Ennis & Ennis, P.A.
Studies Show Higher Risk Of Surgery With Essure Contraceptive Implant
10/14/2015 - A recent study revealed that women implanted with Bayer’s Essure sterilization device were 10 times more likely to require post-procedure surgery than those who underwent tubal ligation. The study followed 52,326 women sterilized in hospitals and surgery centers in New York from 2005-2013. The study showed that one year following Essure implantation, 2.4 percent of the women required follow-up surgery compared with .02 percent of women who underwent tubal ligation. This means roughly 21 more surgeries per 1,000 patients implanted with Essure. More surgeries are expected the longer the device remained implanted.
Dr. Art Sedrakyan from Weill Cornell Medicine led the study and noted that if the New York data were to be extrapolated to nationwide Essure use, there would be nearly 150,000 patients getting this type of additional surgery. Dr. Sedrakyan noted that, “In some instances, these re-operations are quite major surgeries, including hysterectomies.” Dr. Sedrakyan indicated most of the follow up operations were required due to complications with the device or device failure.
These findings fuel a growing concern regarding the safety of Essure and will surely inflame the movement by thousands of women intent on having Essure pulled from the market. The device is facing scrutiny from U.S. health regulators following thousands of complaints. It has also captured the attention of several US congressmen, including Congressman Mike Fitzpatrick who is introducing a bill next week, which if passed, would require the FDA Commissioner to revoke the pre-market approval status granted for Essure in 2002. Such PMA protection prevents injured women from seeking legal recourse and compensation for their injuries.
Since Essure was approved in 2002, the FDA has received thousands of complaints regarding the device. Such complaints include severe pelvic and back pain, painful intercourse, painful and heavy menstrual bleeding, autoimmune diseases and chronic fatigue. There are also numerous reports that the device coils have perforated the fallopian tubes, uterus and other organs, leading to hysterectomies and other serious surgeries.
Dr. Diana Zuckerman, president for the National Center for Health Research indicated the importance of the study as it looked at Essure women in the real world and not the insufficient clinical trial data. She noted that, “The very high rate of reoperations-10 times as high with Essure- is likely to add to concerns about the accuracy of the clinical trial data provided to the FDA when the device was approved.” Bayer official downplayed the study indicating the research was of “poor quality” and that comparing Essure to tubal ligation is like “comparing apples to oranges.”
Women who were injured by the Essure device are encouraged to send their comments to the FDA panel of Obstetrics and Gynecology up through October 24, 2015. For any questions, contact the attorneys at Ennis & Ennis, P.A. for a free confidential consultation at 1-800-856-6405 or visit us online at www.EnnisLaw.com and fill out an online form.