 News stories in 1990s linked silicone implants with autoimmune diseases, setting evolution of implants on a detour :
HOUSTON — The career of Thomas Biggs, M.D., is as entwined with the modern evolution of breast implants as are the staff and snakes of the caduceus. He trained under Thomas Cronin, M.D., who — along with Frank Gerow, M.D. — was responsible for developing the first modern-day silicone gel breast implant in conjunction with Dow Corning. Since then, he has been involved in more than 8,000 breast implant procedures throughout a career that has spanned more than 40 years. Today, the semi-retired Baylor College of Medicine clinical professor of plastic surgery travels the world lecturing about the evolution of breast implants and performing surgery in far-flung locales, from Brazil to India and everywhere in between. Dr. Biggs’ primary message when lecturing about breast implants is that “They are not a way to get a boyfriend back or to keep a husband interested. The breast is the external symbol of a woman’s gender, so anything that we can do to make the breast more appealing to a woman enhances her feeling of her own womanhood and gives her more self-assurance.” This, he says, is what he told his audience back in 2000 when he was among a hand-picked group of physicians who were invited to the Vatican to discuss their medical specialty. “The Vatican decided to have an assemblage of all of the world’s medical knowledge and brought physicians in from across the globe. They selected six plastic surgeons, and I was one of two from the United States, and I was asked to talk about the evolution of breast implants,” Dr. Biggs says. “I stressed my belief that the sole purpose of being a physician should be to make a person’s life longer or better or both, and explained how breast implants make women’s lives better.” IN THE BEGINNING While the history of modern breast implants starts with Dr. Biggs’ colleagues Dr. Cronin and Dr. Gerow, attempts to enhance the size and/or shape of the breast weren’t new — efforts were made even in the 1890s. “Early attempts ranged from very, very bad to not good, and they all failed,” Dr. Biggs says. The implants that immediately preceded Dr. Cronin’s and Dr. Gerow’s “natural feel” implants included sponge prosthetics made of Etheron (polyether foam sponge), Polystan (polyethylene tape) and polyethylene. Within a year, all of these resulted in capsular contraction, which collapsed the sponge and deflated the implants by 25 percent or more. “Then,” Dr. Biggs says, “in 1962, Cronin and Gerow created an implant made out of silicone.” The inspiration for the early silicone gel implant was a blood transfusion bag. Early blood transfusion vessels were made of glass. During the silicone gel implant’s developmental stages, Dr. Cronin visited a blood bank, and upon feeling the new and improved flexible plastic bag that contained the blood, he observed that it felt like a breast, according to Dr. Biggs. The rest, as they say, is history. Silicone was used to make a thin, flexible “fabric bag,” and also to make a gel-like substance with which to fill it. “The cohesiveness of the gel could be altered so that it could be very thin or even solid,” Dr. Biggs says. “They created one small implant and put it into a dog and the dog was fine, so then they implanted it in a person and she got along just great. So then we began to put it into more and more people,” he says, noting that “In those days, there was very little regulation, so there was minimal obstruction to its being manufactured and sold.” Dr. Biggs recalls that Dr. Cronin and Dr. Gerow thought the implant had a great future, because it was virtually nonreactive. Dr. Biggs and his colleagues encountered a multiplicity of problems throughout the developmental phase, but, ironically, the only one that persisted — and resulted in almost every early case — was fibrous capsular contraction. “The body needs to isolate a foreign material from itself, and the wall that built up around the implant would contract and make the implant feel hard. One of the things that we did to minimize this problem was to coat the implant with polyurethane. Once we did this, the incidence of capsular contraction dropped to almost zero,” he says. |
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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Dr. Benchetrit and COSMEDICA'S BLOG - Creating a New You 
August 28, 2010 at 4:52 am
they have to evolve, otherwise it will be obsolete