All posts by BIeditor

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

Published Newspaper or Magazine Articles
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.

 

The Second Coming of Breast Implants

Published Journal Articles
Diana Zuckerman, IRIS Magazine: A Journal About Women, special issue on The Politics of the Body, Issue 38: Winter/Spring 1999

More than 120,000 American women, many of them in their teens and early 20s, underwent surgery for breast implants last year. After years of controversy had cooled enthusiasm for implants, more women are choosing them than ever before.

As a former Congressional staffer who initiated the investigation of the safety of breast implants in 1990, and as a psychologist who has studied women’s body image, I have tried to understand this resurgence. We are, after all, bombarded with images of implanted breasts every time we open the newspaper and see an ad for lingerie. Those very thin bodies with large chests don’t happen in nature very often, but they have become the expected ideal in the 1990s. And yet, more than thirty-five years after the first breast implant, we still know little about the long-term risks, and face growing evidence of the short-term problems. How did this happen?

When I left academia to work in the U.S. Congress, I expected to have to give up my interest in women’s body image and self-esteem. So I was intrigued when I received a telephone call from a young woman, telling me that her mother was having terrible problems with her silicone breast implants. It was 1990, and approximately 100,000 women had surgery with breast implants that year, only twenty percent for reconstruction after a mastectomy. Plastic surgeons were telling patients that implant surgery was the safest of all surgical procedures. In some communities, a teenage girl would receive implants to “look her best” for the senior prom. And television comedies included the topic as a humorous story line.

Since I investigated federal health policies, the young woman asked me to look into the safety of these implants. I promised that I would talk to her mother about her mother’s implants, thereby starting a Congressional investigation that eventually resulted in the Food and Drug Administration (FDA) removing silicone implants from the market.

The Investigation Begins

When I first spoke to women with implant problems, their stories seemed difficult to believe. They told me about silicone dripping from nipples, breasts so hard that they were embarrassed to be hugged, and breasts deformed by ruptured implants or by the surgery that attempted to remove the defective product. As word got out about my investigation, I received many calls and letters, and the stories began to sound eerily alike, a pattern that my post-doctoral training in epidemiology had taught me to take seriously. Perhaps most compelling were the many young women who described feeling like their grandmothers, exhausted by simple daily tasks, unable to recover from flu-like illnesses, or disabled by joint or muscle pain that left them unable to work or care for their families. Virtually all claimed that their doctors did not take their complaints seriously.

I reviewed all the medical literature, looking for confirmation or contradictions. There were only small studies, published by plastic or cosmetic surgeons, talking about the advantages and disadvantages of various types of implants and surgical techniques. In a never-ending cycle, every few years “new and improved” implants or techniques replaced the older ones, which were inevitably unsatisfactory over the long-term.

I spoke with plastic surgeons, and most assured me that breast implants were “completely safe.” They emphasized that women chose surgery for themselves, to become more self-confident, not to please men. One plastic surgeon told me with pride: “My happiest patients are those who have just had breast reduction surgery. My next happiest patients are those who have just gotten breast implants to increase the size of their breasts.” As a psychologist who had studied women’s body image, I believed him. The surgeons also acknowledged that some women’s breasts became very hard or painful, and that some women lost sensation in their nipples – these symptoms were not considered serious. But if reports from the implant patients were accurate, major health problems could develop over the next few months or years, and patients’ satisfaction might be short-lived.

I started with the contradictions: doctors claiming that their patients were very happy, patients claiming that they were ill, and an alarming lack of objective, published research. And underlying it all, the question: How could so many women have undergone breast implant surgery with virtually no human studies to indicate whether or not implants were safe?

A Brief History of Breast Implants

The history of breast implants helps to answer that question. At the end of World War II, barrels of industrial silicone mysteriously disappeared from the docks of Japan; the silicone was injected into the breasts of Japanese prostitutes to make them more attractive to American GIs. Sometimes, the silicone eventually migrated to other parts of the body, including vital organs, causing deformities, illness, and some deaths. Nevertheless, the procedure became increasingly popular, and thousands of Las Vegas show girls, actresses, and others in the entertainment business were injected with liquid silicone before it finally became illegal.

