Surgical Mesh Lawsuit for Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse
Attorney David Szerlag is our managing attorney for these surgical mesh lawsuit cases. Contact David for a free consultation.
Surgical mesh is a medical device that is generally used to repair weakened or damaged tissue. It is made from porous absorbable or non-absorbable synthetic material or absorbable biologic material. In urogynecologic procedures, surgical mesh is permanently implanted to reinforce the weakened vaginal wall to repair pelvic organ prolapse or to support the urethra to treat urinary incontinence.
The U.S. Food and Drug Administration (FDA) today issued an updated safety communication warning health care providers and patients that surgical placement of mesh through the vagina to repair pelvic organ prolapse may expose patients to greater risk than other surgical options and there is no evidence of greater clinical benefit such as improved quality of life.
”There are clear risks associated with the transvaginal placement of mesh to treat POP [pelvic organ prolapse],” said William Maisel, M.D., M.P.H., deputy director and chief scientist of the FDA’s Center for Devices and Radiological Health. “The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh. Mesh is a permanent implant — complete removal may not be possible and may not result in complete resolution of complications.”
From 2008 to 2010, the FDA received 1503 adverse event reports associated with mesh used for POP repair, five times as many as the agency received from 2005 to 2007. The most frequently reported complications from surgical mesh used to repair POP include:
- mesh becoming exposed or protruding out of the vaginal tissue (erosion)
- pain
- infection
- bleeding
- pain during sexual intercourse
- organ perforation from surgical tools used in the mesh placement procedure
- urinary problems.
The manufacturers of these transvaginal surgical mesh products should be held accountable for these complications. Some reports cited the need for additional surgeries or hospitalization to treat complications or to remove the mesh. The manufacturers should pay these expenses. In addition, in many cases the mesh cannot be completely removed, meaning the patient will continue to suffer harm for life. The manufacturers should compensate patients for future pain and suffering and loss of quality of life.
There has not been a recall of these transvaginal surgical mesh products, but you may have a claim against the manufacturer of the surgical mesh that was used in your pelvic organ prolapse surgery.
