MEASUREMENT OF 2,4-TOLUENEDIAMINE IN URINE AND SERUM SAMPLES FROM WOMEN WITH MEME OR REPLICON BREAST IMPLANTS

The objective of this matched case-control study was to determine whet her women with Meme or Replicon polyurethane-covered silicone breast i mplants are exposed to clinically significant levels of free 2,4-TDA f rom biodegradation of the polyurethane foam. Urine and serum samples w ere obtained from 61 patients' with Meme or Replicon breast implants a nd 61 controls on two separate occasions separated by 10 +/- 3 days. F ree TDA was analyzed by gas chromatography combined with negative chem ical ionization mass spectrometry with lower limit of quantitation in both urine and serum of 10 pg/ml. The results were correlated with the length of time since implantation. No patients or controls had detect able free 2,4-TDA in their sera. Thirty patients had quantifiable leve ls of free 2,4-TDA, and 18 had detectable levels in their urine. Contr ols had no quantifiable levels, but 7 subjects had detectable levels. The biodegradative half-life of the polyurethane foam was estimated to be 2 years. A risk assessment using the cancer potency estimate calcu lated by the FDA from rat data and the National Academy of Sciences me thodology provided a theoretical lifetime risk of approximately one in one million. It was concluded that the polyurethane foam cover on the Meme and Replicon breast implants biodegrades. The risk assessment of approximately one in one million derived from this study strengthens earlier conclusions by the Health Protection Branch (Canada) that ther e is no significant risk of cancer from exposure to the 2,4-TDA formed from this biodegradation.