INCIDENCE OF COMPLICATIONS AFTER TRANS-OBTURATOR SLING PROCEDURES

S.H. Boyles, R. Edwards

Oregon Health Science University, Portland, OR

OBJECTIVE: To determine the number of complications associated with trans-obturator slings as reported to a national database.

METHODS: We queried MAUDE, a FDA maintained database that collects physician initiated reports of complications associated with medical devices.  We then tabulated the results by type of complication, by date of occurrence, and by type of sling (ObTape by Mentor, Monarc by AMS, and TVT Obturator System by Gynecare) and compared the results to reported traditional TVT complications.

RESULTS: All three trans-obturator systems have been available in the United States since January 2004.  Between January, 2004 and September, 2004, the reported rate of complications was 0.004 with the ObTape, 0.0001 with the Monarc, and 0 with the TVT Obturator System.  Twenty-five vaginal erosions, extrusions, or vaginal wall separations were reported with the ObTape. 

	ObTape	Monarc	TVT Obturator	TVT
Number implanted	7,000	17,000	6,000	125,000
Number of reported complications	31	2	0	234
Reported complication rate	0.004	0.0001	0	0.002

One occurred in the lateral vagina, one occurred in the anterior vagina; the remaining sites were not described.  Two infections, two bladder perforations, one sling migration, and one suburethral erosion were described.  One infection and one vaginal erosion in an unspecified site were described with the Monarc system.  The total reported complication rate for the traditional TVT between 1999 and 2003 was 0.002; the reported vaginal erosion rate was 0.0004.

CONCLUSION: There is scant literature describing trans-obturator tape systems and the associated complications.  Forty times more complications have been reported with the ObTape and it has twice the complication rate as the traditional TVT. The complications associated with the trans-obturator tapes are relatively minor.  The three commercially available trans-obturator tape systems use different polypropylene meshes and different implantation systems.  These differences may affect rates of erosion and the technical difficulty associated with correct mesh placement.  There is limited data supporting the use of one mesh over another.  These systems should be compared to each other and to traditional procedures to determine their merit.  Previous work has shown that self-reporting databases underestimate the rate of complications by more than ten fold, thus this estimate likely underestimates the true rate of complications. 

Key Words: trans-obturator tapes, complications, MAUDE

Disclosure - Speakers Bureau: R. Edwards, Lilly, Pfizer.