Breast Implants: The Controversy Continues By Sean Swint WebMD Medical News Saline Not Without Risk; Silicone Still Needed March 1, 2000 (Atlanta) -- Breast implants have been cloaked in controversy, fear, and expectation for many years. FDA hearings this week on the safety of saline-filled implants may calm some of the fears and affect the expectations of many, but it's doubtful whether it will lay the controversy to rest. Saline implants, like their more controversial cousin, the silicone-filled implants, have been around for a quarter of a century. But the FDA did not have the authority to regulate medical devices until 1976, so implants were used unapproved for years, and in fact still will be until the FDA makes its official decision on the saline-filled devices this spring. The FDA did suspend silicone-filled implants for almost all uses in 1992 because of insufficient evidence about their safety after widespread claims of adverse reactions to the implants were reported. Many women claimed the silicone implants led to conditions like lupus, rheumatoid arthritis, body aches and fatigue, and other unexplained illnesses. Thousands of the women sued implant manufacturers, leading Dow Corning to settle for $3.2 billion, and other manufacturers to combine in a $3 billion settlement. That was not the end of it, though. Last year, an independent panel convened by the Institute of Medicine (IOM) at the request of Congress concluded that silicone breast implants do not cause cancer or other illnesses such as those previously mentioned. At the time, Marcia Angell, MD, executive editor of The New England Journal of Medicine, told WebMD she thought it was an "excellent report. I'm not surprised by the substance of it. It's been known for a long time that there was no evidence that silicone breast implants cause disease in the rest of the body." An advocate of the ban also told WebMD at the time the lack of evidence is exactly why she found the IOM report inconclusive. "Many of the studies have been funded by Dow or by plastic surgeons, and so, not surprisingly, they are designed in a way that tends to show there are no problems," says Diana Zuckerman, PhD, executive director of the National Center for Policy Research for Women and Families. Zuckerman adds that, based on what's known so far, she still couldn't say whether breast implants are harmful. The majority of the controversy over implants has surrounded those filled with silicone. But both saline and silicone-filled implants have a silicone shell. The theory goes that if the saline implants leak, deflate, or rupture, which they often do, they would release only salt water and not silicone into the body. Thus, saline-filled implants were allowed by the FDA to remain, on the condition that the manufacturers prove their safety at some point in the future. That point comes now with the advisory committee meetings this week. No matter what's in the shell, it's undisputed that implants can pose risks for the woman in the vicinity of the implant. In a previous interview with WebMD, Leroy Young, MD, a professor of surgery at Washington University in St. Louis, spoke about the likelihood that implants will eventually rupture. "I tell most of my patients that their implants probably will have to be replaced over the next 10 years," he says. That brings up additional risks that always accompany surgery, such as anesthesia complications, infection, abnormal bleeding, or clotting, whether for the first surgery or a follow-up operation. According to the FDA, implants of all types can also cause what's called "capsular contracture," which is the hardening of the breast due to scar tissue around the implant. The result can be temporary or permanent change or loss of sensation in the nipple or breast tissue, formation of calcium deposits in surrounding tissue, shifting of the implants, or interference with mammograms. So whatever the FDA decides about saline implants, an element of risk will always be associated with them. In a letter the agency sent to the chairman of the Commerce Committee, which oversees the FDA, a 1997 study in The New England Journal of Medicine was cited that found infections occurred in 2.5% of women undergoing implants. "Other local complications include rupture, pain, ... and disfigurement, all of which may lead to medical interventions and repeat surgeries," the letter stated. And don't expect silicone-filled implants to fall off the front page. Many women reportedly say they're more satisfied with them than the saline devices. And in that same letter citing implant complications, the FDA stated there's a need for silicone gel-filled implants, at least for reconstruction following breast cancer surgery. "Saline-filled breast implants and new breast surgical techniques are not adequate for all women," the letter stated. "There continues to be a public health need for silicone gel-filled breast implants." © 2000 Healtheon/WebMD. All rights reserved.