Poly(L-lactide): a long-term degradation study in vivo. Part II: Physico-mechanical behaviour of implants.

Three different poly(L-lactide) rods (25 x 3 x 2 mm) were produced either by injection moulding or machined out of a solid as-polymerized polylactide block and were implanted for 1-116 months into the dorsal muscle of rats. After recovery, the polylactide specimens were carefully cleaned, dried, photographed and weighed. Bending strength and Young's modulus of elasticity were determined. The surfaces of the broken rods were examined by scanning electron microscopy. Block polylactide samples initially looked milky. They became friable and broke into white or brownish fragments during the implantation period, whereas total disintegration could not be observed. Electron scanning microscopy revealed a porous surface with crystalline elements persisting for the whole time. Mechanical stability fell from 127 +/- 3 MPa at implantation time to about half after 3 wk (61 +/- 4 MPa) and about a quarter (32 +/- 4 MPa) after 6 wk. Both injection-moulded polyactides (A1 and A2) were clear and transparent initially. After implantation they gradually became whitish, fragmented after about 64 wk and disintegrated 90 wk later into small parts and powder. Electron scanning microscopy at first showed a homogeneous surface. A kind of cortex developed after about 4 wk and deep cracks ran through the rod after 32 wk. Round pores of 1.5-10 microns diameter developed after 1 yr of implantation. Bending strengths were 130 +/- 8 MPa (A1) and 115 +/- 14 MPa (A2); these remained nearly stable over about 12 wk, then declined linearly. Although a higher initial mechanical strength is desirable for use in osteosynthetic devices, mechanical stability of amorphous injection-moulded polylactides over the first 12 wk and total disintegration thereafter approaches the requirements for their use as a material for osteosynthesis.