21/05/2008
AO Technical Commission Approved

SynPOR

To meet the growing demand for flexible yet strong implants for use craniofacial reconstruction, cosmetic surgery, and repair of craniofacial trauma the new porous polyethylene implants (SynPOR) are well-suited.

They are manufactured from an inert, non-absorbable polymer formulated to contain a network of open and interconnecting pores approximately 100 m 250 m 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 needed but remains flexible. The implants can easily be trimmed and contoured and can be fixated with screws tacks, wire or suture depending on the surgeons method of choice. Final shape modifications can be made in situ.

Among the possible clinical applications are orbital, cranial or facial augmentation and reconstruction cases such as fractures of the orbital floor and wall, cranioplasty, or genioplasty.

In contradiction porous polyethylene 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 x 50 mm sized square shapes 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. In case a contouring is desired, the sheets can be immersed in heated sterile saline (70 C / 160 F or higher). After a short while the implant can be removed and contoured until the desired form is achieved. The implant will return to the original stiffness when but maintain its new contour after cooling.

Anatomical shapes and incorporated titanium

For the treatment of orbital floor fractures SynPOR implants are also available in anatomical shapes: The guitar pick shaped version comes in 24 x 24mm, 30 x 30 mm, and 35 x 35 mm sizes, each one either 0.8 mm or 1.5 mm in thickness. The fan plates measure 35 mm in radius and are also either  0.8 mm or 1.5 mm thick.

To combine the strength of titanium mesh and the material advantages of porous polyethylene the new SynPOR titanium reinforced sheets consist of commercially pure titanium mesh encapsulated in two layers of UHMWPE. Thus the concern of soft tissue entrapment when placing a titanium mesh implant that has been trimmed to a smaller size, may be reduced. Unlike the other original SynPOR implants, the implants reinforced with titanium allow the surgeon to use an implant that is much thinner to span a large orbital floor defect. In addition, incorporation of the titanium allows for intraoperative and postoperative visualization of implant placement, using standard radiographic imaging.

Hazards and labeling

Due to varying countries’ legal and regulatory approval requirements, consult the appropriate local product labeling for approved intended use of the products described on this website. All devices on this website are approved by the AO Technical Commission. For logistical reasons, these devices may not be available in all countries worldwide at the date of publication. 


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