SILICONE SORROWS Meanwhile, a handful of cases of cancer of the liver occurred in animal studies of the polyurethane-coated implants, and the manufacturer elected to forgo additional studies, stopped manufacturing the implant and went out of business. “I had 600 cases with the polyurethane-coated implants in humans, and none of my patients got cancer of the liver, nor did I ever hear of anyone who did,” Dr. Biggs says.
Other manufacturers created similar implants and coated them with simulated polyurethane. This, Dr. Biggs says, is what became known as “texturing.” While the majority of patients were happy with these silicone implants, according to Dr. Biggs, a news story in the early 1990s linking silicone breast implants with autoimmune diseases set the evolution of breast implants on an almost 20-year detour. This development culminated in the largest class-action lawsuit in medical history, with $4.2 billion awarded to women with silicone gel implants.
“When the expose came along saying that silicone implants may be causing autoimmune disorders, the FDA (Food and Drug Administration) prohibited the use of silicone implants filled with silicone, but they allowed us to use a silicone implant filled with saline,” Dr. Biggs says. “What is paradoxical is that the FDA allowed us to use silicone implants filled with silicone gel for reconstruction in patients who had cancer, but their use was prohibited in healthy women.”
After the FDA’s moratorium, silicone gel implants were available only for patients enrolled in the Special Adjunct Study, which included patients who had mastectomy or severe developmental deformity, or those with failed augmentation following saline implants.
During the moratorium, although many women were happy with saline implants, there were some problems, Dr. Biggs says. “They didn’t feel as natural as silicone gel implants, and there was a propensity to leakage problems,” Dr. Biggs says. “They leaked because of fold flaws, and because of failure of the valve through which they were inflated. We had an annual 1 percent to 5 percent deflation rate.”
In 1999, after years of retrospective outcomes analysis, the FDA concluded there was no evidence showing that silicone gel implants played a substantial role in autoimmune disorders. “But,” Dr. Biggs says, “that didn’t represent an automatic reintroduction of silicone implants. The FDA put very stringent demands on the manufacturers as to what they had to do to show that use of these ‘third-generation’ implants was justifiable.”
The third-generation implants have a triple-layer shell that prevents leakage, and the gel is more cohesive — so much so that even if it were to leak, the gel would stay put, Dr. Biggs says. “We now have a silicone gel implant that we are certain is safe, and last year the FDA decided that it was acceptable to once again offer silicone gel implants for augmentation,” he says.
WHAT’S AHEAD Shaped implants represent the fourth generation of breast implants. For patients who lack sufficient breast tissue in the lower pole, as well as for mastectomy patients, these shaped implants offer significant benefits, according to Dr. Biggs.
“Most patients will be adequately treated with a round implant, but there is a subset of patients who will definitely benefit from a shaped implant,” he says. “One of the deficiencies of the shaped implant is that if it rotates, it creates a significant deformity, whereas the round implant does not. To prevent it from rotating requires a much more careful dissection of the space into which we put the implant. That said, if a woman has deficiency of tissue in the lower pole, she can benefit greatly from the advances that we have made with these shaped implants, even though it is more technically demanding and more costly,” he adds.
Contact Dr. Benchetrit , your plastic surgeon in Montreal, and the team at COSMEDICA for information about all the options available at (514) 695-7450.
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