FDA updates safety communication for robotically assisted surgical devices used in mastectomy

Regulatory NewsRegulatory News | 24 August 2021 |  By 

The safety and effectiveness of robotically assisted surgical devices has yet to be established in the prevention and treatment of breast cancer, according to an updated safety communication released by the US Food and Drug Administration (FDA).
The agency reiterated that use of these devices has been cleared for procedures such as hysterectomy, prostatectomy, and colectomy based on data from 30-day patient follow-up. However, robotically assisted surgical (RAS) devices have not been evaluated as safe or effective based on outcomes of overall survival, recurrence, and disease-free survival in cancer.
“The FDA continues to expect study sponsors to obtain FDA approval of investigational device exemptions (IDE) for studies of RAS devices intended for use in mastectomy procedures for the prevention or treatment of breast cancer,” FDA wrote in the safety communication. “Studies with a potential for significant risk to study subjects, such as the use of RAS devices for mastectomy procedures or in the prevention or treatment of breast cancer, may only be conducted under an approved IDE.”
It is unclear whether FDA will eventually require manufacturers to track these outcomes as part of clinical trials performed under an IDE. FDA had previously issued a safety communication in 2019 where they anticipated RAS device effectiveness in mastectomy or for prevention of treatment of cancer “would be supported by specific clinical outcomes, such as local cancer recurrence, disease-free survival, or overall survival at time periods much longer than 30 days.”
In the 2019 safety communication, FDA also noted outcomes data published in the literature comparing RAS devices and conventional surgical approaches in cancer treatment showed either a lower rate of survival for patients who underwent surgery with RAS devices, or no evidence for improving long-term survival. (RELATED: FDA Urges Caution in Use of Robotic Surgical Devices for Cancer-Related Procedures, Regulatory Focus 28 February 2019)
While FDA did not name a specific company, the agency said it is aware clinical studies are currently underway that evaluate the effectiveness of RAS devices in performing mastectomies to treat or prevent breast cancer “without the FDA oversight required for such significant risk studies.” The updated safety communication follows an investigation by Medscape that found some single-arm studies evaluating nipple-sparing mastectomy using RAS devices at Ohio State University Comprehensive Cancer Center, University of Texas Southwestern Medical Center, and a trial sponsored by Intuitive Surgical do not include cancer outcomes or don’t list them as primary outcome measures.
“The FDA is working to assure device manufacturers, investigators, clinical study sponsors, and IRBs are aware of the FDA’s expectations for an investigational device exemption and clinical endpoints for use of RAS devices for the prevention or treatment of patients with cancer,” the agency said in its safety communication.
In a statement posted on its website, Intuitive, developer of the da Vinci Xi Surgical System, said the company recognizes and supports FDA’s role in public health and clinical trial oversight and follows the agency’s regulation and guidance. Additionally, “Intuitive’s ongoing US clinical investigation on the safety and effectiveness of robotic-assisted surgery in prophylactic nipple-sparing mastectomy has been approved by the FDA under an Investigational Device Exemption,” the company said.
Intuitive emphasized in its statement that FDA’s safety communication is specific to RAS devices used in mastectomy and not for other surgical procedures for which the 30-day patient follow-up requirement has been established.
“The FDA has not evaluated robotic-assisted surgical devices for the prevention and treatment of cancer based on cancer-related outcomes such as overall survival, recurrence, and disease-free survival,” the company wrote. “Intuitive believes that any treatment or medical intervention should be informed by discussions between surgeons, clinicians and patients that consider all options, the associated risks and benefits, the surgeon’s or clinician’s own training, experience and outcomes.”
UPDATE: Caution with Robotically-Assisted Surgical Devices in Mastectomy: FDA Safety Communication

Caution When Using Robotically-Assisted Surgical Devices in Women's Health including Mastectomy and Other Cancer-Related Surgeries: FDA Safety Communication


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