A Sordid History Of Silicone Treatment -- A Society's Obsession, Greed Lead To Experiments On Unwitting Women

The scene: postwar Japan, crawling with randy, victorious American GIs. The "problem:" The breasts of Japanese women were too small, to some American eyes.

The "solution:" Inject women's breasts with liquid silicone, industrial strength transformer coolant stolen from barrels off Japanese docks. When that didn't work - the silicone oozed into the rest of the body - chemicals were added to cause scar tissue to keep silicone droplets in place.

Thus began the sordid story of silicone's careless and sometimes dangerous use in human beings, a story whose full dimensions are coming into focus only today, nearly 50 years later.

Within a few years of Japan's postwar experimentation with silicone, an estimated 50,000 U.S. women, including 10,000 waitresses and showgirls in Nevada, took the injections. The 34B-turned-44DD chest of Carol Doda, a well-known topless dancer, became a veritable icon of silicone.

Today, it is painfully clear how careless research, weak federal regulation and ravenous profit motive, all superimposed on a societal obsession, combined to create a consumer health nightmare. Two weeks ago, the U.S. Food and Drug Administration recommended a 45-day moratorium on the sale of silicone gel-filled implants.

But the silicone story is not just a tale of profits and government inaction. It is also a tale of anguish - and increasingly, anger - among many of the estimated 2 million U.S. women who only now, years after implants or injections, realize they may have been unwitting participants in a vast experiment with human bodies.

Leia Zenderman, a 44-year-old Santa Fe, N.M., painter, is one of these women.

As a teenager she suffered from Poland's anomaly, a condition in which only half the chest muscles and one breast develop normally. Zenderman sought help from Dr. Franklin Ashley.

In 1965, Zenderman had surgery. Ashley reduced the size of her normal left breast and augmented the right side with a silicone implant, newly on the market. But, because she had so little chest muscle he also began liquid silicone injections to make the right breast match the left.

Although it was unknown to the Zendermans, Ashley was one of a few doctors who worked under the auspices of the Dow Corning Center to Aid Medical Research.

In 1965, the Dow center received permission from the Food and Drug Administration to pursue liquid silicone studies in animals and humans. But the Zendermans, who said they paid $3,000 for the surgery and injections, were never told they were part of an experiment. Nor were they told why, after the initial injections, treatment was abruptly stopped.

They were crushed. Zenderman was left with asymmetrical breasts.

She learned to live with the silicone that hung in her breast "like jello hanging in a pocket."

But it was not until Zenderman recently called an implant critic, Dr. Norman Anderson, a Johns Hopkins Hospital surgeon, that she finally learned the truth.

Anderson says Zenderman is "one of the missing ones" he has been looking for for years - women upon whom doctors experimented without permission and whose records were never sent to the FDA.

Zenderman's reaction was pure shock: "We never knew we were part of an experiment. I am horrified."

MASSIVE PUZZLE COMING TOGETHER

For Anderson, who chaired the FDA's breast implant advisory panels in 1983 and 1988 and serves on the panel that is expected to rule on implants in February, Zenderman's story is a tiny piece in a massive puzzle he is trying to put together.

In a letter early this month to the FDA commissioner, Dr. David Kessler, Anderson mentions a 1967 article in the Journal of Plastic and Reconstructive Surgery, whose lead author was Ashley, Zenderman's doctor, who is now deceased.

In that article, Ashley's team describes what happened when liquid silicone was injected into the breasts of Japanese apes and monkeys: In 13 monkeys, the injections caused "marked fibrous response" and "destruction of local anatomy."

In the same article, Ashley says "a selected group of women," which may have included Zenderman, were repeatedly injected with 5 to 10 milliliters of liquid silicone into the breasts. But, as Anderson says, the results were never published or reported to the FDA. Nor, Anderson observes, were data on 149 other women who received injections reported to the FDA.

In 1967, the FDA stopped these studies and revoked its permission to Dow. But in 1969, the FDA once again allowed Dow to test liquid silicone - provided it was not injected into women's breasts.

Dow then began its first large study of silicone injections for soft tissue defects, including facial wrinkles and scars in 1,337 patients, according to Anderson's research. But Dow never gave the FDA data on many of these patients, say congressional investigators for Rep. Ted Weiss, D-N.Y., whose subcommittee oversees the FDA.

`THOUSANDS HOLLERING' IN NEVADA

By this time, the late 1960s, even as Dow pursued liquid silicone, reports surfaced of problems with Nevada women who had been injected with silicone.

"Thousands" of these women "started hollering," recalled Dr. Edward Kopf, assistant professor of plastic surgery at the University of Nevada School of Medicine, complaining of problems such as lumps, silicone cysts and rock-hard breasts.

Kopf in 1975 prevailed upon Nevada legislators to outlaw injectable silicone. Colorado and California quickly followed.

By 1975, though Dow was still pursuing liquid silicone, it was also moving ahead with silicone gel-filled implants, a market that had been dominated since the early 1970s by other companies.

Dan Hayes, Dow's president and chief executive officer, makes no bones about the company's work at that time on new implants: "Yes, there was market pressure, but you have to understand, the ingredients that make up this softer implant were the same ingredients as before, so it was not like we were introducing something new."

Yet corporate memos strongly suggest that Dow knew about implant problems and that the company began putting new implants in women before animal studies were done, a point Hayes disputes.

Most enraging to Anderson is the fact that Dow never tested its implants in or just under breast tissue, an omission, that as he put it to Kessler, "must be unprecedented in the history of device evaluation," analogous to testing artificial hips by "implanting them solely into animal armpits."

REGULATION WEAK

In 1976, Congress finally authorized the FDA to regulate medical devices, but breast implants were temporarily exempted because they were already on the market.

That same year, Thomas Talcott, a Dow chemical engineer who says he had tried "to convince Dow for 13 months" not to use fluid silicone for its gel-filled implants, quit the company. Talcott said "I could see no difference" between the silicone Dow was putting into the gel and the liquid form the FDA in 1969 had said should not be injected into women's breasts.

Although the implant business was heating up, Dow continued to pursue liquid silicone. In 1978, the FDA gave approval to Dow for a study of injectable silicone for severe facial deformities, provided the company complete a seven-year follow up.

In 1990, Dow submitted its results to the FDA - but these reportedly were severely flawed. A third of the 128 people injected did not even have the facial deformities stipulated in the study design, according to Weiss' staff. Dow also submitted "before" pictures but not "after" pictures of many patients. And half the patients were followed for only four years. Two had severe skin tissue breakdown.