Safety of Silicone Implants
Silicon is a naturally occurring element found in sand, quartz and rock. Silicones are a family of chemical compounds made up of silicon, oxygen, carbon and hydrogen.
Silicones have been used extensively in a wide range of everyday consumer products for over 50 years:
Silicones have also been used very extensively in the medical profession. Silicones’ excellent lubricating qualities makes it an ideal coating for surgical needles, sutures and the internal surfaces of syringes and bottles used for the storage of blood and intravenous medicines. Protective silicone coatings have also been used in pacemakers and artificial heart valves. Other medical devices using silicones include artificial joints, catheters, drainage tubes, facial implants, tissue expanders and breast implants.
Silicone implants are far more popular with patients than saline implants because of their more natural ‘feel’ and the fact that they cannot spontaneously deflate like saline implants can.
During the late 1980s concerns were raised that silicone implants could cause various auto-immune diseases such as scleroderma or arthritis-like disorders.
This prompted a number of major independent world studies, in particular those of:
- The Institute of Medicine commissioned by the US Congress;
- The National Scientific Panel appointed by the US courts;
- The Scientific & Technical Options Assessment Programme commissioned by the European Parliament; and
- The Independent Review Group in the United Kingdom, commissioned by the British Minister of Health.
Each of the above studies concluded that in patients with silicone gel implants:
- there is NO increased risk of auto-immune disease or connective tissue disorders; and
- breast feeding is safe
Similarly, the authoritative US Food & Drug Administration (FDA) issued the following statement on 26 September 1991:
“There is no conclusive evidence at present that women with breast implants have an increased risk of developing arthritis-like diseases or other auto-immune diseases. Women with breast implants who have developed such diseases may have done so regardless of their implants”.