The numbers related to the use of transvaginal mesh (TVM) implants for treating pelvic organ prolapse (POP) indicate cause for serious concern:
- Between January 1, 2005 and December 31, 2010 there were nearly 4,000 reports of injury, death and malfunction associated with urogynecologic surgical mesh products.
- Nearly 3,000 of these reports were received in just the last three years of the period studied.
- 1,500 of these were associated with POP repairs and 1,371 were associated with repairs for stress urinary incontinence (SUI).
These numbers represent an explosion of adverse events associated with the use of TVM, particularly for POP repair. According to FDA reporting, the number of adverse events associated with POP repairs increased by more than five times as compared to the number of reports received in the previous 3 years.
Those numbers are hard to come to terms with. Surgical mesh—similar to TVM implants used to treat POP—has been around since the 1950s. Initially used to repair abdominal hernias, in the 1970’s gynecologists began using it for abdominal repair of POP and then in the 1990’s, it began to be used for the surgical treatment of stress urinary incontinence. These products have been around for decades, and now the number of bad medical outcomes is spiking.
So what’s going on? One hypothesis is that the use of TVM implants has increased dramatically even when it is not medically necessary. That is reflected in the FDA’s safety communication from last year: “serious complications associated with surgical mesh for transvaginal repair of POP are not rare….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.”
If you or someone you care for has experienced poor health outcomes as a result of transvaginal mesh—whether to treat POP or to treat SUI—attorneys at Inserra & Kelley are available to hear your story.