Maker Defends Silicone Implants : Health: A review commissioned by Dow Corning Wright found the firm’s studies on the devices “to be complete” despite internal memos to the contrary.

The country’s largest manufacturer of silicone gel breast implants vigorously defended the controversial devices Monday, releasing a review of implant studies that found the products “while not without risk, safe and effective for their intended use.”

The review, commissioned by Dow Corning Wright and submitted to the Food and Drug Administration, also found the firm’s studies “to be extensive and complete.”

However, internal Dow Corning Wright memos--published in recent weeks and first reported Dec. 30 in the San Francisco Examiner--indicated that some scientists within the company were unhappy with its failure to study all aspects of the devices. The memos portrayed Dow as eager to rush a new version of the product onto the market in 1975, before it had been thoroughly tested in animals.

The company report found otherwise. “The non-clinical and clinical studies reported establish that Dow Corning Wright’s breast implant products are safe and effective,” said the study by Dr. Albert Kolbye, former associate director of toxicological sciences at the FDA. “All surgical procedures involve occasional risks of adverse results due to various causes; therefore, ultimate safety should be considered in relative terms, not absolute.”

Last week, the FDA called for a temporary halt to the sale and use of silicone implants while the agency re-evaluated their safety. In November, an FDA advisory committee had declared that studies provided by the company had failed to establish the safety of the devices, but it recommended that they be allowed to remain on the market while studies continued.

Dan Bolton, a San Francisco attorney whose client recently won a $7.3-million judgment against Dow for health problems she said were caused by an implant, said company memos indicated that Dow was in such a rush to get its product on the market that it either dismissed or short-circuited animal studies showing that silicone leaked from the implants.

Rep. Ted Weiss (D-N.Y.), chairman of a House subcommittee that has been investigating the safety of implants for more than a year, said the Dow memos “indicate that women truly have been unwitting participants in a massive experiment.

“It is clearly unethical that a company would conduct studies of women before they had completed safety studies in animals,” Weiss added.

But Robert T. Rylee, vice president of Dow Corning, insisted Monday that basing any conclusions on “internal non-scientific memos is nothing short of intellectual dishonesty.

“Memos are not science,” he said. “They are a printed record of one side of a two way conversation that has been consistently misinterpreted. At best, a focus on memos shows naivete with the product development process,” he continued.

About 2 million of the devices have been implanted since they were introduced onto the market three decades ago. About 150,000 women every year have the surgery--80% for cosmetic reasons, the rest for reconstruction after breast cancer surgery.

Known risks include hardening caused by the scar tissue that develops around the implant, leakage of silicone gel, rupture of the device and interference with mammography.

There are also several suspected dangers, including cancer and autoimmune disease.