PERSPECTIVE ON BREAST IMPLANTS : Women at Risk Are Still in the Dark : The industry’s settlement does nothing for those whose cancers have yet to be detected; shouldn’t they at least be warned?
Last week’s establishment of a $4.25-billion settlement fund seems to add finality to the breast-implant controversy, even though the judge in the case believes that the amount, contributed by manufacturers, will be insufficient for current claims. The settlement also is insufficient because it ignores the risk of breast cancers developing decades later.
The Food and Drug Administration has consistently downplayed any cancer risk from silicone gel implants. But the agency’s sanguine position is contradicted by substantial research, including its own. Why is no one sounding an alarm? Why is no one informing women of their risk and offering all women with breast implants the option of removal?
Studies by manufacturer Dow Corning, discovered in 1987 FDA inspections, showed that silicone-gel injection induced malignant tumors in rats. Internal memoranda by FDA scientists concluded that “while there is no direct proof that silicone causes cancer in humans, there is considerable reason to suspect that it can do so” and urged that “a medical alert be issued to warn the public of the possibility of malignancy following long-term implant(ation).” The FDA’s response was to reassign the report’s writers. Another report, in the July, 1994, Journal of the National Cancer Institute, confirmed that silicone gel is carcinogenic in mice as well.
Supporting this experimental evidence, a 1989 FDA internal report stated: “A survey of the literature indicates numerous case reports of cancer” long after implantation and warned of the “possibility of worsened diagnosis” and prognosis when implanted women developed breast cancer. The report stressed that population studies claimed as proof of safety by industry and surgeons were too short-term and flawed to “negate the potential risk of cancer.”
At known higher risk of breast cancer are 350,000 women with foam-wrapped implants. These consist of a silicone pouch wrapped in industrial polyurethane foam made from the carcinogenic synthetic petrochemical toluene diisocyanate (TDI). The foam is unstable in the body and breaks down into TDI and another carcinogen, TDA, which was removed from hair dyes in 1971 for that reason.
The foam-wrapped implants were developed to reduce scar-like hardening in some women following silicone implantation. However, their use beginning in the early 1980s ignored unequivocal evidence published two decades previously. Beginning in 1960, Wilhelm Hueper, the National Cancer Institute’s leading carcinogenesis authority showed that foam degraded and induced malignant tumors in rats following injection and warned: “Since the polyurethane plastics have been used in cosmetic surgery . . . these observations are of practical importance . . . (and) should caution against indiscriminate use.” He also noted that carcinogenic effects “might require an induction period of some 30 years or more,” as with other carcinogens, notably asbestos. Hueper’s finding have since been fully confirmed and extended by other independent studies.
Polyurethane-wrapped implants are thus carcinogen-impregnated sponges. These gradually disintegrate, releasing carcinogens to which the breast cells of premenopausal women are particularly sensitive.
Scientific publications apart, there is extensive documentation on industry’s secret knowledge of cancer risks from implants, which were nevertheless aggressively marketed with assurances of safety. Dow Corning’s carcinogenicity information on silicone implants is two decades old. Shortly after foam implants were first manufactured, the industry admitted that carcinogenicity data were “significant in those applications . . . for use inside the body.” In 1985, Medical Engineering Corp., a Bristol-Myers Squibb subsidiary, admitted that “degradation products of polyurethane are toxic and in some cases carcinogenic. . . . Whether they are released in such low levels as to be no threat, only time will tell. . . . The breakdown products of the fuzzy implant material may well be carcinogenic. How would anyone defend himself in a malpractice suit if a patient developed a breast malignancy?” At industry-sponsored meetings in 1985, leading plastic surgeons cautioned that “foam could be a time bomb . . . (in view of its) carcinogenic potential. Surgeons should not go on implanting.”
Without mentioning cancer risk, in April, 1992, the FDA banned all silicone implants except for controlled trials. This action was aggressively challenged by the American Society of Plastic and Reconstructive Surgery, the American College of Radiology and the American Medical Assn.
Responsibility for undisclosed cancer risks in 2 million implanted women, most seriously in the 350,000 with foam implants, is broadly shared among: the industry, for egregious conduct; plastic surgeons, for self-interested complicity; the FDA, for reckless unresponsiveness; the American Cancer Society, for silence, and the media, for minimal coverage of longstanding evidence. An immediate medical alert should be sent to all implanted women, with priority for those with foam implants. This should be followed by long-term surveillance with offers to remove the implants of any concerned women, at industry’s but not taxpayers’ expense. And all of this should be thoroughly apart from the inadequate $4.25-billion settlement.
