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General and Plastic Surgery Devices Panel

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General and Plastic Surgery Devices Panel 252 UNITED STATES OF AMERICA DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION + + + CENTER FOR DEVICES AND RADIOLOGICAL HEALTH MEDICAL DEVICES ADVISORY COMMITTEE + + + GENERAL AND PLASTIC SURGERY DEVICES PANEL + + + March 26, 2019 8:00 a.m. FDA White Oak Campus Building #31, Great Room 10903 New Hampshire Avenue Silver Spring, Maryland PANEL MEMBERS: FRANK R. LEWIS, JR., M.D. Chair ANN MARILYN LEITCH, M.D. Voting Member KAREN E. BURKE, M.D., Ph.D. Voting Member MARY H. McGRATH, M.D., M.P.H. Temporary Non-Voting Member KARLA V. BALLMAN, Ph.D. Temporary Non-Voting Member RHONDA K. ENGEBRETSON, B.S., RT(R)(M)(CT), CN-BI Temporary Non-Voting Member ELAINE S. JAFFE, M.D. Temporary Non-Voting Member REBECCA ROGERS, M.D. Temporary Non-Voting Member PIERRE M. CHEVRAY, M.D., Ph.D. Temporary Non-Voting Member MARC E. LIPPMAN, M.D. Temporary Non-Voting Member JEFFREY D. WHITE, M.D. Temporary Non-Voting Member COLLEEN M. GALLAGHER, Ph.D., FACHE Temporary Non-Voting Member STEPHEN LI, Ph.D. Temporary Non-Voting Member HOWARD SANDLER, M.D. Temporary Non-Voting Member BENJAMIN O. ANDERSON, M.D. Temporary Non-Voting Member Free State Reporting, Inc. 1378 Cape St. Claire Road Annapolis, MD 21409 (410) 974-0947 253 LYNN A. PAWELSKI, M.B.A. Industry Representative RACHEL S. BRUMMERT Consumer Representative NATALIE COMPAGNI PORTIS, Psy.D. Patient Representative PATRICIO G. GARCIA, M.P.H. , CDR, USPHS Designated Federal Officer This transcript has not been edited or corrected but appears as received from the commercial transcribing service. Accordingly, the Food and Drug Administration makes no representation as to its accuracy. FDA REPRESENTATIVES: BINITA ASHAR, M.D. Director, Division of Surgical Devices Office of Device Evaluation CYNTHIA CHANG, Ph.D. Chief, Plastic and Reconstructive Surgery Devices Branch 2 Division of Surgical Devices Office of Device Evaluation STEPHANIE CACCOMO Press Contact FDA PRESENTERS: MICHAEL DeLONG, M.D. Division of Surgical Devices Office of Device Evaluation JOSEPH NIELSEN, Ph.D. Division of Surgical Devices Office of Device Evaluation DAVID KRAUSE, Ph.D. Deputy Director I, Division of Surgical Devices Office of Device Evaluation SUNG W. YOON, M.D., FACS Division of Surgical Devices Office of Device Evaluation Free State Reporting, Inc. 1378 Cape St. Claire Road Annapolis, MD 21409 (410) 974-0947 254 INVITED SPEAKERS: EDWIN G. WILKINS, M.D., M.S. Professor of Surgery, Section of Plastic Surgery University of Michigan STAMATIA V. DESTOUNIS, M.D., FACR American College of Radiology (ACR) Elizabeth Wende Breast Care, LLC JONATHAN M. GREEN, M.D., M.B.A. Director, Office of Human Subjects Research Protections National Institutes of Health LYNN JEFFERS, M.D., FACS Past Vice President, Health Policy and Advocacy, ASPS W. GRANT STEVENS, M.D. President, The American Society for Aesthetic Plastic Surgery (ASAPS) Board Member, Aesthetic Surgery Education & Research Foundation (ASERF) INDUSTRY PRESENTERS: STEPHANIE MANSON BROWN, M.D. Vice President, Clinical Development Allergan RAINA DAURIA, M.S. Vice President, Regulatory Affairs Mentor Worldwide, LLC ROSALYN d'INCELLI, CCRP Vice President, Clinical and Medical Affairs Sientra, Inc. ROBERT S. HAMAS, M.D. Founder/CEO/President