Category Archives: Published Newspaper or Magazine Articles

A Split Decision on Breast Implants

Diana Zuckerman, PhD, National Center for Health Research, The Washington Times: October 26, 2003

Breast implants are back in the headlines, with two equally passionate sides to the story. Both claim the science is on their side. Who is right?

In a split decision on October 15, advisers to the Food and Drug Administration voted to recommend that silicone gel breast implants are safe enough to have the FDA ‘seal of approval.’

The 9-6 vote for approval was orchestrated by the six plastic surgeons and breast surgeons on the panel who voted in lock-step. In contrast, most of the other doctors and scientists voted against approving the implants, citing the lack of safety information. To add to the drama, a panel member who seemed ready to vote against approval mysteriously disappeared before the vote. And the panel chairman, who only votes when there is a tie, said he would have voted against and was flabbergasted by the lack of safety information.

The spin machines are already working overtime. Plastic surgeons and implant manufacturers (and the lobbying and PR firms they generously support) remind us that women like silicone gel breast implants. They tell us that there is “no scientific evidence” that breast implants cause disease and that it is time to make them widely available again. They often back up this statement with a 4-year old Institute of Medicine report, which they claim proves that implants are safe.

On the other side, patients testified about the pain and deformity of having leaked silicone scraped from their chest wall– a problem that is considered a “local complication” rather than a “health risk.” Their testimony is the heartbreaking illustration of the Institute of Medicine report’s concerns that breast implants can break, leaking silicone inside the body. Although the Institute concluded that research did not prove implants cause disease, their report was only a review of the research available four years ago, most of it of women with implants for just a few months or years.

Most diseases — lung cancer for example — take more than a few years to develop. Implants tend to break after eight years or more, and the health risks of leaking silicone implants aren’t known. When scientists from the National Cancer Institute and the FDA recently conducted several studies on women who had implants for at least seven years, their results were frightening: Women with breast implants were twice as likely to die from brain cancer, 3 times as likely to die from lung diseases, and 4 times as likely to commit suicide, compared to other plastic surgery patients. Women with leaking implants were more likely to have fibromyalgia and several other autoimmune diseases.

The FDA advisors who voted against approval included a toxicologist, epidemiologist, radiologist, statistician, dermatologist, and cancer surgeon. They understood diseases take time to develop, especially since breast implants tend to break after 10 years, not two years. Their vote against approval was based on their concerns about long-term safety, and their criticisms that the company didn’t bother to study women who had implants for more than three years.

There’s even a divided opinion among our government health officials about the safety of breast implants. At the very moment when the FDA is considering lifting restrictions on silicone gel implants, the Medicare program has successfully sued implant manufacturers for tens of millions of dollars. Why? Because the government claims that women who became sick from their silicone implants have cost Medicare a lot of money in medical care.

You might wonder why the FDA would consider making a product more available when scientists question their safety and when government experts believe that it has cost our already-strapped healthcare system millions of dollars. This is a health question where it doesn’t help to ask your doctor –but you might try the lobbyists on Washington’s K Street. The companies that were successfully sued for billions of dollars by breast implant patients — such as Dow Corning, 3M, and Bristol Myers Squibb — are among the most powerful companies in the country. Perhaps their lobbyists are more effective than the women with implants who are coping with leaking silicone in their bodies.

The FDA’s mission is to safeguard all of us when we eat, use medical products, or are vaccinated. The division of opinion among FDA advisers reflects a frequent split — between those who are selling a product or procedure and think it is safe based on personal clinical experience, and those who believe research is necessary to prove such safety

There is passion (often called hysteria when it’s the “other side”) and science on both sides of this issue. The short-term research shows most women with breast implants don’t get diseases in the first few years. But there is little long-term research, and those studies raises serious questions about leaking silicone, illness, and death related to implants. In the meantime, research also shows extremely high complication rates — including the need for repeated surgeries. The bottom line is: Will the FDA demand a company prove its product is safe before “approving” it, or decide a company can experiment on millions of women while we wait for research to be completed?

We’ll find out soon.

Hype in Health Reporting

Diana Zuckerman, PhD, Extra!: September/October 2002

“Checkbook science” buys distortion of medical news

You’ve heard of junk science–a term coined by corporations to describe research they don’t like–but the real danger to public health might be called “checkbook science”: research intended not to expand knowledge or to benefit humanity, but instead to sell products.

Every day it seems there’s a story touting a “promising” new medical product or treatment. Unfortunately, many of those news stories are based on public relations spin machines going into overdrive on behalf of the company that sells the product–whether it’s a pharmaceutical company, a chain of diet clinics or a plastic surgery practice selling a new technique.

Do reporters know that so much medical news is actually unpaid advertising? The most effective industry influence is so well-hidden that many reporters and producers are totally unaware of it. The role of pharmaceutical companies and other health care industry interests in shaping news coverage of medical products and treatment is as invisible as it is pervasive.

The phone calls, press releases and press conferences that bring attention to new studies are the most obvious ways that companies shape medical news; but there are subtler strategies that are much more effective. For example, Excerpta Medica is a PR firm hired by pharmaceutical and other medical companies to launch new products. On their website and in other public documents, they have claimed responsibility for developing several new medical journals and other strategies to “establish a scientific base” for expanded use of their clients’ offerings.

What about medical stories based on articles in prestigious medical journals? In some cases, these articles are also bought and paid for. When the stakes are high, companies hire public relations firms that hire medical writers to ghostwrite academic-style articles for medical school professors to submit to well-respected medical journals. The companies also establish speakers’ bureaus–lists of selected professors who are paid thousands of dollars in honoraria and travel expenses to speak at newsworthy national and international conferences.

