da Vinci Controversy Spreads to Great Britain

The controversy surrounding risks tied to robotic surgery systems, specifically with the da Vinci robot, are being seen in the United Kingdom.

The da Vinci was cleared for use in 2000 in the United States by the U.S. Food and Drug Administration (FDA). Now, use of the multi-million dollar systems is mounting in Great Britain, according to The Daily Mail. The British paper reports that experts are concerned about the da Vinci robot’s safety and efficacy.

In its report, The Daily Mail sited one U.S. case that involved a male patient who underwent a prostatectomy and suffered bowel damage, a serious infection, organ failure, and cardiac arrest. The man remained in the intensive care unit and went through months of rehabilitation. Although it seemed as if he had fully recovered, he had to return to the hospital and was re-admitted with more serious issues allegedly tied to the da Vinci. His injuries are now the focus of a personal injury lawsuit, which is just one of about 26 other legal filings involving allegations of blood vessel or organ perforation, serious bowel injuries, and sepsis, according to The Daily Mail.

The da Vinci robot is also believed to be the culprit in about 70 fatalities reported to U.S. regulators since 2008, a prior Bloomberg News report indicated, according to The Daily Mail. Since January 2012, some 500 da Vinci-related problems have been reported to U.S. federal regulators, including that the device’s electrical currents arc—or jump—from the robot back into the patient.

Electrical current issues are also being blamed in another case brought by a 45-year-old New Jersey woman who alleges that the da Vinci’s random arcing left her in chronic abdominal pain and with severe bowel injuries, The Daily Mail reported. The lawsuit also includes allegations that Intuitive Surgical knew about the arcing issues.

Many experts have complained that Intuitive’s training on the da Vinci is not thorough, that the systems do not always reduce complication rates, and that da Vinci surgeries may raise certain post-procedure risks. U.K. health regulators are looking at da Vinci issues in the U.S. where 367,000 procedures were conducted last year, according to The Daily Mail. Intuitive Surgical indicated that, as of September 2012, more than 20 hospitals in the U.K. and Ireland are using the da Vinci systems.

The way in which robotic surgery is marketed has been tied to mounting injury reports, according to a new article highlighted by Bloomberg.com. Robot surgeries have never been proven in randomized trials to offer significantly improved health outcomes when compared to standard surgeries, Bloomberg.com reported. Also, several studies have found that robot surgeries are significantly more expensive than traditional surgical options.

Intuitive Surgical bas been faulted for its insufficient training and its aggressive marketing practices. “If there was a Nobel Prize for marketing, it would go to Intuitive Surgical,” John Mulhall, an urologist at Memorial Sloan-Kettering Cancer Center in Manhattan, told Bloomberg.com recently.

A 2012 Columbia University study revealed that 44 percent of hospital websites pushed robot gynecology surgery, yet only 1.6 percent discussed potential complications. Websites for hospitals that conduct robotic prostate surgery for erectile dysfunction have often have included unproven claims of robotic surgery superiority, according to a Memorial Sloan-Kettering study. Many sites also include “generic information copied directly from the web site of Intuitive Surgical,” the 2010 study also found, Bloomberg.com wrote.

A 2011 study published in the Journal for Healthcare Quality, and conducted by Johns Hopkins School of Medicine researchers found that 164 hospital robot surgery websites surveyed “overestimate benefits, largely ignore risks, and are strongly influenced by the manufacturer,” Bloomberg.com reported.