Ideal Implant, Inc. Free State Reporting, Inc. 1378 Cape St. Claire Road Annapolis, MD 21409 (410) 974-0947 255 OPEN PUBLIC COMMENT SPEAKERS: MARISA LAWRENCE, M.D. Plastic Surgeon DANIELLE LeBLANC, M.D. Plastic Surgeon (Read by SUE DYKEMAN) KYNDRA LEE Independent Aesthetic Practice/Software Consultant LISA LYNN SOWDER, M.D. Plastic Surgeon JULIE LYKINS Breast Implant Recipient WILLIAM LYKINS Husband of Breast Implant Recipient PATRICIA McGUIRE, M.D. Plastic Surgeon CATHY McLAIN Breast Implant Recipient EMILY McLAUGHLIN, M.D. Plastic Surgeon Breast Implant Recipient JOAN MELENDEZ Founder, TeamEHR, Inc. COLLEEN McCARTHY, M.D. Plastic Surgeon Memorial Sloan Kettering Cancer Center NINA NAIDU, M.D. Plastic Surgeon National Secretary, International Society of Aesthetic Plastic Surgeons CLAUDIA NUÑEZ-EDDY Project Manager, Insurance Assistance Project National Center for Health Research TROY PITTMAN, M.D. Plastic Surgeon Free State Reporting, Inc. 1378 Cape St. Claire Road Annapolis, MD 21409 (410) 974-0947 256 KERRI REAVIS Breast Implant Recipient (Read by LEIGH HOPE FOUNTAIN) JENNIFER ROBB Breast Implant Recipient LISA ROHLAND Breast Implant Recipient LISA SCHLAGER Facing Our Risk of Cancer Empowered Breast Implant Recipient ANNE ZIEGENHORN Cofounder, The Implant Truth Survivors Committee Breast Implant Recipient SCOT BRADLEY GLASBERG, M.D., FACS Plastic Surgeon American College of Surgeons Consultant for Allergan MICHELE A. SHERMAK, M.D., FACS Plastic Surgeon CAROL SMALL Breast Implant Recipient VARUNA SRINIVASAN, M.B.B.S., M.P.H. Patient, Consumer, and Public Health Coalition MADRIS TOMES, M.B.A. Founder/CEO, Device Events ROBYN TOWT Breast Implant Recipient CARRIE TURCO Breast Implant Recipient BRUCE VAN NATTA, M.D. Plastic Surgeon Board Member, Aesthetic Surgery and Education Research Foundation Medical Advisor to Galatea Medical ROXANE VERMELAND Breast Implant Recipient Free State Reporting, Inc. 1378 Cape St. Claire Road Annapolis, MD 21409 (410) 974-0947 257 ROBERT WHITFIELD, M.D. Plastic Surgeon President Elect, Aesthetic Surgery Education and Research Foundation (ASERF) LAURIE WIEDER Breast Implant Recipient THERESA WILLIAMS-MOTT Breast Implant Recipient SIDNEY WOLFE, M.D. Founder/Senior Advisor, Health Research Group Public Citizen APRIL ZIMMERMAN Breast Implant Recipient DIANA ZUCKERMAN, Ph.D. President, National Center for Health Research KERI McELROY Breast Implant Recipient LALITHA JACOB, M.D. Breast Implant Recipient KAMAKSHI ZEIDLER, M.D. Plastic Surgeon STEVEN TEITELBAUM, M.D. Plastic Surgeon Clinical Professor of Plastic Surgery, UCLA (Read by SARAH WILBURN) MICHELLE MANAGHAN, M.D. Plastic Surgeon Chair, Health Policy Committee, American Society of Plastic Surgeons AKASH CHANDAWARKAR, M.D. Plastic Surgeon LAURIE A. CASAS, M.D., FACS Plastic Surgeon Clinical Professor of Surgery, The University of Chicago Medicine Clinical Section Editor, Aesthetic Surgery Journal Free State Reporting, Inc. 1378 Cape St. Claire Road Annapolis, MD 21409 (410) 974-0947 258 INDEX PAGE CALL TO ORDER AND OPENING REMARKS - Frank R. Lewis, Jr., M.D. 262 INTRODUCTION OF THE COMMITTEE 263 CONFLICT OF INTEREST STATEMENT - Patricio G. Garcia, M.P.H., CDR, USPHS 265 DAY 1 SUMMARY AND OVERVIEW OF DAY 2 - Cynthia Chang, Ph.D. 268 USE OF SURGICAL MESH IN BREAST RECONSTRUCTION AND MASTOPEXY THE USE OF SURGICAL MESH IN BREAST RECONSTRUCTION AND MASTOPEXY – CLINICAL OVERVIEW - Michael DeLong, M.D. 272 THE REGULATION OF SURGICAL MESH FOR BREAST INDICATIONS - Joseph Nielsen, Ph.D. 277 ACELLULAR DERMAL MATRIX IN IMMEDIATE IMPLANT-BASED BREAST RECONSTRUCTION: FINDINGS FROM THE MASTECTOMY RECONSTRUCTION OUTCOMES CONSORTIUM (MROC) STUDY - Edwin G. Wilkins, M.D., M.S. 279 CLARIFYING QUESTIONS FROM THE PANEL 286 OPEN PUBLIC COMMENT Marisa Lawrence, M.D. 301 Danielle LeBlanc, M.D. (read by Sue Dykeman) 302 Kyndra Lee 304 Lisa Lynn Sowder, M.D. 305 Julie Lykins 306 William Lykins 308 Patricia McGuire, M.D. 310 Cathy McLain 311 Emily McLaughlin, M.D. 312 Joan Melendez 314 Colleen McCarthy, M.D. 316 Free State Reporting, Inc. 1378 Cape St. Claire Road Annapolis, MD 21409 (410) 974-0947 259 INDEX PAGE Nina Naidu, M.D. 318 Claudia Nuez-Eddy 319 Troy Pittman, M.D. 321 Kerri Reavis (Read by Leigh Hope Fountain) 323 Jennifer Robb 324 Lisa Rohland 326 Lisa Schlager 327 Anne Ziegenhorn 329 Scot Bradley Glasberg, M.D., FACS 331 RECOMMENDED NEXT STEPS/PANEL DELIBERATIONS Question 4 (cont.) 333 Question 5 354 UTILITY OF MRI FOR BREAST IMPLANT SILENT RUPTURE SCREENING, PATIENT EDUCATION AND INFORMED CONSENT THE HISTORY OF SILENT RUPTURE SCREENING AND INFORMED CONSENT FOR BREAST IMPLANTS - David Krause, Ph.D. 386 INDUSTRY PRESENTATIONS ON CORE STUDY MRI DATA/PATIENT EDUCATION AND INFORMED CONSENT Allergan - Stephanie Manson Brown, M.D. 389 Mentor Worldwide, LLC - Raina Dauria, M.S. 393 Sientra, Inc. - Rosalyn d'Incelli 396 Ideal Implant, Inc. - Robert S. Hamas, M.D. 399 Free State Reporting, Inc. 1378 Cape St. Claire Road Annapolis, MD 21409 (410) 974-0947 260 INDEX PAGE FDA PRESENTATIONS ON PATIENT EDUCATION & INFORMED CONSENT AND CORE STUDY MRI DATA - Sung W. Yoon, M.D. 403 AMERICAN COLLEGE OF RADIOLOGY: CRITERIA FOR BREAST IMPLANT MRI - Stamatia V. Destounis, M.D., FACR 407 INFORMED CONSENT - Jonathan M. Green, M.D., M.B.A. 413 ASPS/PSF COMMITMENT TO PATIENT EDUCATION, SAFETY AND RESEARCH - Lynn Jeffers, M.D., FACS 417 THE ASAPS/ASERF'S COMMITMENT TO DATA COLLECTION AND SCIENTIFIC DATA-DRIVEN RESEARCH TO SUPPORT PHYSICIAN EDUCATION, PATIENT ACCESS AND CHOICE - W. Grant Stevens, M.D. 422 CLARIFYING QUESTIONS FROM THE PANEL 426 OPEN PUBLIC COMMENT Michele A. Shermak, M.D., FACS 436 Carol Small 437 Varuna Srinivasan, M.B.B.S., M.P.H. 439 Madris Tomes, M.B.A. 440 Robyn Towt 442 Carrie Turco 444 Bruce Van Natta, M.D. 445 Roxane Vermeland 447 Robert Whitfield, M.D. 449 Laurie Wieder 450 Theresa Williams-Mott 452 Sidney Wolfe, M.D. 454 April Zimmerman 455 Diana Zuckerman, Ph.D. 457 Free State Reporting, Inc. 1378 Cape St. Claire Road Annapolis, MD 21409 (410) 974-0947 261 INDEX PAGE Keri McElroy 459 Lalitha Jacob, M.D. 461 Kamakshi Zeidler, M.D. 462 Steven Teitelbaum, M.D. (read by Sarah Wilburn) 464 Michelle Managhan, M.D. 465 Akash Chandawarkar, M.D. 467 Laurie A. Casas, M.D. , FACS 468 RECOMMENDED NEXT STEPS/PANEL DELIBERATIONS Question 6 469 Question 7 476 Question 8 497 DAY 2 ADJOURNS 502 Free State Reporting, Inc. 1378 Cape St. Claire Road Annapolis, MD 21409 (410) 974-0947 262 M E E T I N G (8:00 a.m.) DR. LEWIS: Good morning. I would like to call this meeting together. It's a meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee. I'm Dr. Frank Lewis, the Chair of the Panel. I'm a trauma surgeon and a general surgeon by training and a recently retired executive director of the American Board of Surgery.
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