Dive Brief:

• FDA is cautioning against using increasingly popular robotically assisted surgical devices in the treatment or prevention of cancer, a practice it says some healthcare providers are engaging in without FDA-authorized indication for use.

• "The safety and effectiveness of robotically-assisted surgical devices for mastectomy and any cancer-related surgery has not been established," regulators emphasized in a safety communication Thursday. An FDA spokesperson specified to MedTech Dive an agency analysis showed it received 32 adverse event reports referencing cancer, carcinoma or tumor and the use of robotically assisted surgical devices between January 2016 and December 2018.

• The agency suggested its warning was prompted by a rise in scientific literature documenting surgeons' use of the devices on cancer patients. Regulators are encouraging patients and providers to carefully consider benefits, risks and surgeons' level of training in addition to alternative options when contemplating non-indicated use.

Dive Insight:

Since FDA approved the first fully-robotic system in 2000 — Intuitive Surgical's industry-leading da Vinci — the category of devices has been adopted across many specialties, including for urologic, gynecologic and cardiac procedures. FDA notes that the high-definition visuals and precision afforded by the human-operated robotic systems can help reduce blood loss, scarring and recovery time compared to traditional surgical procedures.

But for all the types of conditions and associated surgeries in which robotically assisted surgical systems are supported by FDA, cancer is not one of them, the agency made clear. FDA's position hasn't stopped surgeons from testing the technology, which clinicians can do on an off-label basis.

"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," FDA wrote in its safety communication, pointing to a 2018 New England Journal of Medicine study backed by the MD Anderson Cancer Center and Medtronic that concluded robot-aided minimally invasive radical hysterectomy was associated with lower rates of disease-free survival and overall survival than open abdominal radical hysterectomy among women with early-stage cervical cancer.

Still, an MD Anderson resource page on what patients should know about robotic surgery in cancer treatment says that more than 7,000 robotic surgeries have been carried out at the medical center over the last decade. It also asserts that while some recent studies have shown using robotic surgery might not be as safe or effective when it comes to removing tumors, those outcomes might not be consistent across different cancer types or hospitals, and that success can vary based on type of cancer, region of the body where the surgery is performed, a patient's surgical history and a surgeon's preference and experience.

Intuitive Surgical's safety information statement says risks unique to da Vinci-assisted procedures include longer operative and anesthesia times, as well as system malfunction or failure that could lead to serious injury or the need to switch to another type of surgical approach, which could further increase complications. A broad retrospective study of FDA's adverse event reporting database for medical devices found 10,624 reports submitted between 2000 and 2013 pertaining to robotic surgery across specialties, with 144 cases citing patient deaths. 

Conversely, JAMA released a study this week considering how robotic surgery can decrease complications in treating early-stage endometrial, or uterine, cancer. In this case, the Danish registry-based analysis found severe complication rates in women receiving minimally invasive robotic and laparoscopic surgery were 4.6% and 5.1%, compared to a rate of 11.4% among the total abdominal hysterectomy cohort.

Intuitive's success, to the tune of $1.05 billion in worldwide sales in its most recent quarter alone, has prompted other medtechs to seek a slice of the market. TransEnterix became Intuitive's first abdominal surgery competitor in 2017. Other companies have spent big money within the last six months in the race to catch up, with Medtronic acquiring Mazor Robotics for $1.7 billion and Johnson & Johnson spending $3.4 billion to pick up Auris Health, a robotic tech firm looking to target lung cancer.