Should Australian bans on silicone breast implants be lifted?
Echo Issue Outline 1997 / 30: copyright © Echo Education Services
First published in The Echo news digest and newspaper sources index.
Issue outline by J M McInerney
What they said ...
`In view of these findings [showing no link between silicone and disease development], it must be asked how silicone breast implants were found wanting and how their main manufacturer was reduced to bankruptcy'
Associate Professor Dr Renwick
`The pamphlet I read when I first had the implants said they would last a lifetime. It said nothing about possible leakages, side effects or the disfigurement that happens when something goes wrong'
Ms Anne Johns, an Australian woman who has had her implants removed and is suing their manufacturer
Should the Australian ban on silicone breast implants be lifted?
In May, 1996, an Australian cancer specialist, Dr Stuart Renwick, attacked the current Australian ban on silicone breast implants. Many within the Australian legal profession, some doctors, and a number of women's lobby groups, including support groups for survivors of breast implants believe they should remain banned.
Background
In April, 1991, The United States' Food and Drug Administration, the FDA, required manufacturers of silicone gel-filled breast implants to submit data showing the safety and effectiveness of this product.
This was partly in response to suggestions that one type of implant was coated with a substance that was believed, under certain conditions, to cause cancer in animals.
In January, 1992, the FDA placed a moratorium or stop on the use of silicone filled implants, until the evidence regarding them could be considered by its review panel.
In April, 1992, the FDA continued its restrictions on silicone-filled implants, allowing them only to women who were judged to have an 'urgent need' for reconstructive surgery - after mastectomies, for congenital defects or to replace ruptured implants. These women were to be given very detailed informed consent forms.
In July, 1992, the FDA allowed some silicone-gel implants to be used for reconstructive surgery so that clinical trials of their safety could be made.
Currently, the FDA is considering the safety of saline-filled implants.
In Australia, the federal Health Department's Therapeutic Goods Administration placed a moratorium on all silicone gel-filled implants from January, 1991. This moratorium or stop is still in place and silicone gel-filled implants cannot be imported into Australia.
From 1991, all breast enlargement surgery performed in Australia has used saline-filled implants.
Silicone breast implants have generated an enormous number of Internet pages. The following are of particular interest. (For a brief discussion of what each contains, please refer to the notes under the Internet heading in the sources list at the bottom of this outline.)
Some interesting Internet sources of information include:
* Fenton's Press Room page
* The Law Links Page of the LauNet site
* The FDA's rulings on breast implants
* The Frontline site and their Breast Implants on Trial
* Utah State University's medical library.
* The Australian Society of Plastic Surgeons
A note on breast implants
Silicone breast implants have been in use for the last thirty years. There are two principal types of breast implant. Both have a soft, silicone rubber shell. One is filled with silicone gel, the other with saline (salt water).
Silicone is an inorganic compound of silicon and oxygen. It is generally considered to be inert, that is, to be very difficult to change by chemical reaction. This was held to contribute to its safety as an implant substance. Some of its critics have noted, however, that it will deteriorate over time within the body and thus it is anticipated that silicone breast implants may have to be replaced after about five years.
The silicone gel is also prone to leach or seep through the silicone shell. More recent implants, those made since the mid 1970s have blocking agents either lining the shell or mixed within it to prevent such leaching. The silicone shell may also rupture, especially over time.
What happens to silicone which either leaches out of implants or enters the body as the result of an implant rupture is a matter of disagreement.
A wide range of side-effects have been claimed to arise from the body's reaction to this substance. Probably the most serious are the claims that silicone can undermine the body's auto-immune system contributing to conditions rheumatoid arthritis and that it leads to connective tissue diseases. Recent tests of these claims have failed to establish a connection between silicone in the body and the development of these disorders.
However, it is generally acknowledged that scar tissue or fibrous tissue tends to form around the site of leached silicone.
History of litigation re breast implants
The first lawsuit for an American women claiming damages resulting from ruptured implants was won in 1977. The woman was awarded $170,000 and the case received little publicity.
In 1984 a woman making the first claim regarding silicone-induced immune problems won a settlement of over $1.5 million.
Through the early 1990s there were a series of cases mounted.
In 1992 the first class action lawsuit (involving a large group of claimants) was lodged. In 1994 the class action suit was finalised with manufacturers. This settlement outlined the terms under which women claiming to be affected could make claims against the manufacturers. They were not required to prove that the implants were the cause of their ailments.
In May, 1995, Dow Corning filed for Chapter 11 bankruptcy. Dow Corning had been the largest supplier of silicone breast implants and supplied the raw material to a number of other companies making these implants.
A Chapter 11 bankruptcy allows a company to continue trading while organising its debts.
By 1995, Dow was facing 20,000 lawsuits and some 410,000 potential claims had been filed under the class action or global settlement.
In November, 1995, a new global settlement was devised that did not include Dow Corning. The monetary awards are less than in the previous settlement.
There are still a significant number of individual suits pending against Dow Corning.
In Australia over 50,000 women have had breast implants and currently more some 7,000 have on-going legal claims against manufacturers, including those who are involved in a class action.
