FDA checking on reports of “problems” with da Vinci robot


According to an on-line report in the Financial Times published late last night, “The FDA has received an increase in reports of problems associated with [Intuitive’s  da Vinci robotic surgical technology] and said it is trying to weigh the risks and benefits of using robotic surgery rather than conventional surgery.”

The “New” Prostate Cancer InfoLink is somewhat puzzled by this increase in reports of problems, since the technology has been available for more than a decade. However, the da Vinci robot is now being used far more widely than just in prostate cancer, and it is possible that inappropriate application of the technology is some surgical settings may be an issue.

The Financial Times article quotes an FDA spokesperson as follows:

Since it is difficult to know why the reports have increased, FDA has elected to talk with some surgeons to help in determining if the rise in reports may be a true reflection of problems, or may simply be an increase in reports because of other contributing factors.

The “New” Prostate Cancer InfoLink wishes to be very clear for patients that we do not consider this development to be a reason to cancel or delay (or even not consider the option of) a robot-assisted laparoscopic radical prostaectomy carried out by a skilled surgeon who is used to and experienced with this technology.

Urologic surgeons now have significant experience with the application of this technology in the treatment of prostate cancer. As with any form of technology, it takes time to learn to use it well, and some surgeons are just less competent than others. While are not aware of any underlying problem with the technology itself, we shall certainly continue to monitor this situation with great care.

Additional comment as of 8:55 am today: Apparently variations on this story are also now available on the Bloomberg.com and The Wall Street Journal web sites. (Access to the latter site requires a subscription). Bloomberg has apparently gained access to the questionnaire sent to selected surgeons by the FDA.

2 Responses

  1. The significant part of this discussion is: “robot-assisted laparoscopic radical prostatectomy carried out by a skilled surgeon who is used to and experienced with this technology.”

    When RALP began around 2003, and was FDA approved (read “grandfathered in as an existing procedure”) no one discussed the steep learning curve for physicians as well as the difficulty sparing the nerve bundle. So, what has changed today?

  2. Dear Elucidated1:

    Actually it is generally accepted that the learning curve to conduct high quality radical prostatectomies using the da Vinci robot is significantly less steep than the learning curve for open prostatectomies or for non-robot-assisted LRPs.

    Also, the supposed difficulty related to sparing nerves (as far as I can tell) was never “real”. It was just one of the things that took a while for surgeons new to using the robot to work out how to do properly (just as 10 years earlier it took most urologists a while to work out how do execute nerve sparing at all).

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