Category Archives: We Are Quoted

Implants, Mastectomies Linked to Problems

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Lindsey Tanner, Associated Press: December 5, 2005.

Breast implants in women who have undergone mastectomies often result in complications that require more surgery, a study in Denmark found.

Over a period of up to four years, about one-third developed at least one potentially serious complication, including thick, tight scarring and infections, the researchers reported. Implant ruptures were rare, with only five reported among the 574 Danish women studied.

Overall, about 20 percent of the women studied required surgery to treat the problems, according to the study by Danish Cancer Society researchers and scientists at the International Epidemiology Institute in Rockville, Md.

One surgeon said in an accompanying editorial that the numbers are “alarmingly high and arguably unacceptable.”

The study appears in the December issue of Archives of Surgery. It was paid for by the institute, which receives funding from the Dow Corning Corp., a former maker of silicone breast implants.

Diana Zuckerman, president of the National Research Center for Women and Families, said the complication rate for implants in mastectomy patients is actually much higher than the study suggests.

Most participants got implants several weeks after breast removal surgery, whereas most U.S. mastectomy patients who choose implants get them when their breasts are removed, Zuckerman said. That method, involving a single round of surgery, is often easier psychologically because women wake up from their mastectomies with refashioned breasts, but it is also more stressful on the body, she said.

Also, she said the participants in the study did not undergo MRI scans, which are the best way to detect ruptures.

“This study is really missing the boat,” said Zuckerman, whose group has opposed efforts to return silicone implants to the market.

All of the women studied got implants, most of them made of silicone.

Silicone implants have been restricted in the United States for over a decade because of fears that ruptures and leakage might damage women’s health. But some mastectomy patients have continued to receive them.

The American Cancer Society estimates more than 200,000 U.S. women will be diagnosed with breast cancer this year. At least half will have mastectomies, and Zuckerman said about two-thirds of those patients choose some type of reconstructive surgery. […]

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Silicone Implants Backed by FDA Panel

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Marc Kaufman, Washington Post: April 14, 2005.

A Food and Drug Administration advisory panel recommended yesterday that silicone gel breast implants made by Mentor Corp. be allowed back on the market for wider use — a surprise decision that came a day after the same panel rejected the application of a rival company.

Mentor officials were delighted by the panel vote.

In explaining their decision, several panel members said they were more impressed by Mentor’s data on how and why implants rupture and by the lower rupture rate of its implants. While Inamed reported a yearly ruptue rate of about 1.4 percent, the yearly Mentor rate was 0.2 percent — a figure that had been questioned by FDA reviewers.

The panel decision was sharply questioned by Inamed officials, who had been criticized the day before for not having sufficiently long-term data.

“Inamed views today’s panel decision as curious and inconsistent with the decision reached by the panel yesterday on Inamed’s [application] — we look forward to working with Dr. [Lester M.] Crawford and FDA staff on addressing these inconsistencies,” Inamed president and chief executive Nicholas L. Teti said in a statement.

About 260,000 American women had their breasts enlarged with implants last year, and an additional 60,000 had received them after surgery for breast cancer.

Because of health concerns, the FDA in recent years has allowed silicone gel implants to be used only in women who had mastectomies and in some who take part in clinical trials; all others received implants filled with a saline solution. Many women say the silicone gel looks and feels more natural, and it is widely used in other parts of the world.

The panel’s decision was also criticized by some public interest groups, which have long argued that the potential dangers of silicone gel implants remain insufficiently studied.

“I think this was a triumph of wishful thinking which overruled the lack of science,” said Diana Zuckerman, president of the National Center for Policy Research for Women and Families. “Because of all the conditions, it’s far from a done deal regarding the FDA. It’s not helpful to women to have a product approved on the basis of two years of safety data.”

[…]

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FDA Panel Backs Breast Implants From One Maker

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Gardiner Harris, The New York Times: April 14, 2005.

Silicone breast implants made by a California company should be available to women who undergo cosmetic breast surgery, a federal advisory panel voted on Wednesday, rejecting arguments about serious health problems.

The panel chairman called the 7-to-2 vote to approve an application by the company, the Mentor Corporation, unexpected.

