Poly(ß-hydroxybutyrate-co-13-hydroxyvalerate) have been recently proposed as degradable biomaterials for drug delivery systems, sutures, bone plates and short-term implants. Three P-B\HV (7, 14 & 22 % HV) films were analyzed for in vitro cytotoxicity and aqueous accelerated degradation, in vivo degradation and tissue reactions. The PHB/HV materials and extracts elicit few or mild toxic responses, do not lead in vivo to tissue necrosis or abscess formation, but provoke acute inflammatory reactions slightly decreasing with the time. The degradation of PHB/HV polymers present low rates in vitro as well as in vivo. The weight loss rate generally increases with the copolymer composition (HV content) and ranges from 0.15- 0.30 (in vitro) to 0.25 %/day (in vivo). Compositional and physico-chemical changes in PHB/HV materials were rapidly detected during the accelerated hydrolysis, but were much slower to appear in vivo. The structural and mechanical integrity of PHB/HV materials tend to disappear early in vitro as well as in vivo. After 90 wks in dorsal muscular tissues of adult sheep, there was no significant dissolution of the PHB/HV polymer, 50–60% of the initial weight still remaining. PHB/HV polymers are biodegradable materials, either by hydrolysis or implantation, but with extremely low dissolution or degradation rates.