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11/11/03 - Beauty And The Breast - The Battalion

By Midhat Farooqi

In 1992, at the height of the panic over the safety of silicone breast implants, some women were so alarmed that they tried to remove their own implants with razor blades. That year, the Food and Drug Administration blocked general use of the silicone implants, citing lack of conclusive evidence about their safety and effectiveness.

A decade later, a key advisory committee to the Food and Drug Administration recommended that silicone breast implants be allowed back on the market. The FDA should listen to its advisory board's informed conclusion and permit silicone implants to be used again.

The use of silicone implants, either to enlarge breast size or reconstruct a breast damaged by cancer, dates back to 1963. Since then, more than one million American women have received them.

The possibility that silicone implants could cause disease was recognized as early as 1978, though the issue gained notoriety when CBS aired an implant feature on "Face to Face with Connie Chung" in 1990. During the show, Chung called silicone gel "an ooze of slimy gelatin that could be poisoning" women. The comment caused one stampede of women rushing to have their implants removed and another to file lawsuits against implant makers.

Largely swayed by public opinion, the FDA restricted the use of silicone implants to clinical studies and breast reconstruction in cancer patients. Meanwhile, the barrage of lawsuits drove the main implant manufacturer, Dow Corning, to bankruptcy and led to settlements worth billions of dollars for the 'victims.' Saline implants, though considered to be second-rate in look and feel, took over the market.

Those who scorn cosmetic surgery may see no good reason to give the implants another chance, but a lot of women want them. In 2001, American women spent $668.9 million on breast augmentation, according to the American Society of Plastic Surgeons. Women between the ages of 19 and 34 accounted for 56 percent of the spending.

Plus, silicone implants are generally preferred to saline ones because they give the breast a more natural feel and look. Katina Hudson, a Pompano Beach, Fla., resident who prefers silicone, received saline implants five years ago and soon grew unhappy with them. "You were able to see the saline bag," Hudson said. "My husband wasn't happy at all. He could feel the sack."

Though silicone implants provide a better cosmetic effect, some say they are dangerous since the implants may rupture, releasing silicone into the body. Implants do break: Data from FDA studies indicates that on average, a quarter of implants rupture within 12 years and 55 percent break within 16 years. In the first few years though, the rupture rate is about 1.2 percent. Opponents claim that the silicone released from the broken implants triggers an immune system response that causes a wide variety of diseases, from cancer to rheumatoid arthritis. However, there is little to no scientific evidence to support this assertion.

The Institute of Medicine released a 500-page document in 2000 in which they evaluated research done on silicone implants. After assessing a wide range of scientific studies performed, the Institute concluded that silicone from the breast implants did not result in a nasty immune response, or that the implants were linked to any disease.

Comparatively, the saline implants currently used break as well. Researchers at the Washington University School of Medicine have shown that bacteria and fungi can grow in the saline implant, and there is concern that these may be released into the body if the implant breaks. If saline implants can be approved by the FDA, then silicone ones should be as well.

Also, some 1.5 million patients receive silicone eye lenses and another 670,000 get artificial silicone joints each year. These medical devices have not produced the side effects attributed to silicone implants, though they contain the same chemical. Since both the lenses and the joints are approved by the FDA, silicone implants should be no different.

Even so, a surprisingly high proportion of silicone implant patients - from 21 percent to 46 percent depending on the type of patient - require further surgery within two years due to complications from the implants or to achieve a better cosmetic result.

But, silicone implants should not be banned because of this. Rather, women who wish to use them should know that a large number of patients tend to need follow-up surgery. It makes sense for the FDA to give women the choice of which implant to get as long as the patients are warned of the safety risks.