Surgical robots have been linked to serious side effects such as burns, punctures, tears, and sepsis, among others. We are currently working with some of the more experienced da Vinci Robot Surgery attorneys in the country who are filing lawsuits for these injuries. And, there are no legal fees until you obtain a settlement or award. Please call us toll-free or fill out an online contact form.
A growing number of hospitals in the United States are performing operations with robots. The first operation using such a device was performed in 1985 by the PUMA 560. In recent years another device has increased in popularity, the da Vinci Surgical System. The FDA approved it for sale on the market in 2000 by its manufacturer, Intuitive Surgical. It has four arms which allow doctors to perform surgery by looking at a screen and controlling the arms. Three arms hold instruments, while the fourth arm holds a camera. According to the product’s website, it has been used to treat a variety of conditions, including:
- Cancer: including bladder, colorectal, gynecologic, kidney, lung, prostate, and throat cancer
- Heavy uterine bleeding
- Kidney disorders
- Mitral valve prolapse
- Uterine fibroids and prolapse
This device has also been used in bypass procedures as well as in hysterectomy and prostatectomy procedures. It has been promoted as being less invasive and more precise than open surgery and other types of minimally invasive surgery. The company also highlights the fact that patients have shorter recovery times. Its website states, “Imagine experiencing much less pain, a shorter hospital stay, faster return to normal activities and the potential for better clinical outcomes” (i). One video even shows the device peeling the skin off of a grape.
The da Vinci System is not without dangers. The System has not been recalled but there is a growing number of complications being reported to the FDA. A recent examination of the FDA’s Manufacturer and User Facility Experience (MAUDE) database revealed that there were 211 reports in 2011 and 282 reports in 2012. Additionally, within the first 3 months of 2013 62 MAUDE reports were received by the FDA (ii). A recent NBC News article reported that a series of lawsuits have been filed alleging that the da Vinci System’s insulation can crack allowing electrical currents to cause burns to the patient. Another concern expressed by doctors and medical studies is that the System requires a lot of practice and some cases have alleged that a doctor’s inexperience caused serious injury and even death.
Complications and Injuries Associated with da Vinci Surgeries
Lawsuits and news reports have provided details on the injuries that robot surgery complications may cause, including:
- Peritonitis (inflammation of the abdominal lining)
- Burns, punctures, and tears of tissue and organs
- Punctured blood vessels
- Excessive bleeding
- Intestine injury
- Bowel injury
- Vaginal cuff dehiscence
- Severed uterers
If you have suffered any of these or another injury, then you should talk to a surgery lawyer, who can provide you with important personal and legal advice. An attorney can file a lawsuit on your behalf and there are no legal fees until you receive a settlement.
Intuitive Surgical Issues “Urgent Medical Device Notification”
On May 8, 2013, Intuitive sent its da Vinci customers a letter warning that it had “identified a potential issue with certain versions of its Hot Shears Monopolar Curved Scissors (MCS).” The company stated that “MCS instruments may develop micro-cracks… This may create a pathway for electrosurgical energy to leak during use and potentially cause thermal injury.” This means that cracks in the instrument may allow electricity to leak causing burns. This possible defect can be very serious especially when the burns affect internal organs. The company also warned that the “micro-cracks may not be visible to the user.” This means that a doctor may not discover the dangerous condition until after a patient is injured. Click here to view the letter. This is not the first time the MCS instrument has experienced problems, in August 2012 its tip covers were recalled by the company.
This letter validates the findings of an earlier medical study published by the American Journal of Obstetrics & Gynecology in August 2011. The study tested robotic and laparoscopic instruments at different voltages. It found that robotic instruments had a higher incidence of insulation failure than laparoscopic instruments, especially at high voltages (iii). It has been alleged that these possible insulation defects have caused holes to be burned in patients’ organs leading to death.
Medical Studies Reveal that Robot-Assisted Surgery May Increase Costs
One issue that several studies have addressed is the cost of these types of surgeries. The initial cost of a da Vinci Surgical System can range anywhere from about $1.3 million to $2.6 million. This cost increases when you consider training doctors to use it and maintaining the machine. In May 2010, the Wall Street Journal reported that a hospital needs to use the device in 520 surgeries every year in order to keep the cost comparable to traditional surgery (iv). According, to an article published by the New England Journal of Medicine in August 2010, the additional total cost of having a robot-assisted surgery was about $3,200 (v). Additionally, Dr. Ezekiel Emanual, a former White House advisor, wrote in The New York Times that the device “increases costs without improving patient’s health.” Click here to see his editorial. Most recently, in February 2013, the Journal of the American Medical Association published a study which followed 264,758 women who underwent hysterectomies. It found that using a device increased the average cost of surgery by $2,189 (vi). Even though these surgical systems are costly for hospitals, the medical field has seen an increase in their use. In 2012, Intuitive earned $933 million from selling surgical systems, $903 million selling instruments and accessories, and $343 million from its annual service agreements. In the same year, approximately 450,000 surgeries used this machine showing a 25% increase in use from 2011 (vii).
