Women across the country are suffering injuries and complications following hysterectomy surgeries that were performed using the controversial da Vinci surgical robot designed, manufactured and sold by Intuitive Surgical. A hysterectomy is the surgical removal of the uterus, and surgical robots like the da Vinci Surgical System have become widely used for hysterectomy procedures in hospitals across the United States. However, serious concerns have been raised about the safety of these robotic medical devices, particularly in connection to complications like burn injuries, accidental incisions and wrongful death. If you or a loved one has suffered serious side effects while undergoing robotic surgery with da Vinci, contact an experienced product liability lawyer to explore your possible compensation options.
Since the da Vinci Surgical System was first introduced, the surgical robot has been implicated in one controversy after another, and research has shown that robotic surgery is no better than alternative surgical methods, is more expensive, and may expose patients to a greater risk of injury. For women looking for a safer and less risky alternative to robotic surgery for hysterectomies and other gynecological procedures, the following surgery options may be available:
The da Vinci Surgical System is a multi-armed surgical robot first approved by the U.S. Food and Drug Administration (FDA) in 2000, and used in thousands of procedures in hospitals across the country, including hysterectomies and prostatectomies. The robot is operated by a surgeon using hand controls and monitoring the procedure from a computer screen, an innovative design that allows surgeons to perform delicate procedures in hard-to-reach places, including hysterectomies and prostate operations, without having to open the abdomen. However, opponents of the da Vinci Surgical System argue that the robot is no safer or more beneficial than conventional methods, like laparoscopic surgery, and may even be more dangerous, either because surgeons aren’t properly trained to use the robot, or because of unanticipated system malfunctions.
All surgical procedures come with a potential risk of complications, but research has shown that the da Vinci surgical robot may expose patients to a greater risk of injury, and some patients who undergo hysterectomies or other procedures using the da Vinci Surgical System may suffer severe side effects that require additional surgeries, some of which may be fatal. Among the complications allegedly linked to the da Vinci surgical robot are:
The da Vinci Surgical System has been plagued by reports of serious patient injuries and numerous recalls by the FDA, and as Beth Israel Deaconess Medical Center Chief Executive Paul Levy told the Wall Street Journal, “There’s a medical arms race. Technologies are being adopted and becoming widespread based on the marketing prowess of equipment makers and suppliers, not necessarily on the public good.” In 2013, researchers from Johns Hopkins published a study highlighting thousands of incidents involving the da Vinci Surgical System that occurred between January 2000 and August 2012, among then several fatalities and injuries, and additional studies published in the years since have detailed similar problems.
Patients and doctors across the country who have experience with the da Vinci Surgical System are reporting serious complications associated with the surgical robot, and while the da Vinci Surgical System generated $256 million in sales during the first quarter of 2013, sales fell to $106 million during the first quarter of 2014. At the same time, Intuitive Surgical faces a growing number of product liability lawsuits filed on behalf of patients who suffered serious injuries while undergoing a surgical procedure with the da Vinci system, including burn injuries, tears, accidental incisions, and even wrongful death.
March 2009 – A Washington woman undergoes a routine surgical procedure with the da Vinci surgical robot to treat endometriosis and suffers a torn colon and rectum. She is hospitalized, requires multiple corrective surgeries and receives a temporary colostomy as a result of the injuries. She files a product liability lawsuit against Intuitive Surgical, and the medical device maker settles the case in May 2012.
April 2012 – The father of a 24-year-old woman files a wrongful death claim against Intuitive Surgical, after his daughter dies from internal bleeding allegedly caused by the da Vinci surgical robot. The deceased went in for a routine hysterectomy and died 13 days later, after a main artery was lacerated during surgery.
July 2013 – Intuitive Surgical files a report with the Securities and Exchange Commission, indicating that the company is facing at least 26 da Vinci surgery lawsuits.
March 2014 – Intuitive Surgical faces a da Vinci surgery lawsuit filed by a woman and her husband, after the woman undergoes surgery with the da Vinci Surgical System and suffers “bowel perforation and/or thermal burns and subsequent infections that caused severe and permanent injuries.”
October 2014 – A malpractice lawsuit is filed by a woman who suffered debilitating pain for months after her surgeon left a piece of a surgical robot inside her abdominal cavity.
March 2013 – The FDA has received as many as 4,600 reports of adverse events associated with the da Vinci Surgical System, including reports of severe injuries and deaths.
May 2013 – Intuitive Surgical issues an “Urgent Medical Device Notification” warning doctors and hospitals about burns and electrocution injuries possibly caused by the EndoWrist Monopolar Curved Scissors, or “Hot Shears.”
July 2013 – The FDA sends Intuitive Surgical a warning letter highlighting four separate federal violations related to the da Vinci Surgical System. All of the violations involve the company’s failure to notify the FDA about misleading information and faulty da Vinci equipment.
July 2013 – The FDA issues a Class II recall of 30 da Vinci surgical robots, indicating that the devices may not have been tested in accordance with federal safety standards.
