According to Madris Tomes, chief executive officer of Device Events, the FDA may have significantly underestimated fetal deaths among women who used the Essure Contraceptive device. While the FDA has cited five fetal deaths, Tomes had indicated that there were in fact 303 fetal deaths linked to the product.
Essure is a permanent contraceptive device manufactured by Bayer AG. The procedure which involves implanting a small coil into each fallopian tube causes scar tissue to form and prevent eggs from reaching the uterus. The procedure is generally done by a doctor during a regular office visit and lasts less than an hour.
The FDA approved the procedure in 2002 and since that time there have been over 5,000 adverse-event reports. Complaints include intense pain, heavy bleeding, uterine perforation and fetal death.
In September the FDA said the use of Essure should be limited because not enough research has been performed to prove it safe.
Additionally, a complaint has been filed in Federal Court in California alleging that doctors received illegal kickbacks from Bayer for performing the procedure.U
Unfortunately for women injured by Essure, Bayer is protected from lawsuits because the product received premarket approval from the FDA. Accordingly, their claims are preempted pursuant to the Medical Device Act. This means that Bayer is protected from lawsuits unless it can be proven that the there was fraudulent withholding of data from the FDA. While there are pending lawsuits alleging fraud, it is unclear whether such claims will be successful.