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Trilucent Breast Implants
Trilucent breast implants, or soy-filled breast implants, were originally developed by doctors in the early 1990s who wished to give patients an alternative to saline or silicone filled breast implants. These doctors believed that Trilucent breast implants would be safer than their more traditional counterparts because of the nature of their filler. Soy oil is radiolucent, unlike saline or silicone. In the event of a rupture, it was conceived that the filler in Trilucent breast implants would be absorbed by the body without toxic reaction.
Trilucent breast implants are made with highly refined medical grade triglyceride fats from soy oil, called Trilipid 6. This material had been used safely for decades in other medical applications. Prior to approving the Trilucent breast implants, researchers conducted animal studies; injecting the filler material into rabbits with no toxic or allergic reaction.
Clinical Trials And Recall
In 1995 as part of a human clinical trial, 5,000 women in Europe and fifty in the United States received Trilucent breast implants. It is estimated that at least 8,000 women in Europe and more than fifty in the United States received Trilucent breast implants before they were pulled off the shelves in 1999. The recall of Trilucent breast implants was prompted by many reports of significant adverse reactions to these implants. Numerous women reported implant leakage, local inflammation, discomfort, and some implants even became rancid.
Initial studies concluded that these serious side effects subsided after the removal of Trilucent breast implants. The company who marketed the Trilucent breast implants agreed to pay for women to have them removed. In the countries where women had received Trilucent breast implants, governments recommended the removal of these implants to prevent or terminate complications.
A follow-up Trilucent breast implants study was issued in September 2004 by the UK's medicine and drug regulatory agency. The information contained in this announcement was the result of studies conducted by an independent panel of physicians, chemists, and toxicologists. They maintain that the risk of rupture in Trilucent breast implants is relatively low but that the filler can degrade and release genotoxic materials. While it is unlikely that a patient will endure long term or permanent suffering from Trilucent breast implants, experts still advise patients to have their implants removed if they are appropriate candidates for additional surgery.