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General and Plastic Surgery Devices Panel March 25, 2019 Transcript

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General and Plastic Surgery Devices Panel March 25, 2019 Transcript 1 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 25, 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 2 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 KAVEETA VASISHT, M.D., Pharm.D. Acting Associate Commissioner and Deputy Director Office of Women's Health Office of the Commissioner STEPHANIE CACCOMO Press Contact FDA PRESENTERS: STEVEN NAGEL, M.D., FACS Division of Surgical Devices Office of Device Evaluation NILSA LOYO-BERRÍOS, M.Sc., Ph.D. Deputy Director, Post-Approval Studies Division of Epidemiology Office of Surveillance and Biometrics KAREN NAST, M.S., RN Division of Postmarket Surveillance Office of Surveillance and Biometrics MICHAEL DeLONG, M.D. Division of Surgical Devices Office of Device Evaluation Free State Reporting, Inc. 1378 Cape St. Claire Road Annapolis, MD 21409 (410) 974-0947 3 INVITED SPEAKERS: JOSEF ZÜNDORF, M.D. German Federal Institute for Drugs and Medical Devices Bonn, Germany AMANDA JONES, M.Sc. Medical Devices Bureau Health Canada JAMEE COOK Breast Implant Victim Advocacy ANDREA PUSIC, M.D., M.H.S., FACS, FRCSC Chief, Division of Plastic and Reconstructive Surgery, Brigham and Women’s Hospital Joseph E. Murray Professor of Surgery, Harvard Medical School Director, Patient-Reported Outcomes, Value & Experience (PROVE) Center President, The Plastic Surgery Foundation MARK W. CLEMENS, M.D., FACS Associate Professor MD Anderson Cancer Center JAN WILLEM COHEN TERVAERT, M.D., Ph.D. Director, Division of Rheumatology University of Alberta Edmonton, Canada DIANA ZUCKERMAN, Ph.D. President, National Center for Health Research Free State Reporting, Inc. 1378 Cape St. Claire Road Annapolis, MD 21409 (410) 974-0947 4 INDUSTRY PRESENTERS: STEPHANIE MANSON BROWN, M.D. Vice President, Clinical Development Allergan RAINA DAURIA, M.S. Vice President, Regulatory Affairs Mentor Worldwide, LLC JoANN KUHNE, M.S.N., RAC Vice President, Regulatory Affairs and Quality Assurance Sientra, Inc. ROSALYN d'INCELLI, CCRP Vice President, Clinical and Medical Affairs Sientra, Inc. ROBERT S. HAMAS, M.D. Founder/CEO/President Ideal Implant, Inc. INDUSTRY ADVISORS: JOHN CANADY, M.D. Medical Director Mentor Worldwide, LLC JASON HAMMER, M.D., D.D.S. Medical Director/Global Medical Lead Allergan KELLY CARTY, M.S. Director, Regulatory Affairs Allergan MARK JEWELL, M.D. Consultant Allergan Free State Reporting, Inc. 1378 Cape St. Claire Road Annapolis, MD 21409 (410) 974-0947 5 OPEN PUBLIC COMMENT SPEAKERS: WILLIAM P. ADAMS, JR., M.D. Education Commissioner, The Aesthetic Society Program Director and Associate Professor of Plastic Surgery, UT Southwestern Medical Center Chief Medical Officer, The Plastic Surgery Channel