Breast enlargement surgery is performed via the placement of saline or silicone filled implants in a silicone shell under the skin and muscles of the chest.

Breast augmentation has been performed on millions of women since its inception in Houston in 1963 by Dr. Frank Gerow, who was my professor when I was in training there. Now there is trouble for the French maker of silicone implants PIP, Poly Implant Prothese.

In the 1980s there were a number of breast implant manufacturers in the world. Most of them were based here in the United States. Each company touted its own particular take on the breast implant market. Some had shaped implants, others covered them in polyurethane, etc.

By 1990, a movement had begun, ironically also based in the birthplace of the breast implant, Houston, Texas, that associated silicone implants with a number of medical problems. These diseases tended to be auto-immune diseases (diseases in which the body attacks itself), which are by nature more common in women. They include diseases like rheumatoid arthritis and lupus. It was thought that these diseases may be caused by silicone coming in contact with the body.

After ten years of research, no link has been found between breast implants and auto-immune disease, yet the initial ban implemented by the US government in the early 1990s was enough to cause the downfall of Dow Corning, one of the major breast implant manufacturers, among other companies. Breast implants became the most-studied medical device in history.

The upshot of all this was that only two manufacturers remained in the US, and new manufacturers started up in other countries, such as France. The PIP company’s breast implant was one of these new entrants into the market. Being outside the FDA’s paws, they began to sell their implants all over the world. In fact, 84% of their implants were exported to South America and western European countries. They never were allowed to sell in the US, and the FDA even ten years ago had not cleared them due to safety concerns!

Last week, PIP came under international investigation for faulty manufacturing processes, with over 100 Dutch women having had silicone implants that were failing due to rupture and silicone leakage. PIP has gone pop.

The company, which was supposedly established by a French butcher  (although that particularly curious innuendo has since been denied), is accused of using industrial-strength silicone—as in what you use around your windows for caulking—in their implants. Medical-grade silicone is much more expensive, and in these hard times…

So this is a case of a bad grade of silicone being used for breast enlargement implants. The silicone breast implants used by cosmetic plastic surgeons in the United States are safe. Doubtless, many cosmetic patients may become afraid of silicone implants again, but hopefully science will prevail and their safety will be reasserted.