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Vaginal Mesh Support Systems
Pelvic Organ Prolapse (POP) :: Stress Urinary Incontinence (SUI)
Potential Complications With Transvaginal Placement of Mesh
The vaginal surgical mesh is a medical device that is generally used to repair weakened or damaged tissue in the vaginal wall. It is made from porous absorbable or non-absorbable synthetic material or absorbable biologic material.
One use of the vaginal mesh support system is to help with pelvic organ prolapse (uterine prolapse), which sometimes occurs in women after childbirth or surgery, which causes the womb to fall into the vaginal area.
Organ prolapse may also lead to the bladder and bowels slipping out of place and putting pressure on the vagina, which causes pain and discomfort, as well as urinary incontinence (Stress Urinary Incontinence (SUI)) in some cases.
However, it appears that a growing number of women treated with the vaginal system maybe suffering severe injuries and complications after surgery (potential complications may be based on transvaginal placement of the mesh). It appears that the FDA Maude adverse event reporting system has received many reports on problems associated with the vaginal mesh system.
According to the FDA website, "vaginal mesh Support System includes a sterile, single use, permanent implant that provides long term reinforcement to support structures in the correction of anterior or posterior vaginal wall prolapse (including transvaginal placement).
On October 20, 2008, the FDA issued a Public Health Notification on serious complications associated with surgical mesh placed through the vagina (transvaginal placement) to treat POP and SUI.
And, on July 13, 2011, the FDA issued an update to that Public Health Notification in which it stated that "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. This Safety Communication provides updated recommendations for health care providers and patients and updates the FDA’s activities involving surgical mesh for the transvaginal repair of POP."
A few examples of the potential problems that may be associated with the vaginal mesh in which placement is in a transvaginal orientation, may include:
- Erosion through vaginal epithelium
- infection
- urinary problems
- pain
- Recurrence of prolapse and/or incontinence
- Bowel, bladder, and blood vessel perforation during insertion
- pelvic pain
- vaginal pain
A possible solution to potential problems that may be caused by the mesh may include additional surgeries to remove the mesh. But, removal of eroded or infected Transvaginal mesh may pose a risk of disfigurement, hemorrhaging and other potentially life-threatening problems. Complete Transvaginal mesh removal may require multiple surgical procedures and may result in scarring of pelvic tissue and muscles.
One particular system used in vaginal organ prolapse and stress urinary incontinence surgery is the Bard® Avaulta vaginal mesh support system manufactured by C.R. Bard.
If you or someone you love has depended on a vaginal mesh product to help with the problems it was designed to help manage but experienced problems with the vaginal mesh, please contact us for a free legal consultation.
Please navigate to the links below to find more information on personal injury and what individuals suffering from a personal injury can do to protect their legal rights or contact us.
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