The Breast Science Money Can Buy

ItÕs not often that ordinary Americans get to confront a corporate CEO. But two months ago the studio audience of the Oprah Winfrey Show found itself face to face with Richard Hazelton, the CEO of Dow Corning, maker of the silicone gel breast implants that many women believe are making them sick. In May, Dow CorningÑfacing a flood of lawsuits from women with breast implantsÑhad filed for bankruptcy protection. And Hazelton, eager to defend the safety of implants, agreed to appear on Oprah. Hazelton began the show looking calm and confident, but as he came under fire from women in the audience, it quickly became clear that he was out of his element. Slumped uncomfortably in his chair, an anguished expression on his face, Hazelton glanced toward the ceiling and pleaded with the people in the studio and beyond. ÒWe need to keep this discussion on a level that gets beyond the anger,Ó he said, Òbecause what we really need to understand is the facts.ÓLaura Bowden, a 31-year-old organizer of the Illinois-based Breast Implant Information Network, responded to HazeltonÕs plea by explaining the facts of her case. ÒI got implants in 1990,Ó Bowden said. ÒI was always a very healthy woman, never a problem. Four months later a series of problems started.Ó Bowden looked directly at Hazelton. ÒItÕs not an open wound, so you canÕt see the pain. ItÕs like you are dying from the inside out. ... I got them out and I got better.Ó There are thousands of women like Bowden who believe that implants poisoned their bodies from within. Altogether, approximately 400,000 of the 1 million women who received implants have joined a class-action suit against Dow Corning and other implant manufacturers. When the U.S. Food and Drug Administration (FDA) placed a voluntary ban on the devices in 1992, a slew of horror stories appeared about women disabled by leaking silicone. Their disorders ranged from persistent pain to chronic fatigue; in extreme cases, silicone gel appeared to migrate throughout the body, debilitating women to the point that they could scarcely move. But recently, public attention has been shifting away from the stories of women with implants, and onto Ògreedy plaintiffs lawyersÓ who are waging a legal battle against implant makers. Though Hazelton had trouble delivering this message on Oprah, he found a more receptive audience on Capitol Hill. Speaking before the House Committee on Government Reform and Oversight in August, he argued that shoddy anecdotal evidence has been driving the lawsuits against his company. ÒThe story of breast implants,Ó Hazelton charged, Òclearly shows the consequences when the powerful influence of billion-dollar litigation trumps risk evaluations based on science.Ó And there is no denying that Dow Corning, which is jointly owned by Dow Chemical and Corning Inc., has assembled a substantial body of evidence discounting claims that breast implants are causing women to be sick. The company points to no less than 18 studies that it says show there is no link between silicone gel breast implants and a host of illnesses reported by women. Many of these studies were done by some of the nationÕs leading research institutions, and have received respectful play in the media. In June, the New York Times ran a lengthy front-page article arguing that Òthere is no evidence that breast implants are harmful.Ó The article all but indicted trial lawyers for filing claims that had no foundation in scientific research. Just last month, 60 Minutes ran a story on breast implants that excluded interviews with affected woman and focused solely on the attorneys representing them. Recent media coverage creates the unmistakable impression that most research indicates that breast implants are, at worst, a minimal hazard to women.But do breast implants really have a clean bill of health? A critical review of the research shows that many supposedly ÒindependentÓ studies were funded by breast implant makers, including Dow Corning; that many key implant researchers have worked for implant manufacturers; and that design flaws in most of these studies are so severe that they practically predetermined their outcome. The implant industryÕs ability to reframe the controversy over breast implants raises troubling questions about the way scientific research is conducted in the United StatesÑand reveals the willingness of news outlets to uncritically report results from studies that are far from conclusive. The new wave of research boasts an impressive pedigree. Perhaps the most influential study on implants thus far was published this June in the New England Journal of Medicine. The study, conducted by researchers from the Harvard Medical School and Brigham and WomenÕs Hospital in Boston, Òfound no association between breast implants and the connective-tissue diseases and other disorders that were studied.Ó Initiated in 1992, researchers sent questionnaires to 86,318 nurses, 1,183 of whom had silicone gel implants, making this the largest implant study completed to date.