October 15, 2015 · FLEMING | NOLEN | JEZ, L.L.P.
More bad news today for Bayer’s Essure contraceptive implant. The New York Times reports on a recent study that found that women who underwent an Essure procedure for permanent sterilization were ten times more likely to undergo surgery within a year of implant than women who had their tubes tied. Dr. Art Sedrakyan, the study’s senior author, stated that most of the additional operations were due to complications from the device.
The Essure device is inserted into the fallopian tubes in order to create a blockage, permanently preventing pregnancy. Some potential complications of the device are bowel perforations, device migration, and the device breaking into pieces. This can lead to pain, bleeding, and unwanted pregnancies, among other things.
In September, the Food and Drug Administration (FDA) held a daylong meeting about the Essure contraceptive device. The panelists criticized Bayer for not collecting data that would have predicted the risks for women using Essure. Critics of the device have called upon the FDA to pull it from the market; however that has yet to happen. Since Essure’s approval thirteen years ago, the FDA has received over five thousand complaints, ranging from severe back and pelvic pain, painful intercourse, heavy menstrual bleeding, chronic fatigue, and autoimmune diseases.
If you or a loved one has had an Essure device implanted and are experiencing complications, contact us or call toll free 1-(713) 621-7944 for a free consultation and case evaluation by one of our product liability attorneys.