It’s a win-win for the “experts” and the companies. The professors benefit because their employment status is based on being published in journals and invited to conferences. The companies benefit by having the name of a faculty member from a major university attached to an article or presentation endorsing their product. It’s a real winner when the news headline refers to the industry’s new study by its author’s affiliation–e.g., “the Harvard study”–thus ensuring that the results will be taken seriously.

Few reporters ever know that the prestigious expert speaking on behalf of a new product is, one way or another, a paid spokesperson for the product. The author can honestly say that he or she is not paid by the company–because the money comes from the PR firm (which is paid by the company or its corporate foundation).

Diet Pills: Safe or Not?

One of the most notorious examples of PR-driven medical reporting is the story of fen-phen, the combination of diet pills that was removed from the market in 1997 when Redux (or fenfluramine) was determined to be dangerous. Fen-phen was hailed by the media as a great breakthrough when it gained popularity in the mid-1990s. There was a newsworthy stampede as patients sought the prescriptions from their doctors, at weight loss clinics and over the Internet. By 1996, 7 million women and men were taking fen-phen.

When research was first published linking fen-phen to potentially fatal heart valve damage, the media took notice. Lawsuits and a settlement totaling $13 billion resulted in front-page coverage. But then a funny thing happened: New research articles were published in medical journals, indicating that fen-phen wasn’t really dangerous after all.

Again, the popular media took up the news with great enthusiasm. “Study: No Heart Damage from Diet Drug,” proclaimed a front-page headline in USA Today (4/1/98). The study in question, paid for by Wyeth-Ayerst (the manufacturer of Redux) and authored by Dr. Neil Weissman, found only a small, statistically insignificant increase in heart-valve damage for women who took the diet drug compared to women who didn’t.

Let’s give credit to the reporter: He mentioned that the company paid for the study, and that the women in the study took the diet pill for only three months. He mentioned that the study was presented at a medical meeting, although he didn’t explain that such presentations are not held to the same standards as peer-reviewed medical journals. Unfortunately, those fine points were somewhat lost, because the headline and lead focused on the “news” that the drug was safe. The L.A. Times (4/6/98) and Boston Herald (4/1/98) versions of the story were even more reassuring and less questioning about the data.

When Weissman and Wyeth tried to publish the study in the New England Journal of Medicine, the editor required that they modify their data analysis. As a result, the findings were no longer so reassuring. The published article (9/10/98) was not promoted by the company, for obvious reasons, and received little press attention.

A year later (10/1/99), the New York Times’ Gina Kolata wrote about another new study, published in the Journal of the American College of Cardiology (Vol. 34/No. 4), showing that fen-phen wasn’t so bad after all. The Times did not disclose that one of the authors, Dr. George Blackburn, was paid by Wyeth-Ayerst to speak on behalf of fen-phen at medical meetings across the country. As a member of the company’s speakers’ bureau, Blackburn was paid honoraria and travel expenses when he spoke about the company’s drugs.

Perhaps the New York Times reporter was also influenced by the editorial in the same issue of the Journal of the American College of Cardiology, which concluded that the story of fen-phen was just a big scare. In the fine print, the editorial stated that it was written by a consultant to American Home Products–Wyeth’s parent company.

Only later did anyone learn just how active Wyeth was in making sure that medical journal articles supported their legal defense of fen-phen. Legal depositions revealed that Excerpta Medica, the aforementioned PR company, was paid by Wyeth to supply writers who would ghostwrite or edit medical journal articles to the company’s specifications. Well-known experts were sometimes paid to lend their names as authors. Upon hearing this news, Dr. Robert Tenery, chair of the American Medical Association’s Council on Ethical and Judicial Affairs, told the Dallas Morning News (5/23/99), “What they’re doing here is clearly an advertisement.”

Last year, when journalist Alicia Mundy revealed these unethical arrangements in a book about fen-phen, Dispensing with the Truth, she found it difficult to get the media to cover the story. “As a journalist, I had a great network of friends and colleagues that could have helped me to bring attention to these scandals,” Mundy told Extra!, “but most of the media did not cover the story of how drug companies shape media coverage of their products.”

Breast Implants: Ignoring new Science

Reporting on breast implants provides another example of media manipulation, with coverage that used to focus on science and health increasingly treating implants as a popular if questionable fad. The most important recent studies–three last year and two this year–received little attention, although they showed potentially fatal risks from implants or startlingly high complication rates. With the major public relations efforts on the “implants are perfectly safe” side of the story–paid for by implant manufacturers as well as the organizations representing plastic surgeons–the largest, best-designed studies barely attracted one day of coverage.

When two studies that linked implants to cancer were published in medical journals last year, the newspaper headlines reflected the varied coverage: USA Today’s “Studies Suggest Link Between Breast Implants and Cancer” (4/25/01) was similar to the New York Times’ “Study Links Breast Implants to Lung and Brain cancers” (4/26/01), while Associated Press (4/26/01) decided to emphasize the positive: “Breast Implants Cancer-Safe; No Risk for Most Cancers from Breast Implants, Study Says.” The AP headline seems like satire–how many kinds of cancer does an implant need to be linked to in order to be considered unsafe?–but, to be fair, it was apparently taken directly from the National Cancer Institute’s press release, which led with the good news, only later mentioning that implants were linked to several cancers.

A third major study, showing that implants often broke and leakage was linked to deadly diseases, received brief mention in the Washington Post (6/1/01) and was ignored by most other media.

These implant studies were newsworthy because they were the only government studies that had been conducted, and were based on an unusually large sample of patients with a longer history of implants than in previous studies. Two of the studies were conducted by the National Cancer Institute, the other by scientists at the Food and Drug Administration along with an impressive list of medical school researchers. Since the results were not favorable to implants, there was no multi-million dollar public relations machine encouraging press coverage. Consumer groups contacted the media to tell them about the studies, but the placement of the articles, on pages B6 (Wall Street Journal, 4/25/01), D7 (USA Today, 4/25/01), A19 (New York Times, 4/26/01), and A28 (Newsday, 4/27/01), ensured that the bad news would not attract much attention; there was virtually no TV coverage.

