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.

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.

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.

Capsular 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.

Deflation 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.