Saline and silicone implants have been on the market since the '60s, but their safety was never aggressively challenged until 1992. It was at that time that then head of the FDA, David Kessler, pulled the silicone devices from the market because many women complained that the implants were the cause of a variety of ailments. These complaints led to a lawsuit against manufacturer Dow Corning with a $4 billion settlement.

Amazingly, even while the lawsuit was going on, studies showed no strong connection between implants and the autoimmune disorders the women were suing over. Just last year the Institute of Medicine concluded that silicone implants pose no increased risk of diseases such as cancer or lupus. Still, silicone implants are banned in the United States (except under a few special circumstances), and saline implants remain the only widely available device today.

The less natural looking of the two, saline implants are wildly popular in the United States even though they are not inexpensive (in the range of $5,000 for the surgery) or free from complications. The FDA reviewed safety data about saline devices this year and heard that many of the women who undergo the augmentation surgery will have problems associated with the implants at some point. These problems range from complications at the time of the surgery (bleeding or infection) to rupture of the device and hardening of the breast tissue. Implants may also shift, cause a loss of sensation in the nipple or breast, and interfere with a woman's ability to breastfeed, though data on these complications is lacking.

James L. Baker Jr., M.D., a Winter Park, Florida, plastic surgeon and clinical professor at the University of Florida, Tampa, says that the risks are relatively minimal. Like all procedures, this surgery also carries some, which is why you need to go to an experienced surgeon at a certified facility. He says that about a quarter of the implant patients will develop some firmness in the breast, when the tissue capsule that forms around the implant harden. Only about 4 percent of those patients will have serious discomfort and seek additional surgery. Baker says that there is normal wear and tear on the saline implant's silicone shell, increasing the risk of leakage. "If you live long enough you might have to have another implant," he says. When a saline implant ruptures, you have a "flat tire," so it is easy to detect and repair with little downtime.

For most women, the benefits far outweigh the risks. Rhonda Dillinger (a pseudonym) a 44-year-old mother of two from Philadelphia sought the surgery five weeks ago. At five feet five inches and 140 pounds, she felt that her body was unbalanced with her natural A-cup breasts. Her doctor warned her of the risks, and while nothing prepared her for the pain she experienced after the surgery, she was aware of the potential long-term problems. "The key is an informed patient," says Baker. "There should a uniform consent and evaluation process for each patient." Dillinger has no regrets and is thrilled with her new C-cups. "I feel sexier and more feminine," she says.

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