FDA issues MedWatch Alert warning of serious complications associated with mesh vaginal slings.
On October 20, 2008, the United States Food and Drug Administration, which regulates the medical device industry, issued a MedWatch Alert informing healthcare professionals of serious complications associated with surgical mesh vaginal slings, such as the Mentor ObTape. In that Alert, the FDA notes that it has received hundreds of adverse incident reports concerning these devices over the past three years, including complaints of infection, vaginal tissue erosion, perforation, and recurrence of the very problems that the slings were intended to treat. The Alert also contains a list of recommendations for physicians who have implanted these devices in patients, or who may be treating patients who have had these slings implanted, including vigilance for potential adverse effects of the sling, informing patients that complications associated with the slings may require additional surgery that may not correct the problem, and informing patients “about the potential for serious complications and their effect on quality of life, including pain during sexual intercourse [and] scarring…”.
Firm files lawsuits for women injured by Mentor Corporation’s Obtape-brand vaginal sling
Blasingame, Burch, Garrard & Ashley, P.C. has filed several lawsuits on behalf of women who have been injured by the “ObTape” brand trans-obturator vaginal sling sold by the Mentor Corporation, which Mentor marketed to urologists and gynecologists as a safe and effective treatment for female stress urinary incontinence. All of the plaintiffs in these lawsuits are women who were implanted with Mentor’s ObTape sling, or their spouses The firm presently represents more victims of the Mentor Obtape sling in litigation than any other law firm in the country in federal lawsuits pending in Georgia, Florida, Oklahoma, Maryland, New Jersey, Ohio, and Missouri. The firm is presently investigating cases in several other states. The women represented by the Firm in this litigation suffered many of the same symptoms that were reported in the FDA’s recent MedWatch Alert.
Impact
Female urinary stress incontinence occurs when the pelvic
muscles which support the bladder and urethra are weakened,
resulting in loss of bladder control. Based on
The lawsuits filed by Blasingame, Burch, Garrard & Ashley, P.C. allege that the Mentor ObTape’s design and construction were dangerously defective and that the material of which the ObTape sling was constructed was inappropriate for use in the vaginal area. The pore size of the polypropylene mesh sling was insufficient to allow for proper physiological reaction of the body to the device, which created an increased likelihood of infection or abscess, which consequently resulted in an unreasonably high rate of infection, abscesses, erosion and extrusion. Complications associated with this erosion began manifesting months after the device was surgically implanted.
Contact Us
For Additional Information
- Contact Tammy Tiller at Blasingame, Burch,
Garrard & Ashley, P.C. (Phone: (706) 354-4000; Fax: (706)
549-3545; E-mail: tdt@bbgbalaw.com)