What Is the Da Vinci Surgery System?
In July of 2000, the FDA approved the Da Vinci Surgery System for use in hysterectomy procedures. The system is a four armed robot that has a small camera which allows the physician to perform surgery using a joystick-like console.
The device is manufactured and marketed by Intuitive Surgical, Inc. whose website claims that the device “enables your surgeon to operate with enhanced vision, precision, dexterity and control.”
Is the Da Vinci Surgery System Effective?
The American Congress of Obstetricians and Gynecologists (ACOG) recently issued a statement concluding that there is little evidence to suggest that robotic surgery is as effective as other methods of performing hysterectomy.
Barbara Levy, vice president for health and policy at ACOG indicated that some 600,000 hysterectomies are performed each year in the United States. Regulatory filings show that almost a third of those hysterectomies were performed with surgical robots last year.
Why Do Hospitals Use the Da Vinci Surgery System?
The device costs hospitals between $1 million and $2 million plus an additional $140,000 per year in average annual maintenance. According to documents and testimony from prior salespeople, Intuitive aggressively marketed this product to physicians and hospitals. Emails obtained by CNBC news demonstrate that salespeople were prodding surgeons to “convert” non-robotic surgeries to robotic ones and persuading hospitals to lower the amount of supervised surgeries required before surgeons can use the technology on their own. Ultimately, the sales strategy of Intuitive Surgical Inc., was to link the financial stability of the hospital to the purchase and use of its product. According to the report by CNBC, one salesperson stated:
“We would go to hospitals in a local geography and get docs to pledge they would take business away to other hospitals if their hospital didn’t get the robot.”
These aggressive marketing tactics amount to a manufactured “medical arms race” in any given geography by Intuitive’s sales team. Even more alarming than this marketing strategy is the mounting evidence that the training for surgeons on the Da Vinci robot is woefully inadequate leading to severe injuries and even death in what is normally a routine procedure. Despite a consensus in the medical community that a surgeon should perform 200 supervised surgeries before performing these procedures alone, the company provides two days of education on the use of the device and only 4 supervised surgeries per surgeon.
What Are the Risks Associated with Da Vinci Surgery System?
In addition to the aggressive marketing and inadequate surgical training provided by Intuitive, many experts now claim that the company failed to properly research the device prior to seeking approval from the FDA and failed to adequately warn of its inherent dangers. Others claim there are inherent design flaws in the device including its use of monopolar energy which has led to significant burn injuries in patients. In March of this year the FDA launched an investigation into the safety of the device due to an alarmingly high number of adverse events reported with the procedures.
Over the past three years several disturbing trends have become apparent relative to the Da Vinci system. Several patients have reported serious and even life-threatening injuries following Da Vinci Hysterectomy procedures including:
- Surgical burns of arteries and/or organs
- Punctured or severed arteries and/or organs
- Punctured or cut uteruses
- Severe bowel, bladder or kidney injuries
- Sepsis, peritonitis and other systemic infections
I’ve Had Complications Due to a Hysterectomy Procedure. What Now?
Ashcraft & Gerel, LLP is investigating the safety of the Da Vinci Surgical System and has concluded that many individuals are being needlessly injured by the device and the untrained surgeons using the device. One of the most frightening aspects of these cases is that most patients don’t realize their injured until days or even months after they leave the hospital. If you or a loved one has been injured during a Da Vinci Hysterectomy before May 2013, please contact us online or call 800-829-7037 for a free, confidential evaluation of your claim. Please be aware that claims must be filed in a timely fashion or you may lose your legal rights.
At Ashcraft & Gerel, we consider referrals from one lawyer to another to be the highest compliment. We have handled complex medical device and malpractice litigations for decades as referral partners to other law firms. If you have Da Vinci Hysterectomy clients to refer to us please call us at 800-829-7037.