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MICKEY KARRAM MD DIRECTOR OF UROGYNECOLOGY THE CHRIST HOSPITAL

Vaginal Insertion of Mesh for Incontinence and Prolapse ; How will the Recent FDA Warning Impact our Clinical Practice. MICKEY KARRAM MD DIRECTOR OF UROGYNECOLOGY THE CHRIST HOSPITAL CLINICAL PROFESSOR OF OB/GYN & UROLOGY UNIVERSITY OF CINCINNATI. OBJECTIVES.

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MICKEY KARRAM MD DIRECTOR OF UROGYNECOLOGY THE CHRIST HOSPITAL

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  1. Vaginal Insertion of Mesh for Incontinence and Prolapse; How will the Recent FDA Warning Impact our Clinical Practice MICKEY KARRAM MD DIRECTOR OF UROGYNECOLOGY THE CHRIST HOSPITAL CLINICAL PROFESSOR OF OB/GYN & UROLOGY UNIVERSITY OF CINCINNATI

  2. OBJECTIVES 1-Review current FDA requirements for approval of a drug or device 2-Discuss the history of industry driven mesh kits for incontinence and prolapse 3-Review prevelance of mesh complications after surgeries for SUI and Pelvic Organ Prolapse 4-Discuss impact of recent FDA warning 5-Future of pelvic floor surgery and medico-legal implications

  3. WHY IS THE PROCESS REQUIRED BY THE FDA SO DIFFERENT FOR A DRUG VS A DEVICE? Budget differences between CDRH vs CDER 1976 ruling on devices that occurred after Dalkon Shield problems Differences between financial status of pharmaceuticals vs device companies FDA Regulatory Process;A DOUBLE –EDGED SWORD

  4. Regulatory Approval - Drugs Four phase process IV I III II TIME ( 7 -10 yrs)

  5. Regulatory Approval - Drugs Phase I Safety Initial human exposure – healthy volunteers CV, Metabolic, Bioavailability Pharmacokinetics (half life etc) Pharmacodynamics (unique issues with compound)

  6. Regulatory Approval - Drugs Phase II Class specific adverse events Safety monitoring Dose ranging Pharmacokinetics Usually 20-80 patients 2-3 year process

  7. Regulatory Approval - Drugs Phase III BIG DECISION; REQUIRES HUNDREDS/THOUSANDS OF PATIENTS; RCT – expanded exposure May include active comparator (not absolute) Efficacy / Tolerability / Safety Special patient populations Several year process ;70-90% get approved

  8. DULOXETINE (LILLY) INTRINSA (P&G) Recent Drugs that went through Phase III trials and got rejected by FDA

  9. Phase IV Postmarket studies to define additional information including risks benefits, and optimal use Regulatory Approval-Drugs

  10. Filing for a new device or material 510(K) Premarket Notification Process PMA Premarket Approval Process FDA Regulations

  11. Class I-Low potential for harm (bandages, gloves etc) Class II-May be harmful, requires special controls, labeling requirements, post market surveilence (meshes, instruments etc) Class III-Should require PMA (heart valves,breast implants etc) Classes of Devices

  12. TMJ implant Bladder slings Renu moisture/loc Heart valves Orthopedic prosthesis Examples of 510(k) products that were withdrawn from market

  13. HISTORY OF INDUSTRY DRIVEN MESH KITS FOR INCONTINENCE AND PROLAPSE 1-In 1996 Boston Scientific obtained 510(k) approval for the PrtoGen Sling 2-In 1998 Ethicon/Gynecare obtained 510(k) approval for TVT 3-In 2002 Ethicon/Gynecare obtained 510(k) approval for Gynemesh for repair of prolapse

  14. 510 (k) Clearance of Surgical Mesh (1992-2010)

  15. 510(k) Clearance of Surgical Mesh by Material Category

  16. CURRENTLY AVAILABLE SYNTHETIC SLINGS • RETROPUBIC; below to above vs above to below • PREPUBIC • TRANSOBTURATOR; outside in vs inside out • MINI-SLING; urogenital diaphragm vsobturatorinternus • GENERIC SYNTHETIC SLINGS

