Silicone Implants

As technology improved, in parallel with the intent to remedy defects, silicone filled implants have progressed through a number of “generations.”

  • 1st generation was 1963 with a silicone rubber shell filled with a silicone gel.
  • 2nd generation was a thinner shell which ruptured and/or leaked and gave rise to many law suits against Dow Corning and other manufacturers.
  • 3rd generation was a hybrid of silicone surrounded by saline and by nature of its complicated structure inevitably had more failures.
  • 4th generation saw the introduction of different shapes of prosthesis, different but similar materials in the shell and the gel, and a textured surface to which it was thought the human tissues would adhere and restrict displacement of the prosthesis.
  • 5th generation is filled with a denser form of gel.

There was a wave of medico-legal suits in the 90’s and later from women who claimed the silicone gel had reduced life expectancy, caused cancer, auto-immune diseases, fibromyalgia and other conditions. These claims were never substantiated by actuarial or public health studies, in fact they were essentially refuted.

Studies in the US commenced in 1997 under the National Academy of Sciences reported no causal relationship between implants and any disease or other condition, so in 1998 the FDA approved the implant for breast reconstruction and revision. After the National Academy in 1999 reported no associated conditions (other than local) caused by saline or gel implants, the FDA approved saline implants in 2000 for breast augmentation, but not until 2006 did they give conditional approval for the gel-filled model. The equivalent European agencies have been much less cautious.