Implant Furor: Health Warning or Hysteria?

For years, Marie Walsh has watched her health deteriorate. She has been plagued by fatigue, abdominal pains, irregular menstrual periods and night sweats.

Then one morning in February, 1984, she awoke to find the front of her nightgown damp with a bloody gel that had oozed from her left breast. A surgeon later found that an implant had ruptured, spilling silicone gel inside the breast cavity. He cleaned out as much gel as he could and put in a new implant.

But Walsh’s problems worsened.

The Laguna Hills woman needed multiple surgeries to replace later implants that hardened uncomfortably and to remove silicone-filled tumors. She developed a variety of debilitating diseases: rheumatoid arthritis that made it painful for her to walk; scleroderma that tightened her skin and made her hollow-eyed; chronic lymph, kidney and liver problems.

“I’m disintegrating,” she says. “It’s just a question of time (as to) what is going to go next.”

Walsh, 44, and her doctor are convinced that silicone gel from the implants has migrated through her body and caused chaos in her immune system.

Earlier this year, Walsh won an $80,000 settlement against the manufacturer of the ruptured breast implant. That publicity has spun her into the center of an emerging nationwide network of women who allege that silicone implants, by far the most popular of breast-augmentation procedures, pose health hazards that are kept secret from consumers.

She and other activists are crashing seminars on breast augmentation, courting newspaper and television reporters and filing lawsuits to draw attention to their claims.

Breast-implant manufacturers and most plastic surgeons say such fears are irrational. They contend the devices’ benefits--primarily boosting a woman’s self-esteem--outweigh the risks, and they say there is no scientific evidence linking breast implants to cancer or diseases that attack the immune system.

Dr. Garry Brody, a clinical professor of plastic surgery at the University of Southern California and chairman of the American Society of Plastic and Reconstructive Surgeons device council, complains that the Command Trust Network, a national women’s educational group, discourages women who would benefit from breast implants by “spreading panic.”

Brody says USC is studying more than 3,000 women in Los Angeles County who have had silicone breast implants. So far he has found that they have no higher incidence of cancer than the general population.

Still, breast implants have become increasingly controversial.

Safety concerns have prompted the U.S. Food and Drug Administration and its Canadian counterpart to call for further investigations and to collect test data from manufacturers.

Critics of breast implants have in their corner a Ralph Nader-founded advocate organization, Public Citizen Health Research Group, which has demanded that implants be taken off the market and has sued the FDA for access to manufacturers’ records.

The stakes are high. An estimated 2 million American women have had breast-implant surgery, which is performed about 130,000 times a year. About 85% of breast implant procedures are done for cosmetic reasons alone; the rest are performed for reconstructions after mastectomy.

Dr. William Shaw, chief of the division of plastic surgery at UCLA Medical Center, says of the controversy: “It could be a bigger problem waiting to be confirmed or a smaller problem with a great deal of hysteria.”

At the center of the controversy are devices that look like sacks, with a rubbery silicone skin and silicone gel filling.

They were designed by two plastic surgeons from Houston who were looking for an alternative to plastic sponge implants. Used since the 1930s, sponge implants often made breasts very hard and frequently caused allergic reactions.

Doctors also injected silicone liquid directly into women’s breasts. In some cases, this caused severe health problems, and the FDA banned the procedure in the early 1960s.

First used in 1963, silicone gel implants have become especially popular in recent years as fashion and films have played up the larger-breasted look. Advertisements in women’s magazines and newspapers have enticed women with the purported ease of the implant procedure, which costs from $2,000 to $5,000.

Silicone gel implants give a natural feeling to the breast; the sack is designed to prevent the gel from getting into tissue.

Soon after its introduction, however, patients began complaining about buildup of scar tissue around the implant, making the breast hard and causing pain. This condition occurs in 30% to 50% of breast-implant patients, many of whom have repeated surgeries to try to correct it.

And it is generally conceded that the implants can hamper efforts to detect breast cancer through mammography.

Of far greater dispute is whether silicone gel, some of which leaks out of all implants, can damage a woman’s health. While the medical community once considered silicone “inert” within the body, more recent research indicates otherwise.

There is also concern about the polyurethane foam that surrounds one type of silicone implant.