In contrast, a 1999 report that had concluded that implants probably did not cause diseases was embraced by the implant manufacturers and plastic surgeons–and was very big news on all the major networks and newspapers. The New York Times broke a press embargo with a front-page story, “Panel Confirms No Major Illness Tied to Implants” (6/21/99), and other media followed: “Study Again Clears Silicone,” (Washington Post, 6/22/99, A2); “No Deadly Danger in Silicone Implants,” (USA Today, 6/22/99, D1); “Study Clears Gel Implants of Some Ills,” (L.A. Times, 6/22/99, A1).

In July 2002, two unpublished studies of saline implants were presented at a public meeting of the FDA’s Advisory Committee on plastic surgery medical devices. Neither the FDA nor the two manufacturers involved publicized the meeting, so few reporters were present. The meeting focused on the first five-year studies of saline implants, and the results were important because of very high complication rates for both manufacturers and the exceptionally low response rate for the studies by one of the manufacturers. The manufacturers provided some spin in response to media inquiries, but their major goal was to keep the story quiet. Without an industry-backed PR machine, that’s exactly what happened.

Hormone Replacement Therapy: A Shock to the System

The recent controversy about hormone replacement therapy (HRT) has all the makings of another fen-phen saga–even with one of the same manufacturers–but we don’t know the entire story yet. For years, HRT has been prescribed and described as if it were a fountain of youth that prevents much of the physical and mental deterioration associated with aging. As recently as June 1999, for example, a New York Times article (6/1/99) headlined “New Therapy Builds Bone Without Unpleasant Side Effects” touted the benefits, and a week later a Times article headlined “Study Plays Down Estrogen Link to Breast Cancer” (6/9/99) minimized the one risk that was well-established. Two years later, an AP story (5/16/01) went even further, with the promising headline, “Hormones May Lower Risk of Breast Cancer’s Return.”

So imagine the shock to the more than 6 million women taking HRT when just over a year later the National Institutes of Health decided it was unethical to continue administering hormones in an enormous study because the risks of the treatment were too great. The researchers concluded that HRT not only increased the risk of breast cancer, heart disease and blood clots, but it also was not as beneficial in preventing osteoporosis or other diseases as previously claimed.

The New York Times (7/10/02) captured the mood with its headline: “Hormone Replacement Study a Shock to the Medical System.” Most media covered the story as if this was enormous news that came out of nowhere. The truth is quite different. For several years, article after article published in major medical journals had described the growing evidence that hormone replacement therapy increased the risk of breast cancer and did not help and possibly hurt women with heart disease. Other studies questioned the assumed benefits. Although some of these studies were covered in major newspapers, without a PR machine behind them they received limited media attention. (See Extra!, 3-4/97; CounterSpin, 7/19/02.)

Meanwhile, Wyeth and other manufacturers promoted their products directly and indirectly, with a celebrity spokeswoman and many health experts. As recently as May 2002, a nonprofit women’s health organization held a black tie, standing-room only dinner for almost 1,000 Washington, D.C. luminaries, completely underwritten by Wyeth. The theme was midlife women, and as part of the entertainment program, the audience was reminded that midlife women have better lives than ever before, thanks to hormone replacement therapy and other wonderful advances in medicine.

The media coverage also included a gem about the “father” of hormone replacement therapy, Dr. Robert Wilson. In the early 1960s, Wilson promoted hormones as a miracle cure for the “living decay” that besets the often “dull and unattractive” menopausal woman. His book, Forever Feminine, was enormously influential, and hormone replacement therapy has grown in popularity ever since. Wilson seemed to be speaking from the heart, but in interviews during the July 2002 media onslaught (New York Times, 7/10/02) the late doctor’s son told a reporter that the book and his father’s work were paid for by Wyeth.

Cutting Through the Hype

As I write this conclusion, I receive a call from the Detroit Free Press. The editors are interested in publishing an op-ed I wrote, but first they want to know where the center I work for gets its funds. This is the question that every reporter should be asking, every time they quote me or publish my writing on any medical issue. Almost none of them do. The caller is noticeably uncomfortable as she asks me about possible conflicts of interest, as if she’s asking some terribly personal questions. If more reporters and editors and producers don’t always ask these questions, and dig deeper when they do so, we’ll never cut through the hype that is overwhelming medical news coverage.

Read the original article here.

The Breast Cancer Information Gap

Diana Zuckerman, PhD, National Center for Health Research, RN Magazine: February, 2002

Thanks to early detection, three out of four American women who are newly diagnosed with breast cancer can safely choose breast-conserving surgery rather than mastectomy.1 For those who choose a partial or complete removal of a breast, many patients consider whether or not to undergo breast reconstruction with implants.

In 1999, the most recent year for which statistics are available, nearly 83,000 women underwent breast reconstruction.2 Although breast implants often have the desirable effect of helping to improve a woman’s self-image and body symmetry, their safety remains controversial. The potential complications include pain, breakage, and a possible link to fibromyalgia and other diseases.

As a former Congressional investigator reviewing studies submitted by implant manufacturers to the Food and Drug Administration (FDA), and in my current work on health policy issues, I have studied firsthand the research on the safety of breast implants and quality-of-life issues surrounding them. Here I’ll share with you a number of things I’ve learned that you and your patients may not be aware of.

