The trouble started in mid-November, when FDA advisers reviewed evidence submitted by several implant makers and ruled that none really knew whether its product was safe. The devices have been known to leak or rupture, bleeding silicone into the body. But the makers hadn’t determined how often that happens, or with what possible consequences. Nor could the manufacturers say how long silicone implants normally last, how often they have to be surgically excised from contracting webs of sear tissue or how often migrating silicone prompts the immune system to attack healthy tissues. The advisory panel recommended leaving the devices on the market while the manufacturers conducted belated safety studies. But after canvassing rheumatologists about implant-related immune problems-and reviewing a trove of confidential industry documents–Kessler chose the tougher course.
The documents don’t point to previously unsuspected hazards, but they’re far from flattering. Dow Corning Wright, the leading manufacturer, has long claimed publicly that its implants are safe. Yet company memos disclosed during recent court cases show that the firm’s own scientists have worried about leakage, ruptures and contracting scar tissue since the 1970s. “I have proposed again and again that we must begin in-depth study of our gel, envelope, and bleed phenomenon,” research specialist A. H. Rathjen wrote in 1976. Seven years later another company scientist, William Boley, was still warning that “we have no valid long-term data to substantiate the safety of gels for long-term implant use.”
In mid-December Dr. Norman Anderson, a member of the FDA’s advisory committee, obtained copies of 17 such documents and passed them on to Kessler, along with a letter accusing Dow Corning of misleading the panel during its November hearings (PERISCOPE, Dec. 30). At the same time, Rep. Ted Weiss of New York wrote Kessler a letter saying that the firm may have suppressed damaging research results. He alluded to a 1970 implant study involving several dogs. The animals developed harmless tissue responses to the implants after six months. More severe inflammations developed after two years. But instead of reporting that development and tracking it, Dow Corning put the dogs to death and later published an article describing their condition as unchanged.
Company officials dismiss the internal memos now coming to light as individual, off-the-cuff opinions. And Robert Rylee, chairman of Dow Corning’s health-care businesses, denies that the firm suppressed evidence from the disputed dog study. The inflammations weren’t caused by silicone, he says, and the article that failed to note their increasing severity was just a “broadbrush explanation” for a trade journal, not a formal scientific paper.
The FDA’s advisers may accept those explanations, but Kessler wants the panel to review the whole record before giving the manufacturers the benefit of the doubt. In announcing the moratorium, he sought to reassure women who already have implants, saying that the devices needn’t be removed unless they cause problems. But in light of the unanswered safety questions, he said, “I don’t think I’d be doing the public any service to allow 10,000 implants a month to continue.” The panel will reconvene by late February, and the moratorium will last until Kessler hears its advice.
Reaction to Kessler’s decision was predictable. While consumer activists demanded an outright ban, Dow Corning, the American Medical Association and the American Society of Plastic and Reconstructive Surgeons denounced the FDA action as unnecessary meddling. Dow Corning is now hinting that it will abandon the implant business. “If we’re going to have to continue to work under a very hostile environment from the FDA,” says Rylee, “we may well decide to exit.”
Women, for their part, remain as divided as ever. Sue Gole has suffered various complications from silicone implants since undergoing a mastectomy in 1988, yet the 45-year-old Chicago woman adamantly favors letting people choose their own risks. That’s what Alison Cardinal of Bay City, Mich., thought she was doing when she had surgery at 15. She, her parents and her doctor had read Dow Corning’s literature and concluded that silicone implants were the best way to enlarge her undeveloped left breast. Thirteen years and two implants later, she has only sears to show for the effort. Dow Corning insists Cardinal has suffered no lasting harm. But like many other customers, she now feels she was duped. Informed of the risks, she says, “I would have just learned to deal with the way I was.” Fortunately, most women still have that option.
