In April, 2014 the FDA issued a warning about the mesh saying, ”The U.S. Food and Drug Administration today issued two proposed orders to address the health risks associated with surgical mesh used for transvaginal repair of pelvic organ prolapse (POP). If finalized, the orders would reclassify surgical mesh for transvaginal POP from a moderate-risk device (class II) to a high-risk device (class III) and require manufacturers to submit a premarket approval (PMA) application for the agency to evaluate safety and effectiveness.”
A pelvic mesh is sometimes inserted in a woman who has had a pelvic organ prolapse (POP). When a body part moves out of its normal place in the body, it is said to be prolapsed. When a woman goes through childbirth or surgery, such as a hysterectomy, her muscles stretch and can weaken. If the muscles do not recover, her organs can move out of position. The primary symptoms can include pressure or fullness in the abdomen, lower back pain, needing to urinate often, incontinence, problems with the bowel or pain during intercourse.
The surgical mesh is inserted after putting the organs back in place to keep them in place. Complications to the mesh include the following:
Pain, including pain during intercourse
Infection, including urinary tract infections
Organ perforation – occurs when the sharp edges of mesh cut into or perforate nearby organs such as the bladder. This can cause serious damage and requires surgery to correct.
Erosion through the vagina – occurs when the mesh erodes or passes through the vaginal wall. This causes bleeding, severe pain, infection and nerve damage. When the jagged edges of the mesh erode through tissue and are visible, this is called exposure.
When complications occur sometimes doctors try to remove it causing more problems. Some faulty meshes are impossible to remove.
If you have had complications from the repair of pelvic organ prolapse, including a transvaginal mesh implant, please call the lawyers of Nolan Caddell Reynolds today. The damage that has been done may not be reversible.