|Intuitive Surgical is facing scrutiny over its da Vinci surgical robot.--Courtesy of Intuitive Surgical|
Amid damning concern from doctors and the FDA, Intuitive Surgical ($ISRG) is dealing with at least 10 lawsuits filed by patients who suffered complications during robotic surgeries.
As Bloomberg reports, all 10 cropped up in the last 14 months, with plaintiffs claiming injury from Intuitive's da Vinci robotic system, designed for soft-tissue procedures like gynecological surgery. The devices have been linked to at least 70 deaths since 2009, Bloomberg notes, and the threat of costly litigation is only the latest bit of woe for Intuitive.
Last week, a large-scale study in the Journal of the American Medical Association concluded that using Intuitive's system does little more than pad the cost of surgery, adding $2,200 to the procedure price without making a significant difference for patients. Now the FDA is getting involved, surveying hospitals on complications, outcomes and dangers with da Vinci in response to an increase in adverse event reports, including organ damage and device failure.
Intuitive isn't commenting on the litigation, but the company maintains that da Vinci is safe and that the number of adverse event reports is small compared to how many procedures the robot has under its belt.
But that might not be enough for the FDA, which is concerned that robotic surgery is becoming overused. With the promise of less-invasive surgery and reduced scarring risk, surgical robots have taken the market by storm over the past few years, and Intuitive leads the pack of companies cashing in, pulling in $2.2 billion in sales last year.
However, if the FDA demands a recall or scales back da Vinci's approved indications, Intuitive could take a serious revenue hit. And, if the reports of complications have increased as the FDA says, these likely won't be the last 10 lawsuits to land on the company's desk.
- read the Bloomberg story