FDA warns against robotically assisted surgical devices for mastectomy

breast cancer awareness ribbon FDA warns against robotically assisted surgical devices for mastectomyDoctors should be cautious when using robotically assisted surgical devices for mastectomy and other cancer-related surgeries that are not approved by the Food and Drug Administration (FDA), the agency said in a Safety Communication.

The robotic devices are not generally used for cancer surgeries, and the safety and effectiveness of these devices for mastectomy have not been established, said Terri Cornelison, M.D., Ph.D., assistant director for the health of women in the FDA’s Center for Devices and Radiological Health.

The Safety Communication comes three weeks after Medscape Medical News published a story in which Hooman Noorchashm, M.D., Ph.D., a surgeon turned patient advocate, raised concerns that the robotic devices for cancer patients undergoing mastectomy could leave behind cancerous tissue and adversely impact survival. If action to curtail this use isn’t taken soon, it could be a public health “disaster” in the making, he said.

For him, the use of robotic devices for mastectomy rings eerily familiar to the use of the power morcellator for hysterectomy or uterine fibroid removal. Power morcellators were a favored option for women undergoing these procedures because they were less invasive and offered a shorter recovery time compared to open surgery. Instead of a large incision as with open surgery, the procedure consisted of just a few small incisions. The power morcellator was used to shred the uterine fibroids or the entire uterus inside the body and remove the tissue through one of the small incisions.

However, for women with undiagnosed uterine cancer, the procedure immediately upstaged their disease and worsened their survival. Noorchashm knows first hand the dangers this procedure caused. His wife, Amy Reed, died of uterine cancer in 2017 following a hysterectomy using a power morcellator.

The FDA in its Safety Communication reminded health care providers that use of robotic devices has not been approved for this use nor have the outcomes been evaluated.

Noorchashm called the FDA’s action “a really robust advisory,” and said it should help slow the “willy nilly” use of the robotics devices for this unapproved indication.

Medscape Medical News
FDA Safety Communication
Righting Injustice