Essure is a permanent, non-surgical sterilization procedure that was first marketed by Bayer in the United States in 2002. The Essure device, which has a steel inner coil and an outer alloy coil, contains polyethylene terephthalate fibers that induce inflammation and lead to fibrosis. After implantation into the Fallopian tubes, the resulting fibrosis is intended to prevent egg fertilization.
Since its introduction to the market, thousands of women have made complaints against Essure and Bayer, the manufacturer. The complaints involve severe pain, excessive bleeding, and headaches as well as more serious complications, including perforation of internal organs, hysterectomy, and stillbirth. In response to a citizen’s petition filed with the agency, the FDA is investigating the claims and a panel was to have reviewed the safety of Essure on Sept. 24.
Unfortunately for the women who have suffered significantly due to Essure, there has been no legal recourse available. As a result of the Supreme Court’s federal preemption decision in Riegel v. Medtronic (which held that manufacturers of medical devices that received pre-market approval by the FDA cannot be sued for product defects), thousands of women have been denied access to the courts to recover for their serious medical complications caused by Essure. It is a classic example of where justice denied results in no justice at all.
Efforts are underway to avoid the draconian results of Reigel. A lawsuit is currently pending challenging the preemption effects of Reigel in the context of the FDA’s “conditional” approval of Essure. It’s argued that Bayer violated the terms of the conditional approval. We are monitoring this case and will keep our readers posted on the success of that challenge. Hopefully, it will be successful.
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