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

LSULSU

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)

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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