Safety issues patients may not fully grasp

There are two types of breast implants and they both have an outer silicone shell; one type is filled with saline and the other with silicone gel. Both were on the market for many years before the FDA started regulating medical devices in 1976. When the agency began reviewing safety data on medical devices, it gave priority to lifesaving ones. As a result, the FDA didn’t review the safety of breast implants until 1991.

The FDA started with silicone-gel implants because of concerns that silicone leakage could be harmful. In 1992, dissatisfied with the safety data from the manufacturers of these products, the FDA restricted the use of silicone implants to patients undergoing reconstruction after mastectomy, women with breast deformities, and those who had silicone implants that ruptured and wanted them replaced.3 The FDA further stipulated that these implants had to be used in ongoing clinical trials, which would enable the agency to track patient data and evaluate implant safety over time.

In 1999, the FDA reviewed safety data from manufacturers of saline implants, and, in 2000, approved several styles made by McGhan Medical Corporation and Mentor Corporation (both in Santa Barbara, Calif.) for breast reconstruction in women of all ages and breast augmentation in women 18 years or older.

Although silicone gel implants feel more natural, saline implants are generally considered safer in the event of rupture. Yet, patients need to understand that saline implants also have risks.

According to studies the FDA received from manufacturers of saline breast implants, seven out of ten reconstruction patients will experience at least one serious complication within the first three years of receiving an implant, such as pain, hardness, infection, or rupture of the implant.4 The most common complication – experienced by almost one-third of the women — is a condition called capsular contracture, in which scar tissue tightens around the implant, causing the breast to become hard, misshapen, and painful.5 Patients who have breastfed compare the sensation to being unable to nurse their baby for many hours.

capsular1Capsular contracture occurs when the scar tissue, or capsule, that normally forms around an implant tightens and squeezes the implant. The Baker grades of capsular contracture range from I (breast is soft and looks normal) to IV (breast is hard and painful and looks abnormal). This 29-year old woman suffered a grade IV contracture in her right breast seven years after placement of a silicone-filled implant.

Not guaranteed to last a lifetime

Patients may also not be aware that breast implants will break eventually. A new FDA study shows that most implants break within 10-15 years, although some may break within just a few months.6 One in four patients has an implant removed within three years because of this complication and others.4

When the shell of a saline implant breaks, saline leaks out quickly, or over several days. As a result, the implant gets smaller and may lose its shape. Although the saline is absorbed by the body, the deflated implant will need to be surgically removed.

deflate2Deflation or rupture of a breast implant can be caused by instruments during surgery, trauma or injury to the breast, excessive compression during the mammography, or normal aging of the implant. The left saline-filled implant in this 30-year-old woman deflated after five months. The likely cause was the leaf-value design of the implant, which is no longer being used by manufacturers.

Removing a ruptured silicone implant isn’t so simple. Because silicone gel is “sticky,” it can be difficult, if not impossible, to completely remove from surrounding tissue. When a silicone implant ruptures, a woman may feel the reduction in the size of her breast, bumps, pain, tenderness, tingling, or numbness. Some women, however, experience no symptoms at all. Even in these so-called “silent ruptures,” gel may slowly migrate to other parts of the body.

According to a recent FDA study of 344 women, 79% of the women who had silicone implants for 11-15 years had at least one ruptured implant but weren’t aware of it.7 Their diagnosis was made by means of magnetic resonance imaging (MRI), which also showed that silicone migrated away from the broken implant in one in five women.

There is only one study of the health effects of ruptured silicone implants, and the results, though not conclusive, are disturbing.6 When the silicone migrated from the broken implant, those women were more likely to be diagnosed with fibromyalgia or several other painful and debilitating autoimmune diseases, compared to the other women with implants. In addition, some women have developed symptoms of lupus, rheumatoid arthritis, scleroderma, or other connective tissue diseases that they attribute to their implants. Although most of these concerns center around silicone implants, similar symptoms have been reported anecdotally among women with saline implants, where the silicone shell may “leak” small amounts of silicone.8

Even more disturbing, two recent studies by the National Cancer Institute found that women with silicone or saline breast implants were more likely to develop cancer than other women their age, and more likely to die from brain cancer, lung cancer or other lung diseases, or suicide, compared with other plastic surgery patients.9,10 These studies, however, didn’t include reconstruction patients, and more research is needed before conclusions can be drawn. Meanwhile, a connection between breast implants and serious diseases can’t be ruled out.8

Women who have a saline or silicone implant removed but not replaced may describe the experience as “losing their breast twice,” but this decision is appropriate for women who want to avoid future complications.

Talking with patients about their options

An important part of counseling patients is listening without making assumptions about what patients need or want. Many of us might assume, for example, that breast reconstruction improves the quality of women’s lives. Yet the most recent research by the National Cancer Institute concludes that women who undergo mastectomies report the same levels of satisfaction with their lives whether or not they undergo reconstruction (with implants or autologous tissue transfers such as TRAM–transverse rectus abdominus myocutaneous-flaps).11 In fact, mastectomy patients who underwent reconstruction were more likely to report that breast cancer had a negative impact on their sex lives than women who didn’t have reconstruction.

Such findings remind us that we can’t predict what is best for patients. What we should do is provide them with options and support their choices.

Patients who decide to undergo breast reconstruction with implants may ask your advice about the timing of the surgery. It can take place at the time of tumor removal or months or years afterwards. Immediate reconstruction may reduce costs by combining mastectomy and implantation, although patients may face a longer operation and recuperation. Other patients may prefer to delay reconstruction so that they have more time to consider their options or to complete chemo- or radiation therapy. (For details on nursing care for breast reconstruction patients, see “Oncology Today: Breast reconstruction,” RN, April 2000.)

