Dangerous Complications Associated With Robosurgery

March 31, 2013

If you are going to the hospital for surgery, you're probably expecting an experienced surgeon's qualified hands to perform the procedure. With robotic surgery on the rise, it's becoming more likely that your surgeon will be in a completely different room, using a high-definition screen and a videogame-like console to control mechanical arms that perform the operation. Studies show that robotic surgery can be more dangerous than traditional surgery--the American Journal of Obstetrics & Gynecology found that complications in robot hysterectomies occurred at twice the rate of that in conventional procedures. If this statistic holds true, the rise in robotic surgery complications will likely lead to an increase in product liability lawsuits again manufacturers of these devices. It could also lead to a rise in the number of medical malpractice lawsuits against surgeons and hospitals using these devices, as two recent cases show.

24-year-old Kimberley McCalla underwent a hysterectomy after being diagnosed with early-stage cervical cancer, then died eleven days later due to complications with the surgery. Her father has filed a product-liability lawsuit against Intuitive Surgical, manufacturer of the daVinci robot, contending that the robot is to blame for the injuries that ended his daughter's life. He has also filed a medical malpractice lawsuit against the hospital where the procedure took place, alleging that her doctors did not identify the complications in time to save Kimberley's life. A medical malpractice case could also be made if Kimberley and her family were not informed that much of the surgery would be performed by a robot rather than human hands, or that there is an increased risk of complication in robotic surgery. Intuitive Surgical denies the charges, claiming that in any surgical procedure, risks are unavoidable.

Michelle Zarick has also filed a product-liability suit against Intuitive Surgical and the daVinci robot. On her gynecologist's recommendation, Ms. Zarick chose robotic surgery for her hysterectomy. Unfortunately, her vaginal wound failed to heal properly, resulting in further surgeries to correct the damage, extensive scarring, damaged rectal muscles and a diminished sex life. Mercy San Juan Medical Center, where her procedure was performed, advertises the "extraordinary" benefits of the daVinci system, claiming that "pain and the potential for complications are minimized" with robotic surgery. Initial studies show that these statements could be inaccurate and therefore expose the hospital to further medical malpractice lawsuits based on informed consent.

Informed consent, as defined by the American Medical Association, is a process of communication between a patient and physician that results in the patient's authorization or agreement to undergo a specific medical intervention. The AMA states that the issues a physician should discuss with a patient include the risks and benefits of a proposed procedure, alternatives to that procedure, and any risks involved with those alternatives. Was informed consent provided in Ms. Zarick's case? She alleges that the medical center never alerted her to the risks of complications with robotic surgery. Arguably, any informed consent should have required an accurate explanation of the risks and benefits of robotic versus conventional surgery. Simply standing on the claims of reduced pain and complications made by the medical center's advertising is insufficient and possibly even inaccurate, based on initial studies.

Intuitive Surgical maintains that the robots are "extremely safe," but a rising number of lawsuits filed in the past year creates cause for doubt. An FDA review shows an increase in injury reports involving robotic procedures from 24 in 2009 to 115 in 2012. While the reports only show that robots were involved in the procedures where injuries occurred, not that they caused the injuries, they raise a red flag about possible problems that should not be overlooked.

As medical centers compete for patients, the benefits of robotic surgeries are likely to be marketed as the latest advancement in technology. While doctors may be recommending new techniques, patients should always be informed of the risks inherent with any type of surgical procedure and make decisions that are best for their own health and safety.

Sources:

Businessweek.com, "Robosurgery Suits Detail Injuries as Death Reports Rise" 3-5-13

ama-assn.org, Informed Consent, viewed 3-18-13

 
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