Vaginal Mesh: The FDA Decision and Repurcussions

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Roger Dmochowski MD, FACS Dept of Urology

Vanderbilt University Medical Center Nashville, TN

ANATOMY ≠ FUNCTION

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Mesh vs No Mesh Outcomes Mesh type Number of

patients Length of follow-up

Successful outcome

Sivaslioglu 2007

Self cut 45 mesh 45 no mesh

12 Mesh 91% No mesh 72

Niemenan 2008

Self cut 105 mesh 97 no mesh

24 Mesh 89 No mesh 59

Nguyen 2008 Kit 38 mesh 37 no mesh

12 Mesh 87 No mesh 55

Carey 2009 Self cut 69 mesh 70 no mesh

12 Mesh 81 No mesh 67

Mesh Complications

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EROSION EXTRUSION

FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ

Prolapse and Stress Urinary Incontinence Issued: 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.

Recommendations for Physicians •  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

MDR Reporting:MAUDE Data for SUI Year # of reports

2005-2007 835 2008 368 2009 513 2010 490 Total 1739

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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

MDR Reporting: MAUDE Data for POP Year (s) # of reports

2005-2007 270

2008 303

2009 580

2010 620

Total 1773

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Source: FDA Advisory Panel, OB-GYN. September 2011

FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of

Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary IncontinenceFor updated information about

Surgical Mesh for Pelvic Organ Prolapse

•  UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse

July 13, 2011

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Synthetic Mesh Prolapse Repair: Complications

•  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

FDA Conclusions: SUI •  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. September 2011

FDA Conclusions: POP •  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. September 2011

FDA Action: MUS •  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. September 2011

FDA Action: POP

•  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. September 2011

Abdominal Sacral Colpopexy •  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

Graft Summary!  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!

Future Directions: Where to go from here

•  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

Future Directions •  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

What will we be doing in 2015?

•  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

Where to now, St Peter?

•  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