The transvaginal mesh litigation has been ongoing for several years now but the end may be in sight (or at least visible with a telescope). Transvaginal mesh products have been on the market for several years and some are still being utilized by doctors to this day. Transvaginal mesh products are generally used to treat medical conditions known as pelvic organ prolapse (POP) or stress urinary incontinence (SUI). These conditions are caused by weakened or damaged pelvic muscles, which are fairly common in women. These conditions can be caused by numerous factors, the most common of which are previous childbirth, undergoing a hysterectomy or being post-menopausal. The mesh products at issue are constructed from a plastic called polypropylene. In general, the defendants in this type of litigation allege and therefore marketed that polypropylene is an inert material that is safe for implantation into a female’s pelvic area. However, the plaintiffs contend that the polypropylene is in fact incompatible with human tissue and can lead to severe adverse reactions in women.
Transvaginal mesh products came onto the market in 1996 when the U.S. Food and Drug Administration approved the first surgical mesh for treatment of SUI. Thereafter, in 2002, the FDA cleared surgical mesh for the repair of POP. These approvals came via the FDA’s 510(k) procedure, which allows products to be approved without clinical trial data if they are “substantially equivalent” to a prior product. In this case, the surgical mesh for the repair of SUI and POP were considered “substantially equivalent” to surgical mesh that was already approved for hernia repairs. These new surgical mesh products were considered “permanent implants” as they were intended to remain in the patient’s body indefinitely and were designed to grow into the surrounding tissues.
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