The foam, which is intended to reduce scarring, may break down in the body, and some studies have shown that under certain laboratory conditions, the disintegrating foam emits a chemical, diamino toluene (TDA), known to cause cancer in animals.

The FDA is investigating these issues and demanding more information from manufacturers. Before a 1976 FDA amendment, devices such as silicone implants did not require federal approval or testing.

The agency in 1988 determined that silicone gel implants pose “a potential unreasonable risk of injury”; it is still drafting the testing requirements for manufacturers. For now, the implants can be sold without passing any safety tests specified by the FDA.

The FDA acknowledges that even if preliminary tests show the implants are safe, it may be 10 or 15 years before there is enough data to determine whether implants increase the risk of cancer or immune-system diseases.

On Nov. 27, a District of Columbia federal district court ordered the FDA to release documents to Public Citizen Health Research Group from studies performed by Dow Corning Corp. during the last 25 years on the safety of silicone gel used in its implants. Dow is a major manufacturer of silicone gel-filled implants.

Release of the information, however, has been stopped pending Dow’s appeal. The company argues that the test data it gave to the FDA should be kept confidential, away from competitors; the FDA has not decided whether to join Dow Corning in the appeal.

Robert Rylee, a Dow vice president, claims that competitors could use the test information to obtain FDA approval without performing their own expensive and time-consuming tests. Dow maintains it is sufficient for the FDA, “as the guardian of public health,” to have the information.

But Dr. Sidney Wolfe, the Public Citizen director, says he believes the public deserves “a glimpse at what the companies knew 10 or 20 years ago about the toxicity of silicone and silicone gel.”

Despite her lingering illnesses, Marie Walsh still has implants in her breasts.

“Every doctor has told me it won’t make a difference” in her health to remove them at this point, says the mother of eight. But recently, after consulting a new physician, Walsh decided she will have them taken out.

“Her problem is induced by the silicone, and if she takes it out, there is at least a 50% chance that she will improve,” says Dr. Gharoon Panahi, a Westminster rheumatologist. Panahi says he has six other patients with immune-system disorders who have breast implants.

“I’d give anything to have my life back,” says Walsh, who opted for an implant to correct a left breast that never fully developed. “I would rather be flat-chested and have my health and vitality.”

Walsh, who has been forced by ill health to quit a career in securities sales and go on permanent disability, now devotes much energy to organizing an Orange County support group for women with similar problems.

She is assisted by Marsha Chambers, a Tustin woman who contacted Walsh after reading about her legal settlement. Chambers suffers from hepatitis and other ailments that she blames on her implants, which were removed in June.

Together the women placed a tiny ad in a Tustin newspaper. It attracted 40 other women who meet regularly to discuss their health problems and how to warn others about silicone implants.

They have scoured medical libraries for information about implant hazards, and they show up at public seminars on breast augmentation to distribute flyers.

Their group is linked to the Command Trust Network. The network was founded last year by Kathleen Anneken of Covington, Ky., and Sybil Goldrich of Beverly Hills, both of whom had a history of implant-related problems and a desire to reach out to others.

“We decided an organization had to be established to provide the kind of information not routinely given in physicians’ offices, but information that we believed was essential for a woman to make a completely informed decision about what she was putting in her body,” Goldrich says.

She complains that so far only Maryland has enacted state legislation requiring physicians to inform women, through a standardized brochure, of implant risks.

Joseph Arcarese, director of the FDA’s office of training and assistance for medical devices, says that an FDA advisory panel held hearings in 1988 and determined that “patients are poorly informed.”

In response to the panel’s request, he says, the FDA has created committees representing consumers, physicians and the medical industry to write informational pamphlets for women considering breast enlargement or reconstruction after mastectomy.

But so far, Arcarese says, members of the committees, which include representatives of Command Trust Network, can’t agree on the content of the pamphlets, now in their fifth draft.

In addition, a growing number of women with implant problems are suing manufacturers. The Public Citizen Health Research Group is acting as an informational clearinghouse for plaintiffs.

The group estimates that at least 200 product-liability lawsuits are pending against manufacturers of silicone implants.

In 1984, a federal court jury ordered Dow Corning Corp. of Midland, Mich., to pay $1.5 million in punitive damages and $211,000 in actual damages to Maria Stern, a Nevada mastectomy patient whose implants leaked silicone into her body. Before the case was heard on appeal, Stern and Dow settled.

