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Surgical Mesh for Transvaginal Repair of Pelvic Organ Prolapse in the Anterior Vaginal Compartment

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Surgical Mesh for Transvaginal Repair of Pelvic Organ Prolapse in the Anterior Vaginal Compartment Surgical Mesh for Transvaginal Repair of Pelvic Organ Prolapse in the Anterior Vaginal Compartment FDA Executive Summary Obstetrics and Gynecology Devices Panel February 12, 2019 Table of Contents I. Introduction .......................................................................................................................................... 4 II. Clinical Background on Pelvic Organ Prolapse .................................................................................... 5 A. Overview of Condition ..................................................................................................................... 5 B. Prevalence ........................................................................................................................................ 7 C. Risk Factors ....................................................................................................................................... 8 D. Treatment ......................................................................................................................................... 8 E. Professional Society Positions ......................................................................................................... 8 F. Professional Society Guidelines Regarding Training ..................................................................... 10 III. Device Description .......................................................................................................................... 10 IV. Regulatory History .......................................................................................................................... 11 A. FDA Review of Surgical Mesh Indicated for POP Through the 510(k) Pathway ........................... 11 B. 2008 MAUDE Database Search and Public Health Notification .................................................... 11 C. 2011 Safety Communication and White Paper ............................................................................. 11 D. 2011 Panel Meeting ....................................................................................................................... 12 E. Postmarket Surveillance Studies ................................................................................................... 12 F. Proposed and Final Reclassification Orders .................................................................................. 13 G. Regulatory Actions Outside of the United States ......................................................................... 13 V. FDA Review of Published Literature .................................................................................................. 14 A. Effectiveness of Mesh Placed in the Anterior Vaginal Compartment to Treat POP .................... 15 1. Overview of Effectiveness Results .............................................................................................. 15 2. Effectiveness Results by Timepoint ............................................................................................ 17 3. Effectiveness Results by Mesh Material ..................................................................................... 18 4. Effectiveness Results by Brand ................................................................................................... 18 B. Safety of Mesh Placed in the Anterior Vaginal Compartment to Treat POP ............................... 18 1. Overview of Safety Results ......................................................................................................... 19 2. Mesh Erosion/Exposure .............................................................................................................. 19 3. De Novo SUI ................................................................................................................................ 21 4. De Novo Dyspareunia ................................................................................................................. 21 5. Other Adverse Events ................................................................................................................. 21 6. Safety Results by Timepoint ........................................................................................................ 21 Page 2 of 66 7. Safety Results by Mesh Material ................................................................................................ 21 C. Concomitant Procedures ................................................................................................................ 22 1. Midurethral Sling ........................................................................................................................ 22 2. Hysterectomy .............................................................................................................................. 23 D. Patient Characteristics ................................................................................................................... 23 1. Age .............................................................................................................................................. 23 2. Obesity ........................................................................................................................................ 23 3. Current Level of Sexual Activity .................................................................................................. 24 4. Other ........................................................................................................................................... 24 E. Physician Characteristics ................................................................................................................ 24 F. Literature Review Conclusions ....................................................................................................... 24 VI. FDA Review of Medical Device Reports......................................................................................... 25 VII. FDA Benefit/Risk Assessment ........................................................................................................ 27 VIII. References ...................................................................................................................................... 29 Appendix 1 – Literature Review Methods and Strengths and Limitations .............................................. 36 Appendix II – Literature Review Tables ..................................................................................................... 39 Appendix III – Methods and Limitations of MDR Database Search ......................................................... 63 Appendix IV – MDRs Per Year and Top Ten Patient Problems for Currently Marketed Devices ............ 65 Page 3 of 66 I. Introduction On February 12, 2019, the Food and Drug Administration (FDA) will convene the Obstetrics and Gynecology Panel (the Panel) of the Medical Devices Advisory Committee to discuss surgical mesh placed transvaginally in the anterior vaginal compartment to treat pelvic organ prolapse. In September 2011, the FDA convened the Panel to obtain recommendations on the safety and effectiveness of surgical mesh placed transvaginally to treat pelvic organ prolapse, including the need for additional regulatory action. Based on the evidence available at the time, the Panel’s consensus was that mesh placed transvaginally to treat pelvic organ prolapse did not have a well-established benefit/risk profile. Based on the Panel’s recommendations, the FDA reclassified surgical mesh placed transvaginally to treat pelvic organ prolapse to a higher risk category (class II to class III) and issued postmarket surveillance study orders. Four postmarket surveillance studies for five surgical mesh devices indicated for transvaginal repair of pelvic organ prolapse are currently ongoing, and there are three currently marketed surgical mesh devices indicated for anterior repair of pelvic organ prolapse transvaginally – Boston Scientific Uphold LITE, Boston Scientific Xenform, and Coloplast Restorelle DirectFix Anterior. The FDA will use the results of the postmarket surveillance studies to evaluate the safety and effectiveness of individual surgical mesh devices placed in the anterior vaginal compartment to treat pelvic organ prolapse and determine if the benefit/risk profile of each device supports continued marketing. This executive summary provides an overview of the relevant clinical, device, and regulatory background for surgical mesh placed transvaginally in the anterior vaginal compartment. This document also provides an overview of the published literature for these devices. The FDA’s review of the published literature focuses on key safety and effectiveness outcomes for surgical mesh placed transvaginally in the anterior vaginal compartment, as well as important patient and surgeon factors. This document also includes an analysis of the adverse event reports received by the FDA through the Manufacturer and User Device Experience (MAUDE) database. Based on this information, the FDA is seeking Panel input on how to assess the effectiveness, safety, and benefit/risk of mesh placed transvaginally in the anterior vaginal compartment, as well as how to identify the appropriate patient population and physician training needed for these devices. Specifically, the FDA requests Panel input on (1) whether mesh should be more effective than native tissue repair and at what timepoint, (2) if both anatomic and subjective outcomes should be used to
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