More than 300 fetal deaths have been caused by Essure, a permanent birth control medical device made by Bayer. This staggering statistic was uncovered in an independent analysis of FDA data by Madris Tomes, CEO of Device Events, a medical device data collection service, and made public today. The FDA has reported only five fetal deaths associated with Essure.
Tomes said she searched publicly available FDA data to find 303 fetal deaths among women who were implanted with Essure. These included ectopic pregnancies, miscarriages, stillbirths and terminations as the result of significant birth defects. If you used Essure and you suffered any of these issues contact one of our trusted personal injury atttorneys in Boston today to find out your legal options.
Also, Congressman Mike Fitzpatrick, (R-PA), says a complaint filed in District Court in Northern California claims OB/GYNs received kickbacks in return for buying Essure kits.
This latest news joins the heap of appalling statistics piling up against Essure:
- The FDA said it has received 10,000 medical device adverse reports on Essure so far. Most reports include abdominal pain, irregularities in menstrual cycles, fatigue and possible nickel allergy reactions. Some women have reported perforation of the uterus and/or fallopian tubes or intra-abdominal or pelvic device migration.
- Re-surgeries to remove the device are up to 6,000 in the last three months.
- Women who were implanted with Essure were 10 times more likely to need re-operations than women who had tubal ligations.
- As many as 9.6 percent of patients could become pregnant within 10 years of undergoing hysteroscopic sterilization with Essure.
Bayer and its subsidiary, Conceptus, continue to claim the product is safe. The FDA says it will report the results of a second review of the product at the end of this month.
I recently wrote to my U.S. senator, Sen. Elizabeth Warren (D-Mass) to give her these facts and report my concern. I wrote as a concerned constituent, women’s health care advocate and President of the Women’s Bar Association of Massachusetts.
If you care about this issue, write or e-mail your representative, too. Urge them to support the E-Free Act by Rep. Fitzpatrick, which would strip Essure of its FDA Pre-Market Approval (PMA) status. This would mean that Essure manufacturer Bayer would have to put the device through more clinical trials to prove it is safe before it is allowed back on the market.
Join me in fighting to get Essure off the market until it is re-designed to be safe.