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New focus around requirements for DaVinci use
https://www.nbcnews.com/news/amp/ncna977931?__twitter_impression=true
the robot is not cleared for mesh removal or to handle mesh (soft tissue only typically)
“the FDA was aware that “surgeons have been using the device for uses not granted marketing authorization by the FDA.””
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3 Replies
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My focus is around the dangers of using the DaVinci robot for procedures that have not been cleared by the fda. Intuitive Surgical themselves in their indications for use of the endowrist state they are designed to handle tissue.
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[USER=”2722″]Davinciproblems[/USER] Notification.
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There is nothing in the article you linked that says anything about mesh removal. The article is about cancer surgery. And the statement about diminished long-term survival looks more like somebody saw a correlation but has not done much to determine the basis of the correlation. It would be rational to think that this type of surgery would be used on patients with a lower chance of long-term survival. Beside that, the FDA is not very deep, scientifically, as shown by numerous recent articles about their failures. They seem to be a vary bureaucratic organization, susceptible to influence and corruption. Not sure that their work is worth much, even though they are the primary regulatory agency for medical devices.
Have you been damaged by a Da Vinci mesh removal? Your posts seem to be pointing that way. Good luck.
“The FDA warned patients and health care providers Thursday about using robotically assisted surgical devices for mastectomies and other cancer surgeries because of “preliminary” evidence that it may be linked to lower long-term survival.”
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