Regardless of the timing of surgery, additional procedures are often needed to complete the reconstruction. Breast reconstruction with silicone gel is a one-stage procedure. With a saline implant, the surgeon must first insert a tissue expander, and, over several weeks, inject more saline into the expander so that it gradually stretches the muscle and skin. Eventually, the expander is surgically replaced with a saline implant.

With either type of implant, at a later point, the patient may want a skin graft to create a new nipple or may undergo surgery on her other breast to make the two breasts look more similar in shape and size. So even if there are no complications, many women undergo several surgeries.

Breast implant patients should be encouraged to report any pain, bumps, loss of size or shape, or other symptoms of a problem. Because the implant can interfere with the detection of a tumor during mammography, the patient should insist on having a specially trained technician conduct that test. The technician needs to take precautions to avoid rupturing the implant during compression and take special views of the breast to detect tumors that might be obscured by the implant.

Patients deserve to be given information about what is known and not known about the safety of breast implants. When they know the risks and benefits, they will be more satisfied with the decisions they make. For more information on the safety of breast implants, visit the FDA website and key in “breast implants” in the search box. The Web site of the National Center for Policy Research for Women & Families provides additional links to women’s health research. With your help, patients can make the decision that’s best for them.



Photos are courtesy of U.S. Food and Drug Administration/Walter Peters, PHD, MD, FRCSC, University of Toronto.

The article published in RN magazine contained a few errors that have been corrected in this web version.

Calling for Informed Consent on Silicone Gel Implants or an End to Sales

Diana Zuckerman, PhD, MAMM: Women, Cancer, and Community, Point of View column: March 2001

When women are diagnosed with breast cancer, they may not realize that one of their reconstruction options, silicone gel-filled implants, has never been approved by the Food and Drug Administration (FDA) as safe and effective. In fact, most doctors and patients probably do not know that there are remarkably few published studies on the safety of silicone breast implants for mastectomy patients.

Our think tank, the National Center for Policy Research (CPR) for Women and Families, has called for a moratorium on the sale of silicone gel implants until the FDA can assure that all women considering the implants are fully informed of the risks and the alternatives.

Women were clearly unaware of the risks when implants, which were initially designed for breast augmentation, were first sold in the 1960s. Implants were completely unregulated; it was not until 1976 that a new law required that the FDA determine which medical devices were safe and effective. Other devices took priority, and the FDA did not require silicone gel implant manufacturers to submit safety data until 1991.

In 1992, the FDA concluded that the implant studies were too poorly designed to prove that implants were safe. The law mandates that manufacturers prove that a medical product is safe; lack of proof that a product is dangerous is not sufficient. Nevertheless, the FDA decided that breast implants fulfilled a “public health need” and therefore made an exception, banning their use for most augmentation but allowing their continued sale as part of large clinical trials on mastectomy patients, women with breast deformities, and women with broken gel implants. The implant manufacturers have been conducting these trials ever since. Eight years later, none of the results have been published in a peer-reviewed journal.

Ironically, although the “public health need” for silicone implants was based primarily on the desire to help mastectomy patients, there is still almost no research at all on the safety of reconstruction with either silicone or saline breast implants. Most published epidemiological implant studies excluded mastectomy patients or include them only as a small proportion of patients studied. In such studies, any problems experienced by breast cancer patients may not be statistically significant.

Of the few studies of mastectomy patients with gel implants, one conducted by implant maker McGhan Medical showed that one out of four women had at least one additional implant-related surgery within the first year, and one out of four had at least one implant removed within two years. Since this study was never published, the information is unavailable to most doctors and patients.

Last year, an FDA study reported that many women with silicone implants do not realize their implants are broken and leaking. Using Magnetic Resonance Imaging (MRI), researchers determined that almost half (48 percent) of women who had silicone implants for only six to 10 years, and 79 percent who had implants for 11 to 15 years, had at least one ruptured implant. These women were unaware of the rupture, however, and had not sought any medical care. Since this study excluded women who had already reported implant problems or removal, the actual breakage rate is even higher.

Unfortunately, silicone gel and liquid can be impossible to totally remove, and medical journals have documented serious health risks and fatalities when silicone migrates to vital organs. The FDA study also found that 21 percent of the women had silicone “migrating” away from the broken implant to other parts of their body.

In addition to the risks of broken and leaking silicone implants, there are documented risks of implants that are true for either saline-filled or silicone gel-filled implants. These risks include those associated with surgery, such as infection, hematoma (blood or tissue fluid collecting around an implant), and the risks of repeated surgery to remove or replace implants that cause problems, as well as the risk of capsular contracture, in which a capsule of scar tissue tightens around the implant, often causing hardness and pain. Breast implants can also obscure the view of a breast tumor in mammography, thus potentially delaying a diagnosis of breast cancer. Even with specially trained technicians, some tumors will be hidden by the implants.

The safety of silicone implants should have been studied before they were sold to more than a million women. Mastectomy patients who received gel implants since 1992 are officially part of a clinical trial, but the objectivity of the study has been questioned by patients such as Kim Hoffman. In 1998, while testifying before the Institute of Medicine, a congressionally funded nonprofit, Hoffman said her implant problems were not reported to those analyzing the data. Unfortunately, problems are analyzed only if they are reported by the physicians (and in the case of rupture, the implant must be removed and then examined and reported by the manufacturer.

Obviously, the doctors and implant makers have a financial incentive to help prove that patients are satisfied and that implants are safe and problem-free. Despite congressional requests, no safety studies of mastectomy patients have ever been conducted by the National Cancer Institute. But if Congress hears from constituents, those studies might finally be conducted.

If the federal government allows the continued sale of silicone gel-filled implants without requiring long-term safety data, I believe it needs to at least make sure that all information about the risks of silicone gel-filled implants is provided to women in a clearly written consumer brochure and patient consent form, well before they undergo surgery. (That’s what the FDA requires with the recently-approved RU-486.) The FDA owes it to breast cancer patients to provide them with the same safeguards, so women can make a choice based on what is known and unknown about the risks.

