There has been an increase in the number of so-called “high-end” treatments in United States men who are diagnosed with early, slow-growing prostate cancer between 2004 and 2009. The researchers discovered a rise in robotic and other high-end therapies in men unlikely to die from prostate cancer, according to Reuter Health.
Personal injury lawsuits allege that the da Vinci robotic surgical system marketed by Intuitive Surgical has caused severe internal injuries, including burns, tears, and other complications, some of which have resulted in death or chronic pain and disability. da Vinci lawsuits fault aggressive marketing tactics used by Intuitive Surgical to convince hospitals to purchase the expensive surgical robot, and allege that a combination of design flaws inherent in the robot, coupled with poor physician training on the device, have resulted in serious injuries.
In robotic-assisted surgery, a surgeon sits at a console operating several robotic arms that manipulate small tools that are inserted into the patient’s body via tiny incisions. The system also utilizes a small, lighted camera that displays the surgical area in 3-D video. The da Vinci is the only robotic surgery approved by the U.S. Food and Drug Administration (FDA) for soft tissue surgeries, such as prostate removal.
There is a school of thought about waiting in cases of low-risk prostate cancer to see if the cancer does or does not progress before scheduling surgery or radiation therapy; however, patients and physicians are not always comfortable with the so-called “watchful waiting” or “active surveillance,” researchers said, according to Reuters Health. “There’s no incentive for (doctors) to do it, because there’s no real payment, and it’s very complicated. It’s not easy to do active surveillance,” said Grace Lu-Yao, who studies prostate cancer treatment at Robert Wood Johnson Medical School in New Brunswick, New Jersey, wrote Reuters Health. “Some patients may just feel they’ll go with the most advanced technology and get rid of the cancer, so they’ll feel more secure in a way.”
Dr. Brent Hollenbeck, who worked on the study at the University of Michigan in Ann Arbor, told Reuters Health that he and his colleagues analyzed data on 56,000 older men diagnosed with prostate cancer who were covered by Medicare and found that, in men diagnosed with low-risk cancers, use of robotic surgery, among other high-end treatments, increased to 44 percent in 2009 from 32 percent in 2004, according to Reuters Health.
“In someone who stands to benefit less, when there’s no clear advantage to treatment in terms of preventing death from prostate cancer, the cumulative side effects of the procedure may outweigh the aggregate benefit,” Hollenbeck told Reuters Health, concerning high-end treatments.
Some 89 deaths have been linked to the da Vinci robotic surgical systems since 2009. According to the FDA, the agency has received more than 200 reports of burns, cuts, and infections, since 2007, according to NBC News. As for the da Vinci, the surgical robot has been heavily marketed and used in some 400,000 surgeries in 2012 alone. Associated with a growing number of deaths and serious injuries, the high-tech systems have also been associated with a number of odd accidents. According to a prior Associated Press (AP) report, a da Vinci robotic hand gripped and would not release a patient’s bodily tissue during surgery. In another case, the da Vinci’s robotic arm repeatedly hit a patient in her face as she was prone on the operating table.
Hospitals set credentialing, or training, requirements for doctors who will operate the da Vinci system; however, Intuitive documents reveal that its sales reps were very close to the process, presenting themselves as da Vinci experts, and working toward reduced standards so that training could be eased for busy surgeons, all to increase use of the da Vinci and its sales, according to a recent The New York Times report.
Earlier this year, we wrote that Intuitive Surgical was mandated to face claims that it marketed the da Vinci to physicians without providing appropriate training, according to a judge’s ruling, said Bloomberg News previously. That case was brought over a patient’s death following prostate surgery in which the da Vinci surgical system was used, according to court filings. The family accused Intuitive of failing to adequately train doctors on the da Vinci system and of pushing unsupervised surgeries too quickly, among other issues.