Public Record
Regulatory decisions, public statements, and testimony from 2000 to 2025 at the U.S. Food and Drug Administration's Center for Devices and Radiological Health, and current commentary.
Upcoming
Beahrs Surgical Innovation Summit, Mayo Clinic (November 2026)
Panelist, "When Evidence Isn't Enough: Translating Innovation into Everyday Practice
Current
A Competency-Based Privileging Model for Robotic Platforms
May 2026 · JAMA Surgery 161(7):659–660
Ashar BS, Selber JC. doi:10.1001/jamasurg.2026.1350
Telerobotic surgery and rural access to care
November 2025 · Public Health On Call, Johns Hopkins Bloomberg School of Public Health
A readiness framework for tele-robotic surgery deployment in rural hospitals
2026 · Journal of Robotic Surgery 20(1):223
Recent speaking
End User Panel, A Decade of Learnings with Fermilab, Fermi National Accelerator Laboratory (September 2026)
Collaborative Community on Ophthalmic Innovation, Robotics Session (2026)
Society of Robotic Surgery, plenary (2024, 2025, 2026)
Cleveland Clinic, Robotics in Plastic Surgery Conference (2025, 2026)
Weill Cornell Medicine, Population Health Roundtable (2025)
FDA Record
Surgical Robotics and Device Innovation
Robotic surgery device clearance October 13, 2017 · FDA clears new robotically-assisted surgical device for adult patients
Diabetic foot ulcer device December 28, 2017 · FDA permits marketing of device to treat diabetic foot ulcers
Scalp cooling, expanded indication July 3, 2017 · FDA clears expanded use of cooling cap to reduce hair loss during chemotherapy
Breast Implant Safety and BIA-ALCL
Post-approval study evidence September 14, 2018 · Statement from Binita Ashar, M.D., of the FDA's Center for Devices and Radiological Health on agency's commitment to studying breast implant safety
Signed statement on the agency's position regarding an external analysis of implant post-approval study data.
BIA-ALCL risk communication February 6, 2019 · Statement from Binita Ashar, M.D., of the FDA's Center for Devices and Radiological Health on agency's continuing efforts to educate patients on known risk of lymphoma from breast implants
Signed statement issued ahead of the March 2019 General and Plastic Surgery Devices Panel.
BIOCELL textured implant recall July 24, 2019 · FDA takes action to protect patients from risk of certain textured breast implants; requests Allergan voluntarily recall certain breast implants and tissue expanders from market
Recall request to Allergan on BIA-ALCL risk. Quoted as Director, Office of Surgical and Infection Control Devices.
Prophylactic explantation guidance
February 28, 2024 · CDRH Statement: CDRH's Continued Commitment to Breast Implant Safety
Signed statement responding to a Plastic and Reconstructive Surgery article on BIA-ALCL, setting the agency's position that prophylactic removal of textured implants is not recommended for asymptomatic patients. February 28, 2024
Advisory Committee Service
Presided over FDA General and Plastic Surgery Devices Advisory Committee meetings and workshops, 2013 to 2025.
Breast implants, breast reconstruction, breast cancer (2008, 2019, 2021, 2024)
Robotic surgery devices (2015)
Surgical stapler safety and reclassification (2019)
Dermal fillers and AI-assisted dermatology devices (2015, 2021)
Hemostatic devices and wound dressings (2014, 2016)
Speaking at FDA
Commencement keynote, Carle Illinois College of Medicine (2024)
American Society of Plastic Surgeons Annual Meeting (2019, 2021, 2022)
World Consensus Conference on Breast Implant Safety (2020)
AdvaMed MedTech CDRH Town Hall (2020)
American College of Surgeons Annual Surgical Simulation Summit (2018)
Society of American Gastrointestinal and Endoscopic Surgeons (2016)
Media
The Washington Post · October 27, 2021 FDA requires doctors, manufacturers to disclose breast implant risks to prospective patients
The New York Times · March 21, 2018 More cases are reported of unusual cancer linked to breast implants
These materials are U.S. Government works issued during my federal service and are reproduced by link only. They do not represent FDA endorsement of Clarity Surgical Advisors.