Are The Prostheses Safe? Can They Cause Cancer?

In Australia and Europe current sales figures show a distribution of 90% silicone, 10% saline. As modern silicone gel implants have been available since 1963, surgeons therefore have over 35 years of experience with these types of breast implants. This is more than any other type in use.

Are The Prostheses Safe? Can They Cause Cancer?

Evolution has brought changes and improvements over the years with the introduction of textured surface envelopes made of newer formulations designed to minimize the "bleed" or diffusion of what is usually tiny amounts of the silicone oil fraction of the gel contents. Importantly the standard silicone gel by most accounts, arguably "feels" the most natural of all breast implants. This is probably as a result of the inherent smoothness of the silicone gel content.

A Few Facts On Silicone

Many women considering this type of surgery will no doubt have heard of frightening stories about silicone toxicity or autoimmune/connective tissue disease, due to gel "bleed" or migration. As a result, breast augmentation has, in the last 13 years, received much unfavourable publicity mainly through the irresponsible actions of the media whereby, regardless of the facts, claims have been made with respect to silicone safety.

Undoubtedly, most of these stories began to attract attention after the American Food and Drug Administration (FDA) in January 1992 imposed a ban on the use of silicone gel breast implants. The FDA concluded, "there was no evidence that silicone gel filled breast implants are unsafe, but there was insufficient evidence to prove safety".

All the above was a result of pending law suits against the manufacturers of breast implants from women who had breast implants and were now allegedly suffering from a whole host of symptoms from a disease process arbitrarily termed "silicone related autoimmune disease". In fact a search of court records in America has revealed that no less than 216 separate complaints or symptoms have been filed in association with gel filled devices.

Since this time there has been much activity and debate within the medical community to try to ascertain whether silicone gel breast implants are safe. To this end there have been many numerous statements issued and conclusions deduced. In summary some of these are :

  1. In January 1992 the Chief Medical Officer informed surgeons and doctors that the Department of Health felt no reason existed to withdraw implants from use based on scares in the USA.
  2. In April 1994 a Specialist Committee set up by the Department of Health, concluded that no scientific evidence existed which connected silicone implants with either connective tissue or autoimmune disease.
  3. There have been claims that silicone causes a totally new syndrome. These have been based on anecdotal reports and therefore no studies exist to substantiate this. In response to these the American College of Rheumatology (ACR) issued a statement in October 1995 based on research studies involving over 87,000 women. This read "silicone implants expose patients to no demonstrable additional risk for connective tissue or rheumatic disease" and " there is no reason to discourage women from considering breast implant surgery on the basis of acquiring or worsening a connective tissue disorder.
  4. At least 22 studies have been published from all over the world in the last few years, encompassing over 500,000 women in these studies, and none could find a relationship between so called "silicone autoimmune disease" and breast implants.
  5. The finding of silicone in bodily fluids should be viewed in perspective; silicone is found abundantly in our environment and indeed probably in most people. Our contact with silicone is extensive throughout all of our lives and it is used widely in medicine. Silicone is used as a lubricant in every disposable needle, syringe and intravenous tubing. Silicones are used in lipstick, suntan lotions, food processing, skin creams, hair spray, and cosmetics. Over 1000 medical products use silicone as a component or in the manufacturing process including artificial heart valves, joints, and pacemakers.
  6. In July 1998, the Department of Health published its findings and conclusions following a committee review set up to investigate the safety of silicone implants. The committee which comprised mainly of scientists and academics concluded that it found no scientific evidence linking silicone implants with disease.

In conclusion to these statements, it would be fair to accept that some women who have had Breast Augmentation surgery, may have subsequently developed at some point in their lives a connective tissue or autoimmune disorder. However as these disorders arise fairly commonly in individuals in the general population anyway, regardless of whether they have had breast implant surgery or not, is it not possible that they may have become ill anyway? This type of question can only be answered by careful statistical analysis and examining groups of individuals who have had silicone breast implants and then comparing them to similar numbers and types of individuals without breast implants. If it then appears that the group of women with silicone implants suffers a higher number of individuals with autoimmune diseases then a causal link can be established. However, at the moment, after examination of all the relevant data, it seems safe to say that there is no conclusive scientific evidence that silicone materials in breast implants increases the risk of connective tissue diseases or for that matter breast cancer.