A Confederacy of Boobs

How special interests, assorted ideologues, and a sensationalist press torpedoed breast im plantsand now threaten other medical devices

Michael Fumento from the October 1995 issue

(Page 2 of 5)

There are two ways that women can be exposed to silicone from an implant. One is when microscopic droplets of silicone fluid "bleed" through the envelope of a gel-filled implant. "Low -bleed" implants have been available since the early 1980s and have reduced the amount of silicone that escapes from the implant. In any event, because scar tissue quickly forms around the implant, the gel usually goes no further than one or two millimeters beyond the implant wall.

The other way women can be exposed is through rupture. According to the FDA, about 4 percent to 6 percent of silicone implants have ruptured, though studies in progress indicate this figure is probably too low.

Nonetheless, again the scar "capsule" that invariably grows around the implant tends to hold any silicone even if it breaks, which explains why so many ruptures are outwardly undetectable. While the gel has gone beyond the pouch, it still usually remains in place, although it has been found in the lymphatic system of some women.

That implants can cause physical problems is beyond doubt. It has long been known, for instance, that the scar capsule can harden and constrict, sometimes painfully so. This hardening can make necessary follow-up treatment to remove the scar tissue. Makers of later model implants claim to have reduced this problem, but it's too early to say what success they may have had.

But when critics warn of the dangers of silicone implants, this usually minor problem is seldom what they're talking about. According to Jack Fisher, a San Diego plastic surgeon and outspoken defender of implants, more than 50 symptoms are alleged to be caused by implants, including memory loss, dry mouth, cancer, bladder problems, difficulty swallowing, joint pain, decreased sex drive, and a host of autoimmune diseases. Some have referred to this broad constellation of symp toms as "silicone-gel syndrome." But if it is a syndrome it appears the proper definition would have to be any illness that any woman with implants ever contracts.

To sympathetic observers, such a wide array of symptoms must seem alarming. But a general rule of epidemiology is that the more diverse the symptoms allegedly related to a single cause are, the less likely it is that the suspected cause is real. This basic precept is, in a sense, the mirror image of snake-oil cures that promise to remedy all sorts of unrelated symptoms. Many of the most com monly cited symptoms of silicone exposuresuch as fatigue, headaches, and difficulty swallow ingcan be brought on by suggestion. As a result, people who hear that implants may cause certain problems may then develop them. These are the same "side effects" described by participants in drug studies who are actually receiving placebos.

And, in fact, most of the evidence against implants is anecdotal: It is based on reports from women who are sick and have implants and claim the two conditions are related. Thus, if a woman with implants ever develops symptoms that doctors can't readily explain, everyone simply assumes that silicone is the cause. Sometimes this sort of reasoning is expressed in the very titles of the implant scare articles. Consider the headline for the San Francisco Chronicle's article about Mariann Hopkins: "After Breast Implant, Horror Began."

While such a loose correlation may be appealing to people looking for quick and easy answers, it is essentially the same logical fallacy that blames black cats for inexplicable illness. Yet, in some cases, the silicone-gel symptoms actually predate the implants. Indeed, such a curious time frame appears to have been the case even in the first big implant settlement.

One of Mariann Hopkins's treating physicians testified that, although her diagnosis of mixed connective-tissue disease did not come until after the implants were put in, she had already displayed symptoms of connective-tissue disease as early as two years before receiving implants. The doctor even testified that another physician was so concerned that he subjected her to a battery of tests for one type of connective-tissue illness called systemic rheumatic disease. Those came back negative, but they were not tests specifically for mixed connective-tissue disease. Had they been and had they come back positive, it's unlikely Hopkins would have ever received the $7.3 million award.

But then again, the jury did not seem overly influenced by those most knowledgeable of Hopkins's medical history. At the time of trial, Hopkins was basically free of symptoms, thanks to a low dose of medicine. And none of Hopkins's treating physicians testified at the trial that they believed her illness to be related to the implants. Instead, the jury made its finding on the basis of outside testimony that implants could cause such disease, testimony from professional anti-implant witnesses such as Tampa, Florida, physician Frank Vasey, who makes his living by treating women he says are sick from their implants.

Perhaps the most serious charge against silicone implants is also the weakestthat they may cause breast cancer. Although such influential groups as Sidney Wolfe's Public Citizen (founded by Ralph Nader) have made the claim, repeated studies have shown no such link. The only cancers ever plausibly attributed to siliconein a study released over 40 years agowere connective-tissue sarcomas that appeared in strains of rodents especially susceptible to cancer.

The simple truth is that no epidemiological studies have linked cancer in people to implants. The largest study is also the most recent: After looking at a group of almost 11,000 women from the Alberta, Canada, area, the Alberta Cancer Board concluded, "The incidence of breast cancer among the women who had breast augmentation could not be said to be either significantly higher or lower than that among the general population."

Polyurethane implants, which make up about 10 percent of implants currently in use, are a special case. Manufactured by Surgitek Inc., a subsidiary of Bristol-Myers Squibb Co., these im plants featured a gel-filled pouch with a layer of polyurethane foam coating the silicone envelope. The implants were a special target of Connie Chung's Face to Face report. Under such heat, Surgitek felt it had no choice but to remove them from the market in 1991. (Nevertheless, a USA Today illustration in May 1995 accompanying an anti-implant editorial depicted a polyurethane -coated implant.)

The purpose of the foam was to reduce the chance of scar tissue contracting around the im plant. But when the foam breaks down chemically, it produces a substance called 2-toluene diamine (TDA) that is considered a probable animal carcinogen and a possible human one. Although that would seem to be an obvious source of trouble, it turns out that, like all the other serious accusations against breast implants, the charges against polyurethane implants don't hold up under epidemiologi cal scrutiny. The only difference is that in this case the FDA has admitted it.

In late June, Bristol-Myers Squibb concluded an FDA-solicited study to determine how much TDA really ended up in the system of women with polyurethane implants. The amount (when any was found at all) was so small that even assuming it is a definite human carcinogenusing the FDA's own rating systemthe risk of cancer was one in a million. Since only about 110,000 women have had such implants, the FDA stated in a position paper, "FDA estimates it is unlikely that expo sure to TDA will cause cancer in even one of the women with these implants." The agency added, "The health risk connected with surgical removal of the implants is far greater than the risk of developing cancer."