FDA May Have Dramatically Underestimated Number of Fetal Deaths Caused by Essure
The FDA may have grossly underestimated the number of fetal deaths caused by the birth control device Essure. That is the conclusion from an independent report that found more than 300 fetal deaths occurred because of the Essure birth control device, rather than the 5 originally reported by the FDA.
Essure, the first FDA-approved non-surgical alternative to tubal ligation and laparoscopy for permanent birth control, was first approved in 2002 and marketed by Bayer AG as a safe, effective, less invasive and less costly alternative to surgical tubal ligation. Essure flexible metal coils are implanted in a patient’s fallopian tubes and over a three-month period, the patient develops scar tissue thereby preventing pregnancy. The procedure can be completed in a doctor’s medical office in under an hour, with little recovery downtime and less expense than surgery.
Since its approval, however, thousands of women have complained to their doctors and the FDA of complications and problems following Essure implantation including, but not limited to, heavy bleeding, intense pain, perforated uterus and fallopian tubes, pregnancy, back pain, and fetal deaths. Following thousands of adverse event reports, the FDA concluded only five fetal deaths were due to the Essure device.
But Device Events, an independent agency founded by former FDA employee Madris Tomes to evaluate medical device adverse event reports filed with the FDA, concluded the number of FDA reported fetal deaths is woefully low. Device Events determined 303 cases of fetal deaths from Essure, a huge discrepancy from only five fetal deaths reported by the FDA.
Diana Zuckerman, President of the National Center for Health Research, warns the number of fetal deaths is probably even higher since doctors and patients alike underreport adverse events from Essure.
Because of the public outcry from injured women, and continuing complaints following Essure implantation, the FDA Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee finally held a public meeting September 24, 2015, at which time women injured by Essure urged the panel to remove it from the market. The FDA panel recommended to the full FDA further testing be done to determine the long-term effects of the Essure device, but stopped short of recommending it be removed from the market.
The FDA has several options concerning Essure:
- Order additional clinical trials and testing to evaluate whether the device is causing all the negative health problems about which women are complaining after Essure implantation, and the long-term effects from using the device;
- Require labeling changes on the device;
- Restrict usage of the device approved for women ages 21 to 45 years.
New FDA recommendations and guidelines on Essure use are expected at any time.
In the meantime, Congressman Mike Fitzpatrick, R-Pennsylvania, filed a Congressional bill to remove Essure from the market. Rep. Fitzpatrick was appalled by the totally lack of responsiveness from the FDA and from doctors whose patients have complained of health problems for years following their Essure implantation. There is also a lawsuit proceeding in federal court in the Northern District of California alleging doctors were receiving kickbacks and financial incentives from Bayer AG in return for recommending and implanting the device. Injured patients believe this possible financial incentive may have caused doctors to ignore their health complaints.
If you believe you or a loved one was injured following Essure implantation, our experienced attorneys are here to answer your questions. The FDA would also like to hear about your experience with Essure. Please file an adverse event report at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm.