MICKEY KARRAM MD DIRECTOR OF UROGYNECOLOGY THE CHRIST HOSPITAL CLINICAL PROFESSOR OF OB/GYN & UROLOGY UNIVERSITY OF CINCINNATI Incontinence and Prolapse; Incontinence and Prolapse; How will the Recent FDA How will the Recent FDA Warning Impact our Clinical Warning Impact our Clinical Practice Practice
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MICKEY KARRAM MD DIRECTOR OF UROGYNECOLOGY THE CHRIST HOSPITAL CLINICAL PROFESSOR OF OB/GYN & UROLOGY UNIVERSITY OF CINCINNATI Vaginal Insertion of Mesh.
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MICKEY KARRAM MD
DIRECTOR OF UROGYNECOLOGY
THE CHRIST HOSPITAL
CLINICAL PROFESSOR OF OB/GYN & UROLOGY
UNIVERSITY OF CINCINNATI
Vaginal Insertion of Mesh Vaginal Insertion of Mesh for Incontinence and for Incontinence and Prolapse; How will the Prolapse; How will the Recent FDA Warning Recent FDA Warning Impact our Clinical Impact our Clinical PracticePractice
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
OBJECTIVES
FDA Regulatory Process;A DOUBLE –EDGED SWORD
WHY IS THE PROCESS REQUIRED BY THE FDA SO DIFFERENT FOR A DRUG VS A DEVICE?
1. Budget differences between CDRH vs CDER
2. 1976 ruling on devices that occurred after Dalkon Shield problems
3. Differences between financial status of pharmaceuticals vs device companies
Regulatory Approval - DrugsFour phase process
I II III IV
TIME ( 7 -10 yrs)
Regulatory Approval - DrugsPhase I
Safety
Initial human exposure – healthy volunteers
CV, Metabolic, Bioavailability
Pharmacokinetics (half life etc)
Pharmacodynamics (unique issues with compound)
Regulatory Approval - DrugsPhase II
Class specific adverse eventsSafety monitoringDose rangingPharmacokinetics
Usually 20-80 patients2-3 year process
Regulatory Approval - DrugsPhase IIIBIG DECISION; REQUIRES HUNDREDS/THOUSANDS OF PATIENTS;
RCT – expanded exposureMay include active comparator (not
Examples of 510(k) products that were withdrawn from market
• TMJ implant
• Bladder slings
• Renu moisture/loc
• Heart valves
• Orthopedic prosthesis
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
HISTORY OF INDUSTRY DRIVEN MESH KITS FOR INCONTINENCE AND PROLAPSE
510 (k) Clearance of Surgical Mesh (1992-2010)
510(k) Clearance of Surgical Mesh by Material Category
CURRENTLY AVAILABLE SYNTHETIC SLINGS• RETROPUBIC; below to above vs above
to below
• PREPUBIC
• TRANSOBTURATOR; outside in vs inside out
• MINI-SLING; urogenital diaphragm vs obturator internus
• GENERIC SYNTHETIC SLINGS
Abdominal Sacrocolpopexy
Mesh Overlay Techniques Mesh Overlay Techniques
MESH KITS – TROCAR BASED SYSTEMS
1- Prolift (Gynecare)
2- Apogee & Perigee (AMS)
3- Avaulta (Bard)
MESH KITS; DIRECT ACCESS SYSTEMS
1-ELEVATE (AMS)
2-UPHOLD & PINNACLE (BSC)
3-PROSIMA (GYNECARE)
Manufacturer and User DeviceExperience Database;•Requires mandatory reporting by manufacturer•Voluntary reporting by user; most users do not manage their own mesh complications
MAUDE DATABASE
1.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.
2.The most frequent complications reported were erosion through the vagina, pain, infection, bleeding, dyspareunia, organ perforation, and urinary problems.
3.There were also reports of recurrent prolapse, neuromusculsar problems, vaginal scarring or shrinkage, & emotional problems.
Recent warning from July 2011;What the FDA said
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
FDA Recommendations to Physicians
MESH COMPLICATIONS
• Vaginal Exposure
• Vaginal Pain & Dyspareunia
• Vaginal Scarring and Loss of Vaginal Tissue
• Visceral Injury
• Thigh Pain and Referred Pain
Extensive review of published data with conclusions that question efficacy of mesh for prolapse repair
FDA White Paper
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