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Complications associated with transobturator sling procedures.
Sarah Hamilton Boyles1, Renee Edwards, William Gregory
1Urogynecology & Reconstructive Pelvic Surgery, OHSU Center of Excellence in Women's Health, L466, 3181 SW Sam Jackson Park Rd, Portland, OR 97239, USA. hamilsar@ohsu.edu
Summary
Serious complications, including nerve injuries and abscesses, are reported with trans-obturator slings. Improved medical device complication tracking is needed for patient safety.
Area of Science:
- Urology
- Medical Device Safety
- Surgical Complications
Background:
- Trans-obturator slings are used for stress urinary incontinence.
- Complications associated with these devices require thorough investigation.
Purpose of the Study:
- To identify and categorize complications linked to trans-obturator slings.
- To analyze complication data reported to a national database.
Main Methods:
- Utilized the MAUDE database (FDA) for medical device complication reports.
- Searched for complications related to three commercial trans-obturator slings.
- Tabulated complications by type, date, and sling type.
Main Results:
- 173 complications from 140 reports were identified between January 2004 and July 2005.
- Included previously unreported obturator nerve injuries, significant blood loss, and abscesses.
- Complication types varied between different sling devices.
Conclusions:
- Serious complications occur with trans-obturator tape systems.
- Complication rates remain unknown due to database limitations.
- Enhanced tracking of medical device complications is crucial for patient safety.