Plastic surgeon Dr. Ronald Iverson refers to the “general scare” of 1992 when his own patients canceled scheduled breast implant surgeries and the newspapers were full of plaintive quotes from patients, including one woman who complained, “I’ve got a bomb in my breast.”
“Once the negative publicity of (silicone) gel (implants) was gone . . . they were interested again in having implants,” says Iverson, president of the American Society of Plastic and Reconstructive Surgeons and a clinical professor of plastic surgery at Stanford Medical Center in California.
And so they are.
Breast augmentation–or enlargement–last year was the sixth most commonly performed procedure by American plastic surgeons.
Ninety-six percent of the breast enlargement surgeries used saline-filled implants. Silicone gel-filled implants are now only allowed by the FDA on a limited basis and as part of controlled clinical studies.
The controversial silicone implants came under scrutiny because of allegations that silicone gel had the potential to leak into the body and cause a host of health problems. One former silicone implant manufacturer, Dow Corning, announced in late August that it was prepared to pay $2.4 billion to settle breast implant lawsuits, with individual payments from up to $1,000 to $200,000–although the company’s president quoted research showing that implants “pose no substantially increased risk of disease.”
The FDA is careful to say that although manufacturers have not proved silicone implants are safe, that “did not necessarily mean that the implants were unsafe, but it did mean that FDA could not–as law requires–confirm their safety.”
One explanation for the rebounding confidence among women wanting to enlarge their breasts is that the FDA itself is more confident of the saline implants. This is true even though the FDA acknowledges risks such as deflation or rupture, tightening of scar tissue around the implant and increased difficulty in reading mammograms. The FDA is careful to say that breast implants are not “lifetime devices” and that some deflate in just a few months, while others are still in good condition after 10 years.
But the FDA also says this:
“FDA believes that saline implants present a lower degree of risk than gel-filled implants because leakage or rupture would release only salt water into the body.”
Iverson concurs.
“Those of us using saline for many years are not expecting the FDA to find any problems,” he says. “We expect they will stay available.”
