Silicone Implants

The space sure looked like a science lab, with beakers full of brightly-hued potions and a dry-erase board covered in graphs and mathematical scrawl. But at the heart of the operation sits a hunk of metal with a hand crank on the side. "It's a pasta maker," said Barry Margulies, a biology professor who presides over the Towson University lab. No joke. When it occurred to Margulies' graduate researcher that Williams Sonoma might have the answer to their prayers, it was a major breakthrough for the lab's efforts to treat one of America's most prevalent sexually transmitted diseases.

The space sure looked like a science lab, with beakers full of brightly-hued potions and a dry-erase board covered in graphs and mathematical scrawl. But at the heart of the operation sits a hunk of metal with a hand crank on the side. "It's a pasta maker," said Barry Margulies, a biology professor who presides over the Towson University lab. No joke. When it occurred to Margulies' graduate researcher that Williams Sonoma might have the answer to their prayers, it was a major breakthrough for the lab's efforts to treat one of America's most prevalent sexually transmitted diseases.

Dr. David Kessler, commissioner of the Food and Drug Administration, made a reasoned move when he asked for a moratorium on silicone breast implant surgery. It has been a decade since the FDA first expressed skepticism about the safety of these implants, but nothing substantive has been done.Though the FDA recognized silicone implants as possible health risks in 1981, the government was gripped for a decade by a fervent commitment to deregulation, and the agency, under Reagan-appointee Frank Young -- dragged its feet.

CHICAGO -- When the panic about silicone breast implants erupted back in 1991, it was big news. But when the last chapter of that saga was closed a couple of weeks ago, hardly anyone noticed. Government regulators and journalists often find it tempting to set off loud, clanging alarms. They don't find it nearly so enjoyable to publicize when the alarms turn out to be false. Last month, the Food and Drug Administration decided that the medical evidence was sufficiently positive to let these devices back on the market.

GAITHERSBURG - A Food and Drug Administration advisory panel recommended yesterday against allowing silicone breast implants back on the market, citing concerns about possible health effects and design problems that cause some to break prematurely. The vote to disapprove the application by Inamed Corp. of Santa Barbara, Calif., to market the devices was 5-4. "I don't feel secure about safety," said Dr. Amy E. Newberger, a Scarsdale, N.Y., dermatologist who offered the motion to disapprove the device.

WASHINGTON - Silicone implants for cosmetic breast enhancement moved a step closer to approval yesterday as federal regulators laid out conditions for a manufacturer to begin marketing them. The FDA said it spelled out the conditions in a letter to Mentor Corp., one of two Santa Barbara, Calif.-based companies seeking approval for implants. The letter and the conditions are considered confidential business information and were not released. Silicone gel implants are regarded as having a more natural look and feel than saline-filled ones, but concerns remain about ill effects should they rupture or leak.

For more than a decade, silicone breast implants have been banned in the United States, pulled from the market amid claims that they made women ill. By the mid-1990s, the devices had become a symbol of what many regarded as corporate America's indifference to women's health, with one company, Dow Corning, eventually filing for bankruptcy protection. Now, silicone implants are poised for a comeback. With no fanfare, longtime implant maker Inamed Inc. has taken the first step toward returning the gel-filled devices to the marketplace.

I AM THE proud and happy owner of two very nice, soft, untroublesome saline-filled breast implants that were inserted in front of my chest wall a few years ago after my second mastectomy.Sadly, many women think the implant choice is between silicone or nothing, when they have a perfectly good alternative in saline.I know something about how women feel about losing a breast. I know that some women, hearing of the dangers of silicone implants and not being aware of a good alternative, will avoid mammography, self-examinations, visits to their physicians -- actions that could save their lives.

Boston. -- It is a story that might have sprung full- blown from the deep well of conspiracy fantasies. All the princes of darkness were there at the beginning of the Saga of Silicone. Racism. Sexism. Imperialism. Even the Military-Industrial Complex.Silicone made its entry into the female body almost 50 years ago, because Japanese women were trying to attract American soldiers. The conquerors liked bigger breasts and so industrial strength transformer coolant was injected directly into these women.

