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Plenty of experience fixing complications of pelvic reconstruction and incontinence surgery caused by foreign bodies-mainly grafts and slings-led a group of researchers to make recommendations on how to repair the damage.
St. Petersburg, FL-Plenty of experience fixing complications of pelvic reconstruction and incontinence surgery caused by foreign bodies-mainly grafts and slings-led a group of researchers from Vanderbilt University to make recommendations on how to repair the damage. But it was the eyebrow-raising number of cases they saw that prompted the most discussion among surgeons here at the Society for Urodynamics and Female Urology winter meeting.
Urologists, urogynecologists, and gynecologists have become painfully aware of the iatrogenic complications that mesh procedures pose. In October 2008, FDA issued a public health warning about the complications.
Fortunately, the team's success with repair of serious complications of pelvic organ prolapse and stress urinary incontinence surgery was very good: 52.5% of patients who had erosions and 75% of those who had extrusions were cured; 35% of patients with erosions and 21% of those with extrusions improved.
From November 2000 to September 2009, the team treated 85 women who presented with foreign body complications of prolapse and stress incontinence procedures, 48 of whom had extrusions and 40 of whom had erosions. The majority of complications were after sling surgeries (81% to 85%). About one-fourth to one-third were after prolapse repair.
Although a few patients presented shortly after the original surgery, the average time between surgery and presentation for complications was 6 months for those with extrusions and 10 months for those with erosions. Some patients presented as long as 10 years later. Nearly half of them had undergone a pelvic surgery prior to the procedure that engendered the complications.
The majority of the foreign bodies extruding or causing erosions were type 1 polypropylene mesh. Among the extrusions, porcine dermis accounted for 4.2% and ProteGen slings (recalled in 1999) for 2%. Among erosions, ProteGen slings accounted for 10%, xenografts for 5%, and Gore-Tex for 5%.
Prior outside attempts at repair of extrusions included nine transvaginal procedures and one endoscopic procedure.
The Vanderbilt team managed all these cases with 100% mesh excision and simple vaginal closure. Four patients needed re-excision. Only 6.3% had new urgency and 6.2% new stress urinary incontinence. About 10% had resolution of urgency.
Among erosions, about three-fourths were in the bladder and one-third in the urethra. Prior attempts at these repairs included seven transvaginal, six endoscopic, and two laparoscopic surgeries. The Vanderbilt team's initial management was cystorrhaphy or partial cystectomy for nearly half the patients, urethroplasty in a little more than one-third (with about half receiving interposition grafts), a few endoscopic repairs, abdominal fistula repairs, and one ileal conduit. Four women needed reoperation, and one needed to be operated on a third time.
One patient, Dr. Padmanabhan noted, had had abdominal fistula repair and had not had interpositional material placed initially, but the repair was successful after interpositional material was placed. Only two patients had de novo urgency, and 18% had resolution of their urgency.
"We recommend nonendoscopic vesical erosion repairs and interpositional grafting for complex vesical and urethral repairs," she said.
All cases except for three were from outside Vanderbilt, and that brought up the difficult choices these surgeons face in trying to do something about the complications they see from other surgeons and from outside their own institutions.
"What is our obligation to patients in general when we see those types of problems?" asked co-author Harriette Scarpero, MD. "We all know that we've not very good as a group at really policing our own. Sending notes is something that we do, but beyond that, we don't."