GYNECARE GYNEMESH PS

Pelvic Organ Prolapse is a large problem with it being estimated that by 2030, that nearly 70 million women will be at risk of suffering from it¹. One treatment option is GYNECARE GYNEMESH^TM PS Non-absorbable PROLENE^TM Soft Mesh, which is a specially designed supportive, soft, synthetic mesh that is placed into the pelvis and is used to restore pelvic support. GYNECARE GYNEMESH^TM PS is used as an option for the early onset of pelvic organ prolapse and was the first polypropylene mesh support material for female pelvic floor repair to be introduced into the market. It is approximately 70% more flexible than the standard PROLENE^TM mesh and is specially designed for placement through the vagina to support pelvic organs that have "dropped out" of their normal position (prolapsed).

GYNECARE GYNEMESH^TM PS has been adapted to pelvic floor surgery, including the following:

• Cystocele
• Rectocele
• Vault Repair

The improved mesh characteristics, which include a less rigid polypropylene polymer and a decrease in polypropylene weight, may contribute to less complicated interventions in the unlikely event of mesh exposure.

GYNECARE GYNEMESH^TM PS is identical in comparison to PROLENE^TM Polypropylene Suture as it is constructed of knitted filaments of extruded polypropylene. The mesh itself offers exceptional strength, durability and surgical adaptability and allows for the necessary tissue ingrowth that is required as it is 66% open. The knitted filaments mean that surgeons are able to cut the mesh into different shapes and sizes with ease and without the mesh unravelling. GYNECARE GYNEMESH^TM PS combines the permanent support required with softness and pliability often sought after for vaginal reconstruction.

Blue PROLENE^TM monofilaments have been incorporated into the mesh in order to produce contrast striping in the mesh, which aids sizing and orientation. Due to the knitting process that interlinks each fiber junction, it results in the mesh providing elasticity in both directions. This construction permits the mesh to be cut into any desired shape or size without unraveling. The bi-directional elastic property allows adaptation to various stresses encountered in the body.

In essence, the GYNECARE GYNEMESH^TM PS acts like a “hammock”, supporting internal organs and working in very much the same manner as a women’s connective tissues had previously, when they provided a strong “envelope” around the vagina walls. GYNECARE GYNEMESH^TM PS is designed for placement using the colporraphy procedure.

_{1. Shull B. Pelvic organ prolapse: Anterior, superior, and posterior vaginal segment defects. American Journal of Obstetrics and Gynaecology 1999;181:6-11.}

For clinical information about GYNECARE GYNEMESH PS, view the information below.

Early clinical experience highlighted excellent intraoperative handling for GYNECARE GYNEMESH^TM PS and surgical repair of vaginal wall prolapse using mesh was found to be more effective than traditional surgical repair without it.

Although approximately 91% of women who choose this treatment option are successfully cured, 10% of women may suffer from mesh erosion¹.

The risk of recurrence from an anterior repair without mesh is approximately 30% and current research suggests that with the use of GYNECARE GYNEMESH^TM PS, this recurrence rate is reduced to 9%, with the re-operation rate being further reduced to 1% after 1.5 years².

Although the short-term studies show a significant benefit of using GYNECARE GYNEMESH^TM PS, there are no long-term studies to date for this treatment option.

_{1. Shull B. Pelvic organ prolapse: Anterior, superior, and posterior vaginal segment defects. American Journal of Obstetrics and Gynaecology 1999;181:6-11.}

_{2. De Tayrac, R et al. 2006. A 2 year anatomical and functional assessment of transvaginal rectocele repair using a polypropene mesh. Int Urogynecol J.}

GYNECARE GYNEMESH^TM PS is technologically advanced and driven by innovation as it was the first polypropylene mesh support material for female pelvic floor repair to be introduced into the market. Although lightweight, the added benefits of GYNECARE GYNEMESH^TM PS over competitor products are as follows:

• Non-absorbable
• Available in sizes - Two sizes are available. For surgeons who perform sacrocolpopexy there is the GYNECARE GYNEMESH^TM PS Non-absorbable PROLENE^TM soft mesh extra large (25cm x 25cm) which is an ideal size for abdominal approaches. For surgeons who perform vaginal pelvic organ prolapse procedures, there is the GYNECARE GYNEMESH^TM PS non-absorbable PROLENE^TM soft mesh (10cm x 15cm), which is the ideal size for vaginal approaches.
• Flexible - GYNECARE GYNEMESH^TM PS is 70% more flexible than the standard PROLENE^TM mesh. The reduced diameter fibres are knitted into a patent design, which facilitates this flexibility.
• Tissue incorporation - The larger pore sizes foster proper tissue incorporation¹.
• Strong - While most monofilament polypropylene meshes are constructed of 5-6 mil fibers (5/0 PROLENE^TM suture), GYNECARE GYNEMESH^TM PS is constructed from 3.5 mil (6/0 PROLENE^TM suture) fibers which creates a knit that is designed for strength in both directions and prevents fraying or unravelling when cut.
• Less Invasive
• Reduced Risk of Infection - The knitted monofilament does not potentiate infection².
• Improved Mesh Characteristics - A less rigid polypropylene polymer and a decrease in polypropylene content, may contribute to less complicated interventions in the unlikely event of mesh exposure.
• Non-Reactive - When used as a suture, PROLENE^TM Polypropylene has been reported to be non-reactive and to retain its strength indefinitely in clinical use.
• Bi-Directional Elasticity - Allows for adaptation to various stresses encountered in the body as well as permitting the mesh to be cut into different shapes and sizes without fraying or unravelling.

As the first polypropylene mesh support material for female pelvic floor repair to be introduced into the market, GYNECARE GYNEMESH^TM PS has set the standard. This innovation driven product is modernising pelvic floor repair in today’s healthcare facilities. This product has received a generic appraisal as part of the guidance on surgical repair of POP using Mesh. We are continually investing money into Research and Design to bring the latest, most innovative products to the market place to enable and aid surgical procedures.

_{1. Shull B. Pelvic organ prolapse: Anterior, superior, and posterior vaginal segment defects. American Journal of Obstetrics and Gynaecology 1999;181:6-11.}

_{2. De Tayrac, R et al. 2006. A 2 year anatomical and functional assessment of transvaginal rectocele repair using a polypropene mesh. Int Urogynecol J.}