Silicone vs. Saline
Meanwhile, saline-filled breast implants are already approved for use in breast augmentation and reconstruction surgery. These implants contain a saltwater saline solution similar to that used in IV fluids.
Although saline implants are also likely to leak or rupture over time, research shows that the risks posed by leakage are less serious because the body readily absorbs the saline solution.
But some plastic surgeons say many women would still prefer a choice.
James Wells, MD, president of the American Academy of Plastic Surgeons, says that in other areas of the world where the use of silicone implants is not restricted, about 90% of women select silicone gel breast implants over saline for aesthetic reasons.
"The gel is more natural in terms of the consistency of the breast," says Wells, "and the saline is a little bit more like a water balloon."
Booming Market for Breast Implants
Despite the uncertainty about breast implants, the demand for them is clearly increasing.
According to the American Society of Plastic Surgeons, more than 225,000 women received breast implants for cosmetic reasons in 2002, a 593% increase since 1992. Breast augmentation was also among the top 5 cosmetic plastic surgery procedures in 2002.
Wells says that most women are satisfied with the results of their breast implant surgery and are informed about the potential risks before undergoing the procedure.
"Silicone has been around 30 years so the chemistry and safety of silicone is pretty well acknowledged," Wells tells WebMD. "What you're really looking at are local mechanical problems of the device, which like any man-made device will eventually wear out and have to be replaced."
But Zuckerkman says that if the FDA approves products such as silicone breast implants that have such a high complication rate, the manufacturers will have no incentive to improve the safety of the devices.
The panel will also hear public comment on the issue during its meeting this week before making its recommendation to the agency. The FDA is not required to follow the panel's recommendation, but it usually does.