By Dr Lynette Dumble
Based on proclamations of silicone innocence, ruling medical opinion continues to dismiss claims from implant recipients, the overwhelming majority of whom are women, that their serious illnesses are connected to theirBy Dr Lynette Dumble
Based on proclamations of silicone innocence, ruling medical opinion continues to dismiss claims from implant recipients, the overwhelming majority of whom are women, that their serious illnesses are connected to their reconstructive surgery.
Evidence in three landmark settlements — US$4.2 billion against the implant manufacturing companies Dow Corning, Bristol-Myers Squibb and Baxter International in the US in 1994; another US$6 million in 1995 to an Alabama woman who developed potentially cancerous lumps and immune damage from rupturing breast implants that spread silicone throughout her body; and Bristol-Myers Squibb's out of court Can$28 million reserve for Ontario and Québec women suffering any implant-attributed disease as a result of implants supplied by its subsidiary Medical Engineering Incorporated — has uncovered the scandalous history behind implant surgery.
Added to accruing medical evidence of silicone's toxicity, the information revealed during the course of these legal proceedings suggests that medical dismissal is part of a larger conspiracy to conceal another chapter of medical misogyny.
Toxic
Despite the fact that silicone has been used in the breast reconstructive surgery of an estimated three million women worldwide since 1962, the substance has a long and dubious history that goes back to its use as an insecticide in the 1950s.
A decade later, when the window of opportunity for man-made breasts emerged, scheduled silicone toxicology was pushed aside as the manufacturers and surgeons focussed their attention on a mega-million dollar market. It is less than naive to assume that the silicone hazards were closely kept secrets known only to chemical companies with putrid ethics.
Evidence debunking the myth that silicone was inert has been around in medical literature for more than 30 years. Countless articles within specialist journals of plastic and reconstructive surgery warned that silicone implants underwent alarming changes after contact with body tissues, and often leaked or bled silicone into surrounding tissues.
Animal studies demonstrated that silicone promoted inflammatory and fibrous tissue reactions, and that large amounts of escaping silicone migrated throughout the body. Imprudently, the studies were never extended to establish the long-term consequences of silicone migration, nor was there any research in appropriate animal species to figure out the relationship between silicone and auto-immune disease.
Clinical results indicated that a silicone bleed provoked an even more severe and extensive inflammatory response, and was probably the physiological equivalent of a silicone injection.
Although the licence to inject liquid silicone was withdrawn by the US Food and Drugs Administration (FDA) in 1976, it appears that message was too subtle for manufacturers and surgeons to grasp.
Alternatively, the financial incentive together with a surgeon's perspective that implant surgery was the solution to women's demeaned body-image, overshadowed the welfare of a vulnerable group of health consumers.
It took until 1994, after hearing further evidence that silicone was responsible for an escalating incidence of auto-immune/connective tissue disease amongst women with breast implants, and a much smaller number of men with penile and testicular implants, for the FDA to finally place a moratorium on its use in reconstructive surgery.
Medical smokescreen
Memoranda, bearing an instruction to disregard after reading, warned the implant industry of immune dysfunction from silicone, but concealed the information from authorities until the renewed FDA consultations of 1994. Shamelessly, an editorial in the New England Journal of Medicine instantly argued that the FDA had been "paternalistic and unnecessarily alarmist" in banning silicone implants.
An editorial from the Lancet took an opposite stance, pointing out that the dismissive viewpoint of the New England Journal was largely based on a study from the Mayo Clinic, which was "insufficiently powerful" to detect an increased risk of connective tissue disease. In fact, the Mayo Clinic study was virtually irrelevant to women with breast implants since only asymptomatic implant recipients were interviewed.
Experts predict that 20% of women with silicone breast implants will develop mild, moderate or severe symptoms of toxicity, and more than 4000 women in Australia alone have registered silicone-related illnesses with consumer organisations.
A 1993 medical review of the history and complications of silicone breast implants noted that, given the large number of women with silicone implants, epidemiological studies were warranted. Yet epidemiology, which frequently amounts to decades of follow-up in sizeable populations, is neither appropriate nor essential to establish that silicone is the culprit. Epidemiology can be useful in risk assessment, but three decades of silicone implant case reports and population studies have already fulfilled the benchmark logic and criteria of disease causation.
Largely due to the medical smokescreen, the devastating effects of silicone-related diseases on women's lives have failed to prompt the outrage warranted. More often than not, their personal relationships are adversely affected and many [barely aged 50], unable to fend for themselves, are permanently nursed in homes for the aged or the mentally ill. Some are confined to life in a wheelchair.
Many require around the clock supervision to prevent self-injury because they have been robbed of their manual dexterity. Many endure constant pain, due in part to their silicone-related illness, but frequently worsened by botched attempts to surgically correct technical problems with their implants.
Women's personal efforts to overcome low self-esteem are thwarted, not only by mirror images of their scarred and mutilated breasts, but also by medical dismissal that their atypical illness has anything to do with their implant, or more patronisingly, is a figment of their imagination. Drawn-out legal battles and research by a "handful" of rheumatologists and immunologists promise cold comfort for the large number of women who endure serious illness after implant surgery.
The frequency and severity of implant-related illness is set to be grossly underestimated as cases inevitably escape the networks of an alert "handful", yet Dow Corning has already filed for bankruptcy protection in response to the volume of private claims made after the settlement awarded against them in the US.
Other effects
Based on "severely flawed" studies from prestigious institutions such as Harvard and the Mayo Clinic, the conspiracy to dismiss implant-related illness entices more and more women, and some men, to flirt with death for the perceived benefits of implant cosmetics.
At the same time, other vital issues such as whether breast feeding mothers with implants transmit silicone and its toxic effects onto their children, have been largely ignored. Similarly, although the possibility of silicone-induced breast cancer is denied by some studies, there is clear clinical and experimental evidence that it has the capacity to act as a carcinogen, raising the question of whether an increase in the overall cancer rate may result.
And lastly, given that the early detection of recurrent malignancy is critical to the survival of women who have previously undergone surgery for a primary breast cancer, the mere fact that silicone implants conceal the mammography detection of recurrent tumours in 40% of women gives an insight into the motives and preferences of certain medical prescribers when it comes to the welfare of health consumers who also happen to be women.
Owed the truth
Past experiences indicate that women have good reason both to shout foul and protest that their safety ran a poor second to the ambition and/or financial incentives of medical prospectors. Silicone implant recipients are due the same acknowledgment as victims of any iatrogenic disaster. At present, their plight is ignored or dismissed. Socially, their support comes almost entirely from self-funded consumer groups that operate with little outside financial assistance to meet the spiralling demands.
Women with silicone implants are owed a medical admission that the debilitating illnesses prevalent amongst implant recipients are the direct result of reconstructive surgery that was falsely promoted to be safe.
Studies are urgently required to: establish whether existing implants should be removed, replaced or left undisturbed; develop sensitive clinical and laboratory methods that detect silicone toxicity in its earliest stages; and investigate the advantages and disadvantages of detoxification procedures that could prevent terminal illness as a result of silicone toxicity.
While many within the medical profession are busily dismissing or dodging their responsibilities to silicone recipients, and manufacturers are fudging bankruptcy declarations, women and perhaps some men, are dying marginalised and uncompensated. Others are placed in further jeopardy because appropriate management, including silicone detoxification, is not forthcoming.
More still are inheriting the same risks as they, too, dice with implant surgery that is professed to be safe.
[Dr Lynette Dumble is a senior research fellow at the University of Melbourne's Department of Surgery and a member of FINRAGE, Australia.]