On one hand, Medicare is seeking reimbursement by implant makers for tens, perhaps hundreds of millions of dollars it has paid out to treat injuries the agency says were caused by the products. That effort took a big step forward two weeks ago when a federal appeals court in Atlanta, reversing a lower court, said the government?s suit against Bristol Myers Squibb, Baxter International, 3M, Union Carbide and Union Carbide Chemical and Plastics, could proceed.
On the other hand, the Food and Drug Administration—like Medicare, a part of Health and Human Services—which restricted the use of silicone implants in 1992 because of health concerns, may be poised to reverse course. On October 14 and 15, an FDA advisory panel will meet to consider recommending that silicone implant manufacturer Inamed Corp., located in Santa Barbara, California, be allowed to market its product. This week, opponents of any change in the FDA's stance are beginning a print and broadcast ad campaign depicting a woman's breast with an implant as a ticking time bomb.
The problem, says the National Organization for Women and other groups protesting the FDA's step, is that the agency is considering just two years of safety data submitted by Inamed. Many of the injuries don't appear until at least 5 years post-implant. Studies and experience show that most of the devices eventually rupture, and can cause infection, interfere with mammogram readings and trigger a painful shrinkage of scar tissue around them.
What about longer-term effects when the silicone migrates beyond its capsule? No scientific studies have proven a connection between the implants and diseases like rheumatoid arthritis and lupus, but critics complain that the research hasn't been adequate, or over a long enough time period. Government-funded studies on immune responses following silicone implant leakage or rupture is ongoing, and many women swear there's a cause-and-effect relationship. Mary McDonough, who underwent breast augmentation to help her transition from being a young star of "The Waltons" to other film and television work, became progressively sicker with lupus-like symptoms after she'd had her implants for about five years, she says. "I immediately began to feel better after I got them out," she says. McDonough, now a filmmaker, will speak at the FDA meeting and also shoot it for a project she's working on about implants.
"Over time, all implants will fail, and women must be prepared to replace them every 10 years or so," said Dallas plastic surgeon Edward Melmed, who used to put in breast implants but now removes them.
Even though silicone versions haven?t been widely available in the U.S. since 1992, saline implants have been used extensively and the market is booming: about 240,000 women had implants last year to enlarge their breasts, a sixfold increase over 1992. That?s in spite of the fact that women must be told before getting them that saline implants can rupture and deflate suddenly, requiring immediate surgery. When the FDA conducted its first safety review of saline implants in 2000, it ruled they could continue to be marketed "despite relatively high complications and failure rates."
But women who want implants, as well as most plastic surgeons, tend to prefer the more natural look and feel of silicone. They are immensely popular in Europe, points out Inamed executive JoAnn Kuhne. Which is only one reason why it may be an uphill climb for opponents: The FDA says that contrary to popular belief, its approval of a medical device is a risk-benefit analysis to determine whether it?s reasonable to let consumers make their own decisions— not a certification that it is absolutely safe.
Back at the Justice Department, which is suing implant makers on behalf of Medicare, a spokesman says the government is pleased the lawsuit can go forward. If it succeeds, it won't be the first time the feds have recovered funds to cover the cost of treating implant injuries. A year ago, several agenceis were awarded $10 million as part of the Dow Corning bankruptcy settlement— and also received $100,000 from Inamed, the same company that is the subject of the October FDA meeting. An FDA spokeswoman had no comment on the Medicare lawsuits.