CHRISTINA AVILA Breast Implant Recipient ANU BAJAJ, M.D. Plastic Surgeon Breast Implant Recipient BRADLEY CALOBRACE, M.D. Clinical Professor of Surgery University of Louisville JENNIFER COOK Breast Implant Recipient DAWN CRISS Breast Implant Recipient NICOLE DARUDA Breast Implant Recipient HOLLY DAVIS Breast Implant Recipient LARA DEVGAN, M.D., M.P.H. Plastic Surgeon Chief Medical Officer, RealSelf (Read by KAROLINE NOWILLO, M.D.) TERRI DIAZ Breast Implant Recipient GLORIA DUDA, M.D. Plastic Surgeon CLAIRE DUGGAL, M.D. Plastic Surgeon Breast Implant Recipient JULIE ELLIOTT Breast Implant Recipient Free State Reporting, Inc. 1378 Cape St. Claire Road Annapolis, MD 21409 (410) 974-0947 6 TERRI McGREGOR Breast Implant Recipient DANIELLE VALORAS, MPAS, PA-C Physician's Assistant Breast Implant Recipient MARY GINGRASS, M.D. Assistant Clinical Professor Vanderbilt University School of Medicine Breast Implant Recipient FOAD NAHAI, M.D. Plastic Surgeon Editor-In-Chief, Aesthetic Surgery Journal The Aesthetic Society KRISTI EVANS Breast Implant Recipient BARRY FERNANDO, M.D. CEO, Anzu MICHELLE FORNEY Breast Implant Recipient NANCY GALLEGOS Breast Implant Recipient DANIELLE DeLUCA-PYTELL, M.D. Plastic Surgeon SYBIL NIDEN GOLDRICH Breast Implant Recipient GRETCHEN GOODELL BRIDGE Breast Implant Recipient ASHLEY GORDON, M.D. Plastic Surgeon Breast Implant Recipient CHELSEA HAGOPIAN, D.N.P., M.S.N. Nurse Practitioner MELINDA HAWS, M.D. Plastic Surgeon Chair, ASAPS BII Task Force The Aesthetic Society Breast Implant Recipient Free State Reporting, Inc. 1378 Cape St. Claire Road Annapolis, MD 21409 (410) 974-0947 7 RAYLENE HOLLRAH Breast Implant Recipient TARA HOPKO Breast Implant Recipient MEREDITH KILMER Breast Implant Recipient DAVID SIEBER, M.D. Plastic Surgeon Chair, Grant Committee Aesthetic Surgery Education and Research Foundation KIMBERLY PLATT Breast Implant Recipient JENNIFER HARRINGTON, M.D. Plastic Surgeon Medical Director, Sientra MARIE JOBSON Breast Implant Recipient Sientra Clinical Trial Participant MARIA GMITRO Breast Implant Recipient LAURA BOWDEN Breast Implant Recipient Free State Reporting, Inc. 1378 Cape St. Claire Road Annapolis, MD 21409 (410) 974-0947 8 INDEX PAGE CALL TO ORDER AND OPENING REMARKS - Frank R. Lewis, Jr., M.D. 12 INTRODUCTION OF THE COMMITTEE 12 CONFLICT OF INTEREST STATEMENT - Patricio G. Garcia, M.P.H., CDR, USPHS 15 NATIONAL AND INTERNATIONAL PERSPECTIVES, MEETING SCOPE, AND THE PATIENT PERSPECTIVE OPENING REMARKS - Binita Ashar, M.D. 18 WELCOME FROM FDA'S OFFICE OF WOMEN'S HEALTH - Kaveeta Vasisht, M.D., Pharm.D. 22 EUROPEAN UNION TASK FORCE STATEMENT - Josef Zndorf, M.D. 23 ONGOING REGULATORY ACTIONS AND ACTIVITIES - BREAST IMPLANTS - Amanda Jones, M.Sc. 27 BREAST AUGMENTATION AND RECONSTRUCTION - CLINICAL OVERVIEW - Steven Nagel, M.D., FACS 30 WHAT PATIENTS WHO HAVE HAD BREAST IMPLANTS THINK THAT PATIENTS CONTEMPLATING BREAST IMPLANTS SHOULD KNOW - Jamee Cook 33 STATUS OF INDUSTRY SPONSORED BREAST IMPLANT STUDIES AND REPORTS OF BREAST IMPLANT ILLNESS (BII) AND BIA-ALCL OVERVIEW OF FDA MANDATED POST-APPROVAL STUDIES - Nilsa Loyo-Berrios, M.Sc., Ph.D. 46 INDUSTRY PRESENTATIONS ON PAS STATUS/BREAST IMPLANT ILLNESS/BIA-ALCL Allergan - Stephanie Manson Brown, M.D. 49 Mentor Worldwide, LLC - Raina Dauria, M.S. 54 Sientra, Inc. - JoAnn Kuhne, M.S.N., RAC and Rosalyn d'Incelli, CCRP 59 Ideal Implant, Inc. - Robert S. Hamas, M.D. 66 CLARIFYING QUESTIONS FROM THE PANEL 70 Free State Reporting, Inc. 1378 Cape St. Claire Road Annapolis, MD 21409 (410) 974-0947 9 INDEX PAGE FDA PRESENTATION ON BII SYMPTOMS AND BIA-ALCL MEDICAL DEVICE REPORTING (MDR) - Karen Nast, M.S., RN 77 FDA PRESENTATION ON BREAST IMPLANT ILLNESS (BII) FROM POST-APPROVAL STUDIES (PAS) - Michael DeLong, M.D. 79 CLARIFYING QUESTIONS FROM THE PANEL 84 OPEN PUBLIC COMMENT William P. Adams, Jr., M.D. 97 Christina Avila 98 Anu Bajaj, M.D. 100 Bradley Calobrace, M.D. 101 Jennifer Cook 104 Dawn Criss 105 Nicole Daruda 107 Holly Davis 109 Lara Devgan, M.D., M.P.H. (read by Karoline Nowillo, M.D.) 111 Terri Diaz 113 Gloria Duda, M.D. 114 Claire Duggal, M.D. 116 Julie Elliott 118 Terri McGregor 119 Danielle Valoras 121 Mary Gingrass, M.D. 123 Foad Nahai, M.D. 124 Free State Reporting, Inc. 1378 Cape St. Claire Road Annapolis, MD 21409 (410) 974-0947 10 INDEX PAGE THE USE OF REGISTRIES TO UNDERSTAND BII AND BIA-ALCL U.S. NATIONAL BREAST IMPLANT REGISTRY (NBIR) AND PATIENT REGISTRY AND OUTCOMES FOR BREAST IMPLANTS AND ANAPLASTIC LARGE CELL LYMPHOMA ETIOLOGY AND EPIDEMIOLOGY (PROFILE) STATUS UPDATE - Andrea Pusic, M.D., M.H.S., FACS, FRCSC 128 BREAST IMPLANT ASSOCIATED-ALCL: MD ANDERSON CANCER CENTER EXPERIENCE - Mark W. Clemens, M.D., FACS 137 AUTOIMMUNE SYNDROME INDUCED BY ADJUVANTS (ASIA) AND BII - Jan Willem Cohen Tervaert, M.D., Ph.D. 145 SYMPTOMS AND DIAGNOSES OF 449 WOMEN BEFORE AND AFTER EXPLANT SURGERY: IMPLICATIONS FOR BREAST IMPLANT ILLNESS, REGISTRIES, AND INFORMED CONSENT - Diana Zuckerman, Ph.D. 155 CLARIFYING QUESTIONS FROM THE PANEL 161 OPEN PUBLIC COMMENT Kristi Evans 171 Barry Fernando, M.D. 173 Michelle Forney 174 Nancy Gallegos 176 Danielle DeLuca-Pytell, M.D. 178 Sybil Niden Goldrich 179 Gretchen Goodell Bridge 181 Ashley Gordon, M.D. 183 Chelsea Hagopian, D.N.P., M.S.N. 184 Melinda Haws, M.D. 186 Raylene Hollrah 187 Tara Hopko 189 Free State Reporting, Inc. 1378 Cape St. Claire Road Annapolis, MD 21409 (410) 974-0947 11 INDEX PAGE Meredith Kilmer 190 David Sieber, M.D. 192 Kimberly Platt 194 Jennifer Harrington, M.D. 196 Marie Jobson 197 Maria Gmitro 198 Laura Bowden 200 RECOMMENDED NEXT STEPS/PANEL DELIBERATION Questions 1 and 2 203 Question 3 225 Question 4 243 DAY 1 ADJOURNS 249 Free State Reporting, Inc. 1378 Cape St. Claire Road Annapolis, MD 21409 (410) 974-0947 12 M E E T I N G (8:00 a.m.) DR.
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