Breast Implants: What You Must Know

Walter Erhardt, M.D., Mia Talmor, M.D. and Diana Zuckerman, PhD, McCall’s: February 2001

After liposuction, breast augmentation is the most popular cosmetic surgery in the United States. In 1999 alone, about 167,000 women had the procedure, according to the American Society of Plastic Surgeons. Surveys show that most are happy with their results, but that finding doesn’t mean surgery and recovery are risk-free. According to one study, 60 percent of women who got implants experienced at least one complication within four years. Here are five points to ponder before going under the knife.

Implants don’t last a lifetime. The largest study to date found that nearly one third of the women had their implants removed and/or replaced within three years. The most common reasons: leakage and/or rupture of the implant; capsular contracture (when the scar tissue that forms around the implant tightens, causing hardness and pain); and asymmetrical, wrinkled or scared breasts.

Future mammograms may not be accurate. Implants can block breast tissue from view during mammography, which could delay or hinder a diagnosis of breast cancer.

Breast-feeding may be impossible. Milk ducts may be severed during the operation. Certain surgical techniques may prevent this, but many doctors advise that you postpone surgery if you want a guarantee.

Long-term risks aren’t known. Most of the concerns about systemic health problems – like lupus or rheumatoid arthritis – revolve around silicone-filled devices, which are rarely used today for cosmetic surgery (though saline implant shells are made of a type of silicone). A review of several studies indicates, however, that these conditions are not more common in women who have implants than in those who don’t. Still, some experts believe that further investigation is needed.

You need an experienced doctor. Interview a few surgeons. Ask how long they’ve been doing the procedure, how many they perform a year, what kinds of complications they see most often and how frequently they have to reoperate. There are no “right” responses, but you should feel comfortable with the answers. – Hilary Macht Felgran

Sources: Walter Erhardt, M.D., president of the American Society of Plastic Surgeons; Mia Talmor, M.D., plastic surgeon at New York Presbyterian Hospital; Diana Zuckerman, Ph.D., president of the National Center for Health Research.

Women Can’t Count on the FDA

Patricia Lieberman, PhD, National Center for Health Research, Los Angeles Times, page B11: June 15, 2000

The Food and Drug Administration is known worldwide for having the most rigorous safety standards. Unfortunately, it lowered its standard last month when it approved saline-filled silicone breast implants. That decision will have an impact on the lives of as many as 150,000 women and teenage girls who get those implants each year. And if implant makers have their way, the FDA will approve even riskier silicone gel-filled implants next.

To win approval of their saline implants, two Santa Barbara-based corporations presented the FDA with results of their studies of women who got saline implants three to four years ago. They claimed their patients were satisfied, but reported serious problems such as broken implants, breast pain, infection, deformity and additional surgeries to fix those problems.

The manufacturers touted their implants’ safety, and they were backed up by plastic surgeons, who told the FDA about the wonderful successes in their practices. Like the children of Garrison Keillor’s mythical Lake Wobegon, the surgeons all seemed to be “better than average,” with complication rates that were much lower than the research found and patients more enthusiastic about the changes implants made.

Yet analysis by FDA scientists showed that the manufacturers and physicians had underestimated the true rates of complications. Using data gathered by the manufacturers, the FDA calculated that for one manufacturer, Mentor Corp., 43% of women who got implants for augmentation had at least one complication within three years. For mastectomy patients, it was even worse: Within three years, 73% of women who got implants had at least one complication, and 27% had their implants removed. The statistics were even more troubling for the implants made by McGhan Medical. For both brands, the FDA explained that the complication rates were still rising when the studies were completed, so the long-term health risks are unknown.

The FDA also heard heart-wrenching testimony from women with health problems due to saline breast implants. They heard from women who got sick but are too poor because of extensive medical bills to have the implants removed. They heard from women who were denied health insurance because they were considered high-risk due to their implants and subsequent complications. They heard from women whose symptoms did not improve until after their implants were removed. The FDA utterly ignored these devastating stories.

The FDA also heard a radiology expert testify that breast implants can interfere with mammography. Failure to detect cancer is twice as likely for women with implants. Of the 1.5 million to 2 million women with implants, it is likely that the breast cancer diagnosis of 20,000 to 40,000 of them could be delayed because their implants obscured a tumor. Such a delay can be deadly. When breast cancer is detected and treated in its earliest stages, 90% to 95% of those women are healthy 10 years later. Only 40% live 10 years if the cancer is more advanced.

Although the health risks clearly outweigh the cosmetic benefits for most women and teenage girls, the FDA approved saline implants anyway. The FDA will require that manufacturers provide detailed information about the risks to patients, but what does that mean? Will companies that misrepresented their data to the agency realistically portray the risks to their potential customers? It doesn’t look likely.

Instead, the manufacturers are looking for more business. After the FDA announced its approval of saline implants, McGhan boasted that it would seek FDA approval for silicone-gel implants. The FDA’s own research proves that this would be a tragic mistake. Scientists found that even among women who had not sought medical treatment for implant problems, almost 80% had at least one broken implant after 10 to 15 years. Even more worrisome, the silicone was migrating away from the implants in 21% of those women.

The FDA made no effort to publicize those results. Instead, it issues no warnings and still permits unapproved silicone-gel implants to be sold.

Consumers should have the peace of mind that the term “FDA approved” means that a product has been thoroughly tested and proved safe. Unfortunately, when it comes to breast implants, the FDA has placed the burden on women instead. Women will have to sift through the plastic surgeons’ and manufacturers’ glossy promotional brochures to seek the information they need because we can no longer rely on the FDA to look out for us.

