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A History of Breast Implants

Small-breasted women in America say that they feel inferior or unfeminine in a culture where breast size is a major issue. Popular fashion models today are usually thin, but large-breasted, especially those who model lingerie, evening wear and swimsuits.

The explosive popularity of breast implants over the past three decades has waned recently, however, as a result of a growing controversy over their safety. Are breast implants dangerous? Do they cause otherwise healthy women to become ill? Or are they a safe option for women who either lose a breast to cancer or simply want to change the way they look?

There are two main kinds of breast implants--those filled with silicone gel and those filled with saline (a salt-water solution) enclosed in a hard silicone shell. While critics contend that implants pose a threat to women's health, defenders insist that no cause and effect relationship has been established between implants and disease.

A recent study, published in the New England Journal of Medicine (June 22, 1995), supports the position that implants are safe. But the U.S. Food and Drug Administration (FDA) (5600 Fishers Lane, Rockville, Md. 20857; 301/443-3285), citing safety concerns, in January 1992 placed a voluntary ban on the sale of silicone-gel breast implants. The ban remains in force today, amidst conflicting reports from scientists and medical professionals as to the safety of the implants.

Why Women Want Breast Implants

A 1986 Psychology Today survey found that one-third of American women were unhappy with the size of their breasts. For many women, personal body image and self-esteem are closely intertwined. Young women are bombarded with images of the "perfect" female body--often the sort of body they feel that men most admire and covet, and a standard that is nearly impossible to meet. Many girls first become body-conscious during adolescence, when they notice changes in their breast sizes; some women remain determined, often because of a lingering lack of self-esteem or confidence, to seek through breast augmentation what they consider to be perfection.

Eighty percent of women who seek breast implants do so for cosmetic reasons--they want to have larger breasts. The remaining 20% seek breast reconstruction after they have had a mastectomy (breast removal) due to cancer. Many breast-cancer survivors suffer significant psychological trauma at the loss of a breast, and breast implants are a crucial element in making the women feel whole again.

Despite the thousands of women who say they have encountered problems with implants, 90% of women who have had breast-augmentation surgery are satisfied with the results, according to a 1990 survey conducted by the American Society of Plastic and Reconstructive Surgeons (ASPRS) (444 East Algonquin Rd., Arlington Heights, Ill., 60005; 708/228-9900).

What Are the Dangers?

There are certain undisputed hazards associated with breast implants, and manufacturers say they have been clear about them. Among the risks outlined by implant makers: implants can rupture or leak, tissue around implants can harden, cause pain and change the breast's appearance (a condition called "capsular contracture"), and implants can interfere with doctors' ability to detect tumors.

In addition to these dangers, there has been fear--although unsubstantiated to date--that breast implants can cause cancer. In fact, only one type of implant, formerly made by Bristol-Myers Squibb Co., has been linked to cancer, and that implant was withdrawn from the market in 1991. The FDA now says the risk of getting cancer from that implant is one in one million, and not worth the risk of having the implant removed. [See 1995 Breast Implants and Cancer]

The health debate has centered on the effects of silicone gel on the human immune system. Patients and their doctors allege that silicone implants have caused serious autoimmune diseases. An autoimmune disease is one in which the body's immune system attacks its own cells. The implants are alleged to have caused a number of illnesses, including scleroderma (a hardening of the skin and inner organs, which can be fatal), lupus erythematosus (a disease characterized by inflammation of skin, joints, lungs or kidneys), and rheumatoid arthritis (chronic joint inflammation). The symptoms described by affected women include fatigue, aching joints, rashes and swollen lymph nodes. Some women who have had their implants removed say their symptoms have vanished and they feel perfectly healthy again, while others claim that the symptoms have not disappeared. [See 1995 Silicone's Link to Scleroderma]

Implant manufacturers and plastic surgeons insist that implants are safe. After several studies, the scientific establishment has found no connection between silicone-gel breast implants and these diseases, and even the American Medical Association (AMA) (515 No. State Street, Chicago, Ill. 60610; 312/464-4818) says it's time the FDA lifted the ban. Those who believe that implants play a causative role in disease, such as Dr. Sidney M. Wolfe of the advocacy organization Public Citizen Health Research Group (215 Pennsylvania Avenue S.E., Washington, D.C., 20003; 202/546-4996), complain that the studies have been flawed-- they have not looked at the right indicators for disease, they have looked at too few women and they have been funded by partisan groups who could influence their outcomes. Wolfe and his supporters want the FDA ban to stay in place.