NORFOLK, Va. -- Once again, the ''people's law'' and science have collided in a courtroom. Science and reason are the worse for it. Last month, a jury in Reno, Nevada, ordered Dow Chemical Co. to pay $13.9 million to a woman who claimed her chronic physical maladies -- unspecified fatigue, muscle pain, nerve disorders -- were caused by silicone-gel breast implants that had ruptured.Current medical opinion, based in part on studies by the Mayo Clinic and the Harvard Nurses' Health Study, does not support an association between silicone implants and connective-tissue diseases (lupus, rheumatoid arthritis, scleroderma)

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.

WASHINGTON -- Federal regulators lifted their 14-year ban on breast implants made from silicone gel yesterday, dismissing concerns about harmful effects from leaks as unsupported by extensive testing. Officials at the Food and Drug Administration urged women who get the implants to undergo regular screenings to detect ruptures, and said to expect at least one surgery to remove or replace them. The agency is requiring the two California companies that make the devices, Mentor Corp. of Santa Barbara and Allergan Inc. of Irvine, to continue studying the implants' long-term health effects.

WASHINGTON - Thirteen years after they were banned because of health concerns, silicone gel breast implants are heading for a comeback - but opposition is also returning, and federal regulators are at the center of the re-emerging controversy. With momentum building for final approval of the implants, perhaps by year's end, critics called on the Food and Drug Administration yesterday to hold off until completion of further study on the long-term health effects and of a recently launched Senate investigation into the agency's decision-making.

WASHINGTON - Silicone implants for cosmetic breast enhancement moved a step closer to approval yesterday as federal regulators laid out conditions for a manufacturer to begin marketing them. The FDA said it spelled out the conditions in a letter to Mentor Corp., one of two Santa Barbara, Calif.-based companies seeking approval for implants. The letter and the conditions are considered confidential business information and were not released. Silicone gel implants are regarded as having a more natural look and feel than saline-filled ones, but concerns remain about ill effects should they rupture or leak.

Henry Corden, 85, the voice of cartoon caveman Fred Flintstone for more than two decades, died of emphysema Thursday night at a hospital in Encino, Calif. He took over as the lovable loudmouth Fred Flintstone when original voice Alan Reed died in 1977. Mr. Reed had been doing Flintstone since the character first appeared in 1960. "While he may be best remembered for being the voice of Fred Flintstone the last 25 years, Henry was a part of the Hanna-Barbera family for more than four decades, lending his voice and his inimitable talent to countless characters from series like Jonny Quest and The Jetsons to Scooby-Doo and The Smurfs," 94-year-old animation legend Joseph Barbera said in a statement.

BOSTON - This has got to break the record for the fastest transition from science to sitcom. The hearings on silicone implants for cosmetic surgery closed with a split decision Wednesday. An advisory panel rejected one brand, approved another and dropped the whole issue into the lap of the Food and Drug Administration. For three days, dozens of women had testified that silicone implants had either ruined their lives or restored their self-worth. At one point, a woman with implants nearly got into a fight with a group of women wearing T-shirts that read: "100 Percent Natural."

Researchers investigating one of the health claims against silicone breast implants said they have failed to find any link between the devices and scleroderma, a disease of the skin and internal organs."

WASHINGTON - A day after rejecting another company's proposal, a Food and Drug Administration advisory panel recommended yesterday that silicone breast implants made by Mentor Corp. be approved - with conditions - for women having cosmetic surgery. The 7-2 vote came with nine stipulations attached, including continuing safety monitoring studies, follow-up care of patients, special training for surgeons and voluntary tracking of every woman with implants. But the expert advisers gave a mixed message to the FDA regulators, who must make the final decision on marketing the implants, because the same panel had voted 5-4 on Tuesday to recommend disapproval of silicone implants made by Inamed Corp.

GAITHERSBURG - A Food and Drug Administration advisory panel recommended yesterday against allowing silicone breast implants back on the market, citing concerns about possible health effects and design problems that cause some to break prematurely. The vote to disapprove the application by Inamed Corp. of Santa Barbara, Calif., to market the devices was 5-4. "I don't feel secure about safety," said Dr. Amy E. Newberger, a Scarsdale, N.Y., dermatologist who offered the motion to disapprove the device.