U.S. Federal Drug Administration in a Oct. 20, 2008 FDA Public Health Notification, stated that the number of adverse events reported to the FDA for surgical mesh devices used to repair pelvic organ prolapse (POP) and stress urinary incontinence (SUI) for the previous 3-year period (2005 – 2007) was “over 1,000.” Since then, from Jan. 01, 2008 through Dec. 31, 2010, the FDA received 2,874 additional reports of complications associated with surgical mesh devices used to repair POP and SUI, with 1,503 reports associated with POP repairs and 1,371 associated with SUI repairs. Although it is common for adverse event reporting to increase following an FDA safety communication, we are concerned that the number of adverse event reports remains high.
In the last three years, the agency said, it has received almost 3,000 reports of complications from transvaginal mesh that was inserted surgically to treat pelvic organ prolapse.
Pelvic organ prolapse occurs when one of the pelvic organs — most commonly the bladder, but also possibly the urethra, uterus, vagina, small bowel or rectum — slips from its regular location to press against the vagina, causing pain and discomfort.
Doctors can use surgical mesh to repair those weakened tissues. Implants are put in to reinforce the vaginal wall, or to support the urethra to prevent urine leakage. MedPage Today, a news service for physicians, reports that at least 100,000 such procedures were performed in the U.S. in 2010.
However, in its recent advisory, the FDA reports: Serious complications associated with surgical mesh for transvaginal repair of [pelvic organ prolapse] are not rare. Furthermore, it is not clear that transvaginal [pelvic organ prolapse] repair with mesh is more effective than traditional non-mesh repair in all patients and it may expose patients to greater risk.
Are you suffering complications after receiving a transvaginal mesh implant? If so, you may be entitled to financial compensation for pain and suffering you have endured as a result of these dangerous implants. Call one of our vaginal mesh injury lawyers at McDivitt Law Firm. Our toll free number is 877-846-4878. Or you can click here for a confidential case evaluation form.