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Robotic Surgery Regulations to be Considered at FDA Workshop

Federal health regulators are planning a workshop this summer, to review robotic surgical systems, such as the da Vinci robot, and determine how the complex machines should be regulated. 

The workshop was announced late last month in the federal register, and is scheduled for July 27-28 at the FDA’s White Oak Campus in Silver Spring, Maryland.

The FDA indicates that the workshop will involve attendees from academia and the medical device industry, as well as health care experts, who will look at the safety and effectiveness of the da Vinci robotic system and other potential robot-assisted surgical devices, to determine how the FDA can best regulate them in a way that protects patient safety without stifling innovation.

The meeting comes after several years of growing concerns about the risk of robotic surgery complications and whether devices like Intuitive Surgical’s da Vinci robot were pushed for uses that provide no benefits over traditional, less expensive surgical procedures.

da Vinci Robot Surgery Safety Issues

The da Vinci robot is a complex device with four arms that are remotely controlled by a surgeon through the use of hand and foot controls while sitting at a console that provides a virtual reality representation of the patient’s internal organs.

Over the past decade, da Vinci robotic surgery has rapidly grown in popularity for a variety of different gynecologic, urologic and other laparoscopic surgical procedures. However, several studies have raised questions about the cost and effectiveness of the surgical system.

A study published in the October 2014 issue of Obstetrics & Gynecology indicated that robotic surgery complication rates could be as much as twice as high in procedures where an ovarian cyst or one or both ovaries were removed with the da Vinci surgical robot, when compared with traditional procedures.

In addition to increasing the risk of complications, use of the surgical robot also added more than $3,000 to the cost in some cases, according to the findings.

That study was not the first time the cost of da Vinci robotic surgical procedures has raised questions. There are continuing concerns over whether the costs associated with robotic surgery are justified.

In February 2013, a study published in the Journal of the American Medical Association (JAMA) found that da Vinci hysterectomies increase costs by more than $2,000, while providing virtually the same complication rate as laparoscopic surgery.

The device has also been subject to several recalls, usually involving attachments for the robotic arms, which have been linked to burns, tears, and other patient injuries.

da Vinci Robotic Surgery Lawsuits

Although the da Vinci robot has been rapidly adopted by hospitals throughoug the U.S., Intuitive Surgical has faced a number of complaints raised over their aggressive marketing efforts, which have resulted in more expensive robotic surgery being performed in many procedures where there is a lack of evidence supporting a sufficient added benefit.

Intuitive Surgical has also faced a number of da Vinci robotic surgery lawsuits brought on behalf of patients who suffered complications following procedures, which were allegedly caused problems with the design of the system and instructions provided for surgeons.

According to allegations raised in the complaints, Intuitive Surgical sold the surgical system without ensuring proper training and instructions for surgeons, and without providing adequate warnings for consumers about the risk burns, tears and other robotic surgery problems.

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