December 2013 – The patient side manipulator on da Vinci Surgical Systems is recalled by the FDA, due to “reports of friction within certain instrument arms [that] can interrupt smooth instrument motion” and cause the instrument to stall momentarily.
April 2014 – A recall of the cannula, a tube used with the da Vinci surgical robot, is issued following at least 98 reports of damaged cannulae.
January 2015 – Vision Side Carts used in conjunction with the da Vinci Surgical System are recalled by the FDA, following reports that the caster wheel bolts may gradually unthread and cause the wheels to loosen.
February 2015 – The FDA issues a pair of Class II recalls for the EndoWrist One Vessel Sealer, which the agency warns may “exhibit interference in the back of the instrument grips due to manufacturing variability in some jaws.”
February 2015 – The FDA announces a public workshop to obtain information on the current opportunities and challenges related to the da Vinci Surgical System and other robot-assisted surgical devices.
April 2007 – A study published in the Canadian Journal of Urology highlights complications occurring during robotic-assisted prostatectomies, and finds that malfunctions occurred in nine out of 250 procedures.
September 2008 – The Journal of Endourology publishes a study indicating that “Critical malfunctions occurred in 0.4% of [da Vinci robotic surgery procedures]. The procedure was cancelled in 70% of these cases, converted to open procedures in 24%, and completed as pure laparoscopic prostatectomy in the remaining 6% of non-recoverable malfunctions.”
August 2009 – Research published in the journal Urology indicates that, from July 2005 to December 2008, mechanical failure occurred in 43 out of 1,797 surgeries conducted using da Vinci surgical robots at one hospital in Korea.
April 2010 – The Journal of Endourology publishes research finding that close to 60% of 176 surgeons who responded to a web-based survey reported experiencing mechanical failure of a surgical robot like the da Vinci system.
August 2010 – A study of robotic surgical systems published in the New England Journal of Medicine reports that the da Vinci Surgical System increases the cost of surgical procedures, demands more operating time, and requires extensive maintenance. The researchers also indicate that surgeons would have to conduct 150-200 procedures before being qualified to operate the da Vinci system.
February 2013 – A major study published in the Journal of the American Medical Association finds that robotic surgery for hysterectomy procedures is more costly, and offers no additional benefits, compared to conventional laparoscopic surgery.
March 2013 – The American College of Obstetricians and Gynecologists issues a statement warning women that robotic surgery isn’t the best, or the most cost-effective, minimally-invasive method for hysterectomy procedures.
March 2013 – A report by the New York Times suggests that sales representatives often pressure hospitals and doctors into using the machine, according to internal emails from Intuitive Surgical.
April 2013 – CNBC reports that “there are a growing number of complaints and lawsuits that allege complications and even deaths from the da Vinci surgery.”
June 2013 – A report by NBC News highlights a series of lawsuits filed against Intuitive Surgical over problems with the da Vinci Surgical System, including “microscopic cracks in the protective covers insulating some of the tools that da Vinci uses, which could possibly allow electricity to leak out and burn patients.”
August 2013 – The Journal of Healthcare Quality publishes a study suggesting that complications during da Vinci robotic surgery procedures are “vastly underreported” to the FDA.
July 2014 – Research finds that robotic surgery for bladder cancer is no more effective than laparoscopic surgery at reducing the risk of complications for patients.
August 2014 – JAMA Surgery publishes a study finding that patient safety risks were twice as high during the first few years the da Vinci surgical robot was on the market, suggesting a steep learning curve for the controversial medical device.
October 2014 – A study published in the medical journal Obstetrics & Gynecology indicates that robotic surgery actually costs more than traditional minimally-invasive surgery for removing ovaries and ovarian cysts, and is associated with more complications.
July 2015 – A study of adverse events submitted to the FDA over the course of 14 years, from January 2000 to December 2014, finds that the agency has received reports of 144 deaths and 1,391 patient injuries associated with the da Vinci Surgical System.
Intuitive Surgical has marketed its da Vinci Surgical System as the wave of the future, and since it was approved by the FDA in 2000, the surgical robot has been used in thousands of surgeries, including hysterectomies and prostatectomies. However, what Intuitive Surgical failed to report is the potential risk of serious complications associated with the da Vinci surgical robot, some of which may lead to wrongful death. As a result, patients and their families allegedly affected by da Vinci surgery complications are pursuing legal claims against Intuitive Surgical, alleging that the medical device maker:
As a consumer, it is very important to know your rights, especially when it comes to your medical care. More importantly, as a patient, you would like to think that every instrument your doctor uses to help heal patients is built by a scrupulous and ethical medical device company that thoroughly tests their products and pulls them out of operating rooms if there is any inclination of a defect. Unfortunately, this is not always the case. Medical device companies run trials and tests and make business decisions that are the best for their company and the greater good, but not for the good of every single person. Lawyers for da Vinci hysterectomy surgery lawsuits that allege surgical injuries like bladder incisions, uterus cuts, vaginal cuff dehiscence, bowel injuries, intestinal tears, intestinal cuts and intestinal burns are evaluating claims from around the country. These lawsuits are going to demand financial compensation for pain and suffering, medical bills, lost wages and other damages.