Dan Bolton, a Redwood City attorney who worked on the Stern case, says he has since taken on 10 to 15 cases of women with implant problems. In five of those cases, he says, the plaintiffs have received out-of-court payments to drop the litigation. So far, no cases have gone to trial.

Bolton says that as part of such settlements, manufacturers routinely insist that the payment amount and the plaintiff’s documents be sealed from the public.

Advocates of implant safety say that lawsuits are triggered by greedy lawyers and a small group of hysterical women who are ill and looking for someone to blame.

The American Society of Plastic and Reconstructive Surgeons recently reported the results of a survey of 592 women with implants. It showed that 92.5% were satisfied, and that 82% would, without a doubt, repeat surgery.

And although a Dow Corning study linked silicone to cancerous growths in rats, the company and the FDA agree that the test produced a form of cancer to which humans would not be susceptible.

“There is too much emotionalism that gets into this thing,” says Dow Corning’s Rylee. “What we really need is more understanding and true science.”

Rylee says Dow Corning is trying to develop a national epidemiology study to determine whether there is a link between silicone implants and immune-system disorders. A major difficulty, he says, is that the diseases in question--lupus, scleroderma and rheumatoid arthritis--have always been most prevalent in women ages 20 to 55, the most prominent implant group.

“None of our scientific consultants or internal scientists or physicians have yet been able to show there is a causal relationship,” Rylee says.

The most controversial implants are those covered with polyurethane foam. They are marketed by Surgitek, a Paso Robles subsidiary of Bristol-Myers Squibb Co., the New York-based pharmaceutical and consumer-products giant.

Garry L. Carter, vice president and general manager of Surgitek’s plastic surgery division, says the polyurethane-coated implant “is probably the fastest-growing product in the industry,” representing about 20% of all U.S. implant sales.

However, Dr. Richard Caleel, president of the American Academy of Cosmetic Surgery, says: “There are a lot of cosmetic surgeons who do not use polyurethane-covered implants because they are not sure about what happens to the polyurethane.”

A study by Chris Batish, a biomaterials scientist and professor at the University of Florida, suggested that polyurethane used by Surgitek is not the best choice for medical applications because of its tendency to disintegrate in the body. Once that happens, Batish said in a recent interview, “no one is sure where it goes.”

In addition, Batish said he found that, in the laboratory, he could break the foam into chemical components, including the animal carcinogen TDA.

Surgitek counters that laboratory conditions employed by Batish were harsher than conditions inside the body. The company says other studies that more closely approximate human biology show the foam breaks down very slowly and passes through the body without causing harm.

Surgitek also says its research shows that the amount of TDA produced when the foam disintegrates is medically insignificant.

The Canadian government recently conducted its own laboratory tests on the foam and found no release of TDA, says Irwin Hinberg, acting chief of the research and standards division of the country’s Health Protection Branch.

But, although neither that agency nor the FDA believes there is cause to outlaw polyurethane-coated implants, both advocate more studies.

But a few doctors and scientists say there is more than enough information about implant dangers to raise a red flag.

Dr. Douglas R. Shanklin, a pathologist at the University of Tennessee, calls the silicone implants a disaster waiting to happen. He says some women with implants “go five, 10, 15 years with no problem, and then all hell breaks loose.”

Shanklin says he has seen silicone in tissue taken from the thyroid glands and spleens of women with the implants. “I think they (implants) should be taken off the market pending resolution of these problems,” he says.

He adds that the various immune-system diseases reported by women can be serious: “These are fatal diseases in time. Lupus destroys the kidneys, and scleroderma can affect the heart and lungs.”

Michael Rensch, an assistant professor of engineering mechanics at the University of Nebraska, says he has examined over 500 deflated breast implants. “From all the pain and suffering I have seen, I wouldn’t recommend anyone to use these devices from anyone or any company,” Rensch says.

In the last year, UCLA’s Shaw says he has seen a dozen women with implants who also have arthritis and other immune-system diseases:

“Right now, it is difficult to tell who has severe symptoms from the implants and who would have had them anyway. The causes of the diseases are a mystery. You have to admit it looks awfully suspicious. . . . This is a subject I think should be looked at. We shouldn’t brush these people off.”