This case involves a woman who presented to her doctor with abnormal vaginal bleeding due to a history of fibroids. The patient also experienced many stress incontinence episodes due to an unstable pelvic floor. The physician on her case suggested the use of a urethral sling that would support the female anatomy and improve her condition. The patient underwent a laparoscopic hysterectomy along with a mid-urethral sling placement with an AMS MiniArc Precise Sling. Postoperatively, the patient suffered from worsening difficulties with urination and had continual incontinence episodes.
Question(s) For Expert Witness
- 1. Was the implant device indicated in this patient and what were her chances of attaining a positive outcome?
Expert Witness Response E-004027
Prior to the FDA warning for the treatment of SUI, the MiniArc is just one of many devices used in the past but it was definitely not one that was widely used and had a lower effective rate of cure than most full TVT or TOTV systems. It also sounds like she may have had low leak points and the device would not cure that. This device would not be good for most SUI patients, especially those with low leak points. There are other surgical options that have higher success rates.