Body Of Evidence
Sydney Morning Herald
Friday November 6, 1998
AT FIRST, doctors tried injecting paraffin wax. Then a sponge implant was developed. But both methods left women with rock-hard breasts. Grafting fat from other parts of the body was popular for a while, but the fat died or shrunk, leaving lumpy and uneven-sized breasts. And there was a disastrous technique, never legal in Australia, where some woman were even given injections of liquid silicone into the chest.
So, not surprisingly, when realistic-feeling rubber pouches containing silicone gel came on the market in 1962, they were welcomed by doctors and their patients for breast reconstruction and cosmetic enlargement.
Many women, however, were not informed about the risks of surgery beforehand and were led to believe the implants would last a lifetime. Some were even told they'd have the "best breasts in the graveyard". Yet, the complications of this procedure had been described in scientific papers in the late 1950s.
Another scientific article, published in 1967, describes eight problems, including infection, tissue death and sagging breasts, with dramatic photographic examples. "Every surgeon implanting foreign material into body tissues will eventually encounter complications, and this possibility should be explained to the patient," caution the American authors in Plastic and Reconstructive Surgery.
Their paper describes how the body forms a capsule of fibrous tissue around an implant, which can tighten or contract, causing pain, hard breasts and disfigurement.
As many women discovered, to their distress, implants could also deteriorate with age, "bleed" silicone, and rupture (sometimes as a result of a doctor squeezing the breast to break down a tightened capsule - a technique no longer recommended). Moreover, removing ruptured implants may require tissue to be cut out as well, leaving women with smaller breasts than when they began, and scarred both physically and emotionally.
None of this sad saga is in dispute. Many women around the world who had hoped implants would improve their appearances ended up irreparably damaged.
But a difficult question must be asked, as a class action against the main implant manufacturer is expected to be resolved any day. How much damage to the health of others has the women's quest for financial compensation done, given their additional claims that leaked silicone causes a variety of auto-immune and connective tissue diseases has turned out to be scientifically unfounded?
Some doctors believe the consequences of implant litigation in the United States have been dire. The "exploitation of auto-immune disease" by women and US lawyers for profit is among the "most contentious, costly, dangerous events ever to occur in women's health care", argues an American gynaecologist, Dr Elizabeth Connell, in a recent issue of the Journal of Women's Health.
Connell says lawyers and their medical "hired guns" first attempted to link implants to classic diseases, such as lupus and scleroderma. "When no such link could be proved and, in fact, was ultimately disproven, they resorted to the creation of a new hypothetical disorder - atypical connective tissue disease."
This "frivolous litigation", she says, in which some women were awarded millions of dollars, has led to the loss of other medical devices made of silicone, including life-saving pacemakers and catheters, through fear of similar unfounded law suits. A new contraceptive hormone implant, coated in silicone, for example, will probably never be sold now.
Millions of dollars have had to be spent looking for replacements for silicone in these products as well as heart valves, brain shunts, penile and testicular implants and artificial joints, she says.
Professor Peter Brooks, executive dean of health sciences at Queensland University, says implant litigation has had a further consequence of stifling research and development into new medical devices.
It has also done "enormous harm" in unduly frightening women with successful implants. "I've had patients who were very fearful every time they got an ache or a pain, wondering if they should have their implants out."
Yet the multiple problems claimed to be caused by implants, including fatigue, arthritis, muscle aches, restricted blood flow to extremities, skin rashes, memory loss and hair loss, are very common in the whole population, he says.
Brooks is critical of media coverage of the implant issue for having focused on "emotive and legal aspects" at the expense of scientific evidence.
Professor Stuart Renwick, director of the Sydney Breast Cancer Institute at Royal Prince Alfred Hospital, also describes the history of implant litigation as one in which "anecdote and fear prevailed over science".
The case has galvanised the scientific community, in the US at least, to take a stance against what it calls "junk science", or unproven medical evidence, being accepted by courts. Organisations, such as the American Association for the Advancement of Science, are setting up schemes so judges can request credible experts to give independent guidance on scientific questions.
Two years ago, Judge Sam Pointer, who is hearing a large number of implant cases in the US, also decided that this was the way to go. He set up his own panel of independent experts to review all the scientific evidence on implants and systemic illness.
Ironically, Dow Corning and a tort claimants committee representing 170,000 women worldwide, will conclude detailed negotiations over the company's agreed $US3.2 billion ($5.1 billion) payout to women before this expert panel finally issues its authoritative report.
An announcement about this class action settlement is expected soon. As part of the deal, Australian law firms have already signed an in-principle agreement for $US39.5 million to cover about 4,300 women in Australia and New Zealand, with individual payouts expected to range from $1,000 to $125,000. DISCUSSION of this issue often revolves around money. But talk to families whose lives have been devastated by breast implants and it is obvious that dollars will never compensate for their grief.
