The U.S. Food and Drug Administration (FDA) has issued a warning about using robotically-assisted surgical devices for the removal of breast tissue (such as masectomies) for breast cancer, the removal of the uterus (hysterectomies) for cervical cancer, or the removal of any other cancer specific to women. That's because the FDA has determined that "the safety and effectiveness of robotically-assisted surgical devices for use in mastectomy procedures or prevention or treatment of cancer has not been established." The phrase "has not been established" is a polite way of saying, "we still don't really know what the bleep may happen."
Robots in theory may sound cool and may allow surgeons to make smaller incisions when they operate. That's because robot arms could potentially slip into smaller holes in the body and combined with robot cameras allow surgeons to operate in smaller spaces. Such theoretical advantages have helped the use of robotic devices such as the da Vinci Surgical System grow in popularity. After all, it isn't too difficult to convince patients to get smaller incisions in their body than larger ones. A smaller incision, in theory, should be less painful with less risk of an infection and heal sooner. That's why such robotic surgery is considered a type of "minimally invasive surgery."
There are some caveats, though. Minimally-invasive surgery with robots is not identical to traditional "open" surgery. Open surgery is when you make a large incision in the body. This allows the surgeon to directly see and touch different parts within the body. Doing so may not be as important for relatively simple surgeries such as removing a gallbladder when gallstones and not cancer are involved. But such actions may be quite important when you are trying to determine how much cancerous tissue is around. Naturally, when surgically trying to remove all the cancerous tissue, you don't want to leave any behind. The question then is: has robot technology and the accompanying cameras and sensors advanced far enough to replicate or replace the direct observation and contact of open surgery?
The FDA is not so sure. The FDA announcement does cite the results of a clinical trial published this past November in the New England Journal of Medicine as cause for some concern. This trial randomly assigned over 600 patients with early stage cervical cancer to get either minimally invasive surgery (319 patients) or open surgery (312 patients). Of the 319 minimally invasive surgeries, 84.4% occurred through a laparoscope and 15.6% were robot-assisted.
Results weren't as good for minimally invasive surgeries. Four-and-a-half years after the surgery, 96.5% of the patients who had gotten the open surgery were still alive with no sign of cancer, which was over 10% more than those who had gotten minimally invasive surgery (86.0%). A smaller percentage (91.2%) of the minimally invasive surgery group were free of cancer after three years than those in the open surgery group (97.1%) as well.
The challenge is that robotic surgery is still relatively new. There just isn't enough data out there on its use for such cancer-related surgeries yet. It could be that results will get better as more surgeons get used to and experience using these robots. Moreover, not all surgeons are the same. After all, surgeons can use robots but are not robots. At least, they shouldn't be. Some may be better and some may be worse at traditional surgery. The same applies to using these robots.
Plus, robot technology continues to evolve. The robots that will eventually take over the world as Skynet, replicate Justin Bieber, and make us their slaves haven't been created yet. Over the next several years, robot arms may get more nimble and sensitive. The cameras and sensors may get better and be able to provide better visualizations of what is inside the body. As Sarah Connor said in The Terminator 2: Judgement Day, "The future's not set. There's no fate but what we make for ourselves."
Thus, while Barney Stinson got excited about robots versus wrestlers on the television series How I Met Your Mother, you may not want to use robots versus cancer just yet. The FDA is emphasizing that they have "not cleared or approved any robotically-assisted surgical device based on cancer-related outcomes such as overall survival, recurrence, and disease-free survival." Time and more studies are needed to determine the relative advantages and disadvantages. Meanwhile, technology and its use will continue to evolve. Therefore, as Barney says, "wait for, wait for it."
美国食品药品监督管理局（Food and Drug Administration）（ FDA ）已发出警告，建议使用机器人辅助手术设备来切除乳腺癌的乳房组织（如乳房切除术），切除宫颈癌的子宫（子宫切除术），或清除女性特有的任何其他癌症。这是因为 FDA 已经确定，“用于乳房切除手术或癌症预防或治疗的机器人辅助手术装置的安全性和有效性尚未确定。”“尚未确定”这个词是一种礼貌的表达方式，“我们仍然不知道会发生什么流血事件。”
FDA 不太确定。FDA 的声明引用了去年11月发表在《新英格兰医学杂志》上的一项临床试验的结果，引起了一些关注。这项试验随机分配了600多名早期宫颈癌患者接受微创手术（319例）或开放手术（312例）。在319例微创手术中，84.4%是通过腹腔镜手术，15.6%是机器人辅助手术。
此外，机器人技术还在不断发展。这些机器人最终将以天网的形式占领世界，复制贾斯汀比伯，并使我们成为他们的奴隶还没有被创造出来。在接下来的几年里，机器人的手臂可能会变得更加敏捷和敏感。摄像机和传感器可能会变得更好，并且能够提供更好的身体内部的图像。正如 SarahConnor 在《终结者2：审判日》中所说，“未来尚未确定。”没有命运，只有我们为自己做的。”
因此，当 Barney Stinson 在电视连续剧《我如何遇见你的母亲》中对机器人和摔跤选手感到兴奋时，你也许还不想用机器人来对抗癌症。FDA 强调，他们“没有清除或批准任何基于癌症相关结果的机器人辅助手术设备，如整体生存、复发和无疾病生存。”需要时间和更多的研究来确定相对优势和劣势。同时，技术及其使用将继续发展。因此，正如巴尼所说，“等待，等待。”