A sterilization implant for women, Essure, is the target of several lawsuits and a hearing conducted by the FDA, according to the Wall Street Journal. Since Essure was cleared for marketing in 2002, the FDA has received reports of the deaths of four women who used the device, as well as the miscarriage of five fetuses in women who became pregnant even with the device implanted. About 750,000 of these devices have been implanted around the world.
Essure is essentially a coil made of metal and polyester. It is implanted in a woman’s fallopian tubes by her doctor using a catheter, causing tissue growth that will block the fertilization of eggs. Its purpose is to make the woman permanently sterile.
The FDA has a hearing scheduled for September 24th to evaluate the safety of the product. The agency has received 5,093 reports of complications with Essure to date, most of which were filed since 2013. Among the most common problems are pain or abdominal pain, irregular menstruation, headache, fatigue, and weight fluctuation.
In 2013, Bayer purchased a majority interest in Essure’s manufacturer, Conceptus Inc., thereby acquiring the product. According to the FDA, there is no conclusive evidence to date of “any new or more widespread complications” with Essure that have occurred more than five years after implantation. The FDA will continue to monitor the safety of Essure to make sure that it is not causing an increased risk to the public. Bayer admits on its website that there have been “rare reports of chronic pelvic pain in women who have had Essure” and “rare instances” of the implant moving through the fallopian tubes, which requires surgery
If you think you may have a medical malpractice claim, contact Paul M. da Costa, Esq. at Sarno da Costa D’Aniello Maceri LLC. Mr. da Costa is experienced in handling all kinds of medical malpractice cases. Call us today at 973 274-5200.
