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Medical Devices / Postmarket Safety / Research and Development / Commercial Operations

Report: Robotic-Assisted Hysterectomy Shows Benefits in Women With Benign Disease

Feb. 10, 2014
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Intuitive Surgical is touting a recent study that shows women who underwent hysterectomies via robot-assisted surgery had lower readmission rates, lower levels of blood loss, shorter hospital stays and greater cost savings related to readmissions than women who had laparoscopic, abdominal or vaginal hysterectomies.

The study, published in the Journal of Minimally Invasive Gynecology, looked at 2,554 women who had hysterectomies due to noncancerous tumors, pelvic pain or abnormal uterine bleeding between January 2008 and December 2012.

Specifically, the readmission rate for robot-assisted hysterectomies was 1 percent, compared with 2.4 percent for vaginal hysterectomies, 2.6 percent for laparoscopic hysterectomies and 3.5 percent for abdominal hysterectomies, the authors found. Length of stay was nearly half that of the other procedures. Total readmission costs for robot-assisted procedures were $32,976, versus $50,290 for laparoscopy, $328,230 for abdominal surgery and $51,264 for vaginal procedures.

The report is a spot of good news for Intuitive, whose da Vinci robotic system received stream of negative publicity last year related to device malfunctions and patient injuries.  An FDA survey of surgeons found generally good results from the system, but concerns about inadequate training. Several surgeons reported adverse events, such as cracked, stuck and dysfunctional robotic arms, an instrument that failed to take a reading and failure of the device’s memory system.

Intuitive has received three letters from the FDA regarding the da Vinci system: a 2013 warning letter over unreported field corrections, a 2008 untitled letter and a 2002 Form 483.

The journal article is available at www.jmig.org/article/S1553-4650%2813%2901334-4/fulltext. — Lena Freund

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