New Study Highlights Da Vinci Robot Surgery Complications
A new study published August 27 in the Journal for Healthcare Quality suggests there have been more da Vinci robot surgery complications than previously believed. Study co-author Martin Makary, and his team reviewed the FDA adverse events database for the time period of January 1, 2000 to August 1, 2012, and discovered reports of 245 da Vinci robot surgical complications out of approximately 1,000 surgeries performed. This includes 71 deaths. Hospitals are required to report adverse events and device malfunctions to the FDA, but Makary, an associate professor of surgery at the Johns Hopkins University School of Medicine in Baltimore, Maryland, and his team say this procedure is not always followed.
In addition to reviewing the FDA database, the team also used LexisNexis and PACE to search for da Vinci robot surgery complications in legal documents and news stories. The team cross-referenced these events with those reported to the FDA and found eight cases that had not been properly reported. Of the eight cases, five had not been filed at all and three were problematic. Two of the problematic cases been filed following stories written by the news media, publicizing the surgery complications to the public. One case was submitted to the FDA 930 days after the surgery and another 292 days following the procedure.
Makary is quoted in Medscape as stating, “We think that based on the sample, the 245 reported cases represent a small fraction of the true events out there.” He added that the number of reported cases, “seems very low, given the discussion of these events in the surgical community.” Makary says it is important that da Vinci robot surgery complications are reported correctly, so doctors and patients can be properly informed of safety risks.
da Vinci surgical robot details
Touted as a minimally invasive procedure, the da Vinci surgical robot is commonly used in a variety of operations including hysterectomy, gallbladder, repair of heart valves, and more. A surgeon makes a small incision in the body of a patient, to insert remote-controlled instruments that have the ability to get into smaller spaces than a human can on their own. The surgeon uses a console to direct the robot, often times from another room. As they do not have the ability to feel a patient’s internal organs when performing robot surgery, many surgeons believe it is difficult to make incisions correctly. Recent studies have found that laparoscopic surgery offers the same outcomes as robotic procedures, and costs significantly less money to perform.
da Vinci robot surgery complications
Patients have experienced various injuries from robotic surgeries. Currently, there are several lawsuits pending against Intuitive Surgical, the maker of the da Vinci robot. One case was filed by a woman who had a hysterectomy that failed to heal properly, causing her to have a hip-to-hip scar from corrective surgery, constipation from damaged rectal muscles and a diminished sex life. In another case, a patient’s liver and spleen were punctured during heart and value repair, causing 15 hours of internal bleeding. In yet another case, a man undergoing prostate surgery suffered severe damage to his rectum and bowel.
Nevertheless, in response to these claims, device maker Intuitive Surgical, Inc.stands by its product.
Laura Woods, Author
Since receiving her MBA, Laura Woods has returned to roots in writing and communications. She is deeply committed to her work in patient advocacy and consumer right, and hopes to raise awareness regarding some of the dangers created by the pharmaceutical industry.