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breast implants

Hunter House Inc., Publishers

Chapter One

Whether you are considering getting breast implants, or already have implants and are wondering what to do about them, you might be surprised to learn that breast implants have not been thoroughly tested for safety, and until recently none of them were ever actually approved by the Food and Drug Administration (FDA). In 2000, the FDA officially approved saline-filled implants made by two companies for general use, but many scientists and women's health advocates believe the implants have not been studied thoroughly enough to warrant government approval. For saline- and silicone-gel-filled implants alike, the questions remain: How could women's doctors, whom the women trusted, put something in their bodies that had not actually been proven safe, in neither the short term nor the long term? How did it happen that the regulatory system established to protect us became the focus of what has been dubbed "the implant circus"?

Although the circus has folded its tent, there is still a very large gorilla in the room. The gorilla is the question of safety, but the media chooses to ignore it. Instead of covering the health risks of silicone implants and interviewing women with implants as it did in the early days of the controversy, it has switched its focus to the financial concerns of the implant manufacturers and medical industry.

If you are a current or potential breast-implant "consumer" you have some tough decisions ahead of you. I think the first step in making those decisions is to understand something about the still-unfolding history of breast implants and how we got to this point. It's a story of widely differing motivations, emotional reactions, and opinions among all the players involved: the FDA, the implant manufacturers, the plastic surgeons and other physicians, the attorneys, the consumer-advocate groups, and the millions of women who are caught in the middle-and that means you.

The History of Silicone

Silicone is a synthetic plastic, or polymer, that was first developed in the 1930s. It is made from silicon, a metal-like substance found in nature that when combined with oxygen forms silica. Ordinary beach sand, crystals, and quartz are really silica. When silica is combined with carbon, it forms silicon, and when this is further processed, it becomes polymerized, a process in which simple molecules are combined to form more complex molecules. This polymerized silicon is silicone.

Silicone can be processed into three forms: a fluid, a gel, and a solid rubberlike compound known as an elastomer. In its various forms, silicone has been used for medical purposes for over sixty years. It has been used in artificial joints, pacemakers, artificial heart valves, hypodermic needles, penile and testicular implants, various kinds of tubes, drains, and catheters, lenses used in the eyes, and as a lubricant. Silicone is also used in many items you find around the house-polishes, suntan and hand lotions, antiperspirants, soaps, processed foods, waterproof coatings, chewing gum-even baby formulas and certain nonprescription drugs that aid digestion.

In the late 1940s, physicians began to inject silicone liquid directly into the body to fill out certain parts, including the face to smooth out wrinkles and the breasts to make them larger. But injecting large amounts of silicone caused problems in some women. Some women even died from the injections. Using silicone for this purpose was eventually banned, although some physicians continued the practice.

Early breast implants were made of polyurethane foam, paraffin, steel, and grafts of human tissue. These were unsuccessful, and when the first silicone breast implants became available in the early 1960s, they were hailed as a breakthrough. Although an improvement over the earlier materials, the first silicone implants had problems as well. They were firm, and therefore surgeons were required to make several large surgical incisions to insert them, a practice that often left women with prominent scars.

Gradually, the product improved. With the advent of thinner silicone gel, implants felt softer and looked more natural. They were also quite pliable, so they could be inserted using much smaller incisions.

Before the FDA ruling in 1992 (see page 12), several types of implants were available to all women: silicone-gel-filled implants (the most frequently used type), saline-filled implants, and double-lumen implants (a combination of silicone gel and saline). These are described in greater detail in Chapter 3.

The FDA Enters the Scene

Although breast implants had been available since the early 1960s, it was not until 1976 that Congress gave the FDA authority to regulate implants and other medical devices. At that point breast implants had been in use for some time, so they were simply "grand-fathered." This means they were allowed to remain on the market, even though they had not been subjected to the stringent testing required before approval of brand-new products.

Many other devices and medications were similarly grand-fathered (for example, culture mediums, catheters, pacemaker components, dental materials used in fillings and root canals, the artificial larynx, surgical materials, and artificial eyes), because the FDA felt there was no evidence that they were harmful. The agency's decision was based on the premise that, in general, more is known about the safety of a device that has been in use for some time than about one that is newly developed. The law also gave the FDA authority to go back and require that the manufacturers provide proof that the implants were indeed safe and effective, if it believed there was reason to do so. However, it took the FDA a very long time to decide to take this step.

