Devices

Petition Seeks Restrictions on Robotic Surgical Device

A patient safety group has petitioned FDA urging it to rescind or narrow a recent device clearance that allows use of a robotic surgical system in nipple-sparing mastectomy procedures, arguing that long-term cancer outcomes have not been established. The petition asks the agency to immediately amend or withdraw 510(k) clearance (K252675), granted 12/15/2025, for Intuitive Surgical’s da Vinci SP Surgical System. The clearance added “nipple sparing mastectomy (NSM) procedures” to the device’s indications for use.

Petitioners contend that the agency should remove NSM from the labeling until long-term oncologic safety and non-inferiority to conventional open surgery are demonstrated through completed clinical trials measuring recurrence rates, disease-free survival, and overall survival.

Beyond rescinding or amending the clearance, the petition asks FDA to restore two previously issued safety communications — from 2/2019 and 8/2021 — that cautioned against the use of robotically assisted surgical devices in mastectomy for cancer prevention or treatment. Those communications were removed from FDA’s Web site in 2024.

The filing also calls on the agency to issue updated guidance clarifying that long-term oncologic safety for robotic NSM remains unproven, to consider post-market requirements if the clearance stands, and to conduct an internal review of the clearance process. The petition further requests referral of the matter to the Office of Inspector General.

At the core of the petition is the assertion that FDA cleared the NSM indication based primarily on bench testing, cadaver data, and short-term perioperative outcomes rather than long-term cancer control endpoints. “In surgical oncology, long-term recurrence and survival outcomes are the definitive measure of safety and effectiveness,” the petition argues, maintaining that short-term metrics such as complication rates or margin status do not reliably predict long-term cancer outcomes.

The petition also points to ongoing trials evaluating robotic NSM, including a multicenter randomized study comparing the da Vinci SP system with open surgery, and contends that granting 510(k) clearance while such trials are still underway undermines the protective purpose of the IDE framework.

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