GYNECARE PROLIFT+M™ Total, Anterior and Posterior Pelvic Floor Repair Systems

The active lifestyle of today’s woman should not be held back by pelvic organ prolapse. Together, we aim to empower her social, work and sex life.

Pelvic organ prolapse is a documented cause of yspareunia and patient discomfort.

Prolapse surgery has shown the potential to improve patient well being by reducing Dyspareunia and prolapse symptoms.

For those women seeking increased comfort– and the Doctor’s who want to help them attain it – GYNECARE PROLIFT+M™ Pelvic Floor Repair System may provide a solution.

This unique, partially absorbable GYNECARE GYNEMESH® M graft is made from a revolutionary application of PROLENE® and MONOCRYL® Suture material that in pre-clinical studies have demonstrated improved tissue support post operatively – with less than 50% of the density of foreign material in a large pore graft at 84 days.

The shape and adjustability of GYNECARE PROLIFT® allows you to treat the problem of anatomic repair of Pelvic Organ Prolapse. Now, GYNECARE PROLIFT+M™ offers you a potential solution to transform the functional outcomes for women wishing to transform their lives.

Working with her body from the moment it’s positioned, GYNECARE PROLIFT+M™ Pelvic Floor Repair System allows you to position the graft where it can help restore normal anatomy, conform to each woman’s pelvis and integrate with her natural tissue.

Now, the proven graft and suture material you trust have joined the delivery system you trust to help you deliver better solutions for women.

In order to help your patient really improve not only her pelvic health, but her lifestyle, a synthetic graft must work during AND after prolapse surgery.

Although the ideal graft doesn’t exist, it would demonstrate:

Ideal initial handling properties for surgery and wound healing designed to^2,4,6,3

• Resist wrinkling and folding during placement
• Support the wound through the early phases of healing
• Resist wound contraction

Beyond the surgery^4,5,6,7

• Large pores increase tissue integration and normal collagen generation¹
• Leaves minimal foreign material in the patient over time, and assists tissue incorporation for improved comfort³ Using the new GYNECARE PROLIFT+M™ Pelvic Floor Repair System, GYNEMESH® M provides the initial handling properties to assist you in positioning the graft, and also supports the tissue during the early phases of healing. The MONOCRYL® Suture material absorbs gradually (84 days), leaving a soft, large pore GYNEMESH® M graft. Large Pore Polypropylene Grafts with the addition of MONOCRYL® Suture material have demonstrated excellent results:
• A pronounced reduction in inflammation and improved integration into surrounding tissue
• Reduced foreign body response
• Less fibrosis than traditional grafts

This means your patient can receive the benefits of pelvic organ prolapse repair at the time of surgery and more natural healing after the procedure. GYNECARE PROLIFT+M™…the only pelvic floor repair graft that incorporates PROLENE® and MONOCRYL® Suture material.

References:

<sub>1. Klinge U et al. Impact of Polymer Pore Size on the Interface Scare Formation in a Rat model. J of Surgical Research. 2002, 103: 208-214
2. Klinge U et al. Shrinkage of Polypropylene mesh in vivo. An experimental study in dogs. Eu J Surg 1998: 164:965
3. Klinge U et al. Foreign Body reactions to meshes used for the repair of abdominal wall hernias 1999: 165:665
4. Cosson M et al. Mechanical Properties of synthetic implants used in the repair of prolapse and urinary incontinence in women: which is the ideal mesh. Int Urgynecol J 2003 14: 169-178
5. Klosterhalfen B et al. The lightweight and large porous mesh concept for hernia repair. Expert Rev Med Devices. 2005, 2: (1)
6. Cobb W et al Textile Analysis of Heavy-weight, middle-weight and light-weight Polypropylene is Porcine Ventral Hernia Repair. Journal of Surgical Research 2006, 136: 1-7
7. Rubod C et al. Biomechanical properties of vaginal tissue: preliminary results. Int Urogynecol J 2008 19: 811-816</sub>

Since 2005, the PROLIFT® Pelvic Floor Repair System helped clinicians treat over 120,000 patients

An analysis of the published clinical data highlights the following results to date (Oct. 2008). (Note: n=denominator)

Intra-Operative Results
Mean Operating Time (n=727) 66.12 min
Mean Blood Loss (n=1118) 93.2 Ml

Patient Reported Outcomes
Patient Global Improvement Index Score (n=126) 93.7%
Improved Sexual Health (n=167) 19.4%
Patient Satisfaction (n=209) 79.9%
Recommend to a Friend (n=179) 88.8%

Anatomic Success
All (n=1976) 90.4%
PROLIFT® Anterior (n=372) 92.0%
PROLIFT® Posterior (n=306) 94.1%
PROLIFT® Total (n=49) 87.8%

Post-Operative Complication Results
Recurrence (n=1523) 11.1%
Urinary Tract Infection (n=1523) 8.1%
Dyspareunia (n=860) 7.2%
Erosions/Exposures (n=2342) 4.1%
Groin Pain (n=812) 5.9%
Retention (n=901) 4.1%
Hematoma (n=844) 1.4%

Intra-Operative Complication Rates Reported
Bladder Injury (n=1984) 1.9%
Rectal Injury (n=586) 1.2%
Urethral Injury (n=373) 0.5%

ProliftM_R10.pdf