In a statement issued on Feb. 28, the Food and Drug Administration (FDA) cautioned against using robotically-assisted surgical devices in surgeries like mastectomies and other cancer-related illnesses that specifically affect women’s health.
Women, and some men, who have breast cancer or are at high-risk for breast cancer may opt for the removal of the breast, a procedure known as a mastectomy. People who have the BRCA1 mutation, which increases risk for breast cancer, can undergo a mastectomy as a preventative measure.
Robotically-assisted surgical devices allow surgeons to precisely operate surgical instruments through small incisions in the patient’s body while viewing the surgical site in three-dimensional high definition. Thus the surgery may reduce pain, blood loss and recovery time compared to conventional methods.
While such benefits may exist for certain types of surgeries, the FDA warned that there is insufficient evidence that they hold true for surgeries treating breast and cervical cancers.
“There is limited, preliminary evidence that the use of robotically-assisted surgical devices for treatment or prevention of cancers that primarily (breast) or exclusively (cervical) affect women may be associated with diminished long-term survival,” the statement on their website read.
Currently the FDA has evaluated robotically-assisted surgical devices by comparing the complication rate 30 days post-surgery to those of other established surgical techniques. The statement acknowledged that those evaluation standards may be insufficient in assessing the use of the robotically-assisted devices in surgeries treating breast cancer because cancer recurrence can occur on a time scale much longer than 30 days.
The statement cited a 2018 report published in the New England Journal of Medicine. The clinical study found that among women with early-stage cervical cancer, robotically-assisted hysterectomies were associated with lower rates of disease-free and overall survival compared to a traditional open abdominal radical hysterectomy.
However, other research studies have found no statistically significant differences in the long-term survival rates between robotically-assisted and non-robotically-assisted surgeries.
The FDA has not approved marketing for robotically-assisted surgical devices which may be used in procedures which prevent or treat any cancer.
Doctors Neil Tanna and Alan Kadison performed the first robotic nipple-sparing mastectomy and breast reconstructive surgery in the United States in March 2018. Nipple-sparing mastectomy is a procedure which preserves sensation in the nipple and areola.
The surgery was performed at Northwell Health’s Long Island Jewish Medical Center in New York. Northwell Health is a large network of hospitals, outpatient facilities and physicians.
The doctors confirmed that the procedure followed strict Institutional Review Board protocols. Tanna stated that one of the benefits of robotic surgery is that it makes precise, small incisions near the armpit area rather than long incisions directly on the breast as in conventional surgeries.
In addition to the aesthetic advantages, Kadison believes that robotic surgery has positive implications for recuperation and patient satisfaction.
“We’re seeing very real advantages to using Da Vinci technology for this type of surgery — a decreased length of stay in the hospital, less pain, easier recuperation and most important of all, we’re striving for increased patient satisfaction,” Kadison said in a statement released by Northwell Health.
The statement issued by the FDA outlined recommendations for patients and health-care providers who are considering robotically-assisted surgeries.
The statement encourages patients to weigh the risks and benefits of the procedure, consider alternatives and ask the surgeon about their familiarity with the procedure.
The FDA advises health-care providers to take training on the specific robotically-assisted surgical device procedures they perform. Open, honest communication with the patient is also critical.
The statement affirmed that the FDA assesses each novel robotically-assisted surgical device individually. The agency is monitoring adverse effects in the literature and personal experiences reported directly to them.
In a MdEdge article, Dr. Walton Taylor, president of the American Society of Breast Surgeons, expressed his hope that robotically-assisted surgeries to treat cancers would become mainstream.
“It’s awesome technology that can be great for patients, but we have to gather real data that shows that long-term and short-term outcomes — from a cancer standpoint — are as good as with the open procedure... that there aren’t negative unintended consequences,” Taylor said.
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