Silicone breast implants deteriorate over time, experts say, resulting in an increased risk of implant rupture. One study has estimated that 95% of implants can be expected to break within 20 years after surgical insertion. Experts believe up to two million American women have undergone breast augmentation surgeries involving implants. Twenty percent of those women elected to have the surgeries following mastectomy; the remaining 80% chose to do so for cosmetic reasons.

The FDA investigators contend that, although manufacturers of silicone-gel implants currently promote rupture rates as low as 0.2 - 1.1%, research is revealing that the integrity of breast implants deteriorates greatly over time. One study concluded that the proportion of patients who could expect to have both implants intact was 89% after 8 years and 31% after 12 years, but only 5% after 20 years.

One readily-apparent and unhealthy consequence of gel diffusion occurs when the immune system tries to isolate pockets of gel by forming hard 'granules' around them wherever they appear. In one case, a woman suffered pain, swelling, numbness and scarring in her hand after nodules formed around gel which had migrated to that extremity. Escaped silicone has also been discovered in rib cages, abdominal walls, livers, and groins. Extensive (surgical) dissection may be required to remove migrating silicone gel.

The Lancet, (1997;350:1531-1537)

COMMENT: Some of the sickest women I have seen were a result of silicone implant induced immune dysfunction. These implants are clearly very dangerous. This new study shows very clearly that nearly all of them invariably rupture. That does not even take into account that 100% of these implants leak out silicone. The silicone in the implants is not benign modified "sand". Rather, it is a complex chemical that can have very significant and devastating consequences on the immune system.