Fw: Renewed surge in popularity

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----- Original Message ----- From: Myrl Jeffcoat

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Sent: Saturday, September 28, 2002 6:56 AM

Subject: Renewed surge in popularity

Thank you for sending us the following. . .Myrl

Subject: Renewed surge in popularity

Renewed surge in popularity of breast implants Questions remain about safety -- women seem undeterred Marc Kaufman, Washington Post

Sunday, September 22, 2002

had been "very, very conscious" of her bust size for years, and this summer, the 24-year-old decided to do something about it. It cost her $6,000 and a few days of pain and swelling, but the woman who was a 32A is now a 34C, thanks to her new breast implants. "I just love how it looks, and my boyfriend really does, too," said , a sales clerk from Frederick, Md. "My mom said that if she was my age again, she'd do it, too." The number of women electing to have their breasts enlarged through implant surgery is increasing rapidly. A record 206,000 American women chose to undergo breast augmentation last year, and the industry projects an almost 10 percent increase this year. That is twice the number of women who were getting cosmetic breast implants a decade ago, before the Food and Drug Administration strictly limited use of the most popular type of implant -- the kind filled with silicone gel -- after reports that it might cause debilitating illnesses. At first slowly, and now quite eagerly, many American women have turned to the saltwater-filled alternative to silicone implants. The two breast implant manufacturers in the United States recently reported record sales and profits for their spring quarters, and plastic surgeons say the operation has reached a level of social acceptance unimaginable not many years ago. And not only are more women choosing implants, but they are choosing ever-larger models -- from an average of 250 cubic centimeters in the 1980s to about 350 cubic centimeters today. Even concerns about silicone implants eased significantly following later studies, and manufacturers are expected to ask the FDA later this year to approve them for general use once more. But some public health advocates and physicians remain alarmed about implants of all types -- especially now, with their resurgent popularity. Additional research, they say, has confirmed that planting a device in a woman's breast can cause serious, predictable and often costly complications, and they say the FDA is not providing American women the information and protection they need. The most recent data presented to the FDA showed, for instance, that almost one-quarter of all cosmetic saline, or saltwater-filled, breast implants will need to be followed by another operation within five years, and that few implants can be expected to last more than 10 years. Studies have also found significant levels of internal infection, hardening of the tissue around the implanted device and implant leakage and deflation. "This is a cosmetic operation with serious health consequences, and the FDA is just not treating it with the seriousness it requires," said Zuckerman, president of the National Center for Policy Research for Women and Families and a longtime critic of the breast implant industry. "The benefits are so small compared to the very real risks, so it should be getting more scrutiny, not less." FDA officials say the agency has spent years reviewing breast implants and allows them on the market because they meet the standards for safety and effectiveness. They also say it is important that implants are available to women who have lost breasts to cancer; they accounted for an additional 80,000 implants last year. The boom of cosmetic breast implants is occurring with questions remaining about the largest implant manufacturer, Mentor Corp. of Santa Barbara. A long- standing criminal investigation has focused on Mentor's research procedures and allegations of document destruction and faulty manufacturing. In addition, at an FDA hearing in July, the company was sharply criticized by experts for the small number of women it was able to contact for an FDA-required follow-up study. The potential problems at Mentor are receiving renewed attention because a former compliance officer with the FDA has gone public with what he says were his long-term efforts to push the agency to redress problems at the company. Austin Templer, who was the FDA official in charge of overseeing Mentor in the mid- and late-1990s, has said that the company was in violation of good manufacturing and record-keeping rules, and that the FDA has not been sufficiently aggressive in its oversight. Templer quit the agency in protest in 2000. "I was very concerned about the products that Mentor was putting out," Templer said in a deposition last month. "And I felt that the agency had just not done a good job with handling it." The FDA has declined to comment on Templer's charges. Mentor said in a recent filing that it had no contact with federal investigators since early 2001 and that its research and manufacturing are regularly reviewed and approved by the FDA. The new acceptance of breast implants is remarkable, given the nation's response a decade ago to reports of problems with silicone breast implants. Research linking silicone with a class of often-debilitating illnesses known as connective-tissue disease caused a sensation then, and led to class- action lawsuits and big (although still unresolved) cash settlements. Silicone gel implants were limited to women who needed breast reconstruction after surgery or who would take part in FDA-reviewed clinical studies.