ANALYSIS OF THE EXTRACTIVE AND HYDROLYTIC BEHAVIOR OF MICROTHANE POLY(ESTER-URETHANE) FOAM BY HIGH-PRESSURE LIQUID-CHROMATOGRAPHY

Microthane foam, a poly(ester-urethane) (PU) used in the manufacture of Meme/Replicon breast implants, was analyzed by an HPLC method to determine whether 2,4- and 2,6-toluenediamine (TDA) were formed under a variety of physiological and nonphysiological extraction and hydrolytic conditions. At our detection limit of 20 ppb, no 2,4- or 2,6-TDA was observed in either methyl tert-butyl ether (MTBE), or aqueous buffer extracts of PU foam. The predominant extractable components identified by HPLC UV-analysis, were a mixture of nonaromatic and aromatic PU fragments. Moreover, no detectable amounts of TDA were found in foam or MTBE extract of foam incubated in phosphate buffer, pH 7.4, at 37-degrees-C for 5 days. By contrast, 2,4- and 2,6-TDA were found in foam and foam extracts exposed to low concentrations of either strong mineral acid or base; higher levels were found at higher acidity, treatment temperature, or durations of incubation. Moreover, 2,4- and 2,6-TDA were found in oligomers isolated by preparative HPLC and exposed to alkaline conditions. Finally, 1-2 ppm of 2,4-TDA was detected when PU foam extracts were prepared by the Snyder-Breder method, which employs acidic and alkaline conditions in the work-up procedure. Based on these findings, we suggest that published observations of 2,4-TDA formation from in vitro and ex vivo extractions of PU foam are artifacts resulting from pH effects on oligomeric PU fragments present in or extracted from the foam.