What you should know about the special risks of robotic surgery
There have been thousands of product liability claims about the da Vinci robotic surgery system, since it was FDA-approved in 2000
In my practice as a Houston, Texas medical malpractice lawyer, I have represented many patients who are seriously injured as a result of surgical errors or malpractice. In recent years, Painter Law Firm has seen an increase in patients who experienced with problems related to robotic surgery.
Since the U.S. Food & Drug Administration (FDA) approved the da Vinci surgical robot system in 2000, more and more hospitals and surgeons are offering robot-aided surgical services.
The robotic da Vinci equipment is inserted into the patient’s body through small holes and then the surgeon uses a joystick, foot pedals, and a three-dimensional screen to guide the robotic equipment and performing the surgical procedure. These days, robot-assisted surgeries are routinely offered in a number of specialties, including bariatric (weight loss), cardiac, gynecological, urologic, and colorectal procedures.
In my experience, many surgeons who use the da Vinci system advocate to patients about the benefits of robotic surgery, but spend little to no time on the risks. Surgeons often explain to their patients that robot-assisted surgery allows more precise control of the equipment during surgery, requires fewer incisions, causes less scarring, leads to less blood loss, and has a faster recovery time than conventional surgery.
The da Vinci system is manufactured by Intuitive Surgical. Since gaining FDA approval, there have been over four million operations using the da Vinci system. According to Intuitive’s 2014 regulatory filings, there were 3000 product-liability claims over da Vinci surgeries that took place between 2004 and 2013.
Many product liability claims arising from the early use of the da Vinci system involved parts of the equipment that were eventually recalled by Intuitive. More recent regulatory filings, though, show that Intuitive is still party to a “large number” of product liability claims, in addition to 52 lawsuits where plaintiffs contend that the da Vinci system cause serious injury or death.
Concerns about da Vinci robotic surgery equipment
The most common patient complaints about da Vinci procedures relate to puncturing other organs near the location of the operation, or the heat from the equipment causing burn damages to bodily structures.
A number of claims involve a perforated bowel, for example. A perforated bowel typically means that the small intestine was damaged by an unintentional nick or hole created during the surgery, causing a leak of intestinal contents into the abdominal cavity. When this type of leak occurs, it quickly causes pain and can progress to an infection and sepsis if not surgically repaired quickly.
While I have investigated number of cases where perforated bowel occurred with traditional surgery, it seems that in robotic-aided procedures, there is an additional delay in diagnosing and treating this complication.
For example, a California mother had a hysterectomy during which her gynecological surgeon used the da Vinci system. She initially felt fine after the procedure, but a day later experienced stabbing pain and had to go back to the hospital by ambulance. After her doctors could not figure out what was causing her pain, her gynecologist to go back to surgery and discovered she had a perforated bowel. Even after the leak was repaired, the woman continued to have activity limitations—too much physical activity causes her stomach to swell and harden.
Another key concern with robotic surgery, as well as any new medical device, for that matter, is whether the surgeon has adequate training to use it. Some patients have filed claims against Intuitive Surgical, alleging that it allowed surgeons to use the da Vinci equipment without proper training to ensure patient safety.
What you can do
If a surgeon recommends robotic-assisted surgery, I recommend that you ask a number of questions before giving your consent.
First, ask the surgeon to compare the risks of conventional surgery to the risks of robotic surgery. This is a good time to ask about the surgeons experience with robotic surgery complications, without it seeming like you are pointing a finger at the surgeon.
Second, ask the surgeon to identify what equipment would be used. For example, ask what da Vinci equipment would be used.
Third, inquire about how long the robotic equipment has been used at the hospital or surgical facility.
Fourth, ask the surgeon questions about his or her training and experience using the equipment. How long has the surgeon use the equipment? When and where did the surgeon receive training for the equipment? How long did the training last? How many robotic surgeries has the surgeon performed?
I cannot tell you how many times clients have told me how they would have made a different decision if they had only known about the risks. As you can see, there is a lot of information necessary to make an informed decision about whether to proceed with robotic surgery, as opposed to traditional surgery. Your chance to have those questions answered is before consenting to the surgery.
We are here to help
If you or a loved one has been seriously injured as a result of robotic or other surgery, call the experienced medical product liability and malpractice lawyers at Painter Law Firm, at 281-580-8000, for free consultation about your potential case.
Robert Painter is an attorney at Painter Law Firm PLLC, in Houston, Texas. He is a former hospital administrator who investigates and files medical malpractice, wrongful death, and medical device product liability lawsuits on behalf of patients and their families.
Robert Painter is a medical malpractice lawyer at Painter Law Firm PLLC.
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