第五课 TVT-O治疗女性压力性尿失禁.ppt

* As of September, 2003, more than 500,000 incontinence repair procedures using GYNECARE TVT have been performed worldwide. More than 160,000 have been performed in the U.S. The device is proven safe and effective when used according to the Instructions for Use. GYNECARE diligently reports to the Food and Drug Administration (FDA) all serious injuries and deaths in accordance with federal regulations. As of September 26, 2003, GYNECARE had reported 377 Medical Device Reports (MDRs) to the FDA involving complications of surgery. These serious injury reports include any injury to a patient that potentially is related to the device. This would include injuries to blood vessels of the pelvic sidewall and abdominal wall, hematomas, bladder and bowel injury, urinary retention, erosions, post op pain and any post op complication not previously mentioned. Most complications associated with the GYNECARE TVT device are avoidable with scrupulous adherence to procedural technique and the instructions for use, rigorous attention to anatomy, careful patient selection, and vigilant attention to postoperative symptoms. * Include information regarding the # of years de Leval has been in practice, his commitment to TVT, the number of years/cases using TVT, experience with obturator approach: outside-in and then inside-out and why? Additionally, J. de Leval has recently treated 3 patients who subsequently developed urethral fistula after undergoing the outside-in obturator approach at other institutions. * So why then is there an interest in an obturator approach? The thinking has been that by avoiding the retropubic space both major (e.g., bowel and vascular injuries) and minor complications, especially bladder injury, might be reduced. * The GYNECARE TVT Obturator System is a sterile, single patient use procedure kit consisting of three major components that are packaged in a user-friendly work station with the device positioned ready for use. All components