Baltimore, MDWhile the da Vinci surgical robot delivers maximum “wow” factor for precision from its 10,000 components and is being deployed at more and more hospitals in spite of a $1.5 million price tag to acquire one, some patients have allegedly suffered negative outcomes from the devices, and have responded with a da Vinci lawsuit.
One of those plaintiffs is Michelle Zarick, who underwent a hysterectomy aided by the da Vinci surgical robot. Zarick told NBC’s investigative program Rock Center that her doctor was “excited” about the prospect of using the robot for the procedure. Da Vinci robot surgery is used in an increasing number of hysterectomy procedures. And there is little doubt that most of the 400,000 robotic-assisted surgeries performed in 2012 were successful.
However, Zarick’s procedure, in 2009, was not. In an interview with NBC News chief medical editor Dr. Nancy Snyderman, Zarick felt fine for the first while following her surgery. Then, in February of that year - five weeks after her surgery - the “seal” stitched into place by the surgical robot where her uterus and cervix used to be failed. Sitting on the toilet, “I felt like I had to have a bowel movement, and - as I was bearing down - I felt something kind of pop inside me,” she told the interviewer in comments broadcast on Rock Center in June. She looked down and was shocked to see her intestines drooping out of her vagina.
Zarick had the problem repaired with emergency surgery and is one of several plaintiffs having launched a da Vinci lawsuit.
While the majority of surgeries performed by the da Vinci robot are successful with few or no complication, there have been sufficient incidents of da Vinci robot failure to prompt the US Food and Drug Administration (FDA) to look into the matter.
Not all doctors are sold on the device. Dr. Martin Makary told CNN last month, “The Achilles heel of robotic surgery is that the robot cannot feel the tissue, so the surgeon can make an inadvertent injury to a major structure, and that is a unique problem with this kind of surgery,” said the senior surgeon at Johns Hopkins Medical Institute in Baltimore, in comments published to CNN (8/5/13). “I’m not anti-robot, but for most of the operations where robotic surgery is used, there’s no benefit to the patient. More technology doesn’t necessarily mean better quality healthcare.”
In a separate interview with NBC Rock Center (6/14/13), Dr. Makary noted “We’ve got great, state-of-the-art, minimally invasive techniques that have worked for years, sometimes decades, that are now being replaced with more expensive robotic technology, without a benefit to the patients.”
Supporting Makary’s comments is a published study that determined robotic surgery did not reduce complication rates inherent with hysterectomies when compared with more traditional procedures, while adding $2,189 to the cost.
According to both CNN and NBC, da Vinci made its first sale of the da Vinci robot to a German hospital in 1998, and has been selling the $1.5 million units steadily ever since - first to regional hospitals in major centers, and more recently, to smaller community hospitals trying to compete with the larger centers. Once the expensive system has been acquired, it has been alleged that there is pressure on surgeons to put it to use.
Not lost on any plaintiff having filed a robot lawsuit is concern over training protocols. According to NBC’s extensive Rock Center report, surgeons training to use the da Vinci surgical robot practice on animals and cadavers before being issued a certificate of training from da Vinci. Then it is up to the local hospital to determine at what point the surgeon is granted the privilege to operate solo with the device. There have been reports that some have “soloed” on the da Vinci after just three supervised procedures.
“So the real question is…is it still safe? In the hands of a good surgeon, yes,” Dr. Makary told Rock Center. “In the hands of someone who may not have the advanced skill sets, it could be a real danger.
“The robot is a technical tour-de-force, but I think patients need to know that for some procedures, there’s no benefit.”
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