The FDA has recently warned against the transvaginal placement of surgical mesh to treat pelvic organ prolapse (“POP”) as it carries more risks than other surgical options without any evidence of greater benefit. POP occurs when the pelvic organs fall out of place. While not life threatening, POP causes discomfort and can disrupt sexual or urinary functioning. An estimated 30% - 50% of women may experience POP in their lifetime with 2% developing symptoms. In 2010 an estimated 75,000 of the 100,000 POP repairs were done using transvaginal mesh.
Below is a list of common manufacturers and product lines:
Johnson & Johnson/Ethicon
- Ethicon TVT
- Gynecare TVT
- Gynecare Prolift
- Gynemesh PS
- Prolene Polypropylene Mesh Patch
- Avaulta Plus BioSynthetic Support System
- Avaulta Solo Synthetic Support System
- Faslata Allograft
- Pelvicol Tissue
- PelviSoft Biomesh
- Pelvitex Polypropylene Mesh
American Medical Systems or AMS
- SPARC (SUI treatment)
- Advantag Sling System
- Obtryx Curved Single
- Obtryx Mesh Sling
- Prefyx Mid U Mesh Sling System
- Prefyx PPS System
* This is not a complete list of manufacturers and products.
Mesh is a synthetic material that allows the body’s own tissue to grow around it to provide framework or support. When placed transvaginally (beneath the vaginal skin) the mesh is more susceptible to abrasion. After the mesh is implanted it can move, which in some cases leads to serious complications including puncturing nearby organs, cutting surrounding tissue, and breaking through the skin causing scarring. Additional side effects include: erosion of the mesh or surrounding tissue, pelvic pain, pain during intercourse, infection, bleeding, perforation of organs, and urinary problems. In some cases, women have become septic, a condition that if left untreated can cause death. Often, women who have had surgical mesh placed transvaginally required additional surgeries or hospitalization to treat complications or to remove the mesh. Unfortunately, mesh is a permanent implant so complete removal may not be possible and may not result in complete resolution of complications.
The FDA has received over 2,800 complaints of adverse events from transvaginal mesh since 2008. The FDA first issued a warning about the product in October, 2008. A second warning was issued in July 2011.
The FDA conducted a review of the use of surgical mesh to treat stress urinary incontinence (“SUI”) in September 2011. SUI is the most common type of urinary incontinence in women in which physical activity, such as coughing, sneezing, or laughing, causes an involuntary loss of urine. The study highlighted two significant findings:
1.Serious complications associated with surgical mesh for transvaginal repair of POP are not rare
2. It is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair
The FDA is considering the recommendation that urogynecologic surgical mesh used to repair POP be reclassified from Class II to Class III which includes general controls along with a premarket approval, which is a scientific review to ensure the device's safety and effectiveness.
If you or a loved one is experiencing any side effects from transvaginal mesh, please contact Cohen & Malad, LLP to speak with one of our experienced product liability/personal injury attorneys to discuss your legal options and help you seek the compensation you deserve.