Histological examination of the capsules surrounding Trilucent breast implants.

Following a statement by the UK Medical Devices Agency (MDA), soya-oil-filled Trilucent implants for breast augmentation were withdrawn from sale in March 1999. The most recent report on the toxicity of the Trilucent implant suggests that one of the breakdown products of the filler is an aldehyde with an explicit risk of genotoxic and teratogenic effects. Explantation of all these prostheses was advised by the MDA in June 2000. No guidance regarding capsulectomy was put forward by any publication. The operation of capsulectomy confers an increased morbidity compared with simple prosthetic replacement. This study looks at the capsules of 18 consecutive patients who had received Trilucent implants for cosmetic breast augmentation, and who had undergone explantation and capsulectomy. The mean duration of implantation was 3 years (range: 2 years to 4 years 9 months). The capsules were examined histologically. The significant features of all the capsules included a florid foreign-body type reaction, synovial metaplasia, a villous hyperplasia and the presence of refractile material within the substance of the capsule. It is postulated that the refractile material is filler material that has bled through the wall of the intact Trilucent implant, and as such would represent a potential genotoxic hazard. Until such time as this potential hazard has been investigated fully and a conclusion reached, we recommend acceptance of the increased morbidity, and the performance of capsulectomies when explanting Trilucent implants.