Silicone Rally


Last week a panel of outside experts recommended that the government allow general use of silicone breast implants. Such a decision would reverse the restrictions put in place a decade ago because of the widespread reports of serious side effects. The panel found that the risks today are not so great as to merit keeping the implants off the market. The FDA often just rubber-stamps the decisions of its outside consultants.

Here is what’s wrong with silicone breast implants, according to Command Trust Network, an L.A.-based information clearinghouse begun by two women in 1988: “For women considering silicone breast implants, they should be aware that the substance is known to travel away from the breast. Silicone has been removed from joints and internal organs such as the uteruses, livers, and spleens of women with the implants. Silicone has also been found in the lymph nodes of implanted women. A 2001 FDA study also found that women with silicone implants were almost three times more likely to report that they had a syndrome known as fibromyalgia, which the FDA describes as a syndrome characterized by widespread pain, fatigue, and sleep disturbance. The makers of breast implants report that within the first three years of getting saline implants, 27 percent of reconstruction patients and approximately 10 percent of augmentation patients needed to have their implants removed.”

NOW president Kim Gandy makes the additional point that “the FDA is examining less than three years of clinical trial data, yet the FDA’s own researchers have previously noted in published studies that problems with breast implants dramatically increase at, on average, seven to 10 years post-implantation.” Gandy points out that Inamed Corp., despite its application to restore silicone breast implants to the general market, has on file with the U.S. Patent Office documents stating that silicone gel is not “biocompatible” with human tissue. And Cynthia Pearson, executive director of the Women’s Health Network in Washington, says it is “essentially the same product that the manufacturer tried to get approved in 1992.”

In November 2001, the European Union set up safety procedures governing breast implants. Among them was a regimen of counseling before surgery, in which the pros and cons were spelled out for women considering the operation. The women then were given a cooling-off period to think things over. A detailed monitoring and surveillance registry was established, age limits were set, and standards were created for implant products.

An independent consideration of what the procedure entails is precisely what the American College of Surgeons doesn’t think is necessary. In a statement three years ago, the college declared, “Before any operation, patients are asked by their surgeon to indicate whether they understand the nature of the procedure to be performed, and they must give their permission for the operation to continue. . . . In addition to the time spent discussing their options, anticipated experiences, and expectations prior to the operation, patients who plan to undergo breast implant procedures are provided with the breast implant package insert.. . . The College agrees that it is vital for any woman considering a breast implant procedure to be well informed of all possible risks associated with the procedure, as well as with the device being used. But the key portion of this information exchange must take place in the surgeon’s ‘office’ not at home, possibly alone, with a pamphlet or videotape. . . . Women must be informed, for example, that breast implants do not last forever and that certain complications and perhaps additional operations, possibly years later, may occur.” As for a waiting period, the college said the scheduling of an operating room fills the bill, creating a “de facto waiting period,” and adds, “It is hard to fathom what would actually be accomplished by devising and imposing an arbitrary waiting period, and who would benefit from it.”

In the view of some surgeons, the main reason for getting a silicone breast implant has less to do with health than with a woman’s well-being. “Plastic surgeons have seen firsthand how a woman’s ‘quality of life’ can be tremendously improved by this procedure,” says Dr. C. Lin Puckett, president of the American Society for Plastic Surgery. “Every plastic surgeon can provide numerous stories about women whose self-confidence flourished after augmentation mammaplasty.”

Additional reporting: Ashley Glacel

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