The number of injuries and deaths in the United States as a result of robotic surgery has risen from 13.3 per 100,000 procedures in 2004 to approximately 50 per 100,000 procedures in 2012, according to a draft analysis by physicians at Rush University Medical Center, the University of Illinois, and the Massachusetts Institute of Technology.
The da Vinci Surgical System that is manufactured by Intuitive Surgical, Inc. (“Intuitive’) is the dominant robotic surgery system in the United States. The FDA inspected Intuitive’s facilities between April 1, 2013 and May 30, 2013 due, in part, to a 34% increase in the number of adverse events reported as a result of robotic surgery between 2011 and 2012 (in 2012, there were 282 reports of injury that included 28 deaths).
The FDA subsequently issued a warning letter to Intuitive dated July 16, 2013 that stated, in part, “you failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR 806-Medical Devices; Reports of Corrections and Removals regulation …The FDA has previously informed you of your firm’s correction and removal violations in an untitled letter dated February 19, 2008, and FDA 483 Inspectional Observations issued on December 20, 2002. A follow-up inspection will be required to assure that your corrections and/or corrective actions are adequate and properly implemented.”
According to Intuitive’s most recent quarterly report filed with the SEC, ” We are currently named as a defendant in about 50 individual product liability lawsuits filed in various state and federal courts by plaintiffs who allege that they underwent surgical procedures that utilized the da Vinci Surgical System and sustained a variety of personal injuries and, in some cases, death as a result of such surgery. In addition, we have been named as a defendant in a purported class action filed in Louisiana state court seeking damages on behalf of all patients who were allegedly injured by the da Vinci Surgical System at a single hospital in Louisiana.”
What Are The Benefits And Risks Associated With Robotic Surgery?
The benefits that manufacturers of surgical robots tout are less blood loss, a shorter hospital stay, less pain, smaller surgical scars, more precise surgical methods (especially in tight spaces, surgical robots often provide a better view of the surgical site), and it is less tiring for the surgeons who sit watching a monitor as they perform procedures.
The major criticisms of robotic surgery include the inadequate training and/or experience of some surgeons who use robotic surgical systems, the inadequate laparoscopic surgical skills of some robotic surgeons, and pressure from the people who sell the robotic surgical systems to use the robots more often. A common defense raised by robotic surgeons who have been sued for malpractice is that the robot failed to act in the manner in which the surgeon directed or that the robot acted in an unexpected manner without input from the surgeon.
While the direct costs of surgeries performed using robotic surgical systems may be greater than other types of surgery — a study in 2012 found that the average total patient costs for hysterectomies were $49,526 for a robotic procedure, $43,622 for abdominal, $28,312 for laparoscopic, and $31,934 for vaginal — the overall costs when using surgical robots may be more comparable with other surgical methods when shorter recovery times and shorter hospital stays are taken into consideration.
If you are considering whether to have your surgery performed using a robotic surgical system or a more conventional method of surgery, it is imperative that you fully discuss your questions and the issues with your surgeon and include in that discussion an inquiry into the surgeon’s training and experience with the robotic surgical system the surgeon intends to use on you.
If you or a loved one were injured as a result of da Vinci surgery or some other robotic surgical system, you should promptly consult with a local medical malpractice lawyer in your state who may investigate your malpractice claim for you and represent you in a medical negligence case, if appropriate.
Click here to visit our website or call us toll free at 800-295-3959 to be connected with da Vinci malpractice lawyers (medical malpractice lawyers) in your state who may assist you with your claim.
Turn to us when you don’t know where to turn.