FDA Approves Silicone Breast Implants -- With Mention of Additional Surgery
By Christine Cupaiuolo — November 18, 2006
In 1992, the FDA banned the cosmetic use of silicone breast implants, according to the Washington Post, “after many women who had received them reported pain, deformity and serious illness caused when the implants ruptured or leaked. At the time, the FDA concluded there was ‘inadequate information to demonstrate that breast implants were safe and effective.'”
Fourteen years later, they’re ba-aack.
Manufacturers weren’t taken by surprise — Mentor Corporation already unveiled a website for its MemoryGel silicone implants.
Stephanie Saul writes in The New York Times (which also published a pop-up timeline showing the on-again, off-again history of silicone implants):
The federal agency approved implants manufactured by two California companies, Mentor and Allergan, for breast reconstruction and cosmetic breast augmentation, but limited cosmetic use of the implants to women ages 22 and older.
The decision appeared to end a controversy over the safety of silicone implants that lasted more than two decades and resulted in thousands of lawsuits by women who claimed the implants leaked and caused a number of diseases, including cancer and rheumatoid arthritis. The dispute led to the bankruptcy of the manufacturer Dow Corning, a federal moratorium on the use of the implants, and, finally, findings by both the Institute of Medicine and the Food and Drug Administration that the devices do not cause major illnesses.
Because the implants made of silicone gel are softer than the saline implants currently available, plastic surgeons said they would quickly become preferred among the more than 300,000 women in this country who have breast implants each year.
Critics of the decision lambasted it and said that longstanding safety concerns had not been resolved. But supporters of the implants, including leading surgeons, applauded it. “For us, it’s a triumph of science,” said Dr. Richard A. D’Amico of Engelwood, N.J., president-elect of the American Society of Plastic Surgeons. “We’ve always felt that the science would bear out the use of the implants.”
If only for a while.
Dr. Daniel G. Schultz, director of the FDA’s Center for Devices and Radiological Health, said that while the FDA had determined the implants were safe, the possibility remains that the implants will rupture and women will need additional surgery. One study found that 69 percent of women experienced a ruptured implant, according to the NYT.
“Women should know that breast implants are not lifetime devices,” Schultz told reporters during a telephone briefing. “Women having these procedures done need to be prepared for the fact that there is a likelihood they will require additional surgery.” He also mentioned the possibility of “silent ruptures,” which can occur without a woman’s knowledge.
Which makes the remarks of Dr. Sidney Wolfe, chief of Public Citizen’s Health Research Group, seem quite sane. He called the implants “the most defective medical device ever approved by the F.D.A. The approval makes a mockery of the legal standard that requires ‘reasonable assurance of safety.’”
Amy Allina, program director at the National Women’s Health Network, told the NYT that knowing how long the implants would last — and if leaking silicone causes health problems — are basic safety questions manufacturers had failed to answer.
In a statement posted on the website of the National Research Center for Women and Families, President Diana Zuckerman said:
It’s important for women to know that the FDA has not determined that silicone gel breast implants are safe – only that they are “reasonably safe.” What does that mean? In this case, it means that if a woman lives for 25 years after getting these implants, she will need to remove them at least once, probably twice, and possibly more than that. If she doesn’t, the implants are likely to break inside her body, and possibly leak silicone into her breasts, lungs, and other organs.
What do we know about the risks? Most women with silicone gel breast implants experienced at least one complication within the first three years of getting implants, including breasts that were hard or painful, oddly shaped, or had lost sensation, or the need for additional surgery to fix implant problems. The additional surgery is often very expensive, and almost never covered by health insurance.
Plus: Oh, Canada — Across the border, Canadian health officials came to a similar decision to allow silicone implants just three weeks ago.