On Tuesday, the panel voted, 5 to 4, to reject a similar application from the Inamed Corporation. […]

The three-day hearing on implants began on Monday and included more than 160 witnesses who gave impassioned pleas to approve or reject silicone implants.

Dozens of women said implants had sickened them severely, and some gave gruesome testimony about silicone from ruptured implants squeezing out of their eyes and ears. […]

At the moment, just saline implants are allowed for purely cosmetic operations, even though many patients and doctors say silicone implants feel more natural and look better. Several panel members said they had voted to approved the implants because Mentor made a more convincing presentation than Inamed. […]

Inamed and women’s groups complained about the votes.

“I’m stunned and amazed by a bizarre and strange decision by a few panel members who yesterday demanded longer-term safety data and today accepted shorter-term data,” a vice president of Inamed, Dan Cohen, said.

Dr. Diana Zuckerman, president of the National Research Center for Health Research, called the conflicting votes illogical and predicted that the drug agency would reject both applications.

[…]

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Risking Women’s Health

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SF Gate: April 12, 2005.

IT LOOKS as if two California manufacturers just won’t take no for an answer — even if women’s health is at stake.

In their third attempt, Santa Cruz-based Inamed Corp. and Mentor Corp., have submitted applications for FDA approval that would allow them to sell their silicone-gel breast implants to the general public. […]

If approved, the Food and Drug Administration would lift its ban, imposed in 1992, which limited the use of the implants to controlled research.

Lest the FDA and these manufacturers forget, there’s a reason the ban was imposed.

Numerous reports linked the implants to arthritis, vascular disease and a range of autoimmune disorders that followed after the implants ruptured.

“All the data indicates that rupture is inevitable,” said Diana Zuckerman, president of the National Research Center for Women & Families. “What have these companies shown to prove that it is now safe?”

Not much. […]

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More Teens See Implants As a Right

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Jodi Mailander Farrell, Knight Ridder Newspapers: December 07, 2004.

Melissa Gonzalez knew her family intended to give her enough money to buy a new car when she turned 18. But she had her heart set on something else: Bigger breasts. […]

Gonzalez is not alone. In just one year, the number of girls 18 and younger getting breast implants jumped nearly threefold — from 3,872 in 2002 to 11,326 in 2003, the American Society for Aesthetic Plastic Surgery reports. […]

Dr. Jose M. Soler-Baillo, a South Miami plastic surgeon who performed Gonzalez’s augmentation, says getting implants has become a ”coming-of-age type of thing” for many young women, “especially here in Miami.” […]

Critics say the timing couldn’t be worse for adolescent girls, who are often unhappy with their looks. They say teenagers are too young and shortsighted to comprehend the long-term affects of surgery, particularly the risks, which include the possibility of rupture or permanent scarring, the need for periodic operations to replace or remove the implants and the potential problems with breast-feeding and mammography. Also, little is known about the implants’ long-term safety; no studies have been done on females this young.

”It might feel to a 17-year-old like it’s the end of the world to wait a few years, but their bodies are still changing,” says Diana Zuckerman, president of the National Research Center for Women & Families. ‘Those breasts are likely to get larger, especially when they go off to school and gain the `freshman 15,’ the pounds girls often put on between ages 18 and 21. Their whole body begins to look more voluptuous.” […]

There is no law forbidding implants in patients younger than 18, but the FDA advises against it. In the past 15 years, implants have been the subject of furious controversy over their safety. The FDA has banned silicone-gel implants because of unanswered questions about their safety, but it permits the use of saline-filled implants, which have a silicone shell. Both types are the subject of ongoing FDA studies.

Zuckerman, the mother of two teenagers, says girls should wait until they are 21 to consider breast surgery. […]

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Teens’ Cosmetic Dreams Don’t Always Come True

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Robert Davis, USA TODAY: July 28, 2004.

As a kid, Kacey Long would escape her hometown of Ennis, Texas, by imagining herself as a professional businesswoman. […]

At 19, Long decided to get breast implants. “I was all about doing anything I could to improve myself,” she says. […]

In 2003, almost 336,000 teens 18 or younger had some kind of cosmetic surgery or procedure, a 50% increase over 2002.

