Silicone implants and silicone safety
Posted on February 4, 2009
There are 10,000 to 25,000 breast enlargements performed in the United Kingdom every year. The majority of implants used are silicone filled implants.
There were approximately 350,000 breast enlargements performed in the US in 2007. In the US the majority of implants inserted were saline filled implants following the silicone controversy. This is now changing as silicone filled implants are being re-introduced.
This occurred after the FDA in the US looked at the evidence around silicone implant safety and allowed their use again.
The modern silicone breast implant was first manufactured in 1963. All implants have a similar design, an outer silicone elastomer shell, which can be smooth or textured. It can have other variations of size and shape. The shell is then filled either with silicone or with saline.
The choice of implant is particular to each patients need. The modern silicone implant is filled with a cohesive type gel. This is a jelly like consistency so the silicone does not leak when cut.
This type of implant is called a third generation implant as it replaces two previous developments of implant design. This also includes a tougher outer silicone shell which allows much less silicone “bleed” or diffusion as well as being filled with a more viscous and cohesive gel. A cohesive gel minimises gel spread in the case of rupture of the implant.
Silicone and Breast Implants
The basic substance in all implants is silicone gel. Silicone is a polymer of silicon and oxygen. Dimethylsiloxane is the form of silicone found in breast implants. It is one of the least reactive materials used in medical devices.
The shell is made of a tough rubber like silicone. The shell membrane is slightly permeable which gives rise to ‘bleed’. This leakage of silicone should be put into context. Silicone is everywhere in our surroundings from cosmetics to medical devices and may be present already in the body. The two main issues relating to Silicone Implant safety were regarding the risk of breast cancer and connective tissue disease.
There is no evidence that silicone causes cancer in humans. Furthermore studies have shown that women with silicone implants have 30% less breast cancer when compared to women without implants.
The idea that breast screening may be impaired by the presence of a breast implant has also been shown not to be true in a number of studies. Mammographic screening should take place as it would with any woman. Mammograms should be performed by a unit experienced in displacement views.
Connective tissue disorders
Studies to date have failed to find a connection with any connective tissue disease and silicone. ‘Despite the many reports in the media, exhaustive evaluations by multiple prestigious scientific bodies such as the Institute of Medicine, the British Ministry of Health, a committee of the European Union (EQUAM), and multiple panels of experts established by various courts have confirmed that no evidence exists of any known or new systemic illness definitively attributed to silicones.’ eMedicine Breast Implants, Silicone: Safety and Efficacy 2005.
Silicone Implants in the United States
In April 1992, the Food and Drug Administration of the USA determined that concerning silicone implants was not sufficient to demonstrate the safety of silicone breast implants. The silicone breast implants were removed from the market.
Following this ruling Mentor Corporation and McGhan (Inamed) carried out a number of studies looking at silicone implant safety. In April 2005, third-generation silicone breast implants were given approval by the FDA for use in reconstructive patients. In 2006 the FDA approved the use of silicone breast implants for cosmetic use.
You and Your Breast Implants
Silicone breast implants continue to be the most popular type of implant used in the United Kingdom for breast enlargement. Discussion with your surgeon is important in making up your mind about whether breast enlargement is right for you. It is also important to discuss with you the type of implant you should use.
Consult Peter Butler’s PIP BREAST IMPLANT ALERT blog for information on PIP implants or find out more by calling 0870 780 4000.