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* 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. 避开耻骨后空间可能带来的好处 减少膀胱穿孔,尤其对有手术史的病人 避免耻骨后血肿 避免肠穿孔 减少大血管的损伤 第一篇TOT文章 Delorme E. Transobturator urethral suspension: mini-invasive procedure in the treatment of stress urinary incontinence in women. Prog Urol 2001;11:1306–13. [In French] 悬吊带方向的改变可能带来的好处 减少术后尿潴留的发生率 手术时间更短 * * de Leval J (2003) Novel surgical technique for the treatment of female stress urinary incontinence: transobturator vaginal tape inside-out. Eur Urol 44:724–730 第一篇TVT-O文章 * * 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. A
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