da Vinci Surgical Robots Have Been Linked to At Least 144 Deaths

(This is part of a series, presented by McGowan, Hood, Felder & Phillips, LLC, titled “Life on The Bleeding Edge: How the FDA Won’t Keep You Safe.” To learn more, please read Part One and Part Two.)

When we were kids (well, at least for some of us), the future promised it would be filled with robots. Just look at The Jetsons, or even Lost in Space. Today’s modern world has fulfilled that promise in many ways; we may not have jet packs, but we have self-driving cars, robotic vacuums, and entire labs and companies dedicated to developing nanobots, the tiny little robots that are supposed to save us all.

It was not surprising, therefore, when we learned about the da Vinci Surgical Robotics System almost 20 years ago. Robotics had been used more and more in complex medical procedures, and da Vinci wasn’t  the first: that was the PUMA 560 robotic surgical arm, used in a neurosurgical biopsy in 1985. The da Vinci system was supposed to revolutionize surgical procedures by allowing surgeons a larger, more in-depth field of vision, and by granting a wider range of motion when it came to performing delicate, laparoscopic surgeries. It was supposed to change the world.

Instead, it’s led to a type of surgical dystopia: 144 deaths, 1,391 injuries and 8,061 device malfunctions over the course of 13 years, per a 2013 study published in PLoS One. The researchers concluded that “Despite widespread adoption of robotic systems for minimally invasive surgery in the U.S., a non-negligible number of technical difficulties and complications are still being experienced during procedures.”

Furthermore, according to research done by the New York Times that same year, there is ample evidence that a number of adverse events may not have been reported. It is entirely possible – indeed, it is very likely – that the number of incidents related to botched da Vinci procedures is far higher than what the records reflect.

Robotic surgeries are ruining women’s lives

Jennifer Nelson underwent a hysterectomy after her OBGYN found a large fibroid (and smaller ones, as well) in her uterus. The doctor recommended the da Vinci system (per Nelson, there were no other options) to perform the surgery. The procedure was successful, in that Nelson did have a hysterectomy, but the complications and effects that arose from the surgery are a laundry list of horrors. As she puts it:

“To make a long and macabre story short, as a result of my da Vinci surgery I had three reparative surgeries, a colostomy, treatment for severe sepsis, a drain inserted for the abscesses, and a lot of physical therapy. I have pain always, deal with fecal impact since my colostomy reversal, can only sleep on my back, and live daily with a stomach that resembles what the Bride of Frankenstein’s might look like.”

Jennifer Nelson’s story is not uncommon. It is not a fluke. So many women’s lives have been upturned by disastrous da Vinci surgical operations that there are webpages dedicated to these women.

What makes the procedures by this robotic device so dangerous?

In 2016, the Washington Post reported that men undergoing da Vinci surgical treatment for prostate cancer seemed to recover the same way as men who had traditional procedures, though da Vinci surgeries cost more.

However, the story is different for women who undergo hysterectomy procedures by da Vinci devices versus traditional procedures.  Aside from all of the “normal” complications associated with surgical procedures, such as the risk of infection or scarring, da Vinci surgeries can:

• Take longer, which means more time under anesthesia, as well
• Cause inadvertent burns, tears, punctures or other types of injuries
• Lead to nerve damage
• Leave air trapped beneath the skin
• Force a surgeon to abandon the robot and take over the surgery manually, which increases the time it takes to perform said surgery, because of “irrecoverable intraoperative malfunction”

One of the most common complications was vaginal cuff dehiscence – the separation of the vaginal incision. This is, in a standard hysterectomy, a very rare complication. In robotics surgery, however, it happens more frequently. The reason for the increased risk is the type of suturing used in robotics surgery. If it is not treated, women can develop abscesses, peritonitis, hematomas or bowel evisceration. It always requires surgery to fix, which means additional risks of infection or issues with anesthesia – and the cycle continues.

There is one other overarching concern when it comes to da Vinci procedures: the lack of training. These are complex, complicated machines designed to handle complex, often complicated surgical procedures. The truth is, however, that while da Vinci claimed it would provide a robust training program, most doctors seem to be “winging it.” Matt Beane, an Assistant Professor in the Technology Management Program at UC ­– Santa Barbara, spoke with surgeons and surgical residents at 18 hospitals and observed hundreds of surgeries at 5 different hospitals. This is what he found:

“Residents were stuck either ‘sucking’ at the bedside – using a laparoscopic tool to remove smoke and fluids from the patient – or sitting in a second trainee console, watching the surgical action and waiting for a chance to operate.

In either case, surgeons didn’t need residents’ help, so they granted residents a lot less practice operating than they did in open procedures. The practice residents did get was lower-quality because surgeons ‘helicopter taught’ – giving frequent and very public feedback to residents at the console and intermittently taking control of the robot away from them.

As one resident said: ‘If you’re on the robot and [control is] taken away, it’s completely taken away and you’re just left to think about exactly what you did wrong, like a kid sitting in the corner with a dunce cap. Whereas in open surgery, you’re still working.’”

In an interview with Wired, Beane claimed that the average amount of time a resident spends working with the robot is 5-10 minutes per session.

I had a surgical procedure performed with a da Vinci robot; what do I do?

If you underwent a surgical procedure where a da Vinci robot was used, the single most important thing you can do is trust your instincts: if you don’t feel right, seek a second opinion immediately. Make sure to attend all follow-up sessions with your doctors, and report any adverse effects you experience to the FDA and to your doctor.

The next thing you should do is contact an experienced defective medical device attorney right away if you have been injured. Every state has a different statute of limitations for injury claims, and you want to ensure that you aren’t barred from recovering compensation.

There is a good chance that one day, robotic surgery will be our only option. For now, however, the machines are too imprecise, and the training too little, to reduce the risk of injury. That is why McGowan, Hood, Felder & Phillips, LLC is currently accepting meritorious cases on behalf of catastrophically injured da Vinci victims. Our medical products liability lawyers have the resources and experience  to fight for your best interests. Please contact 803-327-7800, or fill out our contact form, and schedule your free initial consultation today.