FDA urges caution with robotic devices in cancer surgery


A new safety communication from the Food and Drug Administration on the use of robotically assisted surgical devices for mastectomy and other cancer-related surgeries in women encourages physician-patient dialogue and suggests that, moving forward, data on specific oncologic outcomes – not only perioperative and short-term outcomes – are key.

The FDA is “warning patients and providers that the use of robotically assisted surgical devices for any cancer-related surgery has not been granted marketing authorization by the agency, and therefore the survival benefits to patients when compared to traditional surgery have not been established,” Terri Cornelison, MD, PhD, assistant director for the health of women in the FDA’s Center for Devices and Radiological Health, said in a statement.

The safety communication focuses on women and calls attention specifically to robotically-assisted mastectomy and hysterectomy for early cervical cancers. It says 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 FDA cited a multicenter randomized trial that found that minimally invasive radical hysterectomy in women with cervical cancer (laparoscopic and robotically assisted) was associated with a lower rate of long-term survival compared with open surgery (N Engl J Med. 2018;379:1895-1904).

The communication does not refer to any other specific studies. Regarding current evidence on robotically-assisted mastectomies, the FDA safety communication says simply that safety and effectiveness have not been established and that the agency is “aware of scientific literature and media publications describing surgeons and hospital systems that use robotically-assisted surgical devices for mastectomy.”

Robotically-assisted mastectomy

Walton Taylor, MD, president of the American Society of Breast Surgeons and a surgeon with Texas Health Physicians Group in Dallas, said that the FDA’s concern is valid. “I really hope that robotic surgery turns out to be good [for mastectomy]. It’s awesome technology that can be great for patients,” he said. “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.”

Right now, Dr. Taylor said, robotic mastectomy “is not commonplace by any means.”

The technique for robotic nipple-sparing mastectomy (NSM) was first described by Antonio Toesca, MD, of the European Institute of Oncology in Milan (Ann Surg. 2017;266[2]:e28-e30).

In an editorial published recently in Annals of Surgical Oncology, Jesse C. Selber, MD, MPH, of the department of plastic surgery at the University of Texas MD Anderson Cancer Center in Houston, described the technique as a “natural next step in the evolution of minimally invasive breast surgery that has the potential to mitigate the challenges associated with traditional NSM” (Ann Surg Oncol. 2019;26[1]:10-11). Robotic nipple-sparing mastectomy is catching on in Europe” with very promising early results, he wrote.

At least a couple of practices promoted their performance of robotic mastectomy last year. Northwell Health, a large network of hospitals, outpatient facilities, and physicians in New York, announced in March 2018 that Neil Tanna, MD, and Alan Kadison, MD, of the divisions of plastic and reconstructive surgery and surgical oncology, respectively, had performed the first robotic nipple-sparing mastectomy and breast reconstructive surgery in the United States. Their patient carried the BRCA gene and had a preventive mastectomy at Northwell Health’s Long Island Jewish Medical Center.

In October 2018, a surgeon in Tinton Falls, N.J., Stephen Chagares, MD, announced that he had performed the first robotic nipple-sparing mastectomy with reconstruction in a patient with breast cancer at Monmouth Medical Center. His press release described a 3-cm incision “to the side of the breast, tucked neatly behind the armpit.” Both Dr. Chagares and Dr. Tanna had traveled to Milan to train with Dr. Toesca, according to the press releases.

Both of these cases – as well as a decision by Monmouth Medical Center in December 2018 to suspend the surgery pending further review – were mentioned in a letter submitted to the FDA in mid-December by Hooman Noorchashm, MD, PhD, a Philadelphia cardiothoracic surgeon-turned-patient-advocate whose wife Amy Josephine Reed, MD, PhD, died of uterine cancer in May 2017 following a laparoscopic hysterectomy performed with a power morcellator.

In his complaint, Dr. Noorchashm urged the agency to issue a warning about the “potentially dangerous/premature application” of robotic mastectomy for the treatment of breast cancer or BRCA carrier status outside the setting of randomized controlled trials with primary cancer–related outcomes metrics or an investigational device exemption from the FDA. (Receipt of the letter was acknowledged by the Allegation of Regulatory Misconduct Branch of the FDA several days later.)

In an interview, Dr. Noorchashm said he wants to see a regulatory framework that doesn’t allow 510(k) devices (devices requiring a premarket notification to the FDA) to modify an existing standard of care without having been shown to have noninferior primary outcomes. When devices are used in the diagnosis or treatment of cancerous or potentially cancerous tissue, he said, this means primary oncologic outcomes must be shown to be noninferior.

“When you have 510(k) devices able to inject themselves and affect existing standards of care without any sort of clinical trial requirement, you get the standard of care changing without any outcomes data to back it up,” he said. “That’s what happened with the power morcellator. Physicians started using it without any sort of prospective data, level 1 outcomes data, and it dramatically changed the conduct of hysterectomies.”

In its safety communication, the FDA encourages the establishment of patient registries to gather data on robotically-assisted surgical devices for all uses, including the prevention and treatment of cancer. It also says that while the agency’s evaluation of the devices has generally focused on complication rates at 30 days, the FDA “anticipates” that their use in the prevention or treatment of cancer “would be supported by specific clinical outcomes, such as local cancer recurrence, disease-free survival, or overall survival at time periods much longer than 30 days.”

The American Society of Breast Surgeons has a Nipple Sparing Mastectomy Registry that is collecting oncologic outcomes as well as aesthetic outcomes and other metrics on 2,000 patients. “In the last year or two, we’ve seen nipple-sparing mastectomy become much more commonplace,” said Dr. Taylor. Thus far, the registry does not include robotic procedures, but “if there were interest in a registry specifically for robotic nipple-sparing mastectomy, we would do it in a heartbeat.”

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