Jennifer Moore 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 Moore, 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 Diana 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. James 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.
The federal government will receive a $9.8 million settlement from the bankrupt Dow Corning Co. to compensate for government costs in treating injuries and disease from silicone-gel breast implants.
U.S. District Judge Denise Page Hood in Michigan approved the settlement Thursday, a step that participants say will help resolve the long-delayed effort to compensate women with defective or harmful silicone implants.
The federal government sought reimbursement on behalf of the departments of Defense, Veterans Affairs and Health and Human Services; the Indian Health Service; and the Centers for Medicare and Medicaid Services.
"We think this is progress, and will take us closer to providing relief to suffering women," said Sybil Niden Goldrich of the Command Trust Network, a group for women with breast implants. She is also a member of the Dow bankruptcy committee.
"Many women were afraid that they would have to fight the government if they took their money from the settlement, but now that concern is gone," she said.
The agreement prevents the government from seeking additional compensation for implant claims from Dow Corning or from others who had Dow Corning breast implants except in instances of criminal or fraudulent activity. Dow agreed to pay women with implants $3.2 billion in 1999, but that money has not yet been distributed.
The settlement quickly became part of the acrimonious national debate about breast implants. Silicone implants have been available under limited circumstances since 1992 because of concerns they could cause serious illness.
But more recent studies have cast doubt on the health concerns, and several manufacturers have said they plan to apply to the Food and Drug Administration for approval to sell them soon. Critics of the implants said the government's efforts to be compensated in the Dow case show that it believes silicone implants are dangerous.
"This is a classic case of the government's left hand not knowing what the right hand is doing," said Rep. Gene Green (D-Tex.), who has sponsored legislation to increase research into the health effects of implants. "At the same time the DOJ [Department of Justice] is suing breast-implant manufacturers due to their safety concerns, the FDA is considering loosening restrictions on their sale."
Dow Corning sought bankruptcy protection in 1995 after thousands of implant recipients sued. Dow Corning spokesman Kevin Wiggins said yesterday the company views the settlement as a fair resolution to the government's effort to seek reimbursement.
More than a quarter of women who receive saline implants to increase the size of their breasts will undergo another breast operation within five years, according to studies presented yesterday at a Food and Drug Administration advisory committee hearing.
While the most common reason for the additional operations is to select a breast of a different size or shape, two-thirds of the women needed more surgery to correct problems ranging from leakage and wrinkling to deflation of the implanted device and tightening of the scar tissue around the implant.
The new information was presented by the two companies approved to manufacture saline breast implants, Mentor Corp. and Inamed. The FDA required the follow-up studies after approving the implants in 2000, despite protests from critics who said there was not enough information to prove they were safe.
Although the FDA panel of experts was not asked to make recommendations to the agency, as advisory committees usually are, some members expressed serious concerns about both the results presented and the nature of the studies.
Amy E. Newburger of the White Plains Hospital Center in New York criticized Mentor in particular for its "mind-boggling poor results" and "high rates of product failure," and Michael Choti of the Johns Hopkins School of Medicine called the company's data "astoundingly weak."
Public speakers also criticized Mentor for past manufacturing practices, and the FDA informed Rep. Roy Blunt (R-Mo.) this month that a long-standing criminal investigation of the company "is still ongoing." The agency did not comment on the focus of the investigation.
The FDA panel was considerably more positive about the Inamed studies, which had been able to track 80 percent of the patients enrolled in an earlier study. Mentor had been able to track about 50 percent from its previous studies.
The panel members voiced generally strong support for keeping breast implants available, saying women should have the right to choose the operation. But they also said they did not think women are well informed about the risks of the procedure and the chances that they will need further surgery to repair and maintain implants.
The issue of breast implants has been contentious for years. The FDA banned silicone gel implants in the early 1990s because of health concerns, but it came under strong criticism from breast cancer patients and others for that decision.
Silicone implants are still allowed only under limited conditions, but saline implants were never removed from the market and have become popular, especially since the FDA gave them its retroactive approval in 2000. The agency has said it will consider new applications to approve silicone gel implants.
Women with ruptured silicone gel breast implants may be at increased risk of the painful condition fibromyalgia, according to the first study of women whose implants were known to have burst.
The study, conducted by researchers from the Food and Drug Administration and the National Institutes of Health, found that when silicone gel spreads outside the border of scar tissue around the breast area, reports of fibromyalgia increased significantly.
"We found an association between fibromyalgia reports and women who had silicone gel found outside the breast capsule," said Lori Brown, a senior researcher with the FDA's Center for Medical Devices and Radiological Health. "This doesn't mean there is a cause and effect relationship between the two, but that there might be."
Her paper, published in the Journal of Rheumatology, concludes by saying that if the findings are confirmed in later studies, a screening of all women with silicone implants should be considered to determine if their devices had ruptured.
The finding is the latest in a long scientific debate over the safety of silicone gel and saline breast implants. The FDA took silicone gel implants off the market in the early 1990s because of concerns they might cause health problems. But they were returned to the market for medical uses -- mostly for reconstruction after breast cancer surgery -- after researchers concluded they were safe.
Two implant companies have announced they hope to resume use of silicone gel implants for cosmetic surgery, and are working with the FDA to demonstrate their safety. An official of McGhan Medical of Santa Barbara said his company already has one large study underway and is now working with the FDA to design a second for an improved silicone gel now widely used in Europe.
The new study included 344 women from Birmingham who had undergone cosmetic breast augmentation before 1988. The women had their breasts examined with magnetic resonance imaging (MRI) to determine whether the implants had ruptured and whether the gel had spread beyond the breast area. The study found that about two-thirds of the implants had some rupture and that gel had spread in about one-quarter of the women. (Some companies, such as McGhan, had much better records on ruptures.)
While the study found a significant association between that spread and reports of fibromyalgia, it showed no increase in risk for other major connective tissue diseases. Fibromyalgia is a syndrome with no clear biological cause that results in generalized pain and tenderness, sleep disturbance and complaints of mental loss.
Diana Zuckerman, director of the National Center for Policy Research for Women and Families, a Washington-based nonprofit group, said the new study was important because it was the first to focus on women with ruptured implants.
"There is every reason logically to think these women might have different experiences, but there has been an obvious lack of research," she said. "People concerned about breast implants have long said the women with ruptured implants are the ones showing up very sick."
Another recent study of breast implants conducted by the National Cancer Institute found that although women were not at increased risk for most cancers, they appear to suffer from brain and lung cancer at a higher rate than other women who undergo plastic surgery.
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