Safety concerns remain as surgeons explore robot-assisted breast cancer operations

Robot-assisted surgery is being introduced at several hospitals for breast cancer, but some providers are concerned this minimally invasive surgery may not be safe and needs high quality clinical trials to prove its effectiveness, according to

Robot-assisted surgery is being used for post-mastectomy reconstruction, breast cancer prevention, and, most controversially, mastectomy to treat cancer.

In December, the University of Pennsylvania in Philadelphia touted "the world's first" robotic double breast reconstruction using a flap of tissue from the patient's abdomen. The robot was used after the patient had a conventional mastectomy, which avoided any risk that the technology might fragment a tumor and spread cancer cells, physicians said.

"The critical difference is that this is not the same as cancer surgery," said Penn plastic surgeon Suhail Kanchwala, MD. "This is about reconstruction. The outcomes are pretty easy to measure."

Another use of the robot, reported in October by the Asbury Park Press, was suspended the week of Dec. 9 pending review by Long Branch, N.J.-based Monmouth Medical Center. Stephen Chagares, MD, a Tinton Falls, N.J., breast surgeon, performed a robotic mastectomy on a breast cancer patient followed by breast reconstruction with an implant.

Dr. Chagares told he believes robotic mastectomy "does not pose a greater risk of fragmenting the tumor" because it is "the same technical mastectomy as I have been performing for 24 years, just using a scope for more accurate and magnified visualization."

"As a breast cancer surgeon, oncologic outcomes always take precedence" over cosmetic results, Dr. Chagares said. "This approach is brilliant, as it provides for both."

Monmouth Hospital launched its inquiry after Hooman Noorchashm, MD, PhD, a Philadelphia area cardiothoracic surgeon turned patient advocate, said oncologists strive to remove tumors in one piece to avoid leaving residual cancer, which robot technology may not be able to do. 

"If you want to create a new standard of care and advertise it, at the very least you need to do a randomized controlled trial to demonstrate safety and effectiveness," Dr. Noorchashm said. "You shouldn't just advertise 'small incisions, faster recovery.'"

Although there is disagreement about whether minimally invasive techniques should go through a clinical trial before being used for breast reconstruction or preventive mastectomy, several clinical trials are underway.

A clinical trial in Europe aims to compare robotic and conventional mastectomy after cancer diagnosis, including five-year survival. A separate clinical trial in France of robotic mastectomy, however, has no comparison group — considered critical for a definitive study — and seeks to evaluate patient complications and cosmetic results as opposed to recurrence rates or survival.

More articles on clinical leadership and infection control:
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