The Food and Drug Administration on Thursday warned against the use of robotically assisted devices for mastectomies and other cancer surgeries, asserting the products may pose safety risks and result in poor outcomes for patients.

The agency said it decided to issue its warning after reviewing studies suggesting that robotically assisted devices were being used to perform cancer procedures for which there is limited data on their safety and effectiveness. The FDA has not authorized the devices for mastectomy or for the treatment or prevention of cancer.

One recent study reported that use of the devices in radical hysterectomies in women with cervical cancer was associated with lower rates of disease-free survival and overall survival than traditional surgery.

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“We want doctors and patients to be aware of the lack of evidence of safety and effectiveness for these uses so they can make better informed decisions about their cancer treatment and care,” said Dr. Terri Cornelison, assistant director for the health of women in the FDA’s Center for Devices and Radiological Health.

Use of robotically assisted surgical devices is increasing because they allow surgeons to perform procedures through smaller incisions, helping to reduce pain, blood loss, scarring, infection, and recovery time. In such surgeries, computer technology enables a surgeon to control instruments attached to mechanical arms while viewing 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 instance, Northwell Health on New York’s Long Island held a press conference to announce that its surgeons had carried out the first robotic nipple-sparing mastectomy in the U.S., using a da Vinci system, and quoted the patient as saying she “refused to be mutilated” by standard surgery.

Dr. Neil Tanna, of Northwell’s Long Island Jewish Medical Center, explained at the time that conventional nipple-sparing mastectomy leaves long incisions on the breast, but that robotic surgery enters the chest wall near the armpit, which some women find less disfiguring. The surgery was part of an investigational study that found robotic nipple-sparing mastectomy is associated with a shorter hospital stay and less pain.

The maker of the da Vinci system, Intuitive Surgical, said in a statement that the FDA has granted clearance to robotic-assisted surgical systems for use in hysterectomy and prostatectomy procedures through its 510k process, a streamlined review pathway. The company also asserted that more than “15,000 peer-reviewed articles, in aggregate, support the safety and effectiveness of robotic-assisted surgery.”

A 2016 study of robotic surgery of all types, not only for cancer, concluded that “despite widespread adoption of robotic systems for minimally invasive surgery in the U.S., a non-negligible number of technical difficulties and complications are still being experienced.”

The study was based on 14 years of data from the FDA’s MAUDE (Manufacturer and User Facility Device Experience) database, which collects reports of adverse events from medical devices. It found 144 deaths, 1,391 patient injuries, and 8,061 device malfunctions in that period, including burnt or broken pieces of instruments falling into patients, electrical arcing of instruments, and having to interrupt the surgery to restart the system or switch to non-robotic techniques.

The FDA’s warning also recommends that patients and doctors discuss the benefits, risks, and alternative procedure options before making treatment decisions. The agency also advised patients to ask their doctors about training, experience, and outcomes related to the use of robotically assisted surgery.

Sharon Begley contributed reporting.

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  • I believe you are incorrect with your assertion that “the FDA has not authorized the devices for mastectomy or for the treatment or prevention of cancer.” The DaVinci robot was FDA approved for oral cancer surgery (TORS) in 2009. It’s a great application of this technology due to the significant morbidity associated with the surgical procedures it replaced.

    • Recently underwent robotic hysterectomy against my will and ended up being hospitalized for 52 days and being bedridden at home for another 30 days with PICC line and with enteral tube feeding and with more than 3 months of IV antibiotics. Though FDA has approved robotic for Hysterectomy, hospitals are not reporting significant number of “Serious Adverse Events” from robotic surgery to FDA. I think there need to be more attention and scrutiny from FDA.

  • I had a radical prostatectomy done with a DaVinici robot. Subsequently, my PSA increased and I had follow up radiation therapy. At the present time I am suffering with urinary leakage due to damage to my urinary sphincter. I expect to be cleared for surgery within the next month or so.

  • An incredibly important report and facts for patients to have in order to make informed decisions about their care. In addition to the deaths, patient injuries, and device malfunctions that were reported as adverse events from medical devices, was there any data on the financial toxicity and costs associated with robotic vs traditional surgical procedures?

    • I’m expecting to have robotic surgery to remove my R kidney because of transitional epithelial carcinoma in the renal pelvis, probably within the next month as soon as I get rid of a long-standing UTI. The cancer was discovered by means of a pelvic sonogram to try to find out why many diff antibiotics had not cured the infection. A lump was found and biopsies. My urologist recommended robotic surgery to remove the kidney and its ureter. How likely is this to be successful?

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