FDA Investigating Problems, Complications Following da Vinci Robotic Surgery

By Harvey Kirk
Posted March 1, 2013

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UPDATE 5/14/2015: Saiontz & Kirk is no longer accepting new clients for da Vinci Surgical Robot Lawsuits
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The FDA has finally launched an investigation into the mounting reports of serious and sometimes life-threatening complications experienced following da Vinci robotic surgery, which have caused many patients to suffer problems that surfaced days later due to internal bleeding and other injuries that may have been caused by design defects with surgical robot.

The product liability lawyers at Saiontz & Kirk, P.A. represent individuals throughout the United States who are pursuing da Vinci robotic surgery lawsuits against the manufacturer, and it is about time the federal health regulators stepped in to review the activities of the manufacturer of the system, Intuitive Surgical.

▸ Prior Post 5/1/2012: da Vinci Surgery Problems Often Could Have Been Prevented

The da Vinci Surgical System is a complex machine that has been increasingly used at hospitals throughout the United States in a number of different fields for robotic procedures.

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While the system has been promoted as a superior alternative to more traditional procedures, due to the smaller incision and quicker recovery times, robotic surgery is substantially more expensive and there is a lack of evidence establishing that it results in any better long-term outcomes for patients.

In fact, design defects and problems with the training provided to physicians may actually increase the risk of severe and potentially life-threatening injury following da Vinci robotic surgery.

In a study published in the February 2013 edition of the Journal of the American Medical Association (JAMA), prominent experts in the field raised concerns about the widespread use of the da Vinci Surgical System for robotic hysterectomies.

Patients end up paying thousands of dollars more for robotic surgery when the da Vinci robot is used, and researchers indicated that there was little, if any, benefit provided over the cheaper laproscopic hysterectomy surgery.

A recent review of adverse event reports submitted to the FDA that was conducted by an independent investment research firm identified more then 4,600 reports involving problems following da Vinci robotic surgery. Amid the reports of surgical tears, perforations and electrical burns were more than 80 deaths.

According to a recent report by Bloomberg News, the FDA issued a survey to doctors nationwide in January, asking them to outline instances of problems they experienced during da Vinci robotic surgery and complications that developed following the procedures. The survey also asks for information on the training received for da Vinci robotic surgery and insight into what procedures the surgical robot is best and worst for performing.

The initial survey sent out by the FDA mentioned that “data is showing an increase in patient adverse reports,” according to Bloomberg. However, Intuitive Surgical reportedly complained about the letter and the agency has now backtracked on the reasons for the survey, indicating that the first draft was accidentally sent out before it was finalized. However, while the FDA has removed the language from the survey, it remains clear that the agency has serious concerns regarding the safety of da Vinci robotic surgery.

da Vinci Robotic Surgery Lawyers

Individuals who have experienced problems or complications following robotic surgery where the da Vinci robot was used may be entitled to financial compensation through a product liability lawsuit as a result of the manufacturer’s decision to place their desire for profits before the safety and best interests of patients.

The da Vinci robotic surgery lawyers at Saiontz & Kirk, P.A. are evaluating potential claims for individuals throughout the United States. These are not cases being brought against the doctors or hospitals where the procedures were performed, but rather claims against Intuitive Surgical, the manufacturer of the potentially defective and dangerous device.

UPDATE 5/14/2015: Saiontz & Kirk is no longer accepting new clients for da Vinci Surgical Robot Lawsuits
The contents of this page are provided for informational purposes only