O.C. Whistle-Blower Says Women With Implants Are ‘Guinea Pigs’

A Laguna Niguel man who was a whistle-blower in the battle over breast implants said he hopes that women will be given information to “truly convince” them that “they are human guinea pigs” if the devices are allowed back on the market.

Thomas D. Talcott, a former materials engineer for breast implant manufacturer Dow Corning, said that in 1975 he opposed developing what was then a new variety of fluid silicone gel devices because he thought they were too dangerous.

He said in an interview at an Irvine hotel that he welcomed a Food and Drug Administration advisory panel’s recommendation this week that access to such breast implants be limited primarily to women who require reconstructive surgery. Talcott also applauded the panel’s call for research to track future implant recipients to determine whether gel that enters the body causes illnesses such as tissue disease, scleraderma and Lou Gehrig’s disease.

He added, however, that before more women are allowed to have such implants, animal experiments should be conducted to determine the consistency of silicone gel that is least prone to causing implant ruptures or migrating through the body.

Talcott, who has patented an implant with firmer gel that he believes is safer than the fluid variety, said women who participate in the implant study will be “very courageous.”

They face potential danger, he said, especially with fluid gels.

“I think there is a strong possibility that sooner or later they will have mild trauma that will break the device,” he said, “and at that point I think they have only a few days to get that device taken out” before it flows “into the arm or groin and becomes irretrievable.”

Gels that are more dense can also migrate through the body, he said, but it takes longer.

However, all the current discussion about future tests that the Food and Drug Administration may require for continued marketing of silicone gel breast implants could well be moot, Talcott said, if manufacturers decide that the financial risk of further consumer litigation is too great.

New information about breast implants that the FDA recently obtained from lawsuits filed against Dow Corning in California and Michigan sparked the agency’s safety reevaluation. The Michigan-based firm is the nation’s leading manufacturer of such implants.

“With all the litigation, I don’t see how the implants can stay on the market,” Talcott said. “I think each and every one of the companies (that manufacture implants) will have to abandon them.”

Even if no new silicone gel implants are sold, Talcott said, he would recommend that the FDA establish a registry to keep track of women who have their breast implants removed to determine whether certain implants are associated with illness.