Kim Boyd quizzed the doctor hard in 1980 when his wife, Leah, was considering implants. "He convinced me they had been tested, were proven to be perfectly safe and would last a lifetime," he says.
But within months, Leah was back in hospital for the first of repeated operations because of tightened capsules. She kept the implants because the scarring was so bad that "I don't think she could have survived emotionally" if they had been removed, Kim says.
At times, one breast went hard, pointing skywards; the other sagged down. And after 15 years, Leah could take no more. But by then the implants had disintegrated and large amounts of tissue, entangled with globs of silicone, had to be cut out.
A few years ago, Leah began to get sick. She is now virtually bedridden and in severe pain. She has lupus, an unknown disease of the nervous system, and a range of symptoms including tight, blotchy skin.
The Boyd family has no doubts that Leah has "silicone poisoning". And money won't compensate for her years of ill health. "My kids missed out on having a mother," says Kim, who runs the Breast Implant Resource Service.
The Boyds are not convinced by the epidemiological studies that have been carried out during the 1990s, comparing women with implants and those without. They question their independence, when some were funded by manufacturers. And these type of studies don't directly examine what they believe is the central issue: the toxic effect of silicone on the body.
"Lab tests years ago showed silicone gel could kill cockroaches," says Kim. "Why is there lots of money for studies now to show the implants are safe, but none to study the sick women?"
It was the fault of manufacturers, not the consumers, that long-term studies on the safety of implants during their 30 years of use had not been carried out when the litigation began, he points out. And it was only because of the lawsuits that companies were forced to admit they had known their products leaked and ruptured.
"They want the world to think this disaster never happened. But we have to live the nightmare every day."
The scientific consensus, however, is hardening against the women's claims. In July, the British Government's Independent Review Group on breast implants, after considering "immense amounts of complex evidence to ensure we left no stone unturned", concluded there is no evidence of an association between silicone-gel implants and an abnormal immune response or connective tissue disease.
"The incidence of ill-health in women implanted with silicone gel is no greater than in the general population," it concludes.
Other medical organisations which have made similar conclusions include the Australian Therapeutics Goods Administration, the American Cancer Society, the American Society for Clinical Oncology and the American Medical Association.
Silicone gel implants were never banned in Britain, but only saline filled implants have been available in Australia and the US since 1992, for most women.
While Dow Corning does not accept the silicone implants cause disease, the settlement will nevertheless include payment for systemic illnesses.
Asked about scientific evidence, Paula Shelton, of the Melbourne law firm Slater and Gordon, says: "$US39.5m [the deal for Australasian women] is a lot to pay for something you don't believe exists."
Dr Peter Cashman, of the Sydney law firm Cashman and Partners, maintains there is still a shortage of good long-term research and that "scientific truth is an elusive concept". This is why it is "not a bad compromise" for Dow Corning and the tort committee to settle before Judge Pointer's expert panel comes down one way or the other, he says, adding that most Australian women are claiming for physical injuries, not for systemic illnesses anyway.
But Stuart Renwick and Peter Brooks believe implant litigation has demonstrated the need to reform the way courts handle science. Because of the adversarial legal system, each side presents a view most favourable to its argument and chooses expert witnesses accordingly. This means the jury often doesn't get to hear the scientific consensus, they say.
One approach, being closely observed by Australian lawyers, is to formulate guidelines for determining the admissibility of scientific expert testimony. The US Supreme Court did this in 1993. Under these Daubert rules, scientific evidence must not only be relevant but "reliable", in that a theory or technique has been tested, published in peer-reviewed journals and generally accepted by the scientific community.
In late 1996, Judge Robert Jones, in Oregon, applied the Daubert rules in a breast implant case. On the basis of advice from an independent scientific panel, he ruled as inadmissible the evidence of medical experts hired to testify that implants may cause systemic illness, saying the claim was at best "an untested hypothesis".
Similar rulings have since been made in at least five other US States.
Good scientific evidence is the missing key in this saga. And Brooks agrees that the litigation might have been avoided if the companies and doctors had followed up patients with implants from the start. "It's a great shame they didn't." The Therapeutic Goods Administration recommends women planning implants consider the information in its new Breast Implant Information Booklet for 30 days before making a decision. Women experiencing difficulties with implants can report them to the TGA Medical Device Incident Reporting Scheme, Reply Paid 32, Conformity Assessment Branch, PO Box 100, Woden, ACT 2606. Tel: 1800 809 361.
© 1998 Sydney Morning Herald
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