Implants Get a New Classification

Manufacturers were aware that silicone from implants could "bleed" through the envelope and migrate to other parts of the body. However, it was widely believed that pure, medical-grade silicone was inert, chemically and physically stable during contact with body tissues, did not cause inflammation, was nonallergenic, and had no adverse long-term effects on the body. Thus, the overriding scientific reaction to migrating silicone was: So what?

We know now that as far back as 1978, staffers at the FDA wanted to move implants to another product category-one that required more rigorous testing. The FDA commissioner at that time rejected the idea. However, reports of problems with silicone-gel-filled breast implants-including leaking and rupture, inflammation, and hardening of the breasts-became too numerous to ignore.

By 1982, the FDA had received thousands of such complaints and finally moved the devices to Class III, a more stringent category that requires manufacturers to supply scientific evidence to prove the products are safe, even while leaving them on the market. Meanwhile, reports of other adverse effects heated up the controversy. These included allegations of autoimmune diseases such as rheumatoid arthritis, scleroderma, and lupus erythematosus. Six years later, in 1988, the FDA issued final regulations regarding the reclassification and required manufacturers to submit safety data within thirty months. While the public waited, implants boomed in popularity, and the estimated number of women receiving implants annually climbed to over one hundred thousand.

The Controversy Heats Up

In 1990, Representative Ted Weiss, chairman of the House Subcommittee on Human Resources and Intergovernmental Relations that oversees the FDA, asked the FDA what was taking so long. Hearings were held, and patients and doctors testified about the health problems linked with implants. One of these patients was Sybil Goldrich, who told of body rashes, fever, pain, hardened breasts, and several surgeries to remove and replace her foam-covered implants. (Goldrich went on to form a consumer group, the Command Trust Network, and the manufacturer of her implants eventually stopped making foam-covered implants.) The hearings created a lot of sensational media coverage, and Connie Chung and "60 Minutes" both did exposés. Finally, the FDA issued a formal request for safety data within ninety days, or all silicone implants would be withdrawn from the market.

Nearly ten years after the new classification, the manufacturers submitted their data to the FDA, which had a new commissioner, David Kessler. The FDA assembled a twenty-two-member advisory panel to review the material. The panel consisted of health professionals, consumer representatives, and an industry representative. In November 1991, the advisory panel found that the data were insufficient to establish the safety of the implants and recommended that manufacturers be given more time to collect and submit data. Although concerned, at this point the FDA was insufficiently alarmed to remove the implants from the market.

Meanwhile, an increasing number of women suffering from a variety of conditions began to file lawsuits against implant manufacturers. In November 1991, a California jury awarded a landmark $7.3 million to Mariann Hopkins, who had suffered immune-system problems. Her implants had ruptured, and the jury believed her problems were due to the silicone even though her own doctors testified that her symptoms began before she received her implants. (In August 1994, the U.S. Court of Appeals upheld the $7.3 million verdict.)

The defendant, Dow Corning Wright, was found guilty of fraud and was eventually forced to release internal memos leaked from one of the implant patient trials. These were very damning and showed that staffers at Dow Corning Wright, the largest manufacturer of silicone implants, had doubts about the product's safety as early as 1971 but that these concerns were ignored. There were implications that the company had skimped on premarket testing. "Of the 329 studies by Dow Corning, only a handful (if that many) were conducted on humans," according to Dr. Diana Zuckerman. And, she says, most were engineering studies, for example, stretching the implants to see when they would break; however, implants react differently when placed in the human body which has a temperature of 98.6 degrees Fahrenheit. Robert LeVier, a technical director at Dow, testified that the longest testing period of silicone gel before its new thin-shelled, fluid-gel implant was marketed in 1975 lasted a mere eighty days. In fact, it seemed that a Dow employee ordered the reduction of gel testing from ninety days to eighty days to be able to display the implant at trade shows and plastic-surgeon meetings before June 1975. In addition, LeVier conducted a six-month study in rabbits in 1978, using the stiffer gel used in pre-1975 implants. Even this firmer gel migrated and broke down, and LeVier concluded that humans should not be exposed to free silicone until further studies showed it was safe.

