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Published: October 17th, 2008
Women who have received a bladder sling to treat stress urinary incontinence may be at risk of severe and debilitating injury if the Mentor ObTape Vaginal Sling was used. The defective design of the device could lead to infections, erosion and other painful complications.
STATUS OF OBTAPE SLING LAWSUITS: Cases have been filed throughout the United States for women who received the Mentor Ob Tape Sling. Lawsuits filed in federal court will likely soon be consolidated in an MDL, and ObTape sling lawyers are continuing to review new cases.
MANFACTURER: Mentor Corporation
OVERVIEW: The Mentor ObTape is a transobturator vaginal sling which was used in thousands of women between 2003 and 2006 to treat Stress Urinary Incontinence (SUI).
The bladder sling is designed to provide support to the vaginal wall, reinforcing the muscles that control the flow of urine. Stress urinary incontinence affects approximately 14 million women, where the pelvic muscles that support the bladder and urethra are weakened. This could result in involuntary leakage during coughing, laughing, sneezing and similar actions.
The Mentor ObTape Sling contains a “nonwoven” design, which has been found to block essential nutrients and oxygen, leading to a substantial number of serious and debilitating complaints from women treated with the bladder sling.
OBTAPE SLING PROBLEMS: Over 35,000 women worldwide received the defectively designed Mentor ObTape bladder sling between 2003 and 2006. Some estimates have suggested that complications from the vaginal sling could impact over 17% to 18% of these women.
Women treated with the ObTape have suffered severe pain, vaginal extrusions, urinary tract erosion and infection.
Symptoms of Ob Tape problems could include:
- Vaginal or Pelvic Pain
- Bloody Discharge
- Pain During Sex
- Vaginal Infections
- Severe Pain in the Back, Hips and Legs
In many cases, Mentor ObTape Sling complications have required multiple surgeries to remove the bladder sling. Even after surgery, women may be left with permanent and debilitating injuries.
Although Mentor Corporation never issued a formal vaginal sling recall, they stopped selling the ObTape Sling in 2006, just three years after it was introduced.
A study published in the October 2006 issue of the Journal of Urology outlined a number of bladder sling problems suffered by women who received the ObTape sling. Researchers evaluated 67 cases of women treated with the Mentor ObTape. More than 13% of the women developed vaginal extrusions. In adddition, 8 women developed chronic vaginal discharge and 1 developed an abscess on her thigh.
The study also analyzed the cases of 56 women who were treated with another vaginal sling and concluded that none of those women experienced the urinary incontinence sling complications.
OBTAPE RECALL CORRECTION NOTICE: The original article posted on this page contained the sub-headline “Mentor Vaginal Sling Recall” based on an article in the Journal of Urology which indicated an ObTape recall was issued due to a high erosion rate. At the request of Mentor, the Journal published a retraction notice in 2007 correcting that there has not been a vaginal sling recall. Rather, Mentor stopped manufacturing and marketing the ObTape sling in about March 2006, three years after the product was introduced.