FDA Announces Renewed Investigation about the Dangers of the da Vinci Robotic Surgical System

(PRWEB) May 04, 2013

Bloomberg News recently reported on February 28 that the U.S. Food and Drug Administration are conducting a nationwide investigation into the effectiveness of the da Vinci Robotic Surgical System. The FDA is questioning doctors from across the nation who has used the Intuitive Surgical robotic device and is attempting to get feedback amid the growing allegations that insufficient training and the defective design have resulted in severe side effects and surgical errors (i).

The da Vinci Robot Surgical System was approved by the FDA in 2000 and since then the da Vinci Robot manufacturer and marketer, Intuitive Surgical, has sold over 2,000 devices to hospitals around the country and the device has been used in an estimated 500,000 procedures last year, Bloomberg reports (i). Since the growth in the devices operation, a number of incident reports and lawsuits have claimed that the company failed to warn about the devices defective design and stated that by aggressively marketing the systems as a way for hospitals to advertise themselves as state-of-the-art, the company neglected to provide proper warnings or training to the doctors using the system (i).

While the da Vinci System allows doctors to control the surgery from a control console while the arms of the robot perform the actual procedure and is intended to be safer and more efficient, the amount of reports of alleged severe side effects and lawsuits have put the systems efficiency in doubt. The LA Times reported on October 17, 2011 that in a paper published in the Journal for Healthcare Quality, Johns Hopkins University School of Medicine surgeon Dr. Marty Makary stated that “there’s never been a study showing clinical superiority,” regarding the da Vinci robot, and similarly Dr. Hyung Kim, a surgeon who employs the da Vinci robot at the Cedars-Sinai Medical Center in Los Angeles admits that the device’s benefit over risks is still unknown and states that “the jury is completely out” on the issue and that “there is no consensus (ii).” The Wall Street Journal recently reported on February 19 that a study conducted by Columbia University doctors, which was published in The Journal of the American Medical Association, examined over 260,000 women who had a hysterectomies in the past five years via either a da Vinci robotic surgery or a laparoscopic procedure and found that, while there was no clear benefits the da Vinci procedure offered, the cost for the patients was significantly higher for the robotic route (iii).

One of the most prevalent criticisms of the da Vinci Robotic system is that its un-insulated surgical arms are allegedly causing burns and tears on the patients tissues adjacent to the area being operated. Additionally, it is often claimed that the operating doctors lack of training allegedly results in errors and tears and lacerations in the tissue not being operated on. With the FDA now initiating a renewed investigation of the benefits versus risks of the da Vinci Robotic Surgical System, Intuitive Surgical once again finds itself having to justify the machines exceedingly high price in light of growing concerns about both the risk of alleged side effects it carries and the adequacy of the training the physicians receive.

If you or a loved one has been operated on by the da Vinci Robotic Surgery and have been injured, you may be entitled to compensation. The attorneys at dOliveira & Associates are working with some of the most experienced da Vinci Robotic Surgery lawyers in the country who can help you file a claim or da Vinci robotic surgery lawsuit. With a No Win, No Fee Promise, there is no fee until you receive a settlement or award.

Please contact the law offices of dOliveira & Associates, P.C. at 1-800-992-6878 or fill out a contact form for a free legal consultation.


(i) http://www.bloomberg.com/news/2013-02-28/intuitive-surgical-robots-probed-by-u-s-in-survey-of-surgeons.html

(ii) http://articles.latimes.com/2011/oct/17/health/la-he-robotic-surgery-20111017

(iii) http://online.wsj.com/article/SB10001424127887323764804578314182573530720.html

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