The Role of Lawsuits

Although no scientific study has proven that implants cause disease, the nation's court system has been generally sympathetic to women who claim ill health from silicone. The reputation of implants has been tarnished, perhaps permanently, by the fact that women have been awarded millions of dollars in damages by various judges and juries. In the largest single award to date, Pamela Jean Johnson, of Houston, Texas, was awarded $25 million in damages by a Texas state court in January 1993. Johnson had sued implant-maker Bristol-Myers, alleging that she contracted an autoimmune disease from leaking silicone-gel breast implants.

Dr. Marcia Angell, executive editor of the New England Journal of Medicine, noted in a June 16, 1994 editorial that "the accumulated weight of anecdotes" offered in implant lawsuits and out-of-court settlements has been "accepted by courts and the public as nearly incontrovertible evidence" that implants are hazardous.

The FDA's decision to take silicone-gel breast implants off the market has also contributed to the public's perception that implants are dangerous. On Jan. 6, 1992, the FDA placed a temporary ban on the sale of breast implants. FDA Commissioner David A. Kessler said that new information had placed their safety in doubt: an increasing number of doctors had reported autoimmune and connective-tissue disorders (a subset of autoimmune diseases that primarily affect joint tissue) among breast implant patients, and documents had surfaced suggesting that manufacturers had long had safety concerns about implants. In short, the FDA felt it lacked the data to prove breast implants were safe.

Since the ban, demand for implants has "dropped precipitously," according to Dr. Neal Handel, a plastic surgeon at the Breast Center (14624 Sherman Way, Suite 600, Van Nuys, Calif. 91405; 818/787-9911). Trial lawyers reported hundreds of suits filed on the day the FDA announced the moratorium; the agency's move lent credibility to legal claims that breast implants are unsafe.

The documents Kessler cited when announcing the ban were internal memos from Dow Corning Corp. (2200 West Salzburg Rd., Auburn, Mich. 48611; 517/496-4000), a company that until recently was a leading implant maker. The data were introduced as evidence in a suit filed against the company by a San Francisco, Calif. woman, Mariann Hopkins. Hopkins held that her silicone breast implants had ruptured and damaged her immune system. The case resulted in a $7.3 million verdict in Hopkins' favor in December 1991, with the jury finding Dow Corning guilty of failing to disclose dangers it knew about. In one particularly damaging memo, a scientist at the company wrote, "To my knowledge, we have no valid long-term implant data to substantiate the safety of gel for long-term implant use." Dow Corning explained the memo as part of "an airing of differences of opinion, not a consensus of scientists."

Worldwide Class-Action Suit

Although Dow Corning ceased production of silicone-gel breast implants in March 1992, the company was forced into bankruptcy, in May 1995, by a worldwide class-action lawsuit resulting in the largest product liability settlement in U.S. history. In September 1994, U.S. District Judge Sam C. Pointer settled on the amount of $4.25 billion to be paid out over 30 years to women who claimed implants caused them health problems. Dow Corning was to pay out $2 billion, with the rest of the money coming from eight other implant-makers.

By May 1995, more than 400,000 women had registered to join the class-action suit, a number so large that Judge Pointer ruled the previously agreed-upon settlement insufficient to pay the claims and ordered the parties to renegotiate. An estimated 7,000 women are expected to file independent suits against manufacturers. Citing huge litigation costs, Dow Corning filed for bankruptcy.

History of Implants

Researchers Frank Gerrow and Thomas Cronin, who eventually worked for Dow Corning, created the first silicone-gel breast implant in 1962; it went on the market that year. In 1969, saline-filled breast implants were introduced. It was not until 1976 that the FDA assumed responsibility for medical devices, under the Medical Device Amendments to the Food, Drug, and Cosmetic Act. Products already on the market at that time, including breast implants, were assumed to be safe, or "grandfathered in." It was understood that the FDA would later require manufacturers to supply safety and effectiveness data for grandfathered devices.

In the 1970s, Dr. John Heggers of the University of Texas's medical school in Galveston, Texas conducted tests linking silicone-gel implants with human immune response. His research showed that the human immune system reacted to a silicone-gel breast implant by making antibodies against it. Antibodies are part of the body's immune system; they attack or neutralize what they recognize as foreign substances in the body. Heggers' antibodies attacked both the implant and cells of the body associated with it, creating a classic autoimmune response (this occurs when the body's immune system attacks its own cells). Heggers wrote and spoke to Dow Corning in 1978, suggesting that scientists there look at his research, but the manufacturer declined. The same year, Dr. Robert LeVier of Dow Corning informed the FDA that studies should be done to determine risks to women who received implants.

In 1982, the FDA took the first step toward investigating breast implants, proposing that silicone-gel implants be considered Class III devices, which meant that manufacturers were required to submit data on their safety. Six years later, the FDA finalized that decision. In April 1991, the agency notified silicone-gel implant manufacturers that they would have to submit safety data by July of that year. After reviewing the manufacturers' information, the FDA gathered an advisory panel in November 1991 to hear testimony for and against the use of breast implants. The panel reached two main conclusions: that the safety data submitted by manufacturers were not satisfactory, and that there was a demonstrated need for breast implants to stay on the market while better data were amassed.