Read the original article here.

The Role of FDA on Breast Implants – Watchdog or Grandma?

Diana Zuckerman, PhD, National Center for Health Research, Knight Ridder Newswire: May 2000

When the FDA approved saline-filled silicone breast implants last week, it admitted that implants have a tendency to break and cause health problems, and urged women to consider the risks carefully before making a decision. If you thought FDA was supposed to be a watchdog and think that this sounds more like a helpful grandma, you’ve got the picture exactly right.

The FDA’s decision comes weeks after the plastic surgeons gleefully announced that the number of women getting breast implants has doubled in the last two years. In 1999, almost 200,000 women got breast implants, all of them made with silicone bags, most of them filled with saline. None of the breast implants sold to these women had ever been approved by the FDA as safe and effective. But in November, for the first time, implant manufacturers had to provide research data to the FDA to prove that their saline implants were safe.

The manufacturers’ studies, analyzed by FDA scientists, showed that between 73 percent and 84 percent of the breast cancer patients who tried saline implants had complications within three or four years. Those complications included additional surgery, broken implants, breasts that were as hard as a rock, excruciating pain and serious infections. These are not the kinds of problems that a breast cancer patient needs, and a product that causes these problems would not usually be called “safe.”

The bad news doesn’t end there. The complication rate for healthy women who wanted larger breasts was lower, but still was as high as 60 percent for some of the most popular saline implants. Even worse, the FDA was told by experts that breast implants interfere with mammograms, and can hide cancerous tumors, even when experts use more expensive, special techniques. FDA was told that of the almost 2 million women who already have breast implants, one in every eight will get breast cancer, and 20,000 to 40,000 of these women will have a potentially deadly delay in their diagnosis because of their implants.

The FDA decided that, despite those risks, women should have a right to choose implants if they want them. The FDA does not want them to be sold to girls under 18, but they know that they can’t stop that from happening. Apparently, the FDA believes that doctors can be persuaded to provide accurate information about the risks, especially if given an attractive government brochure that provides that information.

Would any woman put a breast implant in her body if she realized that it would break after a few years, could grow bacteria or fungus inside, and might cause her breast to get hard and painful? Would she be reluctant if she knew that each additional surgery would mean that she would lose some of her own breast tissue and she would get new scars where the implants are inserted and removed? What would a young, healthy woman think if she were told that breast implants stretch her own breasts so out of shape that they will never look as good again if she needs to remove the implants? My guess is that she would run out of the plastic surgeon’s office and never come back, but if I’m right, the plastic surgeons will soon learn that providing accurate information to patients is not in their best interest.

I have no doubt that women are smart enough to make good choices if they have good information, but I have some doubts that they will ever get the information they need. Most have already heard, from the media or their doctors, that breast implants are safe. They haven’t seen the fine print, which specifies that the widely publicized studies of breast implants did not measure potentially expensive and devastating “local complications” such as broken implants, repeated surgeries, or breasts that are very hard and painful.

Most patients trust their doctors and believe what they are told. Most doctors rely on information that is conveniently and persuasively provided by the manufacturers, or possibly their local media. You don’t need to be a rocket scientist to know that FDA approval will increase the popularity of implants, and not necessarily increase information about the risks.

Perhaps most distressing, now that the FDA has approved saline implants, the manufacturers have no incentive to improve their implants, because they couldn’t sell a new and improved implant unless they go through a lengthy and expensive approval process. So, even though everyone might agree that it would be better to have safer breast implants available, it is unlikely that any manufacturers will have the incentive to develop them.

A watchdog prevents dangerous products from being sold to the public. A helpful grandmother provides information and advice, and tells the individual to make a decision and live with it. Teen-agers and adults make decisions all the time, but we rely on watchdogs to eliminate risky medical products because the stakes are so high. Once a woman has a breast implant in her body, her body is changed forever, and removal is expensive.

FDA has decided that it’s up to us to determine what is safe. Let the consumer beware.

All articles are reviewed and approved by Diana Zuckerman, PhD, and other senior staff.

Breast Cancer Research and Patient Education Haven’t Gone Far Enough

Diana Zuckerman, PhD, National Center for Health Research, Detroit Free Press: December 1, 1999

Every autumn, newspapers and magazines and the Internet are filled with helpful information aimed at increasing our awareness of breast cancer.

The goal is to improve early detection, and it works. Nevertheless, the sad truth is that many of the 175,000 women who will be diagnosed with breast cancer next year will not have all the information they need to get the treatment that is best for them.

This year, 6,500 Michigan women will have been diagnosed with breast cancer — more than 43 other states. They are beginning a terrifying journey, one that will involve making life-changing decisions. For many, these decisions will be based on inaccurate and misleading information rather than “informed consent.”

Medical experts are finding, for example, that many women are not told about the excellent safety record of lumpectomy — the removal of the cancer and the tissue around it. This procedure is less traumatic for many women than losing an entire breast, but many women are never told about that option. Older women, poor women, and women in the Midwest and South are especially likely to have unnecessary mastectomies.

Michigan is one of the few states that requires that newly diagnosed breast cancer patients receive information about lumpectomies. Unfortunately, research indicates that this law has had limited success — after an initial increase in lumpectomies, there was a return to the old surgical habits. Recent increases in lumpectomies are apparently due to slowly changing habits, rather than legal requirements.

Meanwhile, many mastectomy patients choose breast reconstruction, but this too provides options rather than objective information. Reconstruction using the woman’s own tissue is increasingly popular, but there are very few studies evaluating the safety of the various procedures.

Even more shocking, the Federal Drug Administration has never approved any kind of breast implants as safe and effective, even though implants have been sold since the 1960s. The saline implants that have become increasingly popular in recent years have not been evaluated in any major studies.

