Women who suffer from conditions known as Pelvic Organ Prolapse (POP), and Stress Urinary Incontinence (SUI) may have had their doctor suggest use of a transvaginal mesh product when treating these conditions. The Food and Drug Administration (FDA), in July, 2011, updated a Safety Communication regarding this product, and found: “that serious complications associated with surgical mesh for transvaginal repair of POP are not rare.”
What are these serious complications? Most often they are related to mesh migration and erosion, with the mesh often moving through the wall of the vagina or other abdominal organs, which results in pain, infection, bleeding, painful sexual intercourse, organ perforation and urinary problems. In many of these cases, complications require serious additional medical intervention, surgery, and/or hospitalization.
The FDA went further and also states: “…it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.”
This product is called transvaginal mesh, because the installation of the mesh requires an incision in the vaginal wall. The mesh is actually inserted into place through that incision. While this is convenient and reduces the time required to perform this procedure, it exposes patients to side effects which may not show up for some time after the surgery. And the side effects can be frightening.
In the year 2010, over 75,000 women had transvaginal mesh used to treat POP and SUI conditions. At this point, there have been over 10,000 lawsuits filed against various manufacturers of mesh products.
In the first transvaginal mesh lawsuit that settled, a New Jersey court ruled earlier this year, February 25, 2013, that Johnson and Johnson subsidiary Ethicon, manufacturer of a line of transvaginal mesh products, must pay $3.35 million for failure to warn the patient of the serious side effects associated with this defective product. Within days of that verdict, the jury then awarded another $7.76 million in punitive damages.