Transvaginal Mesh Commonly Reported Injuries
Pelvic Organ Prolapse (“POP”), aka bladder prolapse, and Stress Urinary Incontinence (“SUI”) are common conditions in women. The University of Rochester Medical Center conducted a study[i] of 16,616 women with a uterus and found that 41% have experienced POP. SUI’s prevalence is said to occur in 30% of women five years after a vaginal delivery[ii], but due to its seemingly embarrassing nature, SUI is underreported and many who suffer from it do not seek treatment. Dr. Memel Harrison conducted a study[iii] through a questionnaire, which found that 46% of the 314 women (between the ages of 20-80) that responded correctly to the questionnaire had SUI.
POP is when supportive tissues in the pelvic region become weak and because of the arrangement and location of the uterus, bladder and rectum, they can herniate or bulge into the vaginal canal.[iv] SUI is the unintentional loss of urine due to physical movement or activity (i.e. coughing, sneezing, lifting, etc.[v]) POP and SUI[vi] are commonly caused by pregnancy and childbirth, menopause (decrease in estrogen levels can lead to weak pelvic muscles), age, and obesity.
Surgical mesh, originally developed in the 1950s for the treatment of hernias, became a popular treatment for POP and SUI in the ‘90s, known as transvaginal mesh. It is a type of sling that is positioned to provide support for the affected organ(s) relating to POP, or under the urethra and bladder relating to SUI[vii]. The FDA fast-tracked its approval process to allow manufacturers to begin selling it prior to a full FDA review, which can be lengthy and costly.
Serious complications have been reported after implantation of the device, including:
- Vaginal mesh erosion
- Pain (including during intercourse)
- Urinary problems
- Neuro-muscular problems
- Vaginal scarring/shrinkage
- Emotional problems
- Organ perforation
The FDA conducted a search of adverse event reports received between January 1, 2005 – December 31, 2010, which were directly associated with the transvaginal mesh implants; this search which identified 3,979 reports of injury, death and malfunction.[viii] As a result, the FDA issued an update stating that “…serious complications associated with surgical mesh for transvaginal repair of POP are not rare…furthermore, 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.”viii
In July 2011, the FDA warned that there was a five-fold increase of injury relating to insertion and use of the transvaginal mesh.[ix] According to an article published by the New York Times in January 2012, 185,000 women underwent the procedure for implantation of the transvaginal mesh in 2010 alone. That same year, 15% of those women experienced potential complications.[x] Frequently, surgical revision or removal of the transvaginal mesh is necessary, which can be painful, costly, and dangerous.