Case Details for "Mentor Corporation"

Investigation of ObTape Vaginal Sling manufactured by Mentor Corporation

Urinary incontinence sometimes occurs from weak muscle tone that can result from childbirth, other medical conditions, and growing older. OBTape Vaginal Slings are typically used to treat women who have suffered stress urinary incontinence (incontinence caused by leakage of urine during moments of physical stress such as coughing, sneezing, laughing or exercising. Between 2003 and 2006, more than 35,000 women underwent a surgical procedure to treat stress incontinence and bladder leakage.

The Food and Drug Administration has received reports of complications associated with the placement of mesh through an incision made in the wall of the vagina. Although rare, these complications can have serious consequences. The most frequent complications included erosion through the vagina, infection, pain, urinary problems and recurrence of the prolapse and/or incontinence. In some cases, erosion of the mesh and scarring of the vagina led to discomfort and pain, including pain during sexual intercourse. Some patients needed additional surgery to remove the mesh that had eroded into the vagina.

Many of these women received what we believe to be a defectively designed ObTape vaginal sling manufactured by Mentor. Investigations and evaluations have begun for women who, after being implanted with the vaginal sling, have experienced:

Erosion of the mesh through the vagina

Chronic vaginal Infections of a frequency not experienced before the ObTape was implanted

Urinary Problems, including UTI (urinary tract infections) and urethral erosions

Vaginal or pelvic pain

Unexpected vaginal discharge/bleeding

Posted on:03/02/2009
Company: Mentor Corporation
Affected Class:
Scope: Nationwide

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