Transvaginal mesh is used to provide extra support when repairing weakened tissue caused by pelvic organ prolapse and stress urinary incontinence. Mesh can be made from animal materials or from synthetic polypropylene, which is a thermoplastic polymer.
Despite FDA approval of mesh devices, women implanted with synthetic mesh have experienced a number of health problems, and just this year the FDA updated the classification of mesh from a moderate risk device to a high risk device.
In one synthetic polypropylene study, more than 150 excised mesh devices were shown to feature degradation that appeared to form in vivo. There were inflammatory cells trapped within fissures and cracking of the material contributed to stiffening and deformation of the mesh material.
Despite slightly varied opinions concerning transvaginal mesh, many women have experienced problems with mesh erosion that led to pain and required follow-up surgical procedures to correct issues, ultimately affecting their quality of life.
Additionally, women who received transvaginal mesh have complained of:
- Bleeding
- Organ perforatio
- Severe pelvic or vaginal pain
- Recurrent prolapse
- Incontinence
- Urinary tract infections
- Inability to engage in intercourse
- Vaginal scarring
- Fistulas
- Nerve damage
- Vaginal shrinkage
Most also have reported a number of emotional and psychological trauma due to the pain and suffering related to their issues.
About Transvaginal Mesh
Synthetic polypropylene and transvaginal mesh was approved by the FDA in 1996 for use in repairing issues with stress urinary incontinence. In 2002, the FDA approved mesh for treatment of pelvic organ prolapse. There is some evidence problems occur more frequently when mesh is used to repair pelvic organ prolapse.
In 2016, the FDA updated its classification of transvaginal mesh to a high risk device and warned doctors, surgeons, and patients considering the device that it can cause a variety of complications, including those listed above.
Legal Actions against Transvaginal Mesh Manufacturers
To date, the FDA has received thousands of adverse event reports about synthetic polypropylene transvaginal mesh devices. Over the years, products have been reclassified and the public warned about the dangers of mesh. Lawsuits have been filed against various product manufacturers, including Boston Scientific, Cook Medical, Johnson & Johnson, C.R. Bard, and Coloplast Corp.
Johnson & Johnson is in the midst of settling claims with transvaginal mesh recipients, including one recent settlement for $5 million. The plaintiff filed suit alleging her transvaginal mesh device degraded inside of her, caused painful intercourse, and required follow-up surgeries that eventually led to removal. Additional cases that went to trial in New Jersey and Philadelphia resulted in awards of $11.1 million and $13.5 million.
Currently, Johnson & Johnson’s Ethicon division faces MDL that combines thousands of individual mesh lawsuits accusing the companies of not properly warning doctors and patients of the risks of erosion, movement, inflammatory reactions, and the potential for corrective surgery or removal. Johnson & Johnson alone faces more than 46,000 similar lawsuits.
Sources:
http://www.mayoclinic.org/diseases-conditions/pelvic-organ-prolapse/in-depth/transvaginal-mesh-complications/art-20110300
