Are Gummy Bear Implants Really So Sweet?

by Dr. Tracie O'Keefe D.C.H.

(The Gender Centre advise that this article may not be current and as such certain content, including but not limited to persons, contact details and dates may not apply. Where legal authority or medical related matters are cited, responsibility lies with the reader to obtain the most current relevant legal authority and/or medical publication.)

After my last article on breast implant care and safety I received an irate telephone call from a woman who had had cohesive gel implants (C.G.I. Gummy Bears sometimes known as silicone gel implants) six years ago. In my article I said that C.G.I.s were experimental and I would like to clarify and expand on that further.

The majority of our information on the long-term follow up of breast augmentation undoubtedly comes from America because the American Plastic Surgeons Association (A.P.S.A.) has some of the largest collected data. The A.P.S.A. also claims that more than 264,000 breast augmentations and nearly 63,000 breast reconstructions were performed in 2004 in America and such procedures are becoming much more frequent.

One of the major things to remember, however, is what we call research bias and that researchers often only research the kind of results they would like to find. Methodological flaws in research happen also because of what a researcher neglects to research. This is not necessarily research fraud but this is the innate nature of research.

C.G.I.s do not currently have F.D.A. approval and their use is only approved for people who will be part of a study to record the performance of the implant.

As any researcher can tell you, many people disappear from a trial during the process and results can be lost. Also to study the effectiveness of C.G.I.s we need to look at their performance long term and, since they are a new product, that has so far been impossible.

C.G.I.s are also not immune to the problem of necrosis (tissue death) and wound closure failure. This often happens when both client and surgeon collude to place implants that are too large to go behind the breast.

The pressure of the implants trying to escape can prevent wound closure and healing. If a woman wants large breasts it is often better to have a medium implant first, then have them changed to a larger size later, when the tissue has stretched sufficiently to accommodate the larger implant.

Thirty or more years ago people were jumping up and down about the liquid silicone-filled implants and then in 1992 the F.D.A. restricted their use. This was mainly due to complaints about associated Connective Tissue Disorders (C.T.D.) and autoimmune diseases that some patients claimed were due to those implants. While it has been quantitatively impossible to establish that case, the manufacturer Dow Corning paid out compensation anyway.

Many women have reported that, having suffered those disorders, their health improved considerably when they had their breast implants removed. They have been convinced that their bodies reacted badly to silicone, even if it was at a sub-clinical level that could not presently be recorded by allopathic medical research technology.

Even with saline implants one of the major problems was that the saline could become infected. This was solved by the surgeons filling the implants, while they were in place, with a sealed unit of saline solution as posed to the open delivery system. There are women, however, who have reported that they have also experienced symptoms of silicone poisoning and allergic reactions because the shells of the implants were made from silicone.

While the texture and durability of C.G.I. is heralded by plastic surgeons, we really do not know what the future may bring. We do not know if crystallisation of the gel may take place in years to come or if any kind of degradation of the implant may occur in the future. It is also possible that there will be leakages into the circulatory system that will affect the liver function and end up in the bone marrow. Substance contamination not only happens on a macro level but also on micro level with exposures of parts per million (p.p.m.) having effects upon the body. Patients are often prescribed medications that are measured in p.p.m. so why is it so hard for so many scientists to accept that the molecular binding sites in some people's bodies react abnormally to p.p.m. of silicone?

Some people undoubtedly have an allergic reaction to silicone and no substance is totally innocuous to the whole human race. Even with the experimental C.G.I., one of my patients has reported a form of C.T.D. and immune and body systems collapse and had the C.G.I.s removed. It's possible that most breast implants will give rise to complications eventually over a period of many years as chemical and physical changes happen.

There are some laboratory tests that can be done to give basic idea of whether there is a reaction to silicone from implants, but they are not specific. A test can be done for the anti-polymer antibody levels; however, it is not specific for siliconosis. Another test that can be done is lymphocyte chemical sensitivity (silicone) test and it seems that the worst affected women may have the most sensitivity. Getting these tests done in Australia may be a process of dogged determination and detective work, often not being possible, and it may be easier for a blood sample to be couriered aboard. Also allergic reactions can also give rise to a prolonged low-grade fever.

If you have any kind of breast implant, ask the surgeon to provide you with the make, supplier, date of manufacture, batch number and serial number of the implants, being sure to differential between the right and left augmentation. Store that information as part of your medical history so if you do have any problems, your surgeon or toxicologist will have good information to investigate what might or might not be happening.

Breast implants are a reality in a society that focuses on women's validity often being measured by the size and shape of her breasts. For many women implants have been a gift from the heavens with their ability to aid in construction or reconstruction of a breast being psychologically life-saving. Some women have, however, found their breast augmentation experience littered with complications.

Patients may be able to get some surgeons to implant C.G.I.s in Australia but that does not mean the research has been done and dusted. Even with C.G.I.s there is a need for women to take constant care of themselves and have a continual assessment of the condition of their breasts implants and breasts. Medicine is lacking in educating women how to do that and it is up to all women with breast implants to do their research and educate themselves.

Bibliography

Polare is published in Australia by The Gender Centre Inc. which is funded by the Department of Community Services under the S.A.A.P. Program and supported by the N.S.W. Health Department through the AIDS and Infectious Diseases Branch. Polare provides a forum for discussion and debate on gender issues. Advertisers are advised that all advertising is their responsibility under the Trade Practices Act. Unsolicited contributions are welcome, though no guarantee is made by the Editor that they will be published, nor any discussion entered into. The editor reserves the right to edit such contributions without notification. Any submission which appears in Polare may be published on our internet site. Opinions expressed in this publication do not necessarily reflect those of the Editor, The Gender Centre Inc.I, the Department of Community Services or the N.S.W. Department of Health.