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| |  Trans-Obturator Tape Procedures May Not Be as Safe as Previously Believed: Presented at ICS By Alison Palkhivala MONTREAL, CANADA -- September 6, 2005 -- As trans-obturator sling procedures become more widely used, unexpected and sometimes serious complications are arising. Complication rates may be higher than expected, and different devices used during the procedure are associated with a different spectrum of potential problems. According to Sarah Hamilton-Boyles, MD, and colleagues at Oregon Health & Science University, Portland, Oregon, "a review of the existing literature shows that the complications rates associated with TOT [trans-obturator tape] are low and that the complications are generally minor. … These studies are limited by small numbers and by short-term follow-up and may not capture rare and serious morbidity." Dr. Hamilton-Boyles and colleagues used the Manufacturer and User Facility Device Experience Database, known as MAUDE, to collect data on the complications that have occurred during TOT procedures using any of three types of slings available in the United States since January 2004: OBTape(TM) by Mentor, Monarc(TM) by AMS, and the TVT(TM) Obturator System by Gynecare. MAUDE is a database maintained by the US Food and Drug Administration (FDA) that collects physician reports of complications associated with medical devices. Dr. Hamilton-Boyles presented their findings here August 31st at the 35th annual meeting of the International Continence Society (ICS). From January 2004 to July 2005, according to MAUDE, 173 complications were documented in 140 patients who underwent TOT procedures. By far the most common complication, accounting for 105 of those reported, was vaginal or site unspecified erosion. A total of 25 infections were also reported, 18 of which were associated with an erosion. There were four reports of neuropathy, two of which were linked with impaired ambulation. Other complications were neuropathy, pain, urethral entry, bleeding, and bladder perforation. Assessing complications by device type revealed that 99 erosions occurred with OBTape(TM), compared with four with Monarc(TM), and two with TVT(TM). Twenty-one infections occurred with OBTape(TM), one with Monarc(TM), and two with TVT(TM). Neuropathy did not occur with any patients treated with OBTape(TM) but did occur once with Monarc(TM), and three times with TVT(TM). Pain also did not occur in any patients treated with OBTape(TM) but occurred once with Monarc(TM) and eight times with TVT(TM). Urethral entry only occurred with TVT(TM) and was reported three times with this device. Bleeding and bladder perforation each occurred from zero to three times with each device. Dr. Hamilton-Boyles pointed out that, since it is not known how many procedures using each of these devices were undertaken during the observation period, it is not possible to compare complication rates across devices. What these data do demonstrate, however, is that certain types of complications occur more frequently in some devices than others. Complications most likely to occur with OBTape(TM) were erosions and infections. With TVT(TM), on the other hand, complications were more likely to relate to neuropathy, pain, and urethral injury. "Complications are underreported, said Dr. Hamilton-Boyles. "The FDA currently estimates that the actual number of complications is 10- to 100-fold higher than is reported in the database. … Unexpected complications, such as nerve injuries, abscesses, large blood losses, and cystotomy, can occur with TOT. More severe injuries have been documented as TOT has become widely disseminated. Different types of complications seem to be associated with the different types of devices. While these data are not conclusive, they warrant further investigation."
[Presentation title: Complications Associated With Trans-Obturator Sling Procedures. Abstract 12.]
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