  17. Abdominal Sacrocolpopexy

  18. Mesh Overlay Techniques

  19. MESH KITS – TROCAR BASED SYSTEMS 1- Prolift (Gynecare) 2- Apogee & Perigee (AMS) 3- Avaulta (Bard)

  20. 1-ELEVATE (AMS) 2-UPHOLD & PINNACLE (BSC) 3-PROSIMA (GYNECARE) MESH KITS; DIRECT ACCESS SYSTEMS

  21. MAUDE DATABASE Manufacturer and User Device Experience Database; • Requires mandatory reporting by manufacturer • Voluntary reporting by user; most users do not manage their own mesh complications

  22. Recent warning from July 2011;What the FDA said • Between Jan 1, 2008 & Dec 31, 2010; the FDA received 2874 reports of complications associated with surgical mesh used to repair SUI and POP; with 1503 associated with POP. • The most frequent complications reported were erosion through the vagina, pain, infection, bleeding, dyspareunia, organ perforation, and urinary problems. • There were also reports of recurrent prolapse, neuromusculsar problems, vaginal scarring or shrinkage, & emotional problems.

  23. FDA Recommendations to Physicians 1-Obtain specialized training for each mesh placement technique 2-Be vigilant for potential adverse events especially erosion and infection 3-Watch for c/o associated with the tools; especially bowel, bladder and blood vessel perforation 4-Inform patients about the potential for serious complications; including pain and narrowing of the vagina 5-Provide patients with a copy of the patient labeling from the manufacturer if available

  24. Vaginal Exposure Vaginal Pain & Dyspareunia Vaginal Scarring and Loss of Vaginal Tissue Visceral Injury Thigh Pain and Referred Pain MESH COMPLICATIONS

  25. FDA White Paper Extensive review of published data with conclusions that question efficacy of mesh for prolapse repair

  26. FDA Obstetrics & Gynecology Devices Advisory Committee Meeting; Sept 8 & 9; 2011 Panel will be asked to discuss 1-Risks associated with vaginal mesh for POP repair 2-Based on available data is their adequate assurance of the effectiveness of vaginal mesh used for POP repair 3-Do risks of mesh repair outweigh potential benefits 4-Are more studies needed to document safety and efficacy; if so recommend study design outcome measures etc 5-Does the panel agree with the FDA regarding abdominal mesh repair has been proven to be safe and efficacious 6-SHOULD VAGINAL MESH KITS BE RECLASSIFIED AS CLASS III DEVICES

  27. Mayo Data – Mesh Complications Complications specific to synthetic material use continue to increase Multiple surgeries to address complications may be necessary, and may incompletely resolve symptoms Potential for underreporting – only 14% referred from original treating physician Dyspareunia and recurrent prolapse are common reasons for referral Blandon et al. Int Urogynecol J 2009 Feb10 (EPub)

  28. Mesh Complications; How Common are They The BIG QUESTION Severe mesh complications are occurring; but are the majority of them TECHNICAL or WOULD THEY OCCUR IN THE BEST OF HANDS

  29. What about Complications with Meshes?

  30. Vaginal anatomy; bulge, pressure, mass Visceral symptoms: Urinary and bowel symptoms Sexual activity and expectations Future surgical procedures or medicines to manage failures or complications Outcomes for Pelvic Organ Prolapse

  31. The company that makes and sells the device. The hospital in which the surgeon performs the surgery The medical organization or society that represents the surgeon. A formal credentialling board made up of an expert panel. Certified, trained proctors that have demonstrated competence in this area or device. Other Who should ultimately be responsible for training surgeons to utilize new devices or materials?

  32. Will this warning have a long term impact on our clinical practice? YES 1-How we teach and train 2-How we consent 3-Medico-legal implications 4-Hospital credentialing 5-Reimbursement by third party payers

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