The government has issued a warning about the use of transvaginal surgical meshes to treat pelvic organ prolapse and urinary leakage, noting that thousands of women have reported serious complications including organ perforation, pain, bleeding, infection, and urinary incontinence.
Pelvic organ prolapse affects many women as they age, with the FDA estimating 30 to 50 percent of all women may experience POP during their lifetimes, with 2 percent developing symptoms such as urinary leaking during physical activity. POP occurs when the tissue holding the uterus, bladder, bowel and rectum become stretched or weak and the organs fall down or slip out of place. The mesh is used as a sort of cradle or nest to hold up a patient’s insides.
But over time, erosion or contraction of the mesh – described as being made of a material similar to that of Rubbermaid storage containers — has led to complications, with symptoms including bleeding, severe pelvic pain, painful sexual intercourse and urinary problems.
Transvaginal Mesh Patch Failure
A July 2011 FDA alert warns of serious complications associated with transvaginal mesh patches when implanted to treat pelvic organ prolapse (POP) or stress urinary incontinence (SUI). The FDA has received more than 3,800 reports of adverse effects caused by the surgical mesh or during implantation of the patch.
According to the FDA, significant complications resulting from transvaginal mesh patches are not rare and commonly include serious issues such as:
- Erosion of the vaginal tissue
- Urinary problems such as incontinence
- Pain during sexual intercourse (dyspareunia)
- Organ perforation (puncturing) from surgical tools during mesh implantation
Less frequent problems included
- Return of POP
- Neuro-muscular problems
- Vaginal scarring/shrinkage
- Emotional problems
If you have suffered complications due to the implantation of a transvaginal patch to treat POP, contact the experienced medical device lawyers of McDivitt Law Firm for a free consultation today by calling us toll-free at (877) 846-4878 or click here for a free and confidential evaluation.