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February 15, 1996

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3 Canadians get breast implants filled with special soybean oil.

By Wallace Immen / Toronto Globe and Mail TORONTO

Three Ontario women recently became the first Canadians to receive

a new type of breast implants filled with soybean oil. "The soy implants are more natural in feel than saline or silicone gel," says Lloyd Carlsen, head of a surgical team at Scarborough General Hospital, one of three facilities in Canada testing the new implants.

Medical-grade soy oil "has a consistency very similar to cooking oil and its chemical structure is similar to human fat, which makes it an ideal material for an implant," says Carlsen, a pioneer in Canada in breast reconstruction after mastectomy.

The implants should be safe, because unlike silicone gel, which caused so much controversy it was banned in Canada, soy is a natural substance, Carlsen says.

"Purified soy oil is used in drugs and for intravenous feeding of infants and adults and it has a long history of safety in the body."

The outer shell of the soy implant is made of silicone rubber, a type of silicone that won't enter tissue, Carlsen says. It is the same material used in artificial joints and heart valves.

Carlsen and chief plastic surgeon Sandra Voice did the operations on women who needed replacement of existing silicone or saline implants that had hardened or leaked.

Nearly 2 million women in North America have received breast implants over the past 30 years. Makers of silicone implants faced lawsuits from women who claim silicone affected their immune systems and that material was later banned. Most implants today are filled with salt water, which the body will tolerate if the bag develops a leak.

The surface of the new Trilucent implants is roughened to prevent scar tissue from growing smoothly around it and then contracting and squeezing against the implant, which can lead to hardening, Carlsen says. An added advantage of the oil filling is it doesn't obscure breast X-rays, as some forms of existing implants do.

A unique feature in the design is a small valve that allows surgeons to increase the amount of oil after the sac is in place to adjust the size, although once the incision is closed it can't be "pumped up."

The implants are made by Lipomatrix, a Swiss company that has already tested them in several European countries and received approval for their general use. Each implant contains a tiny microchip containing an identification that can be read by a doctor using a hand-held device. The company says it is included so doctors can determine the specific lot the implant came from if there is a problem in the future.

Patients will be studied at intervals over the next two years to determine how their bodies are reacting to the implants. The study must be completed before the implants can be approved for general use in Canada.