A basin of cold water! FDA warns robots that surgery is not so reliable

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 A basin of cold water! FDA warns robots that surgery is not so reliable


Recently, the Food and Drug Administration of the United States (FDA) issued a warning questioning the use of robotic-assisted surgical devices, including breast tissue removal for breast cancer (such as mastectomy), hysterectomy for cervical cancer (hysterectomy), or any other female-specific cancer.

This is because the FDA has ascertained that Robot-assisted surgical devices for mastectomy, cancer prevention or treatment have not yet been established to be safe and effective. The phrase not yet established is just a polite way of saying, Were still not sure what robots will do.

In theory, using robots to perform surgery sounds cool, and it also allows surgeons to cut smaller cuts. This is because robotic arms can be inserted into the small holes in the body, and surgeons can operate in a smaller space using robotic cameras. These theoretical advantages help to promote robotic assistant devices, such as the Da Vinci surgical system. After all, it is not difficult to persuade patients to accept a smaller incision. In theory, smaller incisions mean less pain, less risk of infection, and faster recovery. This is why robotic surgery is considered a minimally invasive surgery.

However, there are some warnings that robotic minimally invasive surgery is not the same as traditional open surgery. Open surgery is to make a large incision in the skin, which allows surgeons to directly see and touch all parts of the body. For relatively simple operations, such as gallstones rather than cancer, open a large incision may not be so important. However, if you want to determine the number of cancer tissue around you, it may be very important to open a large incision on your body. Surgical removal of all cancer tissue, of course, would like to clean up completely without leaving any trace, but the question is whether robotic technology and attached cameras and sensors are advanced enough to replicate or replace the doctors in open surgery. What about direct observation and contact?

The FDA is uncertain about this. The FDA statement did cite a clinical trial published in the New England Journal of Medicine last November, which randomly assigned more than 600 patients with early cervical cancer to minimally invasive surgery (319 cases) or laparotomy (312 cases). Among 319 Cases of minimally invasive surgery, laparoscopic surgery accounted for 84.4%, robot-assisted surgery accounted for 15.6%.

For minimally invasive surgery, the results are not good news. Four and a half years after surgery, 96.5% of the patients who underwent laparotomy were still alive and showed no signs of cancer recurrence, which was 10% higher than the survival rate of patients who underwent minimally invasive surgery (86.0%).

The challenge is that robotic surgery is relatively new and there is not enough data to illustrate its application in cancer-related surgery. If more and more surgeons are used to these robotic devices, the effect of surgery may be better, but not all surgeons will be improved. After all, although surgeons can use robots, they are not robots themselves, and they still need to possess qualified surgical skills. At least doctors should not rely too much on robots. In traditional operations, doctors may have different levels, some experienced, some slightly inferior, which is also applicable to the operation of robotic-assisted surgical devices. The FDA also emphasized that, based on cancer-related outcomes, including overall survival, recurrence and disease-free survival, they did not approve any robotic-assisted surgical equipment. It would take more time and research to identify the relative advantages and disadvantages of robotic surgery. (Selected from: Forbes Author: BruceY. Lee Compiler: Netease Intelligent Participation: Katrina) Focus on Netease Intelligent Public Number (smartman 163), for you to interpret major corporate events in the field of AI, new ideas and new applications. Source: Netease Intelligent Responsible Editor: Ding Guangsheng_NT1941

The challenge is that robotic surgery is relatively new and there is not enough data to illustrate its application in cancer-related surgery. If more and more surgeons are used to these robotic devices, the effect of surgery may be better, but not all surgeons will be improved. After all, although surgeons can use robots, they are not robots themselves, and they still need to possess qualified surgical skills. At least doctors should not rely too much on robots. In traditional operations, doctors may have different levels, some experienced, some slightly inferior, which is also applicable to the operation of robotic-assisted surgical devices.

The FDA also emphasized that, based on cancer-related outcomes, including overall survival, recurrence and disease-free survival, they did not approve any robotic-assisted surgical equipment. It would take more time and research to identify the relative advantages and disadvantages of robotic surgery.

(Selected from: Forbes Author: BruceY. Lee Compiler: Netease Intelligent Participation: Katrina)

Focus on the smartman 163, to interpret the major events of AI companies, new ideas and new applications.