In September, 1996, all potential claimants under the new global settlement, including those in Australia, were told they had until February 14, 1997, to lodge claims.
Arguments against silicone breast implants
Women seeking compensation for pain and suffering as a result of silicone breast implants have listed the following complaints - hardening of the breast, severe breast pain, multiple breast lumps, chronic silicone lumps, implant rupture and migration of silicone, chronic fatigue, night sweats, sleep disturbances, interference with their immune system and cosmetic damage.
Ms Lorraine Williams who runs the Breast Implant Resource Service had implants for 17 years before having them removed in 1992. Ms Williams claims her implants hardened and caused tenderness and pain, especially when touched.
`Women want to look like a Barbie doll or a TV star but could be dying to achieve it,' Ms Williams has suggested.
Another Australian woman, Anne Johns, has claimed that the implants caused her constant severe pain in her chest, arms and back. Ms Johns also claims that the implants have impaired her immune system and led to migraine and arthritis.
Ms John's implants were part of reconstructive surgery after a double mastectomy, over 20 years ago. She claims that within weeks of their insertion a tear appeared in her skin above her nipple and silicone oozed out. The implants had to be removed and the leaked silicone scrapped out. Replacement implants hardened and had to be replaced in the early 1980s. Ms Johns finally had the implants removed altogether in 1993.
Opponents of silicone implants claim experiences such as those of Ms Williams and Ms Johns are not uncommon among those who have had these implants inserted.
An Australian study released in February, 1996, indicated that 75 per cent of the Australian women surveyed who had had breast implants had had them removed. 61 per cent of the group claimed they could no longer hug their families because of the pain.
They also claimed discomfort when wearing tight clothing, when hanging washing on the line, when performing heavy house work, such as vacuuming, and when carrying children.
Another major criticism made by opponents of silicone implants is that women receiving them frequently were not warned of the dangers.
Ms Anne Johns stated, `The pamphlet I read when I first had the implants said they would last a lifetime. It said nothing about possible leakages, side effects or the disfigurement that happens when something goes wrong.'
Finally, it has been claimed that the implants have damaged the total quality of life of many who have had them, precipitating relationship problems and marriage breakdowns.
An Australian survey has claimed that 34 per cent of a group of 100 women who had had implants believed the implants had contributed to their marriage breakdowns.
Associate Professor Stephen Kermode, of Southern Cross University, Lismore, New South Wales, concluded, `Our findings are that implants not only make you sick, they make you bloody unhappy as well ... When you look at the whole rationale behind why many women have implants it is to make themselves feel better and look better for their partners, and then to find that one of the consequences is that it affects relationships and interferes with their sex lives is a real dilemma.'
Arguments in favour of silicone breast implants
Some of the arguments in favour of silicone breast implants are the same as those for cosmetic surgery of any sort.
Supporters of cosmetic surgery tend to argue that the decision as to whether the surgery occurs is an exercise of the free choice of the person involved.
According to this line of argument, so long as those planning to undergo cosmetic surgery are aware of any risks involved then the decision is rightly theirs, as is the case with other forms of medical procedure.
The second argument offered in favour of cosmetic surgery in general, and thus silicone implant breast enlargement as a particular instance, is that for many people the perceived defect, which they hope cosmetic surgery will correct, makes them very unhappy and has a damaging psychological effect upon them.
It has been claimed that it is particularly important that women who have had their body image damaged through medically-required surgery, such as a mastectomies, be able to have cosmetic surgery if they desire it.
Then there are a set of arguments that relate specifically to the use of silicone breast implants in breast enlargement cosmetic surgery.
Supporters of the use of silicone breast implants argue that many of the claims made about the possible dangers of this procedure are inaccurate.
Firstly, it is argued, silicone implants rarely rupture, leak or leach so the substance rarely finds its way into to the body's circulatory systems.
An Australian cancer specialist, Dr Stuart Renwick, has claimed that only about 1.5 per cent of implants leaked.
Secondly, it is argued, that even on those supposedly rare occasions when silicone does enter the body, the substance has not been proved to cause the disorders sometimes attributed to it.
It has been claimed that some of the evidence levelled against silicone implants is unreliable. Dr Stuart Renwick, has claimed, 'What transpired in the United States courtrooms and in the United States media were judgements based on anecdote and speculation.'
Dr Renwick has further claimed that three studies have confirmed there was no link between silicone implants and connective tissue disorder or cancer.
Dr Renwick has gone on to ask, `In view of these findings, it must be asked how silicone breast implants were found wanting and how their main manufacturer was reduced to bankruptcy.'
It has also been claimed that those who seek breast enlargement are a particular set of women who have a set of lifestyle features which make them different from the majority of other women and may dispose them to certain diseases.
A report published in July, 1997, in the 'Journal of the American Medical Association', has claimed, 'Women who have breast implants for the purpose of augmentation may have, on average, different demographic, lifestyle, reproductive or medical characteristics than other women - differences that may make these women more or less likely to develop certain diseases.'
