Long-term in vivo degradation of poly-L-lactide (PLLA) in bone.

The use of absorbable orthopedic implants has increased substantially during the last decade. Currently, most of them are fabricated from poly-L-lactide (PLLA), its co-polymers, or mixtures with other constituents. In vivo, PLLA persists for years after its surgical role has ended, which is confirmed by a long-term histological study of PLLA implanted in sheep either as functional interference screws or nonfunctional rods. The first tissue reaction is the sequestration of the implant within new bone during the initial 3 months. After a nonreactive period, a second tissue reaction is associated with the early signs of structural disintegration of the PLLA at 1 year. Subsequently, as the polymer mass reduces, it is replaced by a relatively avascular fibrous tissue containing macrophages and having an occasional multinucleated giant cell on the implant surface. After 3 years much of the polymer is still present, although as isolated fragments. The tissue reactions can be explained in terms of the physical chemistry of PLLA degradation. Though biocompatible, the excessive longevity of PLLA and the absence of its replacement by bone, indicates that despite being satisfactory clinically, it is not an ideal implant material, and that improved absorbable materials need to be developed.