Release of chemicals from polyurethane foam in the Même breast implant.
Samples of polyurethane (PU) foam from the Même breast implant were incubated at 37 degrees C in either 0.3-3.0 N sodium hydroxide (NaOH) solutions, normal saline, or methanol. The chemicals released were analyzed by gas chromatography (GC), gas chromatography/mass spectrometry (GC/MS), and Fourier-transform infra-red (FT-IR) spectroscopy. The surfaces of the treated and untreated foam samples were studied by scanning electron microscopy (SEM). The NaOH solutions hydrolysed the foam, releasing toluene diamine (TDA). Incubating the foam in methanol washed out trace quantities of anti-oxidant, 2,4-dimethyl-6-t-butylphenol (DBP). When the foam was incubated in normal saline at 37 degrees C no TDA was detectable but another compound with a mass ion of 173 was detected. Further GC/MS studies confirmed that this compound was polyol, one of the reagents used to manufacture the PU foam. Repeatedly incubating or washing the foam in normal saline or methanol eliminated the release of polyol. SEM studies of the foam samples before and after incubation experiments, showed no evidence of polymer degradation. These findings indicated that polyol was present in the PU foam only as an impurity or residue and did not originate from the breakdown of the foam itself.
Daka
J N
JN
Bureau of Radiation & Medical Devices, Health & Welfare Canada, Ottawa, Ontario.
Chawla
A S
AS
D001940:Breast; D002849:Chromatography, Gas; D005260:Female; D006801:Humans; D013058:Mass Spectrometry; D000432:Methanol; D010655:Phenylenediamines / Q000032:analysis; D011108:Polymers / Q000032:analysis; D011140:Polyurethanes / Q000737:chemistry; D019736:Prostheses and Implants; D012965:Sodium Chloride
D010655:Phenylenediamines; D011108:Polymers; D011140:Polyurethanes; C024617:polyol; D012965:Sodium Chloride; C028279:polyurethane foam; C010914:2,4-diaminotoluene; D000432:Methanol