BinitaShahAsharMD, MBA, FACS

General Surgery • Silver Spring, MD

Director, Office of Surgical and Infection Control Devices US FDA

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Office
10903 New Hampshire Ave
Hfz-410
Silver Spring, MD 20993
Phone+1 301-796-6385
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Education & Training

Cleveland Clinic FoundationResidency, Surgery, 1993 - 1998
Ohio State University College of MedicineClass of 1993

Certifications & Licensure

MD State Medical License 1998 - 2025
VA State Medical License 2013 - 2024
American Board of Surgery Surgery

Awards, Honors, & Recognition

Fellow (FACS) American College of Surgeons

Publications & Presentations

PubMed

Commentary on: US FDA Patient Decision Checklist for Breast Implants: Results of a Survey to Members of The Aesthetic Society, April 2022.
Binita S Ashar> ;Aesthetic Surgery Journal. 2023 Feb 3
48 citations
Best Practices Guideline for the Pathologic Diagnosis of Breast Implant-Associated Anaplastic Large-Cell Lymphoma.
Elaine S. Jaffe, Binita S. Ashar, Mark W. Clemens, Andrew L. Feldman, Philippe Gaulard, Roberto N. Miranda, Aliyah R. Sohani, Timothy Stenzel, Sung W. Yoon> ;Journal of Clinical Oncology. 2020 Feb 11
Breast Implant-Associated Anaplastic Large Cell Lymphoma.
Binita S. Ashar, Sung W. Yoon, Steven Nagel> ;American Family Physician. 2020 Jan 1
84 citations
Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma Etiology and Epidemiology (PROFILE): Initial Report of Findings, 2012-2018.
Colleen M. McCarthy, Nilsa Loyo-Berrios, Ali A Qureshi, Erin Mullen, Gayle M. Gordillo, Andrea L Pusic, Binita S. Ashar, Katie Sommers, Mark W. Clemens> ;Plastic and Reconstructive Surgery. 2019 Mar 1
10 citations
Assessing the Risks of Breast Implants and FDA's Vision for the National Breast Implant Registry.
Binita S. Ashar> ;Annals of Surgery. 2018 Sep 1
3 citations
The US Food and Drug Administration's Approach for Safe Innovation of Medical Devices in Dermatology.
Cynthia J. Chang, Binita S. Ashar, Laura N. Marquart> ;JAMA Dermatology. 2018 Mar 1
Performing clinical studies involving hernia mesh devices: what every investigator should know about the FDA investigational device exemption (IDE) process.
Ashar, B. S.,Dang, J. M.,Krause, D.,Luke, M. C.> ;Hernia. 2011 Sep 13
21 citations
Radiofrequency identification technology in health care: benefits and potential risks.
Binita S. Ashar, Ann Ferriter> ;JAMA. 2007 Nov 21
88 citations
Trocar-associated injuries and fatalities: an analysis of 1399 reports to the FDA.
Janie Fuller, Binita S. Ashar, Julia Carey-Corrado> ;Journal of Minimally Invasive Gynecology. 2005 Aug 1
1 citations
The critical path to new medical devices.
Binita S. Ashar, Mark Barnett, Daniel Schultz> ;Biomedical Instrumentation & Technology. 2005 Jul 1
Surgical technology: a perspective from the FDA.
Binita S. Ashar, Daniel Schultz> ;Bulletin of the American College of Surgeons. 2003 Mar 1
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Press Mentions

FDA Orders New Restrictions, Stronger Warnings for Breast ImplantsOctober 28th, 2021
Health Highlights: April 1, 2021April 1st, 2021
FDA Authorizes First Surgical Robot to Help with Transvaginal HysterectomiesMarch 1st, 2021
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Professional Memberships

American College of Surgeons - ACS
Member

BinitaShahAsharMD, MBA, FACS

Dr. Ashar is on Doximity

Education & Training

Certifications & Licensure

Awards, Honors, & Recognition

Publications & Presentations

Press Mentions

Professional Memberships

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