By Dr Tracie O’Keefe DCH, published in Polare, July-Sept 2006 issue
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 (CGI Gummy Bears sometimes known as silicone gel implants) six years ago. In my article I said that CGIs 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 (APSA) has some of the largest collected data.
The APSA 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.
CGIs do not currently have FDA 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 CGIs we need to look at their performance long term and, since they are a new product, that has so far been impossible.
Thirty or more years ago people were jumping up and down about the liquid silicone-filled implants and then in 1992 the FDA restricted their use. This was mainly due to complaints about associated Connective Tissue Disorders (CTD) 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 individually 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 subclinical level that could not presently be recorded by allopathic medical research technology.
While the texture and durability of CGI 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 ppm (parts per million) having effects upon the body. Patients are often prescribed medications that are measured in ppm 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 ppm 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 CGI, one of my patients has reported a form of CTD and immune and body systems collapse and had the CGIs 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.
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 CGIs in Australia but that does not mean the research has been done and dusted. Even with CGIs 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.
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Kirwan L. Two Cases of Apparent Silicone Allergy. Plastic & Reconstructive Surgery. 96 (1):236-7, 1995 Jul. Surgical Neurology. 49(1):21-4, 1998 Jan.
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Study Finds New Type of Silicone Implant Offers More Natural Looking Breasts, Low Complication Rate
Posted: October 18, 2005
US Food and Drug Administration
US Food And Drug Adminstration, FDA Breast Implant Consumer Handbook – 2004