dr. Katy Moncivais, PhD, Medical Editor, states that, “So much of our Essure adverse event knowledge stems from patients self-reporting their negative experiences.” She continues on to say, “It’s entirely possible that the incidence of adverse events is much higher than it appears today.”
The fact that Essure remained on the market for so long in the United States, particularly after being removed from sale all over the world, shows the serious flaws in both the FDA approval process for medical devices and the post-market surveillance. Clearly Essure should have never been granted pre-market approval and the post-market surveillance has been lax, late and virtually ineffective. Serious overhaul is necessary in the way medical devices are brought to the marketplace.
Not only is change necessary within the FDA, but also legislative change is necessary to affect the ease in which patients harmed by dangerous medical devices can seek recourse from the manufacturers of these defective medical devices. Currently, those harmed by Class III medical devices such as Essure, have a difficult time holding the manufacturers responsible for causing these injures. Legislation entitled, The Medical Device Safety Act will be re-introduced in Congress this Spring, which will make it less burdensome for claimants to hold legally manufacturers liable for their actions in court.