By 1962, breast implants consisting of a silicone envelope filled with silicone gel were “tested” on a thirty-year-old divorced mother of six who had gone to a Texas charity hospital to have tattoos removed from her breasts. She claimed the operation changed the way men looked at her, she recently recalled; within months, she had remarried.

Breast implants remained relatively rare throughout the 1960s and early 1970s. One common complaint was that the “augmented” breasts often felt hard. In the 1970s, the manufacturers developed a silicone implant with a thinner envelope and more fluid “lifelike” silicone gel inside. The new implants felt oily, broke more easily, and when they broke inside the body the silicone gel could spread, making total removal difficult or impossible. These augmented breasts also felt hard; apparently, the scar tissue that formed around the implant caused the uncomfortable and embarrassing hardness, not the consistency of the implant itself.

During all these years, implants were sold without any government oversight. In 1976, the FDA was finally given authority to regulate medical devices, including breast implants. Because of the huge backlog of devices to evaluate, most were allowed to be sold while awaiting review. Since breast implants were considered cosmetic, they were not a high priority.

Over the years, the FDA received thousands of reports of serious problems among implant patients, and scientists at the FDA became concerned. Several physicians published articles about implant patients with serious autoimmune diseases, such as scleroderma. Although consumers were not warned, by the late 1980s, the FDA’s breast implant advisory committee convinced the agency to require manufacturers to conduct safety studies. Meanwhile, the American Society of Plastic and Reconstructive Surgeons (ASPRS) provided information to the FDA in support of breast implants, and claimed that there was “a substantial and enlarging body of medical opinion that these deformities [small breasts] are really a disease.”

The Breast Implant Controversy, 1990-present

By the time I started my investigation, plastic surgeons estimated that two million women had breast implants. With no objective studies, plastic surgeons instead quoted their own marketing survey, which reported that ninety percent of implant patients were “very satisfied.”

During 1991-92, public attention resulted in more reports of serious health concerns and rapidly escalating numbers of “adverse reaction reports” that physicians made to the FDA. It also became apparent that the estimate of two million implant patients had been based on the implants sold, not the number of women who had undergone surgery. Since most women had at least two implants and many had replacements, there were probably fewer than one million women with implants. This smaller denominator meant that the proportion of patients who were ill was twice as high.

When the FDA responded to Congressional pressure to require scientific studies, the ASPRS charged each of its members a fee of $1,050 for a lobbying campaign. They hired professional lobbyists and enlisted the support of their patients, especially those with mastectomies. They flew in almost 400 women with breast implants from all over the country to meet with Congressional representatives, and orchestrated a write-in campaign. Congress received more than 20,000 letters, most from nurses and patients. In addition, the surgeons’ PAC made generous contributions to Congressmen “to express the Society’s support and gratitude to legislators who help us communicate our message on breast implants.” As a result, more than 200 Congressmen and Senators wrote to the FDA Commissioner advising him to keep implants on the market.

Breast cancer patients were very effective lobbyists, because they had chosen implants to help them cope with the ravages of a potentially fatal disease. Ironically, they were advised to use a feminist argument: women should have “the right to choose” breast implants.

Women with implant problems also attempted to lobby their Congressmen; they pleaded that the FDA should make sure that breast implants were safe. Some even brought photographs of their deformed breasts to convey the seriousness of their problems. However, they were much fewer in number than the pro-implant lobbyists. Many of the ill women had lost their health insurance and their jobs, and had limited resources to come to Washington. Unlike the satisfied implant patients, there was no interested financial entity to pay their airfare and hotel costs.

When the FDA held a public hearing at their advisory committee meeting to determine whether breast implants should be sold despite the lack of safety data, the pro-implant breast cancer patients were once again an effective counterbalance to the very sick implant patients who also testified. The FDA was in the uncomfortable situation of deciding whether to “take away women’s right to choose” implants, or follow their regulations and remove implants from the market because the manufacturers had not conducted sufficient studies to determine whether they were safe.

