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http://dx.doi.org/10.1054/bjps.1999.3189DOI Listing

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In response to a Hazard Notice by the Medical Devices Agency of the UK in 2000 regarding the Trilucent breast implant (TBI), an expert panel was convened to implement a research program to determine whether genotoxic compounds were formed in the soybean oil filler (SOF) of TBIs and whether these could be released to produce local or systemic genotoxicity. The panel established a research program involving six laboratories. The program recruited 47 patients who had received TBIs (9 patients had received silicone implants previously).

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Background: The use of Trilucent breast implants dates back to 1995. These implants were produced in an attempt to overcome the perceived shortcomings of other implants filled with saline and silicone gel. The filler material, which was derived from soybean oil, was said to be biodegradable and biocompatible.

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In various fibrotic diseases, matrix metalloproteinases (MMPs) and their natural inhibitors, the tissue inhibitors of metalloproteinases (TIMPs), play an important role. In our study, serum concentrations of MMP-1, MMP-2, MMP-9, TIMP-1, and TIMP-2 were determined by enzyme-linked immunosorbent assay in 17 female patients with Baker grade II (n =9), III (n =7), and IV (n =1) capsular contracture after bilateral cosmetic mamma augmentation with Trilucent implants (AEI, Inc., Caversham, United Kingdom).

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In June of 2000, the U.K. Medical Device Agency recommended the removal of Trilucent implants as a precautionary maneuver in response to reports of local inflammatory reactions.

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