FDA Says 'Yes' to Silicone Breasts

Nov. 17, 2006 — -- After 14 years, silicone breast implants will once again be available to women in the United States.

The decision by the Food and Drug Administration makes silicone implants available to all breast reconstruction and revision patients, as well as women 22 years of age and older seeking cosmetic breast enhancement.

A number of conditions come attached to the approval, including studies and follow-up of a projected 40,000 women over the next 10 years, says the director of FDA's Center for Devices and Radiological Health Dan Schultz.

The move comes less than a month after health officials in Canada allowed such implants back onto the market after the country's moratorium, which began in 1999.

The decision has big implications for the industry, as breast augmentation is the second most-popular cosmetic surgery procedure in the United States today. According to statistics from the American Society for Aesthetic Plastic Surgery, nearly 365,000 women had breast augmentation surgery in 2005 -- a number topped only by that for liposuction.

Since the 1992 moratorium, only saline-filled implants have been allowed on the general market, and silicone implants had been available only to special patients through FDA-approved trials.

"The moratorium was put in place in 1992 by the FDA because they felt that there was insufficient evidence to determine if [silicone implants] were safe," said Dr. Michael Olding, chief of the division of plastic surgery at George Washington University Medical Center in Washington, and a member of the FDA's General and Plastic Surgery Devices Panel.

"This does not mean that they were unsafe," he said, "but rather that more information was necessary, so they pulled them from the market temporarily."

Olding said scientific studies conducted since the moratorium have concluded that there is no scientific link between silicone implants and the systemic diseases many believed were connected to their use.

"It's sort of a vindication because we all knew there was no scientific evidence back in 1992 that necessitated the moratorium," said Dr. David Song, chief of plastic surgery at the University of Chicago Pritzker School of Medicine in Chicago. "Since 1992, there have been several landmark studies, two of which were in the New England Journal of Medicine, that showed there was no correlation between silicone leakage and all the health conditions that were being described.

"I think this is a huge victory for women," Song said, "not just for those seeking cosmetic surgery but also for many reconstructive patients after breast cancer surgery."

Not all see the development as a victory for women.

"We find it shocking that the FDA would make such a move at this time, as more and more evidence has accumulated that critical information has been withheld by the manufacturers that would clearly demonstrate that these implants are not safe," Kim Gandy, president of the National Organization for Women, wrote in a letter sent to members of Congress this morning. "The FDA should not approve silicone-gel breast implants at this time, and Congress should examine these and other instances where FDA is not requiring sound science before making approval decisions."

"Public Citizen has opposed the use of silicone gel breast implants since the fall of 1988, when we petitioned the FDA to ban them after receiving numerous documents from FDA scientists concerned about their safety," says Dr. Sidney Wolfe, director of Public Citizen's Health Research Group.

"In terms of adverse safety and health information known at the time of approval … silicone gel breast implants are the most defective medical device ever approved by the FDA. The approval makes a mockery of the legal standard that requires 'reasonable assurance of safety.'"

Looking Back at the Ban

The FDA issued the moratorium on silicone breast implants for cosmetic use after thousands of women complained that silicone from leaky or burst implants made them seriously ill.

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

"A certain number of women develop health conditions without implants put in the breast," said Dr. Julius Few, a plastic surgeon at Northwestern Memorial Hospital and assistant professor of plastic surgery at Northwestern University's Feinberg School of Medicine. "The same woman who, through heredity or genetics, will develop a condition regardless of implants, will develop the condition after implants are placed because it was predetermined.

"This does not mean the implants caused the problem," he added. "The problem was destined to occur."

"There have been several retrospective studies done, and all of them have shown that there is no statistical correlation between leakage of silicone implants and autoimmune issues," Song said. "I think that all surgeons and most people involved in health care believe there is no correlation."

However, surgeons are quick to point out that FDA approval does not mean silicone implants are entirely risk-free.

"Everyone needs to realize … that any medical device can fail," Olding said. "Implants are no exception. They will not last forever and will ultimately break."

If silicone gel implants break, it is possible that the gel will leak out, causing inflammation of the surrounding area. Aside from the risk of breakage, the implants can also cause infection and painful, hard scar tissue in some cases. The presence of an implant may also obscure the results of a mammogram, making detection of breast cancer more difficult.

Little Surprise for Plastic Surgeons

The FDA decision was largely anticipated by the U.S. plastic surgery community. In July 2005, the FDA issued conditional approval for silicone breast implants manufactured by Mentor Corp. September 2005 saw the same conditional approval for silicone implants manufactured by Inamed Corp. (now owned by Botox-maker Allergan).

And in April of this year, the American Society for Aesthetic Plastic Surgery presented a course in Orlando, Fla., designed to update and instruct American plastic surgeons on the use of silicone gel implants.

"Since the restriction on silicone gel implants in 1992, there has been a generation of plastic surgeons who have limited, if any, experience with these types of implants," said Atlanta plastic surgeon Dr. Foad Nahai in an ASAPS press release. "This program will introduce them to the differences between gel and saline implants."

Surgeons said the reintroduction of silicone will not replace saline implants but simply signald another available choice.

"There are other reasons that I think women would choose saline over silicone," said Song. "When putting in saline implants, the incision is small, but using silicone implants increases the size of the incision. When you make the incision larger, then the scar will also be larger, something that many cosmetic patients would not want."

Song added that the stigma surrounding silicone implants may take a while to wear off completely.

"Eventually, Americans are going to forget about the stigma of silicone," he said. "Still, a lot of women are going to be wary of silicone implants in spite of compelling data."