New York, New York (PRWEB) November 11, 2013
Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective drugs and medical devices, notes that, according to a Nov. 11 Bloomberg report, an increasing number of reported deaths, injuries and malfunctions linked to Intuitive Surgical’s da Vinci surgical robot may pressure hospitals to improve training for doctors who perform procedures using the $1.5 million device. This, the Bloomberg article relates, stems from an FDA survey of surgeons that suggests the “complex robot interface was a challenge to master and that physician training was inconsistent.”
At the same time, the U.S. Food and Drug Administration (FDA) received 3,697 adverse event reports for this year through Nov. 3, compared with 1,595 for all of 2012, an FDA official told Bloomberg.
“The FDA data reveals robot-assisted surgeries are resulting in an increase of adverse events. Intuitive Surgical—as well as the hospitals—should consider this as a call to reevaluate current da Vinci training procedures,” says Gary P. Falkowitz, a Managing Attorney at Parker Waichman LLP. “And more importantly, from a patient perspective, it is essential that those undergoing robotic surgery carefully weigh the benefits and risks associated with this type of surgery.”
The doctor survey, released by the FDA on Nov. 8, included 11 surgeons, each of whom has performed between 70 and 600 robot surgeries, Bloomberg reported, noting that the physicians, who weren’t identified, reported the robots have brought about a diverse range of patient problems, including reversible limb palsy, temporary nerve damage, perforated bowels, and peripheral vision loss.
Intuitive has faced scrutiny this year over the marketing, quality and safety of its robots. The company received an FDA warning letter on July 16 after an inspection found it hadn’t adequately reported adverse events and device corrections. Also, an Oct. 8 Bloomberg report noted that aggressive marketing tactics by Intuitive Surgical, as well as doctors and hospitals seeking to build their robotic surgery practice, were mainly behind the rising use of robotic surgery. Tactics employed, the article added, include advertising that inflates the advantages of robotic surgery by claiming it results in fewer complications—without offering proof.
Parker Waichman LLP continues to offer free legal consultations to victims of injuries allegedly caused by the da Vinci surgical robot. If you or a loved one experienced surgical burns, perforated or torn organs, torn blood vessels or other injuries that could be associated with the da Vinci surgical robot, please contact their office by visiting the firm's da Vinci Surgical Robot Lawsuit page at yourlawyer.com. Free case evaluations are also available by calling 1 800 LAW INFO (1-800-529-4636).
Parker Waichman LLP
Gary Falkowitz, Managing Attorney