NEW CRANIOMAXILLOFACIAL PRODUCTS
SynPOR The new porous polyethylene implants (SynPOR) are ideally suited to meet the growing demand for flexible yet strong implants for the use in craniofacial reconstruction, cosmetic surgery, and in the repair of craniofacial trauma. Manufactured from an inert, nonabsorbable polymer and formulated to contain a network of open and interconnecting pores approximately 100–250 μm in size. These interconnected pores allow fibrovascular tissue ingrowth and relative host incorporation. The result is fast integration and stabilization, which can be advantageous over the host encapsulation of implants as it can be seen when using implants with a smooth surface. The material used for these implants is an ultra-high molecular-weight polyethylene (UHMWPE), which meets the requirements of ASTM standards and has passed ISO standard tests for biocompatibility. It provides strength and stability where required but remains flexible. The implants can easily be trimmed and contoured and can be fixated with screws tacks, wire or suture depending on the surgeon’s method of choice. Final shape modifications can be made in situ. Among possible clinical applications are orbital, cranial or facial augmentation, and reconstruction cases such as fractures of the orbital floor and wall, cranioplasty, or genioplasty. SynPOR implants are not intended for use in the presence of: • Active or latent infection • Inadequate coverage of healthy, vascularized tissue • Full load-bearing applications • Systemic disorders that cause poor wound healing or may lead to soft-tissue deterioration over the implant SynPOR implants are available in 50 × 50 mm sized squares in four different thicknesses: 0.45 mm, 0.8 mm, 1.5 mm, and 3.0 mm. They are provided sterile and pyrogen-free for single patient use. Common cutting and trimming instruments such as scissors, mesh cutters, or scalpels (no electrosurgical devices) can be used for shaping. Loose particles can be removed by rinsing with sterile saline solution. Where contouring is desired, the sheets can be immersed in heated sterile saline (70° C/160° F or higher) for a short while, after which the implant is removed and contoured until the desired form is achieved. The implant will return to the original stiffness but maintain its new contour after cooling.
Published on May 5, 2008