The FDA seemed poised to keep implants on the market, when a court case unexpectedly turned the tide. In December 1991, several corporate documents were made public by a reporter covering one of the implant lawsuits against Dow Corning. These internal memoranda showed that scientists and salesmen had expressed serious concerns about the implants’ safety, but that Dow had sold the implants anyway and had never made these concerns public. Media coverage was scathing, and the FDA reviewed the newly available information.

In 1992, FDA Commissioner Dr. David Kessler put a temporary moratorium on the sale of silicone gel breast implants. He later limited their use to women with mastectomies or ruptured implants that needed replacement. The eighty percent of customers who merely wanted to increase their breast size were no longer permitted to buy silicone gel implants because of potential risks. However, they could buy saline breast implants, which consist of a silicone envelope containing saline. These implants had also never been tested, but were assumed to be safer than silicone gel.

Since then, researchers have published several epidemiological studies on the safety of silicone implants. Most have not evaluated many of the illnesses and symptoms mentioned by implant patients. Most studies have focused on cancer, scleroderma, and a few other classic autoimmune diseases, and found no statistically significant increase. However, the studies have major shortcomings; for example, most include a few hundred or at most a few thousand women with implants, which is not large enough to study rare diseases like scleroderma, which afflict less than one in 5,000 women. Moreover, most of the studies include many women who have had implants for a few months or years, even though these diseases take many years to develop.

Meanwhile, litigation has become a multi-billion-dollar activity. In 1994, the top four manufacturers (Dow Corning, Bristol-Myers Squibb, Baxter International and 3 M) proposed a $4.3 billion settlement, which the court rejected as insufficient when more than 400,000 women signed up. In 1995, Dow Corning filed for Chapter 11 bankruptcy protection, and was removed from the settlement. After years of renegotiation, Dow’s current proposal of $3.2 billion is expected to be approved. Meanwhile, Dow Corning stopped selling any silicone implants, although they still sell silicone to other implant manufacturers. Since the FDA restricted the use of silicone gel implants, the popularity of saline breast implants increased by 1000 percent to more than 120,000 American women last year.

The Role of Women

Women have not been passive victims in this saga. Women first successfully challenged the conventional wisdom that implants were safe, overcoming their embarrassment to contact me, others in Congress and the media. Celebrities Jenny Jones and Mary McDonough (who played Erin on The Waltons) provided important support to other implant patients by being outspoken in discussing their problems.

Although my boss, the late Rep. Ted Weiss (D-NY), chaired the hearing and investigation and was sometimes criticized as a man interfering with “women’s right to choose breast implants,” a woman conducted the investigation, and he was supported by many women who thanked him for his efforts. Meanwhile, a Congresswoman diagnosed with breast cancer, Rep. Marilyn Lloyd, discovered that the implants her plastic surgeon preferred had become unavailable. Rep. Lloyd enlisted other Congresswomen to oppose the FDA’s regulatory efforts because she was convinced implants were safe and wanted them to be available for herself and for other mastectomy patients.

In the early days of the investigation, women reporters were particularly interested in the safety questions. However, male reporters, at NBC News, The New York Times, and The Montreal Gazette, were most persistent in covering the story during the early 1990s, and they were as outraged as any of the women. In the last few years, media coverage has spun 180 degrees, and most newspaper articles now sound eerily like the corporate spin doctors, dismissing the women’s claims of illness and any research supporting their claims, and declaring instead that there is “no research evidence” that implants cause health problems. Two women, Gina Kolata of The New York Times and Dr. Marcia Angell of The New England Journal of Medicine, have been instrumental in supporting the view that implants are safe, and many reporters have followed their lead.

Between the contradictory positions of the ill women with implants, the conflicting research claims, and multi-billion-dollar settlements, where does the truth lie? Nobody knows for sure, not even the women who will exercise their “right” to choose implants this year.

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