Informed Consent: A Story of Personal Tragedy and Corporate Betrayal . . . Inside the Silicone Breast Implant Crisis by John A. Byrne, New York: McGraw-Hill, 1996.
If you've been following the news accounts about breast implants, you might have started feeling sorry for the Dow Coming Corporation some time last year. That's when the media focus turned away from the injured women and the tide of public opinion shifted in favor of the implant manufacturer.
In 1995, Dow Coming filed for Chapter 11 bankruptcy which generated much anger about frivolous lawsuits and how they stifle corporate innovation. The Wall Street Journal ran an opinion article by Dow's CEO entitled, "The Tort Monster That Ate Dow Coming," portraying plaintiff lawyers' criticism of implant research as a ploy to make money from the implant cases. ABC's Nightline moaned about the loss of jobs that supposedly resulted from bankruptcy. (Note to Ted Koppel: Filing for Chapter 11 merely means debt reorganization, not the dissolution of a company.) Dow ran full-page ads in 19 major newspapers ("Here's What Some People Don't Want You to Know About Breast Implants"), which offered free information packets of selectively quoted study results purportedly proving no link between breast implants and disease.
All this, says Informed Consent author John A. Byrne, is part of a defensive strategy by Dow Corning to portray itself as the victim of greedy plaintiffs' attorneys--of a legal system out of control. Rest assured that Dow Corning has used that same legal system to evade its responsibility to women. A million dollar law firm (along with a million dollar P.R. firm) has been engaged by Dow to defend against the 400,000 women claiming implant-related illness. Some received their implants to replace a breast lost to cancer; the majority were implanted for breast enlargement.
Byrne, a senior writer for Business Week, presents a behind-the-scenes view of corporate irresponsibility, evasion, and arrogance. His book is largely from the perspective of the quintessential "company man," John E. Swanson, a 26-year employee of Dow Corning and creator of its ethics program, which is so renowned that it is used as the subject of three Harvard Business School case studies. Over the years Swanson had defended the safety of silicone breast implants . . . until he realized that his own company's product was the cause his wife Colleen's wide array of unexplained illnesses. She is one of the one million women who had received breast implants since 1963.
Byrne described Swanson's odyssey as, "What happens when you make a moral choice that separates you from the company's official position and from your colleagues in a close-knit organization." By the end of 1991 Swanson could no longer abide by his employer's decision to continue making breast implants. (He failed in his attempts to get Dow to call a moratorium until adequate tests were performed.) Not only had he learned, by then, of allegations that two company executives were trying to destroy internal documents about the implants' high complication rates, but thousands of women around the country were accusing Dow Corning of injuring them. He excused himself from making any further statements on the Company's behalf about breast implants, but kept the secret of his wife's experience until just before retirement.
Colleen Swanson had been ill for the 17 years since her breast implant operation with a constellation of symptoms including migraines, severe fatigue, joint pain, weight loss, and rashes. Numerous doctors had examined her but could find no explanation. Colleen Swanson never made the connection to her implants until 1990, when her daughter called after seeing two women on the Geraldo Rivera Show detailing the same symptoms that followed their breast implant operations.
Dow insisted that its product was safe and thoroughly tested, but evaded all requests to show proof on the grounds that a company does not have to release proprietary information on its products. Breast implants slipped through the cracks of the FDA. Though the agency had long required testing for drugs, it did not demand the same proof for medical devices until 1976. By then, breast implants had been grandfathered.
Hardening of the breasts, or capsular contracture due to formation of scar tissue, is the most commonly reported adverse reaction. But some plastic surgeons, as early as the 1970s, began to believe that the silicone gel leaking from implants played some role in the hardening of the breasts. The surgeons were falsely assured by Dow in 1977 that a contracture/gel migration study was underway.
But, generally speaking, the surgeons don't fare well in this story. Byrne says that the market for breast implant surgery was expanded in 1982 when the American Society for Plastic and Reconstructive Surgery decreed that small breasts be considered deformities.
When Dow lost its first breast implant lawsuit in 1984 (the jury found the company guilty of fraud and deceit), the most damning information was found by the plaintiff's lawyers in the company's own files. The lawyers found memos expressing concern about the lack of long-term testing, memos from the company's salesmen relaying complaints from doctors, and--the most damaging to Dow's case--letters from plastic surgeons who groused about Dow Corning implants that ruptured in the operating room as they were being inserted in women's breasts.
Dow insisted that silicone was safe and inert based on animal studies. But the corporation's case rested largely on a 1973 study of four dogs implanted with miniature silicone breast implants. Dow quoted' satisfactory six month results, but one expert for the plaintiff found that the company ignored its own two-year follow-up, which told a different story. Three of the animals suffered a varying degree of severe chronic inflammation, and one had died.
The plaintiff in that lawsuit, Maria Stern, won $1.7 million after showing that leaking silicone was found in her thyroid and lymphatic system. This was the first case to allege that a woman was suffering from systemic autoimmune disease as a result of silicone.
But Dow ultimately lost on the issue of informed consent. The jury decided that no woman could have made an informed decision to undergo implantation based on the rosy picture painted in Dow's brochure. The company's internal memos and studies indicated far more risks than were revealed to women. Among other things, women were told that implants would last "a natural lifetime." (They don't.)
The question of whether silicone causes auto-immune illness, such as lupus, scleroderma, rheumatoid arthritis, remains unanswered despite negative findings from studies published last year by the Harvard Medical School and the Mayo Clinic. Neither is definitive. The latter, for example, included women whose implants were in place as little as one month. The average follow-up was 7.8 years, yet most autoimmune symptoms don't show until 8 to 15 years following implantation.
As for Dow Corning's decision to file for bankruptcy protection, one plaintiffs' attorney describes it as little more than a ploy to buy more time in order to avoid compensating women for their injuries.
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