Amy J. Reed Collaborative/HARMS Petitions FDA to Investigate Mayo Clinic for Premature Promotion of Robotic Mastectomy

Professors David A. Simon and Hooman Noorchashm have filed a citizen petition with the FDA requesting that the agency investigate the Mayo Clinic for its promotion of robotic mastectomy using the da Vinci SP Surgical System “Nipple Sparing Mastectomy” outside the ongoing investigational device exemption.

Amy J. Reed Collaborative/HARMS Petitions FDA to Investigate Mayo Clinic for Premature Promotion of Robotic Mastectomy

03.02.26 —Northeastern Law professors David A. Simon and Hooman Noorchashm, who serve as co-directors of the Amy J. Reed Collaborative for Medical Device Safety (AJRC) and Harmed Americans for Reform in Medical-Device Safety (HARMS), have a citizen petition with the U.S. Food and Drug Administration (FDA) requesting that the agency investigate the Mayo Clinic for its promotion of robotic mastectomy using the da Vinci SP Surgical System “Nipple Sparing Mastectomy” outside the ongoing investigational device exemption.

“The Mayo Clinic has prematurely advertised that robotic mastectomy for the treatment of breast cancer is ‘FDA-Approved’ and ‘Evidence-Based’ and is offering this procedure to patients with breast cancer outside of the designated IDE clinical trial,” said Noorchashm, an internationally recognized medical device safety expert. “This premature advertising undermines the existence of the IDE clinical trial, in which Mayo is a participating center, aimed at determining the long-term oncological safety of this procedure. It is terribly surprising and disappointing to see a U.S. healthcare behemoth of the Mayo Clinic’s prestigious stature, undermining patient safety and the rules of evidence-based medicine in such a nonchalant way.”

“The FDA’s decision and Mayo’s marketing raise more questions than they answer,” said Simon, a healthcare law expert. “The FDA should clarify how it reached its decision and why it did so before it had all the data from the ongoing IDE. And Mayo should carefully inform patients of all the potential risks associated with the procedure. It is also crucial that patients understand there is very limited data on oncologic profile of this procedure,”

The Amy J. Reed Collaborative for Medical Device Safety, a joint venture of Northeastern Law and Tufts Medical Center, is a pioneering academic and activist initiative focused on advancing medical device safety through increased awareness, fostering collaboration and facilitating resource sharing among patients and industry experts. Its mission is to drive positive change in the field by advocating for safer medical devices and promoting transparency and accountability. Harmed Americans for Reform in Medical-Device Safety (HARMS) is a 501(c)(3) not-for-profit corporation. Its mission is to advance medical device safety through advocacy, outreach and organizing.

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