SYSTEMATIC LITERATURE REVIEW OF THE GYNECARE PROLIFT® PELVIC FLOOR REPAIR SYSTEM TREATMENT OUTCOMES

Author(s)

Vanja Sikirica, PharmD, Associate Director, Health Economics & Reimbursement1, David Robinson, MD, FACOG, Medical Director, World Wide1, Aaron Kirkemo, MD, Associate Medical Director, World Wide1, Piet Hinoul, MD, Medical Director2, Jonathan Meek, BS, Worldwide Marketing Director1, Scott H. Jones, MBA, Product Director, Pelvic Floor Repair1, Hillary E. Perkins, MBA, Associate Product Director - Pelvic Floor Repair11Ethicon, Inc a Johnson & Johnson Company, Somerville, NJ, USA; 2 Ethicon, Inc a Johnson & Johnson Company, CEDEX, France

OBJECTIVES To summarize the efficacy/effectiveness, complications and patient reported outcomes associated with the polypropylene mesh kit GYNECARE Prolift® Pelvic Floor Repair System. METHODS A systematic literature review was conducted using MEDLINE, PUBMED and gynecologic conference abstracts from AUGS, IUGA and SGS for primary research focusing on the use of GYNECARE Prolift® from 2005-2008. Included studies needed to report on outcomes after any GYNECARE Prolift® regarding efficacy/effectiveness or safety of Anterior, Posterior or Total Repair. Single case studies, review articles, meta-analyses, non-English language studies and small case series (n<10) were excluded. Kin study results were included only from the primary article. Weighted averages and confidence intervals were calculated. RESULTS Among 33 independent studies included, mean (SD) follow-up time was 7.2 (4.6) months (95% CI: 7.0-7.4) among 24 studies reporting mean; and median follow-up reported was 7-19 months (data range: 2-30) for 9 studies. Objective anatomic success rates were 89.5% (95% CI: 88.2-90.6; n=2614) for all GYNECARE Prolift®, and 89.5% (86.5-92.0; n=532) for anterior, 92.0% (88.8-94.5; n=386) for posterior and 91.3% (87.6-94.2; n=311) for total repairs, respectively. Overall recurrence rate (any compartment) was 9.3% (8.2-10.6; n=2217). Complication rates were: overall rate of any injury (Bladder, Bowel, Vaginal or Urethral) 1.7% (1.4-2.2; n=4,750) of which bladder injury/perforation was the highest relative to other rates: 2.3% (1.8-3.0; n=2486). Exposure rates were 6.9% (6.0-7.8; n=2985). Mesh excision/ resection was reported at 6.4% (5.1-8.1; n=1087). Dyspareunia rates were 6.7% (5.3-8.3; n=1092). Patient satisfaction was 82.3% (77.0-86.9; n=244) and 87.5% reported they would “recommend to a friend” (81.0-92.4; n=144). CONCLUSIONS The evidence for mesh-based repairs is growing. While more randomized, and appropriately powered trials are needed to understand longer-term outcomes, current peer-reviewed data shows that the GYNECARE Prolift® kit is an effective pelvic floor repair device with limited complications and high patient satisfaction.

Conference/Value in Health Info

2009-05, ISPOR 2009, Orlando, FL, USA

Value in Health, Vol. 12, No. 3 (May 2009)

Code

PIH3

Topic

Clinical Outcomes

Topic Subcategory

Comparative Effectiveness or Efficacy

Disease

Pediatrics, Reproductive and Sexual Health

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