ÒThis study should reassure women with breast implants that they are not at substantially increased risk of connective-tissue disease compared to other women,Ó Dr. Matthew Liang, co-author of the study, said at the time. A year earlier, the New England Journal of Medicine published a study conducted at the Mayo Clinic in Rochester, Minn., that looked at 749 women with breast implants, and compared them with 1,498 women who did not have breast implants. Like the Harvard researchers, they had found Òno association between breast implants and the connective-tissue diseases and other disorders that were studied.Ó The mainstream media widely heralded both these studies as compelling proof that silicone implants do not cause illness in women. But few reporters have discussed the serious problems that other researchers have identified in the studies. Perhaps the most significant problem is their time frame. Most researchers who have studied women with implants say that it usually takes 10 years or more for symptoms to develop. In the Mayo Clinic study, women had the implants in for a mean of 7.8 years. In the Harvard study the mean was 9.9 years. ÒItÕs easy to get a negative study; you just look too soon,Ó explains Shanna Swan, an epidemiologist from the University of California at Berkeley School of Public Health. ÒTheir designs are like looking for lung cancer in [smokers] who are in their mid-30s. YouÕre not going to find anything.ÓÒThese things are slowly developing diseases,Ó says Dr. Douglas Shanklin, a pathologist at the University of Tennessee who has been studying implants for the last decade. Since only about a third of all women who have silicone gel implants have had them for more than 10 years (and far fewer have had them for more than 20 years), it is very difficult to gauge their long-term health effects. ÒNeither of the two widely hyped studies lasted long enough,Ó says Shanklin. ÒThey simply werenÕt over a proper time frame to begin to pick up the signs of these diseases.Ó Also, to conduct an accurate study, you have to know what symptoms to look for. According to Shanklin, the researchers at Harvard and the Mayo Clinic Òhave been looking for the wrong diseases.Ó Shanklin notes that both studies look for traditional connective-tissue diseases, such as rheumatoid arthritis and lupus, which, respectively, affect the joints and skin. But Shanklin argues that women with breast implants are reporting illnesses that donÕt fit the standard diagnoses. He believes they are experiencing atypical forms of connective-tissue disease, largely because the body is reacting to the introduction of a foreign substance. Implant-related conditions seem to produce flu-like symptoms, with aches, pains and extreme fatigue. Because these symptoms are associated with a variety of illnesses, they donÕt neatly fit a single diagnosis. The story of Kay Dlugopolski, who now works with the Illinois-based Breast Implant Information Network, is fairly typical. An extremely active person, Dlugopolski regularly biked more than 25 miles. In 1989, she learned she had breast cancer and had a mastectomy, followed by chemotherapy. A few days after her final chemotherapy treatment, Dlugopolski was back riding her bike. Although she limited herself to a few miles at first, Dlugopolski quickly got stronger. In January 1990, Dlugopolski got her first silicone implant. She began biking again in the spring, but by September Dlugopolski could no longer continue. In May, she began to feel sharp pains in the joints of her hands. The pain became so acute that she could no longer grip the handlebars of her bike. She also began to feel shooting pains in her shoulders; her doctor diagnosed rheumatoid arthritis. She got medication for the arthritis, but other health problems, including extreme fatigue, persisted. Her fatigue, and the growing publicity about the hazards of the implants, convinced Dlugopolski to get them removed in 1993. ÒWhen my medical problems started, I hadnÕt even heard about the huge implant settlements,Ó Dlugopolski says. ÒI was looking for answers, a diagnosis, a treatment.Ó Soon after her implants were removed, she began to feel better. Although she takes medication to relieve the pain in her joints, she still feels fatigued much of the time. ÒI feel that I survived cancer only to be plagued by silicone implants now and for the rest of my life,Ó she says.The pattern in cases like DlugopolskiÕs is not unprecedented. According to Swan, ÒUsually when you have a new toxic exposure that the body is not used to, the body responds in new ways, such as toxic shock syndrome caused by DES,Ó a hormone used to prevent miscarriages, which was banned by the FDA in 1971. Swan believes the Harvard and Mayo Clinic studies were fatally flawed because Òresearchers were looking for the traditional connective-tissue diseases, despite the fact that many, many case reports suggest that there is a new disease here.