On January 6, 1992, FDA Commissioner Kessler asked for a temporary moratorium on the sale of breast implants until more conclusive research could be conducted. This move was followed by the announcement on April 16, 1992 that breast implants would be made available, but only under strictly limited circumstances. "We know more about the life span of automobile tires than we do about the longevity of breast implants," Kessler said at a news conference. "These are not approved devices, and any women who wants one will have to be in clinical studies."

According to the FDA's new policy, women who need breast reconstruction surgery and women whose implants have ruptured can receive implants, but they have to participate in closely monitored follow-up studies. A limited number of women are eligible to receive implants for breast augmentation--only the minimum amount required for study. As a result, only two manufacturers, Mentor Corp. (5425 Hollister Ave., Santa Barbara, Calif. 93111; 805/681-6000) and McGhan Medical Corp. (700 Ward Drive, Santa Barbara, Calif. 93111; 805/883-6761) continue to sell implants.
Saline Implants Investigated

In January 1994, the FDA notified makers of saline-filled breast implants that they would have to submit data demonstrating their devices' safety. The FDA held hearings on saline-filled breast implants in June of 1994, listening to advocates for and against their use. On August 4, 1994, Dr. Wolfe of Public Citizen Health Research Group urged the FDA to ban saline implants until their safety could be proven. But the FDA has not moved to ban saline implants and still awaits safety data from manufacturers.
Reaction to the Ban

The FDA's decision to limit the use of silicone breast implants has been criticized from all sides. Consumer safety advocates say that until breast implants are proven safe, the FDA shouldn't let women have them at all. Those who want to make implants available say that women should be able to evaluate the risks involved and make their own decision about whether to get implants. Kessler explained the FDA's decision in the June 18, 1992, issue of the New England Journal of Medicine. He wrote that the FDA was bound to require manufacturers to prove their products safe and effective. Responding to charges that women ought to be able to decide for themselves whether implants are too risky, he wrote: "'Caveat emptor' ['Let the buyer beware'] has never been--and will never be--the philosophy at the FDA."

In the November 30, 1993 issue of the Journal of the American Medical Association, the AMA criticized the government's ban on silicone breast implants, and urged the FDA to make them available. In the article, the association's Council on Scientific Affairs acknowledged safety concerns about implants, but concluded that the benefits--often psychological--of receiving implants outweighed the risks. FDA head Kessler called the AMA's position "insupportable," and said that its recommendation that the FDA lift the ban was an "abrogation of responsibility on the part of physicians."
Debate over Implant Safety

On one side of the argument over breast implant safety are the more than 400,000 women who have filed suits against breast-implant manufacturers, the women's doctors and lawyers, and consumer safety advocates. This group contends that breast implants are a health hazard. On the other side are implant makers, plastic surgeons and the majority of the scientific community, who say there is no evidence to support the allegations that implants cause disease.

Two recent studies published in the New England Journal of Medicine, one on June 16, 1994 and one on June 22, 1995, support the case for implant safety. The more recent study, conducted by doctors at Harvard Medical School, Brigham and Women's Hospital, and the Harvard School of Public Health, all located in Boston, Mass., found no evidence that implants caused connective-tissue diseases such as rheumatoid arthritis, systemic lupus erythematosus and systemic sclerosis (severe scleroderma). The Harvard findings reaffirmed the results of a study done at the Mayo Clinic, in Rochester, Minn., published in June 1994. That investigation had been the first to find no causative link between breast implants and connective-tissue illnesses.

But doctors who question breast implant safety have problems with these and earlier studies. Some say that women with breast implants have a new, unidentified disease the studies didn't look for. Some question the research methods behind the findings. And some maintain that the findings are suspect because implant manufacturers and plastic surgeons have funded much of the available research on implants.

'Silicone Disease' Considered

Critics of the Harvard and Mayo Clinic studies have asserted that study investigators only considered "classic" immune-system diseases, and did not take into account the diffuse group of symptoms sometimes reported by women with silicone implants. They suggest that there may be a new "silicone disease" with different characteristics than those associated with traditional connective-tissue diseases.

Dr. Gary Solomon, associate director for rheumatology at the Hospital for Joint Disease Orthopedic Institute in New York City, finds fault with the Harvard study. First, he says, investigators looked only at patients' charts, and not at patients themselves, which could result in symptoms of atypical connective-tissue disease being missed. Secondly, he says, women with breast implants have symptoms that the study didn't look for at all, including chronic fatigue, pain in joints or muscles and high levels of antibodies, which would indicate an activated immune system.

