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Unexpected complications with TOT reported.(Gynecology)
MONTREAL -- Although the complication rate remains low with the use of transobturator tape to treat stress urinary incontinence, unexpected complications are beginning to emerge as this treatment becomes more widely used, according to Sarah Hamilton Boyles, M.D., an instructor and fellow in obstetrics and gynecology at Oregon Health and Science University's Center for Women's Health in Portland.
"There are documented cases of complications that the companies had said could not occur, and it's important that we are all aware of these complications," Dr. Hamilton Boyles said in an interview.
In a study she presented at the annual meeting of the International Continence Society, Dr. Hamilton Boyles searched the Manufacturer and User Facility Device Experience (MAUDE) database to identify all complications reported with the use of three transobturator tape (TOT) techniques available in the United States. These included ObTape (manufactured by Mentor, Minneapolis), Monarc (American Medical Systems, Minnetonka, Minn.), and the TVT Obturator System (Gynecare, Somerville, N.J.).
MAUDE, maintained by the Food and Drug Administration, collects voluntary physician reports and mandatory reports from manufacturers, distributors, and user facilities. A review of published literature revealed that documented complications with TOT are low, and include bladder, urethra, and vaginal perforation; vaginal and urethral erosion; thigh pain; infection; urinary retention; and bleeding of 200-300 cc, she said. In addition, many of these problems were associated with a different TOT (UraTape), which is no longer on the market.
However, her search of MAUDE revealed some other unexpected complications. "Unique complications that are only easily discovered when searching a large surgical database such as MAUDE were found in the categories of infection, neuropathy, and bleeding," she reported.
The study revealed 173 reports of complications in 140 patients from January 2004 to January 2005. Among the complications were 25 cases of infection, 4 cases of neuropathy, and 5 cases of bleeding. A total of 18 of the ...
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Source: HighBeam Research, Unexpected complications with TOT reported.(Gynecology)