When a product promises the sky but fails to deliver, one anticipates a legal battle between its users and the manufacturer/s; Essure has met with a similar fate. Essure® is an intrauterine device developed by Conceptus Inc., a subsidiary of Bayer AG and approved by the FDA in 2002. It was marketed as a permanent surgical sterilization option for women. This device is composed of two metal coils made from polyester fibers, nickel-titanium, stainless steel, and solder that are placed in the fallopian tubes to induce fibrosis and block them to prevent fertilization.
Essure brought with it many promises: a perfect option for women looking out for a permanent surgical sterilization and a perfect alternative to the then existing tedious tubal ligation procedure. The timing couldn't have been better. Essure qualified for all the 4 P's of marketing - Product, Price, Placement, and Promotion. It entered a ripe market that was willing more than ever to use this new product. It wasn't surprising to know that Essure became the market leader, gaining prescriptions, in thousands, within a short span of time.
However, this rise was followed by a fall; the sale figures started plunging. Between 2002 and 2015, the company, itself, received more than 30,000 adverse event reports. No initiative was shown to resolve these. The list included persistent pain, perforation of the uterus and/or fallopian tubes, intra-abdominal or pelvic device migration, abnormal or irregular bleeding, and allergy or hypersensitivity reactions, including reports of unintended pregnancies.
Despite such grave complaints, the product wasn't withdrawn from the market. Subsequently, the FDA passed an order for the product package to carry a 'black box' warning, a patient checklist to be completed by the patient and also ordered Bayer to conduct a post-market surveillance.
Aggrieved women have taken Bayer to the court; lawsuits were filed across the country. To prevent duplicity and inconsistent ruling, Judge Smith from California, consolidated 11 Essure lawsuits in August 2016 as they had common factual and legal questions. The judge ordered these cases to proceed on the liability issue. This was followed by the coordination of 55 more cases in November 2016. The ruling of the first case will be a turning point for hundreds of pending Essure cases. The long wait may end anytime; one verdict will change the fate of thousands. Be ready for the high tide of cases to hit you. Get a quality Medical Record Review for Essure Litigations at a flat rate of $100 per review from Neural IT to plug every loophole and make it a watertight case. We invite you to benefit from our record review services.