LSULSU 1
Roger Dmochowski MD, FACSDept of Urology
Vanderbilt University Medical CenterNashville, TN
LSULSU 2
LSULSU
Mesh type Number of patients
Length of follow-up
Successful outcome
Sivaslioglu 2007 Self cut 45 mesh45 no mesh
12 Mesh 91%No mesh 72
Niemenan 2008 Self cut 105 mesh97 no mesh
24 Mesh 89No mesh 59
Nguyen 2008 Kit 38 mesh37 no mesh
12 Mesh 87No mesh 55
Carey 2009 Self cut 69 mesh70 no mesh
12 Mesh 81No mesh 67
LSULSU 4
EROSION EXTRUSION
LSULSU
FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ
Prolapse and Stress Urinary IncontinenceIssued: October 20, 2008
Dear Healthcare Practitioner: This is to alert you to complications associated with transvaginal
placement of surgical mesh to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). Although rare, these complications can have serious consequences. Following is information regarding
the adverse events that have been reported to the FDA and recommendations to reduce the risks.
LSULSU
Obtain specialized training for each mesh placement technique, and be aware of its risks.
Inform patients that implantation of surgical mesh is permanent, and that some complications associated with the implanted mesh may require additional surgery that may or may not correct the complication.
Inform patients about the potential for serious complications and their effect on quality of life, including pain during sexual intercourse, scarring, and narrowing of the vaginal wall (in POP repair).
Provide patients with a written copy of the patient labeling from the surgical mesh manufacturer, if available.
http://www.fda.gov/cdrh/safety/102008-surgicalmesh.html
LSULSU
Year # of reports
2005-2007 835
2008 368
2009 513
2010 490
Total 1739
7
Rank Adverse Events # MDR’s Percentile rate %
1 Pain 479 34.9
2 Erosion 436 31.8
3 Infection 260 18.9
4 Urinary Problems 220 16.0
5 Organ Perforation 110 8.3
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Year (s) # of reports
2005-2007 270
2008 303
2009 580
2010 620
Total 1773
8
Source: FDA Advisory Panel, OB-GYN. September 2011
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UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse
released July 13, 2011.
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Complications UNIQUE to mesh Extrusion “Vaginal Erosion” rate – 8.3-11% [10.3%
(FDA)]Hardiman P, et al: BJOG, 2000
Urinary Tract Erosion – True incidence unknown Mesh related pain – trigger points / bands /
contraction (12%, 2.8% re-op) Caquant J OB GYN Res 2008
Complications of prolapse surgery Pain Dyspareunia:
Up to 20% using anterior mesh (6.3% extrusion) Higher incidence expected in posterior compartment.
Milani, et al: BJOG, 2005
LSULSU
Comparative effectiveness data (large volume) demonstrates effectiveness.
1st generation slings (retropubic and TOT) are equally effective to colposuspension
Vaginal mesh erosion at 3.5% Retropubic vs obturator “trade-off” in
complications 2nd generation slings possibly less effective
than MUS Reoperation for SUI 2x likely, and erosion rates
higher
11
Source: FDA Advisory Panel, OB-GYN. September 2011
LSULSU
Increase in activity in MAUDE database, signals safety issues Tissue repair, not device – no MAUDE reporting
Erosion and contraction are unique complication of mesh procedures
No proven anatomic or clinical benefit in apical or posterior compartment repairs
Anatomic “benefit” to anterior compartment, but no proven clinical benefit – no clear benefit
RR of re-operation for revision was 2.26X greater in women with mesh 1-2 year follow-up bias re-op rate to mesh procedures
12
Source: FDA Advisory Panel, OB-GYN. September 2011
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Did not recommend re-classification of MUS Will remain class 2, with “special exception”
Premarket review: New SUI Slings No premarket data for 1st generation slings Premarket data for 2nd generation mini-slings
Must be Class II comparison to MUS
Post-Market Review: FDA cleared, marketed No post-market data for 1st generation Post-market data for 2nd generation
13 Source: FDA Advisory Panel, OB-GYN. September 2011
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Re-classify mesh for POP to Class III Require any new product or device to undergo
rigorous PMA clinical trials prospectively prior to launch
Post-market 522 studies with design mandated by FDA for devices on market Any alteration in device will be Class III
During the Interim PMA analysis, cleared products will be available.
14
Source: FDA Advisory Panel, OB-GYN. September 2011
LSULSU
Multiple authors report a 90+ % success rate
Many consider gold standard
Synthetic mesh superior to biologic materials Maher et al (Cochrane database,
2007) Culligan et al (Am J Obstet
Gynecol, 2008)
Mesh erosion rate of approx 1% (PPM) Nygard et al (Obstet Gynecol,
2004)
15
Blanchard K, Vanlangendonck R, Winters J : Urology, 2004
Biologic Materials: Variability in outcomes btw grafts Intermediate failures more common Think Transformation
Synthetic Mesh Type I Macroporous monofilament most desirable Abdominal sacrocolpopexy:
Nonabsorbable mesh is fairly standard Recent adverse publicity is not about this
Posterior vaginal repair: mesh disadvantages appear to outweigh advantages
Anterior vaginal repair: Balance pros and cons Inform patient; involve her in choice
Think technique and volume!
Biologic Materials: Variability in outcomes btw grafts Intermediate failures more common Think Transformation
Synthetic Mesh Type I Macroporous monofilament most desirable Abdominal sacrocolpopexy:
Nonabsorbable mesh is fairly standard Recent adverse publicity is not about this
Posterior vaginal repair: mesh disadvantages appear to outweigh advantages
Anterior vaginal repair: Balance pros and cons Inform patient; involve her in choice
Think technique and volume!
DIFFERENTIATE: Mesh MUS from mesh POP procedures
JUDICIOUS: Routine mesh usage for POP discouraged. Strict selection
INFORM: Informed consent should be complete and thorough as standard Inform of potential mesh benefit (why) Inform of non-mesh alternatives Inform of mesh related complications Inform of potential permanence of
procedure
ATTENTION: Physician must understand, recognize and competently intervene when complications arise
Most Important:
COMMUNICATION: Starts with evaluation and counseling. Explain any adverse event and communicate
management plan with patient
Many more robotic ASC procedures (expensive) Vaginal surgeons:
Those doing tissue repairs before, will be doing more Those only doing kits will be doing less (or none at
all) Less mini-slings Hopefully no change in MUS
Less strict anatomic criteria for success More QOL inclusion as standard
FDA has performed role as enforcement agency…
Litigation is next. This could very easily change the landscape Emerging claims of auto-immune disease after mesh Aka: Breast implantation lawsuit
These trends may include MUS
Be Proactive: Educate and instruct SUI ? POP patients – assiduously
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