Test to Study Breast Implant Made With Soybean-Oil Fat

Fifty U.S. women will test an experimental breast implant filled with a natural fat from soybean oil, in the first such study of a new implant since scandal erupted over the devices in 1991.

The Food and Drug Administration approved the pilot study of the implant made by LipoMatrix Inc. Company officials said the new breast implant should be safer than the silicone-gel and saline implants that thousands of women blame for sickening them--and would be the first implant a mammogram could see through.

“This is a very different implant,” said LipoMatrix president Dr. Terry Knapp. “It’s a natural substance.”

The FDA banned silicone-gel implants in 1991 for everyone except breast cancer survivors in clinical trials. Scientists haven’t proved the implants are dangerous, but manufacturers have agreed to pay $4 billion to settle 9,000 lawsuits.

FDA also is wrestling with how to regulate saline-filled implants, which are silicone shells filled with salt water that some women say harbor bacteria and fungi that infect them when they leak.

The new implants have silicone shells, which some women also fear. Knapp said the shells are a new form of silicone that shouldn’t leak into tissues; the study will look at that as well.

Knapp’s Trilucent implant uses a form of triglyceride, a natural fat in the body. The unsaturated triglyceride, from soybean oil, is the same kind fed to infants allergic to milk.

Doctors at five U.S. sites, including two in California, will implant 10 women each, who will be followed for one year. The women must already have an implant that needs removing because of leakage or other problems--but cannot have systemic medical problems because the study is not sophisticated enough to account for major illnesses. The California sites are at Stanford University and at the Breast Center in Van Nuys.

Women interested in participating can call 800-839-3020.