FDA Approves Tryout of New, Natural-Filled Breast Implant
WASHINGTON (AP) _ Government regulators are allowing 50 American women to try out an experimental breast implant filled with a natural fat from soybean oil - the first advance in implants since widespread problems with the devices were reported in 1991.
LipoMatrix Inc. said today that its 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.
The Food and Drug Administration said animal studies show the implants are safe enough for limited testing in women.
″This is a very different implant,″ said LipoMatrix’ president, Dr. Terry Knapp. ″It’s a natural substance.″
Breast implants have been one of the FDA’s most wrenching controversies. It banned silicone-gel implants in 1991 for everyone except breast cancer survivors in clinical trials.
Thousands of women claim leaking gel made them ill, in some cases causes crippling autoimmune diseases like lupus. Scientists haven’t proven the implants are dangerous, but their manufacturers have agreed to pay $4 billion to settle 9,000 lawsuits.
And FDA is wrestling with how to regulate saline-filled implants, silicone shells inflated with saltwater that some women say harbor bacteria and fungi that infect them when they leak. Critics say both silicone and saline build up in tissue.
Knapp believes his implant is much safer because it uses triglyceride, a natural fat in the body.
Most people associate triglycerides with heart disease because too much of a certain animal-based triglyceride can clog arteries. Knapp’s Trilucent breast implant uses an unsaturated triglyceride from soybean oil, the same kind fed to infants allergic to milk.
Were the implant to leak, animal studies show the body would metabolize and excrete the fat just as it would had the woman eaten the fat, Knapp said in a telephone interview from his headquarters in Neuchatel, Switzerland.
″Hopefully, this will solve the problem for us and it will be a viable alternative,″ said Sandy Finestone, who heads the Women’s Implant Information Network in Irvine, Calif.
However, the implants were developed by scientists at Washington University in St. Louis because mammograms can’t adequately penetrate the older implants, meaning early breast cancer could be missed.
Mammograms can penetrate triglyceride just as they penetrate normal breast fat, Knapp said.
The pilot study should give the FDA enough information about the implants’ safety and whether they are mammogram-friendly to justify a full-scale clinical trial, said spokeswoman Susan Cruzan.
The FDA also will look at results from trials in Britain, Germany and Italy that began last October. Ninety women there have received the implants without problems, but it’s way too early to draw safety conclusions, Knapp said.
Doctors at five U.S. sites 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 small study is not sophisticated enough to account for major illnesses.
The new implants do have silicone shells, which some women also fear. Knapp said the shells are a special new form of silicone that shouldn’t leach into tissues; the study will look at that as well.
Trial sites include: Johns Hopkins University in Baltimore; Stanford University in California; The Breast Center in Van Nuys, Calif.; the University of Florida, Gainesville; and Washington University in St. Louis.
Women interested in participating may call 800-839-3020.