A recent study in the Journal of the American Medical Association (JAMA) concluded that a better process is needed for integrating new surgical innovations into clinical care. The study cited that the adoption of the da Vinci Surgical System in 2005 resulted in increased complications in minimally invasive prostatectomies because surgeons were learning on the job – at the patient’s expense.
The likelihood of patient safety indicators (a measure of adverse events) was twice as high in minimally invasive prostatectomies than invasive prostatectomies in 2005. This finding, the authors of the article in JAMA Surgery wrote, can be attributed to surgeon mistakes resulting from a lack of familiarity with newly available robotic surgery techniques. Surgeon error, not manufacturer error, was the problem.
According to Reuters, sales of the da Vinci robot took off in 2006, by which time 10% of prostate-removal surgeries utilized the device. The difference in complication rates between invasive and noninvasive surgeries was not statistically significant that year.
Intuitive Surgical, the manufacturer of the da Vinci system, disputed the findings and said they are based on incomplete and inaccurate data, according to Reuters.
But mounting safety concerns are taking their toll. Shipments of the product fell by about 50% in Q1 2014 compared to Q1 2013. Intuitive issued a recall of more than 1,300 systems in November 2013. In addition, cost-effectiveness concerns and FDA warnings that some gynecology procedures could increase cancer risk have also contributed to the slump in sales.
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