What is Pelvic Organ Prolapse?
Pelvic organ prolapse (POP) occurs when the tissue and muscles of the pelvic floor no longer support the pelvic organs resulting in the drop (prolapse) of the pelvic organs from their normal position. The pelvic organs include the vagina, cervix, uterus, bladder, urethra, and rectum. The bladder is the most commonly involved organ in pelvic organ prolapse.
What is Stress Incontinence?
Stress incontinence occurs when your bladder leaks urine during physical activity or exertion. It may happen when you cough, lift something heavy, or exercise.
What is a Trans Vaginal Mesh?
Urogynecologic Surgical Mesh Implants
Surgical mesh is a medical device that is used to provide additional support when repairing weakened or damaged tissue. The majority of surgical mesh devices currently available for use are made from man-made (synthetic) materials or animal tissue.
Surgical mesh made of synthetic materials can be found in knitted mesh or non-knitted sheet forms. The synthetic materials used can be either absorbable, non-absorbable, or a combination of absorbable and non-absorbable materials.
What are the side effects of using TV mesh for Pelvic Organ Prolapse or Stress Incontinence?
On Oct. 20, 2008, the FDA issued a Public Health Notification and Additional Patient Information on serious complications associated with surgical mesh placed through the vagina (transvaginal placement) to treat POP and stress incontinence.
Based on an updated analysis of adverse events reported to the FDA and complications described in the scientific literature, the FDA identified surgical mesh for transvaginal repair of POP as an area of continuing serious concern.
The FDA issued an update on July 13, 2011 to inform the public that serious complications associated with surgical mesh for transvaginal repair of POP are not rare. This is a change from what the FDA previously reported on Oct. 20, 2008. 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. 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.