Robotic Surgery Injuries Rising Faster than Actual Procedures
As U.S. hospitals experience a significant jump in number of surgeries using robots, like the Da Vinci Surgical Robot, with approximately 350,000 operations being performed last year (up 60 percent since 2010), doctors and Intuitive Surgical Inc., the company that manufactures the $1.5 million robots, are claiming that robot-assisted procedures carry fewer risks and are a safer alternative for patients than some tradtional procedures. These claims are being made despite a clear lack of evidence.
What data has been able to confirm is that these procedures tend to cost thousands of dollars more than more traditional alternatives and the adverse events associated with these devices are rising more rapidly than the procedures’ popularity.
Adverse Events Tied to Robot-Assisted Surgeries
- In February, Bloomberg reported on the FDA surveying surgeons about increases in the number of adverse events being reported in connection to robot-assisted surgeries with 70 deaths being attributed to robotic procedures since 2009.
- Even more alarming is that the number of injuries tied to robot-assisted surgeries seems to be rising at a much more rapid rate than the number of procedures being performed.
- Though the number of robotic surgeries is up by 60 percent from 2010, the number of injuries and complications reported over the first eight months of this year is more than double the number reported between January and August of last year.
- In July, the FDA issued a warning latter to manufacturers claiming that they had not properly acknowledge device corrections and adverse events to patients.
Doctors Ignore Potential Risks
- Despite growing numbers of injuries and a lack of evidence proving the efficacy of robot-assisted surgeries, doctors and hospitals continue to endorse these procedures to the point that they even neglect to mention less invasive alternatives.
- In 2010, Theresa Hershey, 41, suffered a penetrated bowel during a robot-assisted hysterectomy. The problem was discovered after she was hospitalized for 9 days due to agonizing abdominal pains.
- After 9 operations and incurring about $1 million in medical bills, Hershey plans to sue the hospital for malpractice after discovering her doctor failed to tell her about a much less invasive procedure in which a few small incisions are made and the doctor completes the surgery with a laparoscope.
- Similarly, a general surgeon, Warren Kortz, of Porter Adventist Hospital in Denver had is license to conduct robot-assisted procedures suspended following 14 counts of unprofessional conduct including failure to mention non-robotic alternatives.
- According to a complaint filed by the Colorado Medical Board, while Kortz was endorsing robotic procedures after completing a series of gall bladder removes, he failed to acknowledge 10 former patients who suffered from complications including:
- Punctured and torn arteries
- Objects being left inside after patients’ bodies after surgery
- Nerve damage
- A need for cardio pulmonary resuscitation
Conflicts with Medical Device Marketing
Since Bloomberg's February report, shares for Intuitive Surgical Inc. have fallen by 34 percent. As the manufacturer continues to make unfounded claims of safety, aggressively marketing its product to hospitals and surgeons, the FDA has begun to face criticism for its inability to properly regulate medical device advertising.
A 2011 study conducted by doctors with the John Hopkins School of Medicine concluded that 164 hospital robot-assisted surgery websites not only overestimated benefits of robotic procedures, but also neglected to adequately address patient risks due to strong manufacturer influence.
While the FDA currently has 60 people responsible for monitoring the advertising and marketing of pharmaceutical medication, there are only two individuals reviewing marketing for medical devices.
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