title: The history of Trilucent implants, and a chemical analysis of the triglyceride filler in 51 consecutively removed Trilucent breast prostheses.
abstract: This study set out to detect specific classes of potentially genotoxic aldehydes resulting from soybean-oil peroxidation in oil samples from 51 Trilucent implants in 26 patients and two factory-retained prostheses. The chemical analysis was performed independently of AEI inc. All of the implants showed evidence of shell deterioration suggestive of lipid absorption, and of lipid bleed throughout the implant shell. The mean implant weight loss was found to be almost 2% per year. Although none of the implants had actually ruptured in-situ, we identified specific problems with anterior and posterior patch delaminations, making the implant prone to rupture. Our data suggest that the soybean oil in all the explanted Trilucent implants and the two factory-retained prostheses had undergone peroxidation, yielding aldehyde by-products in millimolar concentrations. These concentrations are over 1000 times that thought to be potentially genotoxic. The clinical implications of these findings remain unclear. Capsular tissue was submitted to AEI Inc for histological and chemical analysis, but the data have not been forthcoming, which is disappointing as this may provide further evidence for the risks of long-term complications in these patients.
authors.affiliation: Department of Plastic and Reconstructive Surgery, The Wellington Hospital, London, UK.
authors.forename: W N A
authors.initials: WN
authors.lastname: Kirkpatrick
authors.forename: B M
authors.initials: BM
authors.lastname: Jones
mesh_terms: D000328:Adult; D000368:Aged; D000447:Aldehydes / Q000032:analysis; D018427:Breast Implants / Q000009:adverse effects*; D004867:Equipment Design; D005260:Female; D006801:Humans; D015227:Lipid Peroxidation; D008875:Middle Aged; D011475:Prosthesis Failure; D012826:Silicone Elastomers / Q000737:chemistry; D013024:Soybean Oil / Q000737:chemistry*; D014280:Triglycerides / Q000737:chemistry*; D014783:Viscosity
chemical_list: D000447:Aldehydes; D012826:Silicone Elastomers; D014280:Triglycerides; D013024:Soybean Oil