Scientists who disagree with Solomon say that the existence of common symptoms in women with breast implants does not mean there is a new disease. Much of the breast implant litigation over the past five years has rested on plaintiffs' complaints of various aches and pains, fatigue, insomnia, headaches and memory loss, symptoms critics say are too frequently occurring in the population at large to prove anything.

Dr. George Erlich, a rheumatologist who heads the arthritis advisory committee to the FDA, distrusts the "new disease" diagnosis. "Vague clusters of symptoms bother me," he told the New York Times (June 22, 1995). Erlich reasons that once women with implants hear a list of possible symptoms associated with a new "silicone disease," they may believe that since they share the symptoms, they have it too. Erlich says that although he doesn't think women are lying, "I can't find anything to convince me that this new disease exists."
Study Methods Questioned

Critics of breast implants point out that like the 1995 Harvard study, the 1994 Mayo Clinic study was based on reviews of medical charts, rather than on doctor's examinations of patients. Another criticism of the Mayo study concerned the groups of women it examined. Some doctors allege that the women who made up the implant group (749 women) were healthy to start with, while women in the nonimplant group (1,498 women) had originally gone to see a doctor because they were sick.

Joanne Mott, a staff attorney for Public Citizen Health Research Group, complains that the Mayo Clinic study was far too small to have reached any real conclusions about whether breast implants do harm. Mott says that the findings, based on a group of 749 women with implants, had only a 30% chance of detecting a statistically significant increase in disease among them. To get results with an 80% chance of accuracy, she says, the group of women with implants would have had to number 2,589.

What's more, Mott says, the Mayo study didn't follow the women long enough. The study tracked women with implants for a mean of 7.8 years. Mott says many women do not notice symptoms of illness until they have had implants in place for 10 to 15 years.

The Mayo Clinic researchers admitted their population study was too small to detect all of the problems linked to breast implants, and that they couldn't prove breast implants had no adverse affects.
Objectivity Issues Raised

Many who doubt the safety of breast implants point to the funding behind certain studies, suggesting that research paid for by the implant industry cannot be trusted. Dow Corning sponsored a University of Michigan study, published in 1994, that found no link between breast implants and the development of scleroderma. The Mayo Clinic study, influential because it was the first to suggest that there is no link between breast implants and connective-tissue disease, was funded in part by the Plastic Surgery Educational Foundation, a unit of the American Society for Plastic and Reconstructive Surgeons. The ASPRS had actively lobbied the FDA to keep implants on the market.

Researchers for both the University of Michigan and Mayo Clinic studies insist that industry donors did not influence their work. The director of the University of Michigan study, Dr. David Schottenfeld, told the New York Times (May 29, 1994) that he was contractually allowed to publish his findings no matter what they were. He added that he felt that Dow Corning should pay for research on the effects of its product.

Silicone Research Ongoing

Scientists and medical professionals will continue to investigate the role of breast implants, and the role of silicone, in the development of disease. An important study published in the August 29, 1992 issue of the British medical journal Lancet pointed to silicone as a trigger of immune response in humans. The authors, Dr. Randall Goldblum and Dr. John Heggers of the University of Texas, reported that two children with silicone-coated tubes implanted reacted severely to the implants, and actually produced antibodies to silicone. Dr. Noel Rose, chairman of the department of immunology and infectious diseases at the Johns Hopkins School of Hygiene and Public Health in Baltimore, Md., called the study "thought-provoking because it is contrary to what many scientists thought, indicating that silicone can elicit an antibody response." According to Dr. Eric Gershwin, chief of rheumatology at the University of California at Davis, "reasonable people are not asking whether silicone causes disease, but how often."

With the future of breast implants resting on the outcome of more studies like these, controversy over the existing research is inevitable. Scientists who argue for and against the use of silicone-gel implants agree that the only way to determine their long-term safety is to follow two groups of women--with and without breast implants--for several years, and to closely monitor the symptoms experienced by the two groups.

The current situation--hundreds of thousands of women claiming injury with no hard scientific evidence to substantiate their claims--has understandably frustrated the medical and scientific communities. But the women and their health problems cannot be ignored. Steven R. Weiner, an associate professor of medicine at the University of California at Davis, says, "I've been treating these women since 1981, before the lawyers showed up. All the epidemiology in the world doesn't make the patients go away."

Sources:

Angell, M. "Breast Implants--Protection or Paternalism?" New England Journal of Medicine (June 16, 1992).

Associated Press. "Silicone Triggers Immune Reaction." Washington Post (August 28, 1992).

Associated Press. "Further U.S. Ban on Breast Implants is Urged." New York Times (August 5, 1994).

Associated Press. "Judge Asks Lawyers to Renegotiate Breast Implant Suit." New York Times (August 2, 1995).