TThe Food and Drug Administration warned Thursday against the use of robotic devices for mastectomies and other cancer surgeries, saying the products could pose safety risks and lead to poor patient outcomes .
The agency announced that it had decided to release this warning after reviewing studies suggesting that robot-assisted devices were used to perform cancer procedures for which there is limited data on their safety and effectiveness. . The FDA has not allowed devices for cancer surgery.
Media reports and scientific publications have, however, established that robot-assisted devices are used in these procedures. A recent study showed that the use of devices in radical hysterectomies in women with cervical cancer was associated with lower disease-free survival and overall survival rates than traditional surgery.
"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 treatments and their care," said Dr. Terri Cornelison, Deputy Director for Women's Health in Colombia. Center for Appliances and Radiation Health of the FDA.
The use of robot-assisted surgical devices is increasing as they allow surgeons to perform interventions in the form of small incisions, thus helping to reduce pain, blood loss, scarring, infections and recovery time. In such surgeries, computer technology allows a surgeon to control the instruments attached to the mechanical arms while visualizing the surgical site in three-dimensional high definition video.
For many hospitals, the ability to perform robotic surgery is a selling point. Last year, for example, Northwell Health, in Long Island, New York, held a press conference to announce that its surgeons had performed the first nipple robotic mastectomy in the United States, at the same time. help from a da Vinci system, and quoted the patient as being "refused to be mutilated" by conventional surgery.
Dr. Neil Tanna, of the North Island Jewish Medical Center on Long Island, explained at the time that conventional mastectomy sparing the nipples leaves long incisions on the chest, but that robotic surgery penetrates the chest wall near the chest. armpit, which some women find less disfiguring. The surgery was part of an experimental study that found that nipple-free mastectomy was associated with shorter hospital stay and less pain.
A 2016 study of all types of robotic surgery, not only against cancer, concluded that "despite the widespread adoption of robotic systems for minimally invasive surgery in the United States, a significant number of complications is always present. "
The study was based on 14 years of data from the FDA's MAUDE database, which collects reports on adverse events related to medical devices. He found 144 deaths, 1,391 injuries and 8,061 device malfunctions during this period, including burnt or broken instrument pieces that fell on patients, electric arches and the fact that they were damaged. interrupt the operation to restart the system or switch to non-robotic techniques. .
The FDA warning also recommends that patients and physicians discuss benefits, risks, and alternative procedural options before making a treatment decision. The agency also advised patients to ask their doctors for information about training, experience, and results related to the use of robot-assisted surgery.
Sharon Begley contributed to the reports.