The polyurethane foam covering the Même breast prosthesis: a biomedical breakthrough or a biomaterial tar baby?
Because controversy continues to surround the implantation of the polyurethane foam-covered Même breast prosthesis, in vitro experiments were conducted to determine: (1) whether the polyurethane foam contains extractable toluene diamine isomers (TDAs), and (2) whether the polyurethane foam releases TDAs on exposure to mild hydrolytic conditions. Results confirmed the presence of extractable TDAs and other impurities in the foam covering the unused Même prosthesis, and that the concentrations of these impurities could be significantly reduced by washing the foam in a regular detergent. This washing step was omitted from the manufacturer's production process. Furthermore, on exposure to mild alkalis, the foam exhibited significant degradation, rapid fragmentation, loss of mechanical strength and physical integrity, as well as the release of additional TDAs. Because of the potential long-term risks associated with the release of TDAs in vivo, continued clinical use of the Même prosthesis containing this particular type of foam appears questionable.
Guidoin
R
R
Department of Surgery, Laval University, Quebec, Canada.
Therrien
M
M
Rolland
C
C
King
M
M
Grandmaison
J L
JL
Kaliaguine
S
S
Blais
P
P
Pakdel
H
H
Roy
C
C
D001672:Biocompatible Materials; D005260:Female; D006801:Humans; D016462:Mammaplasty / Q000295:instrumentation*; D008422:Materials Testing; D008855:Microscopy, Electron, Scanning; D011140:Polyurethanes; D019736:Prostheses and Implants; D011474:Prosthesis Design; D013499:Surface Properties
D001672:Biocompatible Materials; D011140:Polyurethanes; C028279:polyurethane foam