Plastic Surgeons Assail Moratorium on Silicone Implants as ‘Political’

Officials of the California Society of Plastic Surgeons on Sunday blamed publicity over the U.S. Food and Drug Administration moratorium on silicone gel breast implants for creating anxiety among former and potential patients that is “way out of proportion” to the dangers.

While California plastic surgeons have opposed for a decade the use of liquid silicone, they felt that gel implants “were safe all along,” said Dr. John O. Strong, a Santa Ana plastic surgeon and president of the statewide society, which will conclude a four-day conference Tuesday at the Hyatt Newporter.

“The question is why are (FDA officials) discussing it now after 30 years?” Strong said.

The organization of more than 400 plastic surgeons has taken no official position on the FDA moratorium on silicone implants. However, Strong and others said physicians at the conference were “distressed” and “irritated” by the moratorium, which they say is motivated more by politics than by science.

“It’s a change in their lives,” Strong said. “It’s an irritation.”

Strong said doctors across the state have received hundreds of calls, lasting 30 to 45 minutes each, from former and potential patients asking about the risks and dangers of silicone gel implants and how to detect ruptures or leaks.

Many are concerned whether leaks of silicone from the implants may cause systemic illness. As yet, there are no test results that prove a link between silicone and autoimmune diseases such as scleroderma and lupus. But in January, the FDA called for a voluntary moratorium on silicone implants and last month limited their use for cosmetic reasons pending controlled scientific studies. The devices still may be used in reconstructive surgery.

Short of surgery, it is difficult to tell if an implant has been ruptured, Strong said. The only outward indication of a break is a change in breast shape. In that case, he said a woman “might want to consult her physician” for tests.

According to papers presented at the conference, diagnostic tests such as multiple resonance imaging, ultrasound and mammography may detect a rupture but are not foolproof. Despite manufacturer’s recommendations that ruptured implants be replaced, Strong said many doctors do not believe it is necessary. Unlike the liquid silicone used in injections, loose silicone gel in the body may be a “non-problem,” he said, because “the body walls it off and isolates it.”

In any case, he said the moratorium makes it difficult to replace a broken gel implant with an identical product, Strong said. Saline implants, introduced about 15 years ago, could be used but would not produce a symmetrical result.

“Women are sometimes picky on little things,” Strong said. “It’s nice to fill their need.”

The society’s past president, Dr. Garry S. Brody of Downey, said there are distinct risks and benefits to both silicone gel and saline implants. “We want a variety of products to suit a variety of needs,” he said.

Both doctors complained that the general public does not understand the value of cosmetic breast surgery. “The only people who understand are the patients,” Brody said.

Rather than succumbing to fashionable trends or family pressures, he said they often choose breast augmentation because it is what they truly want.

“Studies show they are basically secure women, often married with children, whose husbands say, ‘Don’t do it for me,’ ” Brody said.

The typical patient has breasts that “didn’t develop to fit their physical needs” or they changed after nursing children, he said. Psychological counseling has “failed abjectly” to deal with their needs, he said. “It is not an emotional disturbance. . . . They have a single focus of concern.”

Studies show that 95% of cosmetic implant patients say they would have the same surgery over again, Brody said.

California is a healthy market for the plastic surgeons. With 11% of the nation’s population, the state accounts for about 15% of the breast augmentations that until recently were being performed at a rate of 100,000 a year, he said.

Plastic surgery and breast implants are now decreasing, the doctors said, partly because of the economy and partly because of the silicone gel controversy.