Two weeks ago, the manufacturers of saline implants were required to submit safety studies to the FDA for the first time. Which manufacturers submitted safety studies and what do those studies indicate? None of that information is public, and it will be months before any of these studies are available to patients or doctors. Even then, since the manufacturers’ economic well-being depends on the conclusions, it would be difficult to consider these studies objective.

Members of Congress from Detroit and elsewhere have worked hard to increase funding for government research on breast cancer, and yet our government has never funded a single study of the safety of breast implants for mastectomy patients. It’s difficult to believe, but former officials at the National Institutes of Health decided it was too complicated and expensive to study what happens to breast cancer patients who get breast implants.

When Congress required the National Cancer Institute to study the safety of breast implants, NIH ignored its plea to include mastectomy patients. It’s crazy but true: When the government’s study is published in the next few months, it will not include even one mastectomy patient.

McGhan Corp., a breast implant manufacturer, recently conducted a five-year study of mastectomy patients. It showed terrible problems: One out of four of the women need additional implant surgery within a year, and one out of four had their implants removed within two years.

The study results were provided to the Institute of Medicine for their expert panel’s recent review, but perhaps because it was unpublished, those experts didn’t think these problems were important enough to mention in their widely publicized report. As a result of this omission and others like it, the headlines gave implants a clean bill of health instead of warnings for mastectomy patients.

“It was hard enough losing my breast to cancer — I was devastated to lose it again when the implant failed” is a comment I have heard from many cancer survivors, whether they tried silicone or saline breast implants.

Even worse are the stories from cancer patients who describe terrible pain, infections that wouldn’t go away, and sores or lesions on their breasts, back or arms. When these terrible side-effects were duly noted by their doctors and reported to the manufacturers or the FDA, they were referred to as merely “local complications.”

Meanwhile, breast cancer patients and their doctors read the headlines about the safety of breast implants, and assume that implants are safe for mastectomy patients. They are not warned about the lack of research on mastectomy patients, or told that the few existing studies indicate the need for multiple surgeries, many of which are unsuccessful.

Tuesday’s $3.2-billion settlement by Dow Corning Corp. represents a bittersweet compensation victory for the 170,000 women who claimed injury from their silicone breast implants. But for those women who chose implants after being diagnosed with breast cancer, better information about the risks of implants and alternatives to mastectomies could have enabled them to avoid the heartache of additional health problems and a lawsuit.

Public support for medical research has probably never been higher. Awareness campaigns are working. But isn’t it time we spent more of those resources to make breast cancer patients aware of the safe alternatives to mastectomy and to develop the safest possible reconstruction options for women who truly need them?

When The Subject is Breast Implants, How Much Information is Enough?

Diana Zuckerman, PhD, National Center for Health Research, Knight Ridder Newswire: July 1999

Breast implants have been incorrectly given something resembling a “clean bill of health” by the media, in response to a recent Institute of Medicine report. The report was not a new study, but it was based on more than 3,000 articles and book chapters. So, how dare I suggest that this isn’t enough information to conclude that breast implants don’t cause serious diseases?

Neither the report’s spokespersons nor the media reports mentioned that the controversial conclusions regarding autoimmune disease were based on only 17 epidemiological studies, almost all of which were conducted with funding from implant manufacturers or plastic surgeons. Certainly, both have overwhelming financial motives to support research designed to “prove” that implants are safe.

Despite the attention that everyone knew would be focused on autoimmune diseases, the report said very little about the well-established shortcomings of those 17 studies. In fact, the scientists who wrote those studies were more critical of their own results than this report was. The 400-page report devoted only 8 pages to the topic of epidemiological studies of autoimmune diseases, and those primarily described the studies, rather than carefully analyzing their strengths and weaknesses.

Most scientists would agree with the report’s conclusion that the available studies do not provide convincing evidence that implants cause autoimmune disease. But, there is a proverb in medical science that “If you haven’t proven a product is harmful, that doesn’t mean you have proved it is safe.” Some of the diseases studied, such as scleroderma, are extremely rare, striking one in several hundred thousand women. Many diseases also take many years to develop. We can’t draw conclusions about long-term safety regarding rare diseases based on studies of a few thousand women, especially when many had implants for only a few months or a few years.

Although it received much less attention, the report also pointed out that breast implants break, usually after 5-10 years, and that the silicone gel can spill into the body. These ruptures can result in silicone dripping from the nipples or terrible pain, and certainly require surgery. In addition to those serious problems, many of the women who are seriously ill believe their problems started when their implants broke. It would certainly make sense to study those women to see if they are more likely to have autoimmune or other diseases, but that has never been done.

The report was limited by the existing published research, but more information will be available in the coming year. A study of more than 13,000 implant patients, who had implants for a relatively long period of time, is being completed by the National Cancer Institute. In addition, government researchers will analyze medical information about implant patients who received payments based on a court-approved diagnosis of scleroderma. Until a few weeks ago, the implant manufacturers had successfully blocked access to that information, making such research impossible. If the large number of women involved are proven to have scleroderma, which is very rare, that would convince any reasonable person that implants can cause serious illness.

The Institute of Medicine report’s results are consistent with today’s conventional wisdom that breast implants are safe. But let’s remember that the conventional wisdom used to be that cigarettes were safe and that Agent Orange did not harm Vietnam vets. And sometimes erroneous conventional wisdom has been based on the views of the same kind of “blue ribbon panels” and university scientists as the current “wisdom” on breast implants.

When will we have enough information to conclude whether implants are truly safe? The number of studies is not as important as their quality. When well-designed research has studied larger numbers of patients who have had implants for a longer period of time, then we will have the answers that so many women are waiting for.