FDA Disregards Essure Hysterectomy Risk
This is Amy German, Managing Associate attorney for The Michael Brady Lynch Firm.
It still shocks me how much the FDA shows a blatant disregard for public health. Essure manufacturer, Bayer and the FDA are fooling women into choosing a seemingly easier method of female sterilization, instead of the surgical alternative of tubal ligation. However, Essure hysterectomy risk and pregnancy risk is higher than tubal ligation.
The FDA doesn’t mention any of these risks in their regulatory history. The regulatory process was established in 1906 with the passage of the 1906 Pure Food and Drugs Act. It was first started to combat misbranded food and drugs. It was supposed to protect the American people. Who is supposed to protect them now?
The FDA approved Essure in November of 2002. As a Class III device, Essure was supposed to receive a strict FDA review prior to going to market using the Pre-market Approval (PMA) process. One of the conditions of the PMA process is two Post-Approval studies that provide 5 years of follow-up data and placement review for newly trained physicians.
Since the initial PMA approval, there have been only three changes to Essure. In 2011, labeling was updated to warn patients to not use the IUD if sensitive to nickel. In 2012, labeling was updated to include patient follow-up after 5 years. Finally, in 2013, labeling was amended to include risks of chronic pain and device migration.
Nowhere does the warning literature mention what happens to many women who want to remove Essure. They only have one option: a complete hysterectomy. Many times the fallopian tubes and uterus are too scarred and damaged to be saved. The long-term effects of just having a hysterectomy are staggering (incontinence, bowel dysfunction, and pelvic organ prolapse). The FDA required 5 years of follow-up data for the PMA process, but only 366 of the original 618 participants were followed. Out of those 366, 15 had hysterectomies. Why isn’t this mentioned?
The labeling also does not mention the 10% increased risk of pregnancy women with Essure face. This was discovered by a 2014 study by a Contraception journal. This is four times the risk of pregnancy than those with a tubal ligation.
At The Michael Brady Lynch Firm, we believe patients should be given the facts to make an informed decision. We will fight to make sure you won’t be victimized again. If you or a loved one have been a victim of Essure, please call us at 877-513-9517.