Robotic surgery safety, efficacy still unclear, FDA says

[ad_1]

Dr. Stephen Chagares of Tinton Falls is the first to use robotics for breast reconstruction surgery.
Doug Hood, Asbury Park Press

Breast cancer patients facing mastectomies should be cautious before agreeing to robotic surgery, federal regulators say, noting the procedure hasn’t been shown to be safe and effective.

The U.S. Food and Drug Administration in a recent safety communication said doctors should discuss with their patients the benefits, risks and alternatives to the robotic surgery.

“It should serve as a robust red flag to medical marketers and hospital risk managers: slow down and innovate properly and safely,” said Dr. Hooman Noorchashm, a surgeon and patient advocate in the Philadelphia area.

The procedure made waves last year when Dr. Stephen Chagares, a surgeon based in Tinton Falls, performed two robotic mastectomies last year at Monmouth Medical Center in Long Branch.

The hospital stopped the procedure, saying there wasn’t enough evidence to show patients had equal or better outcomes to its existing treatment.

It caught the attention of patient advocates who have called on the FDA to put the brakes on the use of robotics, noting innovation can be tantalizing, but it still needs to be tested to ensure it delivers on its promise.

MORE: Breakthrough? New Jersey surgeon performs robotic mastectomies

MORE: Monmouth Medical Center clamps down on robotic mastectomies

Chagares said he welcomed the FDA’s safety communication.

“What I just have to do is sit tight for right now,” Chagares said. “I think as this proceeds and people start to see this is safe and it is equivalent, if not superior, this will open the door to programs being a little more open minded about having procedure in the hospital.”

Robotic devices are more commonly used for patients undergoing colorectal and urology surgeries. They offer surgeons the ability to control the instruments with precision and see their work in three dimensions and high definition.

The procedure increasingly has been used in the U.S. for mastectomies, too. But the FDA stepped in, saying it was concerned that doctors and patients weren’t aware that robotic mastectomies hadn’t been established as safe and effective.

The agency can’t stop surgeons from performing the procedure; it can only offer warnings and ban certain products, experts said.

But it reminded doctors and patients that it hasn’t evaluated the use of robotics for mastectomies. And it encouraged doctors and researchers to gather data to study long-term clinical outcomes.

Michael L. Diamond; @mdiamondapp; 732-643-4038; mdiamond@gannettnj.com