U.K. Lacks Oversight of Potentially Risky Robot Surgery

After a recent study by Johns Hopkins University found more injuries and deaths linked to da Vinci robotic surgery than were previously reported, the Daily Mail voiced concern about growing robotic surgeries in the United Kingdom. An October 21, 2013 article in the UK-based publication noted the pros and cons of the new technology, stating that though many patients are being asked to subject themselves to robotic surgery, some experts are far from convinced that robotic surgery offers the benefits often touted in the manufacturer’s marketing materials.

Increasing Popularity of Robotic Surgery

The FDA approved the da Vinci Robot in 2000 for use in urologic, laparoscopic, gynecologic, and non-cardiovascular thoracoscopic surgical procedures. The surgeon operates the system, which includes four mechanical arms, from a nearby console with a 3D video screen. Manufacturer Intuitive Surgical has advertised the system as being more accurate than the human hand. Patients are told they’re likely to have smaller incisions, faster recovery time, and less scarring.

Over the past several years, the number of da Vinci robots in hospitals has grown, despite some concerns about lack of physician training and the resulting safety risk to patients. Now, the same thing is happening in the U.K., as robots perform more and more operations in British hospitals.

Injuries Associated with the da Vinci Robot

Many patients have reportedly made out great with robotic surgery, experiencing the benefits promised by the technology. Others, however, have allegedly suffered serious complications, including organ perforation, torn ureters, infections, and even death, and Intuitive Surgical is now defending a number of lawsuits across the country. Plaintiffs typically claim the company failed to provide adequate warnings about the risks associated with the da Vinci Robot, and that in some cases, the technology was allegedly defective.

Similar stories are now starting to circulate in the U.K. According to the Daily Mail, a man in the Northeast suffered grievous injuries from a robotic procedure that nearly killed him. He went through surgery to remove his prostate, which is a common procedure for which the robot is used. He alleges that the remote camera attached to the robot arm damaged his bowel, leading to “severe infection, organ failure and cardiac arrest.”

In the U.S., the robot has been linked to at least 70 deaths since 2009.

Study Questions Widespread Use of Robotic Surgery

Alarmed by the uptick in reported problems with the robot, the FDA started surveying physicians earlier this year to gain answers about the technology’s strengths and weaknesses. A March 2012 study published in the Journal of Clinical Oncology found that women treated for endometrial cancer with a hysterectomy experienced no additional benefits when the da Vinci was used compared to traditional surgery.

“Despite claims of decreased complications with robotic hysterectomy,” the researchers said, “we found similar morbidity but increased cost compared with laparoscopic hysterectomy. Comparative long-term efficacy data are needed to justify its widespread use.”

Meanwhile, the Daily Mail notes that in Britain there is no readily available database to keep track of any problems occurring with robotic surgery, “due to the fact no official body is taking responsibility for overseeing the safety of this technology or monitoring its effectiveness.”

The manufacture notes that more than 20 hospitals in the U.K. now have da Vinci robots, but the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) does not have regulation responsibility for the machines. The Royal College of Surgeons added that they don’t run training courses on the robot because “the equipment is so expensive.”