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Are Gummy Bear Implants Really So Sweet?
by Tracie O'Keefe
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
Brownlee J.D., Brodkey J.S. & Schaefer I.K. Colonic perforation by
Ventriculoperitoneal Shunt Tubing: A Case of Suspected Silicone Allergy. Surgical Neurology. 49
(1):21-4, 1998 January.
Kirwan L. Two Cases of Apparent Silicone Allergy. Plastic & Reconstructive Surgery. 96
(1):236-7, 1995 Journal. Surgical Neurology. 49(1):21-4, 1998 January.
Jimenez D.F. Keating R., Goodrich J.T. Silicone allergy in Ventriculoperitoneal shunts. Childs
Nervous System. 10 (1):5963, 1994 January.
Jordan D.R., Nerad J.A. An Acute Inflammatory Reaction to Silicone Stents. Ophthalmic Plastic &
Reconstructive Surgery. 3 (3):147-50,1987.
Internet
Study Finds New
Type of Silicone Implant Offers More Natural Looking Breasts, Low Complication Rate Posted: October 18,
2005. 
U.S. Food and Drug Adminstration.

U.S. Food and Drug Adminstration, (F.D.A.) Breast
Implant Consumer Handbook - 2004.

Silicone Breast Implants and Injections.

Television
"The Day My Boobs Went Bust" Granada Television,
U.K., date unknown (broadcast on Channel 7, 4th April
2006 in Australia).
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