Silicone Implants

The days around a holiday are typically quiet in the offices of plastic surgeons. But a long-awaited decision to approve silicone breast implants for women older than 22 has prompted a flurry of excited calls and inquiries from prospective patients. The giddy welcome may not last. Even as the two U.S. manufacturers of silicone implants gleefully projected a surge in demand for their products, physicians began poring over the fine print of the Food and Drug Administration's recommendation and finding reasons for caution.

An article in yesterday's Sun should have stated that manufacturers of silicone breast implants have agreed to pay $4.3 billion into a settlement fund to compensate women claiming injuries.The Sun regrets the error.

WASHINGTON - Pamela Dowd drove her 20-year-old motor home 2,500 miles from Boise, Idaho, to tell a government panel how her silicone breast implants led to health problems that have sapped her vitality and made her medically uninsurable. Terry Heide took time off from her Pentagon job to urge just as forcefully that women be allowed to make their own decisions about the risks and benefits of silicone gel implants, which many believe have a more natural look and feel than the available saline-filled ones.

WASHINGTON -- When the Food and Drug Administration is deciding if a medical device is safe, should it be swayed more by scientific studies or anecdotal evidence? That's the issue confronting the FDA as it weighs whether to follow an advisory panel's advice and allow silicone breast implants to be reintroduced into the marketplace. This week, a special FDA advisory panel convened in Gaithersburg to consider if a new implant made by the California-based Inamed Corp. should be available to consumers.

A Pikesville doctor and her colleagues have developed a new breast implant that they say is safer than silicone implants and will make it easier for doctors conducting mammograms to detect breast cancer.The implant, patented by Dr. Judy Destouet and four colleagues, is filled with fats such as peanut, soybean or sunflower seed oils that, unlike other implants, are translucent and thus give doctors a clearer view of breast tissue.Dr. Destouet is hoping U.S. Food and Drug Administration approval by year's end will allow the implants to be tested on humans in five cities, including Baltimore, early next year.

Dow Corning Corp. and lawyers for women claiming injury from silicone breast implants agreed yesterday to a $3.2 billion settlement, a long-awaited step toward ending one of the most heated disputes in American corporate history.The agreement, which if accepted would end a nearly 10-year legal battle, would allow women seeking damages because of implants to receive money as early as next year.It would enable Dow Corning, a joint venture of Dow Chemical Co. and Corning Inc., to emerge from Chapter 11 bankruptcy, which Dow Corning entered for protection from as many as 19,000 implant-damage suits.

NEW YORK -- Millions of American women rely on the health information that appears each month in the women's magazines. I recently reviewed 24 articles in 13 of these magazines published between 1989 and 1995, looking for information about the safety of silicone breast implants. What I found was a frightening array of inaccuracies and disinformation.Most of the articles on silicone breast implants claimed that they are dangerous and cause a variety of health problems.A 1989 Vogue article cataloged the alleged effects of silicone implants on the immune system and connective tissue.

ANNAPOLIS -- A House committee yesterday approved a weakened version of a bill designed to limit silicone breast implants in Maryland.The Environmental Matters Committee voted 16-4 for a bill requiring physicians to comply with Food and Drug Administration requirements on silicone breast implants. Under the bill, a doctor who violates those requirements would be subject to disciplinary action in Maryland.Introduced by Del. Joan B. Pitkin, a Prince George's Democrat, the bill originally had called for a temporary statewide ban on the implants in the wake of concerns about their safety.

The Food and Drug Administration, which until now has taken a responsible role in the silicone breast implant debacle, seems to have knuckled under to corporate pressures. Last week, it took punitive action against a member of the advisory panel charged with deciding if silicone-gel implants are safe.Dr. Norman Anderson, a Baltimore physician, made the mistake of having an opinion on this issue. Worse, he has said he thinks the FDA should take breast implants off the market. That's not a shocking position since the safety of the implants has been in question for years.

Women with silicone gel breast implants still face agonizing questions after yesterday's recommendation by a federal panel to restrict use of the product for cosmetic reasons.After months of controversy over the safety of the implants and yesterday's compromise proposal by a Food and Drug Administration advisory group, what should they do?Many women have called their doctors or support groups for reassurance or advice. Others have called malpractice lawyers, some of whom are advertising heavily for clients in Baltimore and other cities.