In the early 1960's the silicone gel-filled implants were developed to improve options for women who needed mastectomies to treat breast cancer. These implants were very different to the ones made today. They had a smooth envelope which was not as strong as the outer covering today and were prone to rupture. Also through this one layer there was diffusion of silicone gel. This silicone was also liquid and couldinfiltrate into the surrounding tissues. Today it is a viscous gel, much like toothpaste. This is quite sticky and can possibly cause a local inflammatory reaction but will not spread everywhere.
In the early 1990's the capsules were made thinner in France and America to improve the texture and more closely mimic natural full breasts. More ruptured and claims were made that this caused connective tissue diseases eg scleroderma, rheumatoid arthritis or systemic lupus erythematosus. In America some regulatory authorities imposed restrictionson the use of silicone implants. Many surgeons starting using saline filled implants but these still have a silicone elastomere covering.
Since then silicone has been extensively tested in laboratory studies as well as clinical studies. In 1986 the University of Southern California studied 3000 women in Los Angeles who had implants between 1959 and 1980. In 1992 a Georgia, New Jersey, and Washington study investigated over 2000 women. All these studies found no increased risk of breast cancer following breast implant surgery.
In 1994 the Mayo Clinic compared 749 women who had breast mplant surgery with 1498 women who did not have implants. This study found no association between breast implants and connective tissue diseases.
Connective tissue disorders occur independently in the general population. Statistically,women have a higher incidence of auto-immune disease than men. These types of diseases may occur coincidentally along with implants. This does not mean the implants caused the disorders. The cause and effect relationship between breast implants and these diseases has never been proven.
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