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Second Thoughts on Breasts

From the March/April 2007 Issue

The FDA banned silicone implants in 1992 despite a lack of evidence that they were unsafe. Now, the ban has been reversed Where’s the apology? asks Amity Shlaes. Where do the shareholders go to get their equity back?

Last November, the Food and Drug Administration reversed its 14-year ban on silicone-filled breast implants. The news seemed a sign of the changing times. In the old days opponents of breast implants were regular Karen Silkwoods, classic American whistleblowers who exposed how creepy corporations endangered lives. Opponents charged that implants leaked, that the gel they contained poisoned women—and that it was all happening because men were exploiting women.

The FDA’s press release last fall was, by contrast, cheerful. The agency said it would monitor any adverse effects of implants in the future, but women 22 years and older could proceed, “now that the products have been determined to be safe and effective.” This is a new decade, the FDA seemed to be saying, one of forgiveness and cosmetic surgery. And that attitude, too, is classic Americana: move on, don’t look back, no loss.

PQ1aBut in fact, in such stories, there is always loss.

During World War II, Dow Chemical Company and Corning Glass Works created a joint venture to exploit the commercial possibilities of silicone. Among the first products were airplane parts. Soon, however, the new company—based in Dow’s hometown of Midland, Michigan—was making the medical devices for which silicone was ideally suited. Among the innovations: tubes implanted in the brain to lessen the effects of hydrocephalus.

Meanwhile, executives became aware of the market for cosmetic surgery: some women wanted larger breasts than what nature had given them, and, in 1962, a woman named Timmie Jean Lindsey became the first to receive a silicone pair. Dow Corning, along with several other companies, started manufacturing the implants, both for cosmetic augmentation and reconstruction after mastectomies. The silicone variety looked and felt better than the saline-filled alternative.

There were problems. Some implants leaked and wore out. Ralph Nader’s Public Citizen Health Research Group started sending out warnings that the implants could cause cancer. Then the lawsuits began to fly. After testimony indicated a connection between silicone and autoimmune disorders, a jury awarded a San Francisco woman one and a half million dollars. Later, in Hopkins v. Dow Corning, the company was ordered to pay $7.3 million, and the Supreme Court refused to rehear the case.

Still, most Dow Corning employees believed that they were contributing to social and economic progress. To cancer survivors, the implants meant the difference between looking normal and looking surgical. In any case, the product was popular. By the early 1990s, more than one million American women had silicone implants.

Then in 1992, David Kessler, commissioner of the Food and Drug Administration, banned them. Kessler, a lawyer and physician who was appointed to the post by President George H. W. Bush, had his reasons—a desire to show the authority of the FDA and his own suspicion, Silkwood-wise, that leaks from the implants were causing disease. “We want surgeons to stop using these implants in patients until this new evidence can be thoroughly evaluated,” he told a news conference. “I’m asking patients to understand that the Food and Drug Administration commissioner cannot assure the safety of these devices at the present time.” Dow Corning stopped producing implants. Kessler submitted an article justifying the FDA’s move to The New England Journal of Medicine. The executive editor there, Marcia Angell, decided to publish it, giving Kessler a seal of approval.

All these acts provided precious courtroom evidence, even validation, for lawyers. What had been a river of lawsuits now became a tidal wave. Women, with encouragement from plaintiff’s lawyers, were alleging that the implants caused disorders such as lupus and rheumatoid arthritis. By 1994, the breast implant makers, in hopes of halting the litigation, agreed to create a $4.3 billion fund for settlements. By mid-1995, a total of 410,000 potential claims had been filed against Dow Corning alone.

Meanwhile, women with implants, even those with no symptoms, became desperate at the thought that their implants might hurt them—though Kessler did not recommend instant removal. A woman in Austin, Texas, even pricked one of her implants through the skin with a scalpel in order to force surgeons to remove her pair. In the courts of law and public opinion, the case against implants had been heard, and implants had been convicted.

Yet the science was still nowhere near that point. A Mayo Clinic study published in 1994, after the class-action settlement, showed no connection between breast implants and illness. One of the people who noticed was Marcia Angell. In 1996, she wrote an astonishing manifesto, Science on Trial: The Clash of Medical Evidence and the Law in the Breast Implant Case, about her second thoughts. “I consider myself a feminist,” she wrote. “As such, I am alert to discriminatory practices against women, which some feminists believe lie at the heart of the breast implant controversy. I am also a liberal Democrat. I believe that an unbridled free market leads to abuses and injustices.”

PQ2aThen after conveying a few more details, she went on: “Because of this view, I am quick to see the iniquities of larger corporations. I disclose my political philosophy here, because it did not serve me well in examining the breast implant controversy. The facts were simply not as I expected they would be.”

The Institute of Medicine, part of the national Academy of Sciences, agreed. A 400-page report by an independent committee of 13 scientists found that, while implants may be responsible for localized problems like the hardening and scarring of breast tissue, they do not cause diseases like lupus or cancer. But the facts, at this point in the game, did not matter. On May 15, 1995, in Bay City, Michigan, Dow Corning lawyers had filed for Chapter 11 protection.

The damage from the ban—personal, professional, and economic—was extensive. Workers in Midland felt demoralized. “It was hard emotionally for the employees,” John Walter, a retired Dow Corning corporate economist, told me over the phone recently, trying to sum up the effect over the years. They didn’t know what to think. “We had been told right along that the implants didn’t cause the problems, that this just wasn’t the case.” At Corning, the confusion was similar. “Corning, New York, is a town with less than 11,000 people, and Corning still employs 4,500,” says Larry Wilson, the reporter who covers the company for the Star-Gazette newspaper in nearby Elmira. “The people here just couldn’t understand why the bankruptcy when there was no legitimate science to prove this about implants.”

Shareholders also lost, and sometimes dramatically. The stock price of Corning, for example, had dropped by half, to $34 a share, within three months of the Kessler moratorium announcement. Half of Dow Corning’s sales were overseas, and the company, in bankruptcy for years after agreeing to pay billions of dollars to claimants, worked hard to refocus its projects—often, understandably enough, toward high-tech business uses and away from consumers. In May 1998, the company announced it would cut its workforce of 9,300 by 1,000. Other reductions followed. As for the implants, some provision was made so that silicone implants might be available for reconstruction in women with cancer—if they participated in certain studies. Recently, Dow Corning finally came out of bankruptcy, but it was a different company.

Then came November’s news. Some mastectomy patients were ecstatic. “Just saw this on AOL breaking news!” wrote one happy woman on www.facingourrisk.org, a website for people with a genetic predisposition to cancer.

But to others, exoneration by simple proclamation was insufficient. And they, unlike the anti-implant attorneys, will not have their day in court. Hearing the FDA’s news, John Walter says, “Most of us who were involved in the past said, ‘Where is the apology?’” Larry Wilson, the reporter, compares Dow Corning to Ray Donovan, the secretary of Labor under Ronald Reagan. Donovan was exonerated by a Bronx jury and three separate independent-counsel investigations of possible links between his company and the Mafia. After it was over, Donovan famously said, “Which office do I go to to get my reputation back?”

Scientific innovations can be controversial, and Americans will always raise legitimate concerns about their safety. But we need also calculate the price tag that arbitrary regulation, driven by fear and greed, imposes. Investors will want to offer their own version of the Donovan question: Where do I go to get my equity back?

Photography by Eddie Berman


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