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.

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.

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.

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.

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?