Patient-safety advocates believe that many of the teens having surgery are unnecessarily putting themselves at risk of injury or even death. Teens face different obstacles in making a decision like this, experts say. They are often insecure and naive about medical risks. And they literally are not always finished growing up.

Plastic surgery, like any surgery, can go wrong, as it did for Long. […]

Although research has not proved that implants can cause serious diseases, Long says she has been diagnosed with systemic silicone poisoning from the shells surrounding the saline implants, rheumatoid arthritis, fibromyalgia and chronic fatigue syndrome. […]

Nobody tracks deaths or injuries caused by plastic surgery, but one study found that one in 50,000 liposuction surgery patients die. […]

“The big problem with adolescents is they are being operated on at the most tumultuous time in their bodies. They may not recognize the permanence of what they’re doing,” says David Sarwer, a psychologist at the Center for Human Appearance at the University of Pennsylvania medical school. […]

“You’re not going to have too many plastic surgeons saying you don’t really need this,” says Diana Zuckerman, president of the National Center for Policy Research for Women & Families. “Once you get in the door, of course, the doctors are saying everything they can to persuade you to have surgery.”

Zuckerman wants rules to protect girls from plastic surgery.

“Breast implants are not approved for anyone under 18, but any doctor can perform the surgery legally,” she says. “I’d like to see the American Society of Plastic Surgeons have a policy saying we think our doctors shouldn’t do this on anyone under 18.”

Experts disagree on whether teens are too young for surgeries such as breast augmentation.

Zuckerman says girls should be encouraged to develop more before having surgery. “A lot of teens gain weight during their freshman year in college,” she says. “If they had just waited a few years, they might have been less flat-chested.[…]

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FDA Rejects Silicone Gel Breast Implants

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Steve Sternberg, The Associated Press: January 9, 2004.

Silicone breast implants were dealt a new blow Thursday when the Food and Drug Administration rejected Inamed Corp.’s bid to bring them back on the market a decade after earlier versions were ruled unsafe and banned. […]

“There’s additional information that we think is necessary for this product to pass the threshold of what we consider necessary for open marketing,” said Daniel Schultz, the FDA’s director of device evaluation.

Silicone breast implants are now allowed only for reconstruction after breast cancer surgery and in controlled trials for women who want them for cosmetic reasons. […]

Some women say they prefer silicone-filled breast implants over those made with saline because silicone implants have a more natural feel. Critics worry about the long-term health consequences when implants break and leak. They cite studies linking silicone implants with cancer, immune disorders and crippling fatigue. But a 1999 Institute of Medicine analysis found no proof that silicone implants cause severe health problems. […]

“Even the FDA advisers who recommended approval all agreed that we don’t know the long-term safety (of these devices). It’s terrific that the FDA heard that message,” said Diana Zuckerman, president of the National Center for Policy Research for Women and Families, a Washington-based think tank.

Zuckerman hailed a provision in the FDA guidance document calling for the development of new external performance tests that better mimic conditions within the breast. […]

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Popularity of Breast Implants Rising

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Marc Kaufman, Washington Post: September 22, 2002.

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. “My mom said that if she was my age again, she’d do it, too.” […]

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 cosmetic 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.

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 Research Center for Women & 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.” […]

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Silicone Implants Generate Renewed Debate

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Colette Bouchez, HealthDay: August 21 2002.

As federal health officials ready for hearings on whether silicone breast implants should be allowed back on the U.S. market, a 2002 study offers evidence of a reduced rate of implant rupture. The study, conducted by a group of Danish researchers, used magnetic resonance imaging (MRI) to study implant rupture rates in some 300 women for a period of three years. From that data, the researchers extrapolated a rupture rate of 15 percent to 17 percent 10 years after the women received the implants. […]

Diana Zuckerman, a former member of the National Cancer Institute advisory committee on breast implants, says the study offers a gross underestimate of the implant rupture problem.

