Complications resulting from sling surgery for stress urinaryincontinence may happen far more frequently than is reported in theliterature, data from UCLA suggest.
Complications resulting from sling surgery for stress urinary incontinence may happen far more frequently than is reported in the literature, data from UCLA suggest.
Larissa V. Rodríguez, MD, and colleagues undertook a systematic review of large sling series published since 2001. They also consulted the FDA's Manufacturer and User Facility Device Experience (MAUDE) database and examined outcomes from their own center.
They found that published studies on sling procedures consistently reported major complication rates to be less than 1%. But of the 869 slings reported in MAUDE, there were 33 "major vascular injuries" that led to two deaths, along with 38 bowel injuries leading to six deaths.
MAUDE also yielded 46 unrecognized bladder injuries, 26 unrecognized urethral injuries, 10 nerve entrapments, and two cases of necrotizing fasciitis. What's more, UCLA itself had 26 patients referred to its medical center for treatment of major complications following sling placement.
"No sling is minimally invasive," Dr. Rodríguez said. "Slings placed blindly with trocars can lead to devastating complications. Complication rates are likely much higher than those reported by companies or in the academic literature."