Biodegradable polydioxanone and poly(l/d)lactide implants: an experimental study on peri-implant tissue response.

Several implants for orbital wall fracture treatment are available at the present, but they have drawbacks: resorption, risk for migration and foreign body reaction. Alloplastic resorbable implants would be advantageous: no removal operation and no donor side morbidity. The purpose of this study was to evaluate the foreign body reaction, capsule formation and mechanical properties of two bioresorbable implants. PDS and SR-P(L/DL)LA mesh sheet (70/30) with solid frame (96/4) implants (SR-P(L/DL)LA 70,96) were placed into subcutaneous tissue of 24 rats. Immunohistochemistry was used to evaluate reactivity for Tn-C, alpha-actin, type I and III collagens and two mononuclear cells: T-cells and monocyte/ macrophage. GPC, DSC and SEM were performed. Student's t-test or nonparametric Kruskall-Wallis test were used for statistical analysis. Histology of peri-implant capsule exhibited an inner cell-rich zone and an outer connective tissue zone around both materials. Tn-C reactivity was high in the inner and alpha-actin in the outer zone. At the end of the study, the difference of type I collagen versus type III collagen reactivity in inner zone was statistically significant (P<0.0001) as was the difference of type I collagen versus type III collagen reactivity in outer zone (P<0.0001). Immunohistochemistry did not reveal any statistical differences of T-cell and monocyte/macrophage reactivity around PDS versus SR-P(L/DL)LA 70,96 implants, nor any differences as a function of time. PDS were deformed totally after 2 months. SR-P(L/DL)LA 70,96 implants were only slightly deformed during the follow up of 7 months. PDS degraded rapidly in SEM observation. Particles were detaching from surface. SEM observation revealed that polylactide implant was degrading from the surface and the inner porous core became visible. The degradation came visible at 7 months. There were cracks in perpendicular direction towards to the long axis of the filaments. M(w) of PDS decreased fast compared to the polylactide implant. Foreign body reaction was minimal to both materials but continued throughout the whole observation period. Mechanically PDS was poor, it looses its shape totally within 2 months. It cannot be recommended for orbital wall reconstruction. New mesh sheet-frame structure (SR-P(L/DL)LA 70,96) approved to be mechanically adequate for orbital wall reconstruction. It seems not to possess intrinsic memory and retains its shape. The resorption time is significantly longer compared to PDS and is comparable to other studied P(L/DL)LA copolymers. Thus, the new polylactide copolymer implant may support the orbital contents long enough to give way to bone growth over the wall defect.