FDA Warns that Robotic Cancer Surgeries Aren’t an Improvement
The Food and Drug Administration (FDA) has released a warning for cancer patients who are planning on undergoing robotic procedures. There is no evidence that cancer patients who receive robotic surgeries live longer than those who undergo traditional procedures.
Robotic surgeries have not been approved for cancer-related treatments, but doctors widely use the equipment to operate on patients with various forms of cancer. The systems have been on the market for more than 15 years. The robot’s arms are controlled by a computer that’s manipulated by the surgeon. The movements of the robot are supposed to replicate the operating surgeon.
In 2000, the first robotic surgery system was sold. In addition to other surgeries, the system was cleared for some urological and gynecological procedures. The effectiveness for cancer treatment had not been evaluated by the FDA, but the systems have been frequently used for mastectomies. The FDA’s approval was only for the device as a surgical tool.
To support their findings about the surgical outcomes, according to The New York Times, the FDA points to two studies published in the New England Journal of Medicine. In one clinical trial, a woman with cervical cancer experienced four times as many cancer recurrences after robotically assisted procedures that those who underwent traditional surgeries. This was especially shocking because a radical hysterectomy usually cures patients with cervical cancer.
The second study, which was funded by the National Institutes of Health, compared the outcomes of 2,461 patients with cervical cancer who had different types of surgery. Four years after the procedures, 9.1 percent of those who had robotic surgeries had died, while only 5.3 percent of those who had traditional surgeries died.
Even with those findings, many surgeons continue to recommend robotic procedures to their patients. While it’s not yet clear why the outcomes for minimally invasive surgeries are worse, Dr. Pedro T. Ramirez, the director of minimally invasive surgical research at M.D. Anderson Cancer Center in Houston, Texas, suspects the instruments used in robotic surgeries may cause the cancer cells to spread. Another theory proposes that the carbon dioxide pumped into the abdomen during robotic surgeries may increase the chances of cancer cells implanting.
In additional warning doctors and patients about the outcomes associated with robotic cancer surgeries, the FDA is also urging health care providers to complete the necessary trainings to use the robotic systems. Patients should question their doctors about trainings, experiences, and surgical outcomes.
Many surgeons prefer minimally invasive surgeries because of the smaller incisions, shorter recovery times, less pain and blood loss, and fewer infections or scars; however, it’s likely a patient with cancer would rather stay in the hospital for an extended period of time if they knew the risk of their cancer returning was less after a traditional surgery.
It’s suspected that physicians who continue to use robotic cancer surgeries may put themselves in legal jeopardy because of the FDA’s warning. But no matter the type of surgery, if you’ve been injured by a negligent physician, we have the experience needed to evaluate and investigate your claim to prove you were wronged. If you’re ready to take legal action and seek compensation for your losses, get in touch with our lawyers today.