KJ McElrath  |  April 10, 2019

Category: Legal News

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Robotic surgery for cervical cancer is on the rise, despite evidence that it may lead to cancer recurrence.

The FDA, which has never approved robotic surgery for cancer, has recently issued a warning to that extent. Furthermore, researchers have found that patients undergoing robotic surgery for cervical cancer have poorer outcomes than those who are operated on by an actual surgical team.

What is Robotic Surgery?

The terms “robotic surgery” and “robotically assisted surgery” refer to minimally-invasive surgical procedures using miniaturized instruments that can be inserted through very small incisions. It has been developed as an attempt to overcome the limitations formerly associated with minimally-invasive surgery while providing greater capabilities for surgeons when doing open procedures.

The first fully robotic surgery was carried out at the Ohio State University Medical Center in the 1990s. In May of 2006, the first unassisted robotic surgery using artificial intelligence and operating remotely carried out heart surgery on a 34-year-old male. The device had been programmed with data on over 10,000 similar procedures. At the time, designers said it was “more than qualified to operate on any patient.”

Robotic Surgery Fails Cervical Cancer Patients

Two recent studies appearing in the New England Journal of Medicine highlight failures of robotic surgery in the treatment of cervical cancer.

The first was a clinical trial carried out by an international team, comparing outcomes among patients who underwent a minimally-invasive robot-assisted radical hysterectomy to those who had the more invasive open-abdominal type of surgery. The trial was halted when it was found that patients undergoing robotic surgery were 300 percent more likely to experience a recurrence of the disease and less than a 17 percent chance of long-term survival compared with those who underwent an open procedure.

The second study carried out under the auspices of the National Institutes of Health did a similar comparison among a group of nearly 2,500 cervical cancer victims, approximately half of whom underwent robotic surgery. The researchers found that the four-year survival rate for those who had open surgery was over 40 percent higher than the robotic surgery group.

These findings are particularly alarming in light of the fact that radical hysterectomy generally has a high success rate, according to gynecologic oncologist Dr. Pedro Ramirez, who heads research on minimally invasive surgery at the M.D. Anderson Cancer Center.

Robotic Surgery Continues to Increase

It is not fully understood why cervical cancer patients are at much greater risk, though Ramirez believes the fine, precision tools employed or the use of carbon dioxide in robotic surgery may promote the spread of cancer cells. More alarming, some of these robotic surgeons have been FDA approved through the 510(k) Premarket Notification process, which allows medical device manufacturers to bypass the usual rigorous (and expensive) clinical trials.

Meanwhile, despite there being no evidence of better outcomes with robotic surgery, it appears that the technology will remain and even become more common in the future. According to a recent report in Business Wire, the market for robotic surgery is expected to grow by over 100 percent by 2025. At the same time, a significant number of physicians continue to recommend robotic procedures to their patients, citing reduced recovery time and fewer risks.

The fact is that, although robotic surgery has been around for nearly three decades, the technology is still in its infancy – and there is much yet to be learned.

Join a Free Cervical Cancer after Hysterectomy Lawsuit Investigation

If your cervical cancer progressed after laparoscopic radical hysterectomy, or if your loved one died after such surgery, you may have a legal claim. See if you qualify to file a cervical cancer after hysterectomy lawsuit by filling out the form on this page now.

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