Intuitive Surgical ($ISRG) already faces lawsuits and regulatory scrutiny challenging the safety and effectiveness of its da Vinci surgical robots. But here comes another slam: A second study knocks their use in hysterectomy procedures, concluding that they offer no added benefit and could even heighten the risk of pneumonia.
The findings, published in the journal Obstetrics & Gynecology and highlighted by Bloomberg, come from a group of researchers at the University of Texas Southwestern Medical Center. Their study follows another body of research published in the Journal of the American Medical Association (JAMA) earlier this year that gave a thumbs-down to the use of the $1.5 million da Vinci robots in hysterectomy procedures for not countering the added cost with any measurable health gain, Bloomberg notes. Johns Hopkins researchers earlier this month concluded separately that robotic surgery-related complications are grossly underreported, adding to the body of academic evidence that questions robotic surgery's value and overall safety.
This study was a large one, involving a look at hysterectomy data for close to 16,000 women in 2009 and 2010 who had benign conditions. Patients who received robotic hysterectomies didn't need blood transfusions as often, but they faced twice the risk of pneumonia following the operation. Also, researchers calculated an 8.8% complication rate for robotic hysterectomies, almost identical to the 8.85% complication rate for standard, minimally invasive hysterectomy procedures. As Bloomberg points out, those findings come even as robotic surgical procedures cost close to $2,500 more per procedure. And in an era in which providers and insurers are much more attentive to managing healthcare costs, those results aren't good.
In response to the study, a company spokeswoman criticizes the validity of the study itself. Angela Wonson of Intuitive noted to Bloomberg via email that the UT Southwestern study involved heavier and older patients, a group of which faced higher chronic conditions and "would have otherwise received an open hysterectomy."
As Bloomberg points out, the study authors suggest the increase in pneumonia cases may stem from more robotic hysterectomy patients needing intubation post-surgery, due to being placed in a "steep head-down" position during surgery, which can contribute to fluid buildup in the airways.
It's another study, and another obstacle for Intuitive to overcome. The company relies heavily on its da Vinci robots for revenue (they're in more than 1,300 hospitals and that number is climbing, the article notes), and they are Intuitive's main revenue engine. And investors are worried. While the company's stock closed Sept. 9 at $384.90, the number isn't as good as it seems at first glance. That's down from a high of $583.67 on Feb. 1, right around where the increased regulatory and legal scrutiny started to become more robust.