Implant test generates interest

August 03, 1994|By Jonathan Bor | Jonathan Bor,Sun Staff Writer

Within 24 hours of an announcement that the government would allow 50 women across the country to try a new breast implant filled with soybean oil, hundreds of women were phoning doctors' offices to register their interest.

Dr. Ronald Schuster, an Owings Mills plastic surgeon who will fit 10 patients with the device, said yesterday that his office had received calls from 100 women wishing to take part in a safety experiment.

That response, however, was nothing compared with the 1,000 calls that flooded a medical practice in Van Nuys, Calif.

The spark was an announcement Monday by LipoMatrix Inc., a Swiss company established for the sole purpose of producing the implant, that it had received approval from the U.S. Food and Drug Administration to test the device at five medical centers in the United States. Each site will select 10 patients.

The oil-filled implant was developed by physicians at the Washington University in St. Louis, where Dr. Schuster trained in plastic surgery. He will perform the operations at the Johns Hopkins Hospital.

Breast implants have been a source of intense controversy for the FDA. It banned silicone-gel implants three years ago for anyone except breast cancer survivors. Aside from a concern over mammograms, thousands of women claimed leaking gel gave them crippling autoimmune diseases such as rheumatoid arthritis, lupus and scleroderma.

Scientists haven't proved the implants dangerous -- indeed, several studies found no dangers whatsoever -- but manufacturers have agreed to pay $4 billion to settle 9,000 lawsuits. Lingering concerns have caused many doctors to abandon silicone altogether, using saline both for mastectomy patients and healthy women wanting larger breasts for cosmetic reasons.

Tests of the oil-filled implant have been in progress for several months in Germany, France and Britain. In those countries, 75 women have received the device.

Although U.S. doctors have yet to work out the criteria for selecting patients, initial rules limit participation to women who already have implants filled with silicone or salt water and want them replaced because of leakage or pain.

Also, women who are concerned that their implants may interfere with mammography are eligible to participate. The X-rays used in mammography are incapable of penetrating saline or silicone gel, making it difficult to detect tumors that might develop behind an implant.

But Dr. Judy Destouet, a radiologist who helped create the oil-filled implant while working at Washington University, said X-rays penetrate soybean oil because the liquid has practically the same density as the fat in the human breast tissue.

"We can see through fat, so we should be able to see through these implants," said Dr. Destouet, who now practices in Pikesville.

While a California study found that breast tumors are sometimes detected late in women with implants, studies have not been in progress long enough to determine whether these women are more likely to die of cancer.

"If you can come up with an implant that doesn't interfere with mammography," Dr. Schuster said, "I would want to use that on my patients."

Creators of the new implant say it may be less prone to rupture. The fatty contents, they say, should lubricate the outer shell and prevent it from weakening. The shell is made of a tough silicone similar to that used in other implants.

If the implant does break, they say, the soybean oil should cause little harm. "If the envelope breaks, the body will absorb the soybean oil and use it as a food source," Dr. Destouet said.

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