Soya Oil / Trilucent Breast Implants

 

 

Soya Oil / Trilucent Breast Implants

Soy oil filled implants, also known as Trilucent breast implants, were conceived of by Dr. Leroy Young, and others at Washington University in St. Louis in the early 1990's. These doctors wanted to give women another choice in breast implants, one that would allow for a clear mammogram reading. Like natural breast tissue, the filler, soy oil, is radiolucent, while saline and silicone gel are not. If soybean implants accidentally rupture, the soybean oil was thought to be absorbed by the body, and have no toxic actions.

The filler of the Trilucent breast implant contained Trilipid 6, which contains highly refined medical-grade triglyceride fats extracted from soybean oil. In short, this means purified soy oil. Before the soya oil implants were marketed, several animal studies were done in order to establish whether or not the implants would be safe for use in humans. Triglycerides from soybean oil have shown biocompatibility in both animals and humans. The filler was injected into rabbits, with no toxic or allergic reaction. Furthermore, for over 40 years, triglycerides from medical-grade soybean oil have been used as intramuscular drug carriers and as intravenous nutrition for critical care patients. None of the studies showed evidence of the soya oil being a safety concern. Prior to the onset of the clinical trials in Europe, the Trilucent implants had received an IDE (Investigational Device Exemption) in the United States. Fifty patients in the US received these implants.

Clinical Studies and Safety information on Trilucent Breast Implants
Trilucent breast implants were first marketed in 1995, in the United Kingdom. An estimated 5000 European women received the implants. Additionally, fifty US women received the implants, as part of a clinical trial.

In 1995, following clinical trials in Europe, the Trilucent breast implant was marketed by LipoMatrix. An estimated 5000 European women received the implants. Lipomatrix was required to report any adverse reactions regarding these implants to the MDA (Medical Device Agency), the British equivalent of the FDA. LipoMatrix, as well as the MDA, both received reports of local reactions in women with Trilucent implants. Studies have shown that the soya oil can leak out and infiltrate body tissue. The adverse reactions consisted of inflammation and swelling, both of which subsided when the implant was removed. Even though the removal of the implants alleviated the swelling and/or inflammation, and there was no evidence that they caused long-term health problems, the U.K. Department of Health recommended that the implants no longer be used. LipoMatrix voluntarily recalled the implants in March of 1999.

No new clinical studies are planned for the Trilucent breast implant.

 

Trilucent breast implants have a small computer chip on the center surface of the implant. The purpose of the microchip is to allow the implant to be traced, as well as store the patient's history.

 

For more information on these implants, click here.