Hopes for Silicone Implants May Have Been Over-Inflated

Women Still Cautious Despite FDA Ruling


Jan. 10, 2007 — -- When the Food and Drug Administration lifted the 14-year moratorium on silicone breast implants in mid-November, many believed that the move would have women rushing to their plastic surgeons for these once-forbidden enhancements.

However, some prominent plastic surgeons say the reaction remains tepid.

"In my own practice, I have not seen people necessarily swinging one way over the other," says Dr. Darrick Antell, an official spokesperson for the American Society of Plastic Surgeons and a surgeon in private practice in New York City.

"Most women in my practice remain skeptical of the FDA approval of silicone gel and continue to choose saline implants," says Dr. Ronald Friedman, director of the West Plano Plastic Surgery Center in Plano, Tex.

The reason, Antell and Friedman say, is that many women remain wary of silicone implants, despite the FDA's exoneration of the devices months ago.

"I think that with regard to silicone implants, while it is nice to know that science has put everything to rest, people still have reservations," Antell says.

"Many women are excited by the lifting of restrictions on silicone gel, but many more remain concerned about the safety of silicone gel," Friedman says. "After $3 billion of lawsuits and a 14-year federally-mandated moratorium, it is no surprise that silicone gel remains controversial.

"I think that we may be sending out mixed messages by putting in silicone gel implants in the 1980s, taking them out in the 1990s, and putting them in again in the 2000s."

For 14 years, an FDA-issued moratorium on silicone breast implants for cosmetic use drastically limited their use in the United States. The moratorium was adopted after thousands of women complained that silicone from leaky or burst implants made them seriously ill.

Since then, however, the implants largely have been cleared of concerns that they might cause serious or chronic illnesses such as cancer or lupus.

And though critics said that the FDA had not fully examined all of the facts surrounding the dangers of silicone, the FDA revoked the moratorium, making silicone implants available to women over the age of 21, as well as all breast reconstruction and revision patients.

Yet, continued patient apprehension could mean that the use of silicone breast implants could remain low for some time to come.

"I think it's going to persist," Antell says. "I think it will take time for people to embrace what science has told us. It just shows how people can be influenced by the media and hysterical lawyers."

"I think that sales of silicone gel implants, while partially revived by the FDA approval, will continue to lag behind sales of saline implants for several years," Friedman says.

Even less likely to come to fruition is the prediction of "upgrade" operations, in which women who already have saline implants have surgery to replace them with silicone.

"For sure, as saline implants wear out or have to be replaced for other reasons, women will be requesting silicone gel implants," says Dr. Henry Kawamoto, professor of surgery at the Division of Plastic and Reconstructive Surgery at UCLA. "But, who knows? There might be something better in the distant future."

While some patients steer clear of silicone implants because of safety concerns, other women simply prefer saline.

"There is certainly a role for silicone gel implants," Friedman says. "However, there are definite disadvantages relative to saline."

He says that since silicone implants are pre-filled -- unlike their saline counterparts, which are "pumped up" only once they are in the body -- the surgeon must make a longer incision to put them in.

Silicone implants are also about $1,000 more expensive, and their risk of capsular contracture -- a condition in which scar tissue around the implant makes the breast hard and misshapen -- is higher.

And on top of these considerations, some surgeons simply prefer saline.

"There are doctors who have always embraced saline implants, even when silicone was available years ago," Antell says. "We will not be discarding saline implants just because silicone has been approved."

He adds, however, that silicone is still an important addition to the range of options available to patients.

"The important thing is that there are more options available so that the informed patient can now make her own choice," Antell says. "Some will choose saline, and some will choose silicone."

Plastic surgery experts also say that the women who do choose silicone may not hold up their end of the deal with regard to strict screening regimens prescribed by the FDA.

One of the conditions that came attached to the approval of silicone implants is that manufacturers must conduct studies and follow-up of a projected 40,000 women over the next 10 years.

Part of this follow-up involves periodic magnetic resonance imaging (MRI) scans intended to detect the signs of implant rupture. Yet, Friedman says it is unrealistic to believe that every woman who gets silicone implants will actually get the prescribed scans every three years.

"Who will pay for this $1,000-or-more test?" Friedman asks. "Certainly not the FDA, the implant manufacturers, the plastic surgeons or the patients' insurance companies.

"Ultimately, this expense will fall upon the patients, most of whom will simply decline to undergo MRI."

"Most surgeons consider the FDA's recommendations of repeated MRI's unnecessary and onerous (and expensive)," says Dr. Brent Moelleken, assistant clinical professor of plastic surgery at the UCLA School of Medicine and a surgeon in private practice in Beverly Hills.

And Kawamoto says the monitoring guidelines imposed by the FDA make it significantly more difficult to get silicone implants now than it was before the moratorium.

"It is more difficult because they are more expensive and require more acknowledgment, and hence more paperwork, for the patient," he says, adding that all patients wanting silicone implants must also read a 60-page list of risks and considerations.

"Isn't 60 pages excessive?" he asks. "I guess not for governmental projects and legal disclaimers."

While some women continue to worry about the risks of silicone implants, surgeons say that all implants carry certain risks. Kawamoto says he stopped inserting breast implants altogether in 1982 because of the problems he saw associated with them.

Still, he says, some patients will still opt for the implants.

"The FDA has stressed that the implants are not totally safe," Kawamoto says. "Neither is buying and driving a car, which costs more, is more problematic and doesn't last as long as implants."

And many surgeons remain optimistic that more women are coming around to the idea of silicone once again.

"Women are less concerned overall about the safety of silicone gel implants now that numerous studies have not shown there to be a link between health problems and silicone gel implants," says Dr. Brent Moelleken, assistant clinical professor of plastic surgery at the UCLA School of Medicine and surgeon in private practice in Beverly Hills.

"Women nowadays tend to be better informed and don't rely on a single sensationalistic news story before making a decision."

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