Around the time of the hearing, the American Society of Plastic and Reconstructive Surgeons (ASPRS) mounted a four-million-dollar campaign for "balanced coverage" of the issue; the money was spent on lobbying, advertising, patient education, and research. The ASPRS also conducted a letter-writing effort and brought four hundred women who were satisfied with their implants to Washington to lobby Congress.

The lawsuits, media coverage, and new information heightened the FDA's concern and created even more public hysteria. In January 1992, FDA Commissioner Kessler declared a voluntary moratorium on the distribution and use of silicone-gel implants. In addition, the advisory panel was to meet again after public hearings were held in February 1992 to decide what to do about the implants.

During the deliberation period in 1991 and 1992, the FDA received thousands of letters from women with breast implants. The majority were satisfied, but a small group (112) was not. Among the dissatisfied group, there were four patterns of experiences:

* They had not received enough information before surgery * They were not taken seriously by their doctors when they complained about pain or other symptoms * They had trouble maintaining their usual activities * They had concerns about the future and lack of information

In February 1992, the FDA established a Breast Information Line; it was in operation until July 1992 and responded to forty-one thousand callers. More than 90 percent of the callers were women, and more than 70 percent had breast implants. The information specialists who took the calls reported that half the women sounded upset, sad, fearful, or worried, and a small number sounded angry. Over half said they had physical problems, many of which were associated with autoimmune disease, implant ruptures, hardening of the breasts, and infections.

The Findings of the FDA Advisory Panel

After the February 1992 meeting, the FDA panel felt it still lacked enough information to determine whether silicone implants were safe. The members did conclude that the rupture rate may have been higher than previously thought; that rupture may go undetected in some patients; and that the implants "bleed" small amounts of silicone, but they felt it wasn't clear yet whether this was harmful. Although Dow Corning Wright conducted 329 studies and submitted thirty thousand pages of documents, we still did not know:

* how often saline implants leak * how often implants rupture * how long implants last in the body * how much and how often silicone implants leak * what happens to the escaped gel in the body * how often women with implants suffer adverse effects * to what extent implants interfere with mammography examinations * whether implants increase the risk of developing cancer * the relationship between breast implants and autoimmune and connective-tissue disorders * the best way to detect leaks and ruptures

The FDA's Recommendations

Because of concerns about the lack of information, on 20 February 1992, the advisory panel recommended that breast implants be restricted. On 16 April 1992, the FDA made its official decision, based on the panel's recommendations. Silicone-gel-filled implants remained available only to women who agreed to become part of clinical studies and be closely monitored. They were restricted to women who wanted breast reconstruction after breast cancer surgery, women who had silicone implants that had ruptured and who wanted them replaced, and women with breast deformities. They all had to sign an informed consent form delineating the risks and benefits of implants-something that had not previously been required. Because the FDA considered them to be less risky, saline-filled implants, on the other hand, were allowed to stay on the market and available for both reconstruction and augmentation. The FDA also required prospective (forward-looking) studies to be conducted, but these were slow in getting started, and few and far between. Eight years later the government finally published an FDA study and the two by the National Cancer Institute; these are summarized on page 23.

A Range of Reactions

The implant controversy and the FDA's 1992 ruling received some praise and a lot of criticism, and it stirred up a fascinating stew of emotional reactions and opinions. Patients, consumer advocates, and health professionals differed widely in their reactions to what has been called the biggest medical-device controversy since the furor over the intrauterine Dalkon shield in the 1970s.

Finally, Scientific Studies

Most agreed that it would be wise to finally have reliable scientific information about implants, which would settle the dispute as to whether they were safe and effective or not. In its response to the FDA decision, the National Women's Health Network said it was pleased that the FDA was "formally acknowledging the experimental status of silicone breast implant surgery.... This communicates the serious intent of the FDA to require sound research, and to hold manufacturers and surgeons responsible for providing accurate information about breast implant risks as well as benefits." But opinions differed as to how much more we really needed to know and whether manufacturers would be able or willing to pay for definitive studies.

The FDA Went Too Far

Some feared that because of severe restrictions and all the hoopla about possible adverse effects, silicone implants would disappear, taking a perfectly good device-one that had benefited many women-off the market. Our options would be reduced, these critics concluded, perhaps with little or no reason. Some worried that the concerns about silicone-gel implants would be "distorted" to include saline implants as well.

(Continues...)

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Excerpted from breast implants by Nancy Bruning Copyright © 2002 by Nancy Bruning. Excerpted by permission.
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