The advent of robotic surgery is intersecting with key concepts related to informed consent. The surgeon’s skill set always matters for every surgery. However, when technologies are introduced, even the best of surgeons will need to learn new skills to ensure they are providing the best of care to patients. The question then becomes – how much do patients need to be informed regarding the experience of “that [person] behind the robot?” Medical societies are struggling to set standards for credentialing surgeons, especially when it comes to the minimum number of required procedures to be performed. Likewise, hospitals determine their own criteria for granting privileges for robotic surgery. Each robotic procedure has its own learning curve. Robotic surgeons are considered competent when they have performed enough procedures to learn the technique sufficiently well to have an acceptable complication rate.
In the meantime, patients undergoing these procedures must give their informed consent. ACOG recommends that the discussion of robotic procedures include the indications for surgery and risks and benefits associated with the robotic technique compared with alternative approaches and other therapeutic options. ACOG asserts “Currently, there are no standardized credentialing and privileging guidelines; guidelines vary across institutions and hospitals.” However, in addition, ACOG in a Committee Opinion, developed jointly with SGS, states
As with any procedure, informed consent should be obtained from patients before surgery with discussion of the surgeon’s experience with robot-assisted surgery, indications for surgery, and potential risks and benefits associated with the robot-assisted technique compared with alternative surgical approaches and other therapeutic options.
In the case of Forrest v. Bonifield, 2017 N.J. Super. Unpub. LEXIS 103, the defendant surgeon failed in his attempt to have the medical malpractice case dismissed on the grounds that the injured patient did not have a claim for lack of informed consent. The patient suffered the known potential complication of a ureteral injury when she underwent a DaVinci robotic hysterectomy. During the lawsuit, it was discovered that the surgeon had only done three such procedures when he obtained patient consent. At the time of surgery, he had performed 10 such procedures. The standard for competency that was presented as resulting in an acceptable complication rate is a minimum of 20 procedures. The court determined that a reasonable patient could have declined having the surgery performed by an inexperienced operator.
Therefore, this case suggests that surgeon experience may become further entwined with informed consent in the future. It is likely that surgeons and institutions will need to address and possibly standardize competencies to ensure consistency in patient counseling and informed consent.
Surgical Robots are all the Same, but Robotic Surgeons Aren’t
ACOG Committee Opinion 810: Robotic Surgery in Gynecology
Informed consent in robotic surgery: quality of information and patient perception
Robotic Surgery: Risks vs. Rewards
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