Miss. Woman Alleges She Was Injured in da Vinci Robotic Surgery

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A Mississippi woman filed a da Vinci robot surgery lawsuit against Intuitive Surgical Inc. for injuries she sustained after undergoing laparoscopic surgery in which the da Vinci Surgical System was used.

Plaintiff Dana McDonald came to her doctor with complaints of pelvic pain, dysfunctional uterine bleeding and other gynecological problems. It was decided that McDonald needed a hysterectomy and cystoscopy. Her doctor provided her a wealth of information and materials extolling the benefits of a da Vinci robotic hysterectomy over the traditional methods. Her physician, Dr. Gebhart, specifically pointed out a faster healing time and better outcome potential. Based on the information and suggestion, McDonald agreed.

According to the da Vinci robot lawsuit, she underwent surgery on May 15, 2012, with no recorded complications. However, on Sept. 10, 2012, McDonald suffered a vaginal cuff dehiscence and had to undergo another surgery to repair it. Again, on Dec. 19, 2012, the same issue occurred, this time with her bowel protruding from her vagina. McDonald underwent yet another reparative surgery. She says she now suffers continuously from fatigue, pain, and still has to undergo corrective surgeries and procedures to repair the harm allegedly caused from the da Vinci hysterectomy. Now McDonald’s da Vinci robotic surgery lawsuit joins the many others that have made similar claims against the device manufactured by Intuitive Surgical.

The da Vinci Surgical System is a set of robotic surgical arms used to assist surgeons in laparoscopic surgery. Controlled directly by physicians, the system translates the gross-scale movements of surgeons in near-microscopy motions mechanically. These microscopic movements are necessary for laparoscopic surgery, as this is a type of surgical procedure wherein streamlined tools and tiny cameras are inserted through a small cut to perform the surgery within the patient’s body. The smaller incisions often aid in shorter recovery times and less risk for patients. But it’s been alleged in da Vinci robot lawsuits that the da Vinci Surgical System is potentially more dangerous than regular laparoscopic surgery.

Da Vinci’s Risks

It has been alleged that the da Vinci system is potentially more dangerous than regular laparoscopic surgery. “The use of Defendant’s robotic device in surgery presents substantial risks of complications and injuries, including de-vascularization of the vaginal cuff impeding healing, partial thermal injury burns, post-surgical abcesses, tears, dehiscences, bleeding, hematomas, sepsis and fistulas,” the robotic surgery lawsuit states.

At a cool $2 million, da Vinci is not an inexpensive system. At such cost, plus maintenance fees, critics say hospitals are employing the device as much as possible in spite of inadequate training or possible risks; trying to “get their money’s worth” as it were. But with an ever growing number of robotic surgery lawsuits, the costs are not adding up.

Traditional Methods Preferred

Some da Vinci lawsuit plaintiffs say that Intuitive “has promoted its device as safe and safer than other comparative methods of surgery,” but that may not be the case. As of January 2013, there were a number of adverse events reported in the Manufacturer and User Facility Device Experience (MAUDE) database with the U.S. Food and Drug Administration (FDA), which contained information concerning patient injuries and deaths.

Intuitive was allegedly aware of the injuries and da Vinci robotic surgery complications incurred during the use of their da Vinci system. After an adverse event spike in 2013, the FDA took notice. The FDA asked surgeons who used the device around the country to take a survey regarding their usage of robot-assisted surgeries. The FDA survey on the da Vinci Surgical System came at a time of questioning about the value of robot-assisted surgery in general. A study published in February 2013 in JAMA reported that a robotic hysterectomy posted similar complication rates to a traditional laparoscopic hysterectomy but cost almost $2200 more per procedure.

Weeks later, the American College of Obstetricians and Gynecologists issued a statement that said that “studies have shown that adding this expensive technology for routine surgical care does not improve patient outcomes. Consequently, there is no good data proving that robotic surgery is even as good as, let alone better, than existing, and far less costly, minimally invasive alternatives.”

They recommended a traditional vaginal hysterectomy as the procedure of choice, and advised doctors to reserve a robotic hysterectomy “for unusual and complex clinical conditions in which improved outcomes over standard minimally invasive approaches have been demonstrated.”

McDonald’s da Vinci robotic surgery lawsuit accuses Intuitive of products liability, negligence, fraud, and breach of warranties.

The da Vinci lawsuit is Dana McDonald v. Intuitive Surgical Inc., Case No.: 3:14-cv-00402-HTW-LRA, in the U.S. District Court, Southern District of Mississippi, Northern (Jackson) Division.

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