“If it were truly 15 percent at 10 years, that would be an improvement, but I do not believe for a minute that it is 15 percent. It’s an estimate based on an assumption that I don’t believe this study supports,” says Zuckerman, executive director of the National Center for Policy Research for Women and Families.

Zuckerman notes the research, published in an issue of the Archives of Surgery, only studied women for three years. And without specific 10-year data, there’s no real way to accurately project the rate of rupture across an entire decade, she says.

A study published in 2000 by the U.S. Food and Drug Administration (FDA) found a silicone implant rupture rate as high as 55 percent, with up to 69 percent of all women likely to experience a rupture in at least one breast. […]

“Up until two years ago there were no specific studies done on the health problems of women whose implants ruptured. And when this research was finally conducted, in one study by the FDA and two by the NCI (National Cancer Institute), there was a significant increase in certain health problems in the women with the ruptured implants,” Zuckerman says.

Zuckerman says the findings from the NCI studies were even more troubling. In this research, doctors compared women who had breast implants to other plastic surgery patients, and found the implant group (most of whom had silicone gel implants) were more than twice as likely to die from brain cancer, and three times as likely to die of lung cancer.

“If I were a woman contemplating silicone breast implants, this would sure scare me,” Zuckerman says. […]

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All But Forgotten

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Tinker Ready, Special to The Los Angeles Times: October 1, 2001.

In the made-for-TV movie about two women who took on Dow Corning Corp. and other medical device makers over the safety of silicone breast implants, the women emerge as winners. In real life, P.J. Brent’s story did not have such a happy ending.

Like the movie heroines, the Atlanta mother of six believed she had been poisoned by leaking implants. […] But a Pennsylvania pediatrician contradicted her, telling the FDA that there is no scientific evidence linking Brent’s implants to her children’s severe leg numbness, rashes and difficulty swallowing.

Brent’s story ended a few months after the FDA hearing. One summer morning, she drove to the top of a five-story parking garage at a shopping mall in suburban Atlanta, climbed over the railing and leaped to her death.

For years, women like Brent who blame breast implants for chronic illnesses had lawyers, activists, journalists and a small but determined group of doctors and scientists to back them up. […]

Then, in the mid-1990s, their cases began to unravel. New research failed to find a connection between their symptoms and their implants. Even as breast implant manufacturers agreed to a record-breaking class-action settlement, prestigious medical journals were publishing studies concluding that women with implants were no more likely to be sick than the rest of us. […]

P.J. Brent’s suicide was not the first among women who believe they are ill from implants, Melvin noted. Women with silicone breast implants are four times more likely to commit suicide than other plastic surgery patients, according to a study by the National Cancer Institute. […]

Stuart Bondurant, the dean emeritus of the University of North Carolina medical school, headed the congressional panel, which was based at the prestigious Institute of Medicine. […] Bondurant’s group issued its report in 1999, concluding that the evidence linking silicone implants to serious illness is “insufficient or flawed.”  […]

The Institute of Medicine report was not intended to be the last word, but many doctors, judges and journalists have interpreted it that way, said Diana Zuckerman, the director of the National Center for Policy Research for Women & Families, a Washington, D.C.-based think-tank. As a result, the two reports had “an enormous chilling effect” on both the legal case against implants and the potential for further research, she said.

“It’s a travesty,” said Zuckerman, an epidemiologist and former Capitol Hill aide who organized the first congressional hearing on implant safety. “The women are desperately trying to get someone to help them. They are told it is in their head, and they are treated as if they are just out to get money.”

Zuckerman and others have put their faith in several government studies. One FDA study suggests that women with silicone in their bloodstream may be more vulnerable to health problems, she said. And the first of several NIH studies found that women with implants are more likely than other plastic surgery patients to take their own lives or die from brain tumors and lung cancer. […]

“They feel very invalidated,” she said. “They feel that no one is listening to them.” So they get depressed, only to be told that depression is causing their physical problems, she said. […]

So they turn to each other, mostly through Internet support groups, where they trade stories, find doctors willing to remove implants and vent their anger. Often, it is not enough. “Realistically, what these groups do is provide information and shoulders to cry on, and that’s all they can do,” Zuckerman said. […]

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