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Medical experts assess the impact of new breast implant legislation on women. 10.16.03

One study says silicone breast implants do not cause systemic illness. 12.02.98

The legal debate over breast implants. 10.01.96

An update on the lawsuits filed against breast implant manufacturers. 5.30.96

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After 11 years, silicone breast implants might soon be back on the market despite opposition from women's groups, concerned parents, doctors and others who believe the implants have serious side effects and cause some diseases.

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The issue has sparked heated debates about medical ethics, acceptable risks and the cultural forces that influence how women view their own bodies.

This month an expert panel set up by the Food and Drug Administration (FDA) listened to testimony over two days from a variety of people both for and against the implants' sale. The panel, made up of plastic surgeons and other medical specialists, then voted 9-to-6 to recommend that silicone breast implants be allowed back on the market after an 11-year ban.

The most widely available breast implants in the United States are currently made of a silicone envelope filled with saline, or salt water, instead of silicone, which is a gel-like substance.

In its recommendation the panel said that certain conditions must be met including the reeducation of doctors and patients and the monitoring of women who receive silicone implants. The monitoring would have to be overseen by an outside group and any research conducted on the safety of the devices would have to continue for as long as ten years.

The public hearings were held after a California company that makes silicone and saline implants, Inamed Corp., petitioned the FDA for the right to sell them again in the United States. Inamed claims that the silicone medical devices are safer than saline implants and that research has shown that the silicone implants do not cause systemic diseases, like cancer or lupus -- a disease that effects the immune system, as some critics claim.

Though not bound by the panel's recommendation, the FDA usually takes their advisory panels' advice. Yet due to the divided outcome of the panel's vote, FDA officials said the decision would be more difficult than usual. According to agency spokeswoman Kathleen Quinn the FDA would decide in "weeks to months," without a specific timeline.

Silicone implants were banned for general use in the United States in 1992 after thousands of women reported serious side effects from leaking silicone including brain, nervous system and connective tissue disorders such as arthritis or lupus. Only women who have undergone mastectomies -- the removal of the breast due to diseases such as cancer -- or take part in clinical studies can use silicone implants. Saline implants are the alternative. Some users claim that the saline devices are not as natural in appearance and texture.

Several studies since then could not find a definitive connection between the implants and disease, including a large review of many studies by the Institute of Medicine in 1999. But critics say that the studies were too small and too short to rule out any connection.

More controversial are the results of an Inamed study of 900 women with new implants that show that although more than 90 percent of the women were satisfied, between 20 and 40 percent required more operations to deal with side effects like severe pain and scarring within three years.

The modern history of breast implants began in 1962 with the introduction of silicone breast implants. They were more realistic than previous attempts to augment, or make the breast larger, which included inserting foam and other materials directly into the breast.

In recent years breast enlargement has become increasingly popular. Though some women get the surgery for medical reasons -- 73,026 in 2002 -- many more have the procedure for cosmetic reasons. According to the American Society of Plastic Surgeons, 32,607 women had breast augmentation in 1992. That number grew to 225,818 in 2002, an increase of 593 percent.

This dramatic increase has some worried that cultural norms devalue girls and women and encourage healthy women to believe that they should enlarge their breasts.

"We are hammering our children with the notion that how they look is more important than who they are and what they can do. And that is just wrong," said Joseph Kelly, president of Dads and Daughters, a national nonprofit organization.

Others believe that women should have the freedom to make informed choices about breast enlargement without the government's regulation.

"Men have the right to choose Viagra even if they have a risk of heart disease. Women have the right to make a choice like that, too, with silicone implants," said Caroline Glickman, a plastic surgeon at Memorial Sloan-Kettering Cancer Center in New York.

-- Annie Schleicher, Online NewsHour

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