GYNECARE PROLIFT^® Total, Anterior and Posterior Pelvic Floor Repair Systems

ETHICON Women’s Health and Urology GYNECARE PROLIFT^TM system consists of a trocar delivery system to streamline the placement of a pre-cut piece of GYNECARE GYNEMESH^TM PS Non-absorbable PROLENE^TM soft mesh into the anterior and/or posterior vaginal components, when symptomatic prolapse requires surgical intervention. Over 35,000 procedures have been performed worldwide.

As ETHICON^TM Women’s Health and Urology GYNECARE PROLIFT^TM uses pre-cut GYNECARE GYNEMESH^TM PS for the repair of pelvic organ prolapse, it inherits all of the benefits that come with ETHICON^TM Women’s Health and Urology.

On top of the standardised benefits found to be associated with GYNECARE GYNEMESH^TM PS, there are additional benefits that are unique to the ETHICON^TM Women’s Health and Urology GYNECARE PROLIFT^TM system. These are:

Quicker Recovery – Patients are able to go home the next day and return to normal activities within three to four weeks. Most completely recovery within a two to three week period. This means that there are more beds available in the hospital as opposed to a hysterectomy where a patient could be hospitalised for several weeks. In turn this will free up hospital resources meaning less expenditure is required for patient care after the surgery.
Optimal Mesh Implant Size and Shape – Large pre-cut shape to maximise success designed with 2cm wide pre-shaped mesh for all anterior, posterior and total repairs. The pre-shaped mesh allows for versatility in all procedure types. The larger mesh can be trimmed to accommodate a smaller pelvis.
KOL Support
Level 2 Delancey Support – The larger mesh allows surgeons to address this.
Research - The design and the manufacturing of GYNECARE PROLIFT^TM was a process over 5 years, which researched different elements of mesh size and shape as well as mesh placement. It was designed to offer long support of the pelvic organs. As a result of the TVM research (4 year study), the delivery guide was specifically shaped to allow the surgeon to place the mesh deep enough in the pelvis to replicate the natural anatomy of the pelvis (i.e. through SSL).
Low Risk of Complications – Retrospective, multicenter study demonstrated improvement with few complications1. Prospective, multicenter study found perioperative complications were rare2. Another multicenter case study demonstrated a return of sexual function after surgery3.
Customised Training – Peer to peer training is available through Proctorships and Preceptorships.

Total Mesh Implant

The Total mesh implant is constructed from GYNECARE GYNEMESH^TM PS and is shaped for performing a total vaginal repair. The implant has 6 straps: 4 for securing the anterior portion of the implant via a transobturator approach and two for securing the posterior portion of the implant in the sacrospinous ligament via a transgluteal approach. Alternatively, the 2 posterior straps may be cut to reduce their length and secured in the sacrospinous ligament via a vaginal approach. The proximal and distal anterior straps have squared and triangular ends, respectively, while the posterior straps have rounded ends.

Anterior Mesh Implant

The Anterior mesh implant is constructed from GYNECARE GYNEMESH^TM PS and is shaped for repair of anterior vaginal defects. The implant has 4 straps that are secured via a transobturator approach. The proximal and distal anterior straps have squared and triangular ends, respectively.

Posterior Mesh Implant

The Posterior mesh implant is constructed from GYNECARE GYNEMESH^TM PS and is shaped for repair of posterior and/or apical vaginal vault defects. The implant has 2 straps that are secured in the sacrospinous ligament via a transgluteal approach. Alternatively, the 2 posterior straps may be cut to reduce their length and secured in the sacrospinous ligament via a vaginal approach. The posterior straps have rounded ends.

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%