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Robotic surgery has never been approved for a mastectomy or any other cancer-related treatment, but this has hardly deterred doctors in the operating room. The equipment is widely used to operate patients with various malignant tumors, from breast cancer to prostate cancer.
Yet, there has been a long-standing question about the level of physician training on machines and whether devices are better for patients than traditional methods.
Now, the Food and Drug Administration warned that there was no evidence that cancer patients who undergo robotic procedures live longer than those who undergo traditional procedures. In addition, some research shows that patients with cervical cancer are worse.
"We want doctors and patients to be aware of the lack of evidence of safety and effectiveness for these uses so that they can make more informed decisions about their treatment and care," said Dr. Terri Cornelison, Assistant Director for Women's Health at the FDA's Center for Devices and Radiation Health.
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Robotic systems have been on the market for over 15 years and have been used for cancer surgery for a lot of that time. The tower of the machine, which is positioned on the patient, looks a bit like a Star Wars multi-arm droid. Three of his arms hold surgical devices, while a fourth holds a camera.
The arms of the robot are controlled by a computer that reproduces the movements of the surgeon operator, who manipulates the robot's controls while watching a monitor providing an enlarged high-definition image of the operating site.
The F.D.A. it is noted the results of two studies published last year in the New England Journal of Medicine.
One of these was a clinical trial that was stopped soon after the investigators found that women with minimally invasive hysterectomy, including robot-assisted procedures, had four times as many cancer recurrences and six times more deaths than patients. who had the most traditional procedure.
The results of the trial are particularly striking because surgery, a radical hysterectomy, usually heals patients with cervical cancer, said Dr. Pedro T. Ramirez. lead author of the paper and Director of Minimally Invasive Surgery Research at the M.C. Anderson Cancer Center in Houston.
A second study funded by the National Institutes of Health used a database compare the results of 2,461 women with cervical cancer who underwent different types of surgery. Four years after surgery, 9.1% of patients with minimally invasive surgery died, compared to 5.3% of those who underwent open surgery.
Yet, many doctors continue to recommend robotic surgery to patients, despite evidence of harm. "Many surgeons have said," I can not find a flaw in your study, but I can not help but do it, "Dr. Ramirez said.
Dr. Ramirez's own department stopped practicing mini-invasive radical hysterectomies in October 2017, when the results of the first study were confirmed.
"My feeling is that it's patient care," he said. "It's not about how much time you spent on your training or your ego. It is a cancer problem and it is very likely that the cancer will reappear if you are having surgery on this approach. "
It is not clear why the results of cervical cancer were worse after minimally invasive surgeries. Dr. Ramirez suggested that the instruments used to manipulate the cervix of the uterus and the uterus could cause the spread of cancer cells.
Another possibility is that carbon dioxide injected into the abdomen during robotic procedures and other minimally invasive procedures (providing a work and visualization area to the surgeon) may increase the risk of implanting cancer cells, said Dr. Ramirez.
The warning of F.D.A. was not limited to cervical cancer: robotic surgery devices are not allowed for the prevention or treatment of any cancer, nor for mastectomy (removal of the breast), said the agency.
The agency also urged health care providers to "follow the appropriate training" required for robotic surgery, and invited patients to question physicians about their training and experience, as well as the results their patients achieved. .
In 2000, the F.D.A. authorized the sale of one of the first robotic surgery systems, the da Vinci surgical system, as part of a process called 'pre-market notification', often used to market medical devices without the rigorous safety and efficacy tests required for new drugs.
In pre-marketing notification, devices are "cleared" for use. on the grounds that they are similar to the devices already available. The da Vinci system is authorized for certain urological and gynecological procedures, among others.
A similar robotic device, the Senhance Surgical System, has been approved for gynecological and colorectal surgery, among other procedures.
But the effectiveness of one or the other system for the treatment of cancer has not been evaluated by the F.D.A. And none of the systems have been licensed for mastectomy or breast removal, which has become a frequent use.
The approval of F.D.A. was "based on evaluating the device as a surgical tool and did not include evaluation of cancer treatment outcomes," the agency said. The F.D.A. reviewed the short-term data on the results, said a spokesperson, not long-term data important for cancer patients.
So, why are these machines licensed for cancer surgery? According to a spokeswoman, the F.D.A. does not regulate the practice of medicine.
"If a medical provider determines that it is appropriate to use a non-compliant product, we do not regulate that," she said. "However, in this case, we were concerned about scientific journals and media reports referring to non-compliant uses."
Many surgeons tout the benefits of robotic surgery, with its smaller incisions, claiming that procedures allow for shorter recovery times, less blood or blood loss, as well as fewer scars and infections.
These are important measures, said Dr. Ramirez. But "if you tell a patient that you can stay in the hospital one or two days more than when you get home the same day, but your cancer is more likely to come back, what will you choose?" you as a patient? Of course, you will stay in the hospital. "
Proposals to conduct another clinical trial to test the results of cervical cancer would be unethical, said Dr. Ramirez, as the results of the first study were clear.
Doctors who continue to use robotic and minimally invasive approaches to cancer treatment "in light of the evidence could put themselves at risk," said Dr. Michael Carome, director of the Health Research Group at Public Citizen, a consumer organization.
Patients mwere not the only ones caught off guard by the warnings of F.D.A.. Officials at Intuitive Surgical, maker of the da Vinci robotic system, said their device was compatible with radical hysterectomies and prostate removal. The latter would only be used to treat cancer.
"We reached out to the F.D.A. for clarification, "said Peper Long, spokesperson for the company.
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