The trilucent breast implant was developed at Washington University, St. Louis, U.S.A. in the 1980's by Drs. Leroy Young, Judy Destouet, John Eichling, Louis Guila, and Barbara Monses. The implants were designed for radiolucency, safety, and long life. It has been used in Europe (1994) and United Kingdom (1995) and about 10,000 trilucent breast implants have been sold. The implants are made by LipoMatrix of Neuchatel, Switzerland, which is owned by Collagen Corporation, Palo Alto, California. The implants have not yet been approved for use in the United States by the Food and Drug Administration (FDA). Long-term clinical trials on humans and mammals are being conducted in the United States and Canada. About 70 people in the U.S. and Canada have participated so far. There will be additional clinical trials. Those wishing to participate should contact Collegan Corporation at Phone 800 722-2007.

Silicone implants are not radiolucent and obscure mammogram. Breast tissue consists of glands and fat and has an atomic number six. Substances with atomic number similar to that of human breast (six) have been found to be radiolucent. The soybean triglycerides used in the breast implant have an atomic number of 5.9 and are radiolucent.

The breast contains a significant amount of fat and thus use of soybean oil does not in itself cause problems. Soybean oil has been used in medicines for years as a drug carrier and does not present a problem. It is proposed that small leakage of soybean oil from the shell of the implant into the breast would be absorbed and metabolized by the body. Animal studies involving rabbits and rats indicate that soybean oil leakage is not a health problem.

Eventually, breast implants "wear out", do to leakage from the implant into the body. In a few cases the shell can rupture and fluid (soybean oil in this case) will leak in to the breast tissue.

This happens infrequently and results in distress to patients but no apparent sustained problems. The main reason for the rupture type leakage has been attributed to fold flaw problems. The portions of the shell folds against itself and rubs against each other and the result is rupture and leakage. More common is slow leakage. Very small quantities of the soybean oil pass from the shell into the breast on a constant basis. The soybean oil used in the implants acts as a lubricant and provides prolonged resistance to abrasion. For this reason, it is expected that these implants will last as long or longer than silicone gel-filled implants.

Capsular contracture is a common problem associated with breast implants. The body forms a fibrous membrane capsule around the implant. In the case of silicone-gel implants (and to some extent saline implants) bacteria present in the body will grow in the capsulimplant and cause capsular contracture and result in the breast becoming rounder and firmer. This problem appears to occur, but to lesser extent, with trilucent breast implants possible because the bacteria have more difficulty growing in soy oil then in the silicone-gel or saline.

For information about participating in future clinical trials in America or Canada contact:

Ms. Pauline Brook

International Marketing - Trilucent

Collagen (UK) LTD

10 Thame Park Business Centre

Bertie Road

Thame, Oxfordshire OX9 3FR

United Kingdom

Phone 44 1844 261161 (ext 309)

FAX 44 1844 261186