10th January 2012
If you have breast prostheses they may be PIP implants, which have been causing concern.
Personally I have used these prostheses for twenty years or more and actually have been very pleased with them. My primary reason for using the PIP implants was that I liked the thickness of the envelope (shell) of the prosthesis, which felt much more robust than most of the other prostheses available. We used them not only privately but also in the plastic surgery unit at Mount Vernon Hospital for many years, and all had the certification mark which is supposed to guarantee their quality.
Sometime around 2001, apparently, the company in France changed the content of the prosthesis and also slightly changed the envelope. The exact differences I am uncertain of, but certainly they appeared to be the same. If you take the content, silicones can be rock hard, soft or medium firm. It all depends on their content and how they are made up. The French AFSSAPS, which is an agency monitoring products, carried out tests on mice, trying to emulate the conditions of implantation of these prostheses. It was also supplemented by in vivo tests. These two additional tests revealed no alteration in the DNA of mouse cells, and therefore the results of these tests do not show any genotoxic effect of this PIP gel. Essentially, scientifically it does not appear to stimulate any malignancy. We know in any case that silicone, which has been around for over forty years, actually statistically reduces your chance of getting breast cancer.
The other question is there has been a suggestion of some heterogeneity of the envelope with highly variable rupture rates up to 10%. They also state that there is some leakage of the gel through the shell, confirmed at a rate of 11%. I have no idea how they managed to get this information, as clinically it must be very difficult to do. Fluid between the envelope and your capsule may or may not be silicone. If one were to approach trying to remove this fluid with a needle, it would almost certainly rupture the prosthesis. I have on a number of occasions explored breasts which, on scans, suggest that they were ruptured, and found that they were intact.
Probably of more importance the Therapeutic Goods Administration of the Australian Government also tested out PIP silicone prostheses and found that these implants conformed to the relevant international standards of this type of product, including those for gel toxicity and shell strength. We do know in any case that a small amount of silicone leaches out from every prosthesis. The only thing I would like to say about this is that one would like to have a comparison with other prostheses to see whether there is really any difference.
At the moment, as of 10 January 2012, there doesn’t seem to be any reason to panic. All one can really do is carry out an ultrasound investigation to see whether there is any reason to believe the prosthesis is ruptured. The ultrasound is a relatively inexpensive assessment and probably should be carried out every year, much as one would service one’s car. All investigations have false negatives and false positives, and you have to remember that taking you to theatre and giving you an anaesthetic is similarly not without risk.
Remember that replacing your prosthesis with another does not guarantee that there will not be similar problems with them in the future.
posted by DH Harrison | Comments 4
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