Devices

Publish Guidance on Robotic Mastectomy: Petition

Harmed Americans for Reform in Medical Device Safety (HARMS), an organization with no Internet presence and no information available in a Google search, is petitioning FDA to evaluate new studies and publish guidance or public information on robotic mastectomy to treat breast cancer. The petition, which was signed by cardiothoracic surgeon and patient advocate Hooman Noorchashm, who is listed as the HARMS president, also calls on the agency to update and make publicly available previous safety communications.

The petition discusses a 2019 agency safety communication expressing concern that healthcare providers and patients may not be aware that the safety and effectiveness of robotic devices had not been established for use in mastectomies or the prevention or treatment of cancer. It also cites an 8/20/2021 safety communication reiterating that the safety and effectiveness of robotically assisted surgical devices for use in mastectomies or the prevention or treatment of breast cancer had not been established. The petition says the communications were removed from the FDA Web site sometime in 2024 and asks that they be immediately restored.

Noorchashm writes about two recent retrospective studies from South Korea on the use of robotically-assisted devices for 1,300 mastectomies and asks that FDA evaluate them as he believes they do not adequately address the safety and effectiveness concerns and the authors disclose significant conflicts of interest.

“FDA should specifically cite and explain the studies described in the petition and explain what action sponsors should take and list prohibited sponsor activities that may include off-label promotional activities,” the petition concludes. “FDA should also update its Web site and repost the original 2019 and 2021 safety communication and publish the results of its new analysis of these studies.”

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