Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Organ Prolapse
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.
Surgical mesh can be used for urogynecologic procedures, including repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). It is permanently implanted to reinforce the weakened vaginal wall for POP repair or support the urethra or bladder neck for the repair of SUI.
Based on an updated analysis of adverse events reported to the FDA and complications described in recent scientific literature, on July 13, 2011 an FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse was issued to inform the medical community and patients that:
- serious complications associated with surgical mesh for transvaginal repair of POP are not rare
- it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair
Transvaginal mesh complications include the following:
*Mesh erosion into the vagina, bladder, intestines and uterus infection
*Urinary problems, including recurrence of prolapse and/or incontinence
*Development of urinary retention bowel, bladder, and blood vessel perforation during insertion
*Dyspareunia (pain with sexual relations)
*Recurrence of prolapsed organs
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