Tumorigenicity of poly‐L‐lactide (PLLA) plates compared with medical‐grade polyethylene

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Abstract
Poly‐L‐lactide (PLLA) plates, 20 × 10 × 1 mm in size, with flat surfaces, were implanted into 50 young male Wistar rats subcutaneously, and the incidence of tumors for 2 years under specific pathogen‐free (SPF) conditions was evaluated. Tumors arose in 22 rats (at the implant sites in 20, and distant from the implantation site in 2). As a control, plates of medical‐grade polyethylene of the same shape were implanted into 50 rats. Tumors appeared in 23 of these rats (21 at the sites of the plates, and 2 ectopically). In 30 rats given sham operations, no tumors appeared in the 2 year observation period. Histologically, all the tumors were mesenchymal malignant tumors resembling fibrosarcoma or malignant fibrous histocytoma (MFH) in humans. In 6 of the PLLA tumors and 3 of the PE tumors, bone formation was observed. There was no significant difference between the incidence of tumors caused by PLLA plates and that of tumors caused by medical‐grade polyethylene plates. Macroscopically, PLLA plates retained their initial shape for 2 years. Scanning electron microscopy revealed small holes on the surfaces of the plates, and their molecular weight was reduced to 8% of the initial value. © 1994 John Wiley & Sons, Inc.