According to this line of argument, the set of characteristics these women have in common may cause them to develop certain medical conditions. If this is the case, supporters of silicone implants argue, then the silicone need not have caused these conditions.
Further, it has been claimed, silicone gel-filled implants are cosmetically more satisfactory than saline-filled implants.
According to this line of argument, the density and viscosity of the silicone gel implant make it more aesthetically satisfactory.
Dr Renwick has claimed that silicone-filled implants are 'extremely good cosmetically' and that surgeons are now forced to use saline-filled implants, which, Dr Renwick claims, cosmetically they consider inferior.
Further implications
It is not clear what will happen with regard to those women who are suing either Dow Corning or other implant manufacturers. What does seem highly likely is that future settlements will be less generous than many of those already awarded.
It is also interesting to note that an American circuit judge, Robert Colombo, recently ruled that Dow Chemical Co., the parent company of Dow Corning, could not be held responsible for any ill-effects caused by implants manufactured by Dow Corning.
Of concern to some surgeons is the possibility that silicone implants of all sorts will cease to be available. Some recent testimony before the FDA has indicated that many companies producing silicone as a raw material have ceased to supply it to companies making surgical implants of any sort. The suggestion is made that these companies are afraid of being sued.
Dr Renwick has noted that silicone is currently used in a wide range of implants, including artificial joints, tendon sheaths, pacemakers and defibrillators.
'The permanent withdrawal of implantable silicone ... would be a significant loss for surgeons and society,' Dr Renwick has said.
Whatever happens on the silicone front it seems unlikely that breast implants will cease to be available. One version is currently being tested that is filled with soy bean oil.
It has been claimed that there has been a recent increase in demand for implants.
In Australia nearly 7000 women had implants inserted in 1995, with the growth in demand strongest among the 19 to 22 age group.
Ms Williams has suggested, `Popular celebrities (who have had implants) are virtually telling young people that it's not only OK to have implants but that it's even desirable.'
Sources
The Age
5/5/96 page 3 news item by Darren Gray, `Silicone implants are safe: professor'
7/5/96 page 6 news item by Sandra McKay, `Cancer specialist attacks ban on implants'
17/5/96 page 14 cartoon by Leunig, `Song for Dannii Minogue'
22/3/97 page 16 news item, `US judge dismisses silicone implant suit'
6/7/97 page 3 news item by Lyall Jones, `Implant girls just wanna have fun'
7/9/96 page 7 news item, `Women urged to act on breast implant claims'
The Australian
17/2/96 page 3 news item by Janet Fife-Yeomans, `Quality of life pays price of breast implants'
7/9/96 page 5 news item by Janet Fife-Yeomans, `Implants case drags on'
The Herald Sun
12/5/96 page 11 news item by Barbara Biggs, '16/9/96 page 11 news item by Nicola Webber, 'Implants safe, say experts'
28/7/96 page 19 news item by Graeme O'Neill, `Silicone is safe, says US expert'
16/9/96 page 11 news item by Nicola Webber, `Implants safe, says expert
The Internet
This issue has generated an enormous number of Internet sites. Some appear to present information from a definite, if not biased, position.
Fenton Communications presents itself as America's `leading socially responsible public relations and advertising firm.' If you scroll down Fenton's Press Room page, located at http://www.fenton.com/docs/press.html#breast , you will find a large number of click throughs under the general heading, Silicone Breast Implant Controversy. These click throughs take you to a range of medical and scientific reports and a series of summaries outlining the progress of American litigation on the issue.
The Fenton site appears to adopt a stance supportive of the litigants suing those who supplied them with silicone-filled breast implants.
The Law Links Page of the LauNet site, belonging to a California law firm, Lau and Lau, has an excellent series of click throughs canvassing all sides of the issue. (Again, you will need to scroll down their links page to find them.) Of particular interest is their click through to the American Food and Drug Administration's rulings on silicone breast implants, tracing developments since 1976.
This Law Links Page can be located at http://www.launet.com/Law.Links.Page.htm All the click throughs are worth pursuing.
If you want to go directly to the FDA's rulings on the issue these can be found at http://www.fda.gov/oca/breastimplants/bichron.html
One of the best sites for investigating this issue is the Frontline site. Their Breast Implants on Trial page at http://www2.pbs.org/wgbh/pages/frontline/implants/index.html has click throughs to women's breast implant support groups; legal opinion; the corporate (business) point of view; and a range of medical opinions. There is a real attempt to give a balanced overall range of sources.
Also clickable to from this page is a chronology or time line of major events.
Utah State University's medical library has placed a series of photographs of various breast diseases on the web. Included on this site are a photograph of a silicone-filled implant, a still from the surgery in which implants are inserted and a close-up of some of the fibrous tissue formed in response to silicone leakage.
The first photograph in this set of three can be found at http://www-medlib.med.utah.edu/WebPath/BRESHTML/BREST051.html
Finally, if you would like some information on the issue form an Australian perspective, the Australian Society of Plastic Surgeons has reproduced a report by Helen Dalley, which is critical of many of the legal attempts to gain compensation and of the medical evidence which has supported them. This report can be found at http://www.geko.net.au/~asps/health_law.html