Recently the U.S. Food and Drug Administration (FDA) scrutinized the surgical robot following reports of death.
The high-tech robot is being used to operate on gallbladders, prostates, wombs, organ transplants, repairing heart valves, and even to shrink stomachs to achieve weight loss in patients. However, reports of problems ranging from sliced blood vessels to patients being hit in their face have been reported.
Surgeons claim there are many advantages to the da Vinci robot, including the ability to use small, robotic hands, free from shaking or tremors, while the surgeon sits at a computer just feet from the patient. The FDA is investigating problems, including death, possibly linked to robotic surgery.
The newest, innovative technology in operating rooms nowadays is a million-dollar, multi-armed robot named da Vinci, used in approximately 400,000 surgeries nationwide last year alone, which is three times the amount performed four years earlier.
Many strange incidents have been reported during operations using this robotic arm. In one case the robot’s hand would not let go of tissue it grasped during a surgical procedure. In another instance, it was reported that the robotic arm hit the patient in the face as she lay on the operating table.
Some surgeons say it is time to curb the use of the robot. They say the “wow” factor and aggressive advertising has increased the popularity of this new device. The doctors argue that not enough research supports that the robotic surgery is at least as good or better than conventional surgery.
Heavy marketing by U.S. hospitals to promote the robotic surgery in brochures, billboards, online, etc. is used to help defray the costly robot.
Advocates for the robotic arm say patients sometimes have less bleeding and the hospital stay is shorter than with conventional surgery, laparoscopic procedures and operations involving large incisions.
The FDA is investigating a spike in reported problems during robotic surgeries since there has been an increase in the number of reports received about da Vinci. Since early last year, there have been reports of five deaths. Whether there truly are more problems recently is not certain. FDA spokeswoman, Syrim Rivers said she couldn’t quantify the increase and it may simply reflect more awareness among doctors and hospitals about the need to report problems. Doctors are not required to report such things; device makers and hospitals are.
It could also reflect wider use. It was reported that 367,000 robotic surgeries were performed last year versus 114,000 performed in 2008, according to da Vinci’s maker, Intuitive Surgical Inc. of Sunnyvale, California.
Da Vinci is the company’s only product, and it is the only robotic system cleared for soft-tissue surgery by the FDA. Other robotic devices have been approved for neurosurgery and orthopedics.
After conducting a search for the company’s name in an FDA database, there were 500 reported problems related to medical devices since January 1, 2012. Many of these incidents came from Intuitive Surgical. However, some of the reports were from many years ago, some may have been reported more than once.
Some of the reports that were filed this year include:
- A woman who died during a hysterectomy in 2012 when the surgeon-controlled robot accidentally nicked a blood vessel.
- A Chicago man who died in 2007 after spleen surgery.
- A New York man whose colon was allegedly perforated during prostate surgery. DaVinci’s maker filed that report after seeing a newspaper article about it and said the doctor’s office declined to provide additional information.
- A robotic arm that wouldn’t let go of tissue it grasped during colorectal surgery on January 14, 2013. “We had to do a total system shutdown to get the grasper to open its jaws,” said the report filed by the hospital. The report said the patient was not injured.
- A robotic arm hit a patient in the face during a hysterectomy. The company filed that report, and said it’s unknown if the patient was injured but that the surgeon decided to switch to an open, more invasive operation instead.
An upcoming research paper suggests that problems linked with robotic surgery have been under reported. They include cases with “catastrophic complications,” said Dr. Martin Makary, a Johns Hopkins surgeon who co-authored the paper.
Almost 1,400 U.S. hospitals (nearly one out of four) have at least one da Vinci system. Each system cost about $1.45 million, with an additional $100,000 or more annual service agreements.
Makary led a study which was published in 2011 reporting that four in ten U.S. hospitals promoted robotic surgery on their websites; often worded by the manufacturers. Some of these claims promised exaggerated benefits and represented misleading, unproven claims, the study said.
Certain surgeries, such as head and neck cancer and rectal surgeries, require operating in small, difficult to reach areas. For these cases, surgeons prefer the robotic arm over conventional methods, Makary said. The robotic method is advantageous for weight loss surgery in extremely obese patients, whose girth can make conventional surgery challenging.
Last year a jury awarded $7.5 million to the family of Juan Fernandez. The Chicago man died in 2007 after receiving robotic spleen surgery. The surgeon accidentally punctured part of his intestines, leading to a fatal infection.
A 2010 New England Journal of Medicine article and a health policy reported that surgeons be required to perform at least 150 procedures to become proficient in using the robotic system. Despite performing the required number of cases, many freak accidents can occur when a robotic arm is used as a substitute for a live surgeon’s hands.
Would you entrust your life or the life of a loved one to a robot? Some say the promise of a small incision and minimal blood loss when compared to large scars and longer hospital stays are more attractive and worth the risk. The patients who lost their lives after the robot ripped through their intestines or were hit in the face by the metal arm would probably prefer having a larger scar and being here to talk about it.
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