Ennis & Ennis, P.A.
Bayer Fails To Act Despite Fifth Essure Related Death
04/27/2015 - FDA records reveal there has been a fifth death associated with the highly controversial Essure birth control device. Despite the demands of thousand of women nationwide, Bayer refuses to acknowledge the significant harm and injuries this device is inflicting upon thousands of women. These injured women have banded together in a vocal group called the E-Sisters and are a force to be reckoned with. They share a common mission, and strong bonds cemented by years of shared pain and support. They will not stop until Essure is recalled from the marketplace.
The fifth death found in the FDA database occurred during the actual procedure when the Essure device was being implanted. The FDA report shows that the patient “coded” during the procedure when the doctor was attempting to insert the second coil into her fallopian tube. The report reveals, “prior to coding the patient was noted to be shaking a lot and experienced generalized seizure activity.” The autopsy revealed that her uterus was punctured and her abdomen was filled with blood. This is important as Essure is marketed as an easy, non-surgical procedure which can easily be performed in a physician’s office when in fact, studies show that Essure is very difficult to implant, even by experts and there is a 14% insertion failure rate. Additionally, women describe the insertion experience as agonizing and excruciating.
There have also been four previous deaths reported which are associated with the Essure device. Three late term miscarriages and another female’s death in 2013 while being implanted have been associated with the device. Bayer maintains that, “death is not a known failure mode related to Essure.” However, Bayer has also made numerous representations in its advertising and marketing of Essure that is less than truthful and accurate. More than 4,500 doctors and patients have reported health concerns to the FDA regarding the Essure device and the misrepresentations made by Bayer.
According to Bayer, about 750,000 women have had Essure implanted, but even this representation is not likely accurate. This figure represents the number of kits sold, and not the actual number of kits that have been implanted. Doctors often use multiple kits or devices when attempting to implant the Essure as the procedure can take several attempts to correctly implant the devices. Additionally, doctors who regularly implant the devices and are given the expensive operative hysteroscope to perform the procedure are required to purchase a certain number of kits from Bayer whether they are utilized or not, making it impossible to determine how many women have been implanted with the device.
If you or a loved one has been injured by an Essure device, contact attorney Holly Ennis at Ennis & Ennis, P.A. for a free confidential consultation.