Da Vinci Hysterectomy Surgery
On June 18, 2013, MSN News published a report on a California woman who, when she opted for robotic hysterectomy surgery, was promised less pain, bleeding, and discomfort. Instead, she experienced serious injuries and had to go through emergency corrective surgery.
Approved by the FDA in 2000, Da Vinci robotic surgery is now used in many hospitals across the nation for surgeries like hysterectomies. Manufacturer Intuitive Surgical states the Da Vinci robot allows faster recoveries and smaller scars for patients.
Post-marketing reports, however, reveal that some patients have suffered serious injuries during and after robotic surgery. California resident Michelle Zarick is one of them. During her recovery period, she “felt something pop” while in the restroom, and later saw a portion of her small bowel spill out. After emergency corrective surgery, she was left with physical and emotional scars. She filed a da Vinci robot lawsuit in December 2012 in an attempt to recover damages.
Da Vinci hysterectomy
According to the Intuitive Surgical website, women facing a hysterectomy today have a “state-of-the-art minimally invasive surgical option—Da Vinci hysterectomy.”
The da Vinci robot features a magnified 3D high-definition vision system and four robotic arms that are operated by the surgeon. These arms are advertised as having special wristed instruments “that bend and rotate far greater than the human wrist.”
“As a result,” Intuitive Surgical says on their site, “DaVinci enables your surgeon to operate with enhanced vision, precision, dexterity and control.”
The robot translates the hand movements of the surgeon into smaller, more precise movements of the instruments working inside the human body. For a hysterectomy—an operation in which all or part of a woman’s uterus is surgically removed—the surgeon operates the surgical arms and wrists to perform a minimally invasive operation.
While the patient lies on the patient cart, to which are attached the robotic arms, the surgeon operates from an ergonomically designed console to control the robot’s movements. He watches everything, including the robot’s movements and the results on the patient’s body, through a high-resolution viewer located at the console.
Pros of daVinci hysterectomy
Intuitive Surgical advertises that use of DaVinci in hysterectomy surgery provides benefits such as:
- Smaller incisions
- Smaller, less noticeable scarring
- Enhanced surgical vision, precision, dexterity, and control
- Fewer complications
- Less pain
- Less blood loss
- Lower risk of infection
- Shorter hospital stay
- Shorter recovery period
Whereas a hysterectomy is typically performed through a large abdominal incision, da Vinci allows the doctor to remove the uterus via smaller incisions.
Studies on da Vinci surgery
While Intuitive Surgical has many of their own clinical studies establishing the safety and efficacy of robotic surgery, other studies have produced conflicting results. In 2011, for example, the Journal of Clinical Oncology published research comparing Da Vinci hysterectomy surgery to regular laparoscopic hysterectomy. Scientists concluded that despite claims of decreased complications with robotic hysterectomy, study results showed similar outcomes for both types of surgery.
“Comparative long-term efficacy data are needed to justify its widespread use,” the researchers said.
Other studies have found that robotic surgery for hysterectomy can result in serious injuries. In 2009 for instance, researchers reviewed two cases of vaginal cuff dehiscence—a rare but serious complication in which the vaginal incision separates after hysterectomy. Once the vaginal incision has separated, women are at risk of losing abdominal or pelvic contents out through the vaginal opening, as in the case of Michelle Zarick. Though the researchers expressed the need for further observation, they also observed that the condition “may be occurring more frequently with the advent of robotic laparoscopic hysterectomies.”
Recommendations against using DaVinci robot in hysterectomy procedures
In March 2013, the American Congress of Obstetricians and Gynecologist made a statement concerning robotic hysterectomy. “Expertise with robotic hysterectomy surgery is limited,” they wrote, “and varies widely among both hospitals and surgeons. While there may be some advantages to the use of robotics in complex hysterectomies, especially for cancer operations…studies have shown that adding this expensive technology for routine surgical care does not improve patient outcomes.”
They added that there is no good data proving that having a hysterectomy performed using the machine is any better or even as good as existing alternatives.
Meanwhile, the FDA has announced that it is investigating complications, outcomes, and dangers associated with robotic surgery, in response to the increasing number of adverse event reports—five of which involved the death of the patient.
Other potential complications linked to DaVinci hysterectomy include:
- Bladder injuries
- Tears and/or burns of the intestines or other organs
- Peritonitis (painful inflammation of the lining of the abdomen)
- Punctured or cut ureters
- Excessive bleeding
- Punctured blood vessels
- Severe bowel injuries
- The need for additional surgical procedures
- Death
Considering a DaVinci hysterectomy lawsuit
Women who have been seriously injured by a da Vinci robot used in their hysterectomy may be eligible to file a lawsuit. Those who have already done so claim Intuitive Surgical overpromoted the benefits of the machine while downplaying the potential risks. They add that the company did not provide adequate warnings about the potential injuries that could occur during surgery. Plaintiffs further allege that Intuitive Surgical failed to provide adequate physician training on the device.
Approximately 25 DaVinci lawsuits have been filed around the country against Intuitive Surgical. Included in this number are women whose hysterectomies were botched in some way due to the robot. Plaintiff Gilmore McCalla, for example, had a 24-year-old daughter who had a DaVinci hysterectomy as part of her cancer treatment in a Bronx hospital in 2010. She died two weeks later from complications. According to her lawsuit, the robot allegedly burned her artery and intestines.
Resources
- MSN, Is robotic surgery safe? Lawsuits bring more scrutiny, http://news.msn.com/science-technology/is-robotic-surgery-safe
- Da Vinci Surgery, Minimally Invasive Robotic Surgery with the da Vinci Surgical System, http://www.davincisurgery.com/da-vinci-gynecology/da-vinci-procedures/hysterectomy/
- WebMD, Hysterectomy—What Is a Hysterectomy? Why Is a Hysterectomy Performed? http://women.webmd.com/guide/hysterectomy
- Da Vinci Hysterectomy, http://www.davincihysterectomy.com/
- Intuitive Surgical, Da Vinci hysterectomy patient brochure, http://www.uamshealth.com/upload/docs/Clinics/Surgery/Hysterectomy-patient-educational.pdf
- Journal of Clinical Oncology, Comparative Effectiveness of Robotic Versus Laparoscopic Hysterectomy for Endometrial Cancer, http://jco.ascopubs.org/content/30/8/783.full
- UpToDate, Vaginal Cuff Dehiscence After Robotic Total Laparoscopic Hysterectomy, http://www.uptodate.com/contents/vaginal-cuff-dehiscence-after-hysterectomy
- UpToDate, Vaginal cuff dehiscence after hysterectomy, http://www.uptodate.com/contents/vaginal-cuff-dehiscence-after-hysterectomy
- FierceHealthIT, OB/GYN group: Robotic surgery not the best choice for routine hysterectomies, http://www.fiercehealthit.com/story/obgyn-group-robotic-surgery-not-best-choice-routine-hysterectomies/2013-03-15
- NY Daily News, Surgical robot da Vinci scrutinized by FDA after deaths, other surgical nightmares, http://www.nydailynews.com/life-style/health/surgical-robot-scrutinized-fda-deaths-nightmares-article-1.1311447
- NIH Public Access, Vaginal Cuff Dehiscence After Robotic Total Laparoscopic Hysterectomy, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2896382/