Allegations of Medical Malpractice in Robot-Assisted Surgeries
In addition to product liability lawsuits, these devices have given rise to medical malpractice lawsuits. It has been alleged that patients have been injured by such medical negligence because there are no standardized training requirements for the device and it has a steep learning curve. Dr. Jim Hu, a surgeon at Brigham and Women’s Hospital, said that it can take urologists anywhere from 250 to 700 surgeries to master using these surgical systems (viii). Additionally, in August, Obstetrics & Gynecology published a study that reported 21 out 510 patients who underwent a robot-assisted surgery suffered vaginal cuff dehiscence (ix). According to Bloomberg, between 2009 and 2013 government agencies received reports that surgical robots had been involved in 70 deaths. View the article here.
da Vinci Lawsuits
Surgical robot lawsuits have been filed against Intuitive, hospitals, and doctors. For example, on September 9, 2008, Fred Taylor suffered severe injuries after undergoing a prostatectomy using the da Vinci Robot. During the procedure a number of complications arose causing it to last more than 13 hours. Mr. Taylor survived the incident but became incontinent needing a colostomy bag. It also led to kidney damage, lung damage, sepsis, stoke, and death. His wife has since filed a lawsuit against Intuitive. The New York Times has followed this story and also uncovered aggressive marketing tactics by the company. A March 25, 2013 article gave the details of company e-mails, which stated “Don’t let proctoring or credentialing get in our way” and “Be prepared to challenge each trained surgeon every time you see a lap or open [surgery]. Be unsatisfied with the thought of ending a day without a converted case.” The article stated that sales directors at the company encouraged doctors to use the robot device even though they lacked experience with it. Click here to view the article.
In another lawsuit, Michelle Zarick alleged that she underwent a hysterectomy on February 2, 2009. Several weeks after the procedure she felt something “pop” when she was using the bathroom and saw her intestine protruding from her body. She now has a scar across her waist from corrective surgery. She alleges that her injuries were caused by the da Vinci device. On March 2, 2009, a doctor at Wentworth-Douglass Hospital accidentally cut Sherry Long’s ureters, which are the tubes connecting the kidneys to the bladder, using a similar device. This medical mistake required her to undergo four additional surgeries over a period of 8 months in order to correct the mistake. She filed a lawsuit alleging that her injuries were a result of her surgeon’s lack of training.
In August 2010, 24-year-old Kimberley McCalla died at Montefiore Medical Center after undergoing robot surgery to treat her cervical cancer. The doctor lacerated her iliac artery using the da Vinci System. Her father filed a lawsuit alleging a design defect, inadequate insulation causing electrical burns. And, in February 2012, a jury returned a $7.5 million award for the family of Juan Fernandez, a 49 year-old man, who died from punctures two his small intestine caused by doctors using a similar system (x). Most recently, on April 30, 2013, a lawsuit was on behalf of 17 plaintiffs who are seeking $1.2 billion. They allege that Intuitive has misrepresented the safety of the da Vinci Robot and failed to warn patients about its risks. They also claim that the device has shut down in the middle of surgery. View the article here.
Do You Need Legal Advice Regarding Your Robotic Surgery Injuries?
If you or a loved one has been injured while undergoing a robot-assisted surgery, then you should talk to a personal injury lawyer. Our law firm works with some of the more experienced da Vinci attorneys in the country who can file a lawsuit on your behalf. There is no legal fee until you receive a settlement or award for your da Vinci injuries. Contact us toll-free at 1-800-992-6878 or fill out an online contact form.
- (i) Product Webpage.
- (ii) Medscape Medical News, April 30, 2013.
- (iii) American Journal of Obstetics & Gynecology, August 2011.
- (iv) The Wall Street Journal, May 4, 2010.
- (v) The New England Journal of Medicine, August 19, 2010.
- (vi) Journal of the American Medical Association, February 20, 2013.
- (vii) Investor Presentation, Accessed July 5, 2013.
- (viii) The Wall Street Journal, May 4, 2010.
- (ix) Obstetrics & Gynecology, August 2009.
- (x) Chicago Tribune, February 25, 2012.