Doctors are calling robotic surgery “the latest, greatest” minimally invasive technique available. But multiple lawsuits and recent inquiry from the U.S. Food and Drug Administration have cast a shadow over one of the fastest-growing medical technologies — and Intuitive Surgical, which dominates the field. Bloomberg Businessweek reports.
The California-based company received most of its $2.2 billion in revenue in 2012 from its da Vinci Surgical System, with its robot arms and joints designed to mimic natural hand movements (pictured).
In robo-surgery, a doctor peers into a video game-style console (pictured below) several feet from the patient. Foot pedals and hand controls allow the physician, guided by a 3D camera, to maneuver mechanical arms equipped with surgical tools.
The $1.5 million machines were used in 367,000 procedures in the U.S. in 2012, boosting Intuitive’s stock market value 83 percent in the last three years to about $23.2 billion.
But in addition to the high price, critics say there aren’t enough large, controlled trials that show clear long-term benefits. According to a study published last month, robotic uterus removal costs 33 percent more than standard minimally invasive hysterectomies, without lowering the complication rate.
In the past 14 months, at least 10 lawsuits have been filed that stem from serious (and just horrible) complications involving Intuitive’s robots.
And in January, the FDA sent surveys out to surgeons about the safety of Intuitive’s robo-surgery gear – hoping to determine if a rise in reported mishaps is a real reflection of problems.
One early warming system for medical device safety is the adverse event report: self-reported filings from from doctors and patients. A review of these reports shows:
- Reported injuries involving procedures done using Intuitive machines jumped to at least 115 in 2012, from 24 in 2009.
- Deaths rose to 30 from 11.
- The robots have been linked to at least 70 deaths since 2009. (But remember, this doesn’t necessarily mean the robots caused the deaths.)
The original prototype was developed under a U.S. Army contract in the 1980s to build a system for remote-controlled battlefield surgery. The company’s products remain the only robotic systems approved in the U.S. for procedures such as general surgery, gynecological surgery, and prostate operations.
[From Bloomberg Businessweek]
Images: Intuitive Surgical