Ó The Harvard and Mayo studies also have their own unique peculiarities that make their results questionable. The Mayo ClinicÕs control group consisted of other patients at the clinic, who were clearly more likely than healthy subjects to have diseases similar to those afflicting women with implants. In fact, three of the 10 women with connective-tissue disease in the non-breast implant control group had ankylosing spondylitis, an extremely rare inherited disease. Having these women in the control group skewed the comparison to women with implants. Meanwhile, the Harvard study, which many journalists have touted as the definitive word on silicone gel implants, has its own serious oversights. Of the 1,183 women with implants who were included in the study, only 876 had silicone gel implants; 307 of the women had implants made with saline or other substances. Why these 307 women were included in the study is a question that has puzzled many critics. Unfortunately, the lead researchers from the Harvard and Mayo studies are no longer responding to media queries about their work. They say the publicity has resulted in harassment from plaintiffs lawyers. The researchers have complained that the attorneys have launched spurious attacks on their methodology and unfairly questioned their ties to Dow Corning and other implant manufacturers. But a close examination of their links to implant makers suggests the charges have substance. The Mayo Clinic study was funded in part by the Plastic Surgeons Education Foundation, a group that receives funding from breast implant manufacturers, including Dow Corning. In addition, Mayo researchers did not disclose that the Mayo Foundation, which runs the clinic, was a defendant in a silicone gel breast implant case when the study was published. The Harvard study was funded by the National Institutes of Health. But it, too, suffered from significant, if less immediately obvious, conflicts of interest. Three of the studyÕs six authors, Dr. Jorge Sanchez-Guerrero, Dr. Graham Colditz and Dr. Matthew Liang, were either personally receiving money from breast implant manufacturers for their work on other studies, or had agreed to act as consultants for implant makers while the study was under way. In late 1994, Dr. Liang resigned from a second study on implants because he felt his work as a paid consultant for Dow Corning created Òthe appearance of a conflict of interest.Ó That study, known as the WomenÕs Cohort Study, was funded directly by Dow Corning, which had contributed $6.2 million to Brigham and WomenÕs Hospital. Implant activists and plaintiffs attorneys are alleging that many of the same conflicts of interest exist in the WomenÕs Cohort Study. Only this time, they argue that the implant industry is burying unfavorable test results: The studyÕs 1993 interim findings, which analyzed some 212,500 women, disclosed that women with implants might be up to 59 percent more likely to develop rheumatoid arthritis than women without implants. Although the study is designed to add another 200,000 women, the 1993 interim report examines by far the largest number of women yet to be studied. Because the research is still ongoing, Dow Corning will not comment on the interim findings. The study is expected to be completed in early 1996. The research institutions offer only guarded comment on the study. ÒThat was an interim report based on only half the sample,Ó says Brigham and WomenÕs Hospital spokeswoman Terri Hornbach-Torres. ÒOnce the study is complete, the numbers could reverse themselves. ItÕs misleading to take that information and to assume that thatÕs credible scientific information.Ó Not surprisingly, many implant activists are skeptical about Dow CorningÕs involvement in the study. Hornbach-Torres admits that Dow Corning looked at the questionnaire being used in the WomenÕs Cohort study before it was sent out to women, but she insists that the company has Òno influence over that protocol at all.Ó Mainstream media coverage notwithstanding, the Harvard and Mayo studies are, fortunately, not the last word in implant research. Other, more independent, studies have taken a dramatically different approach to the researchÑand have begun to identify a suggestive link between silicone implants and illnesses. Harvard and Mayo researchers conducted broad epidemiological studies that presumed women with implants would only be suffering from a few specific diseases. But researchers such as the University of TennesseeÕs Shanklin have directly studied women who have implants to determine how the body is reacting to the silicone. Shanklin and a colleague at Tennessee, Dr. David Smalley, have published several important studies in peer-reviewed journals this year describing this reaction. Their article in a recent issue of the International Journal of Occupational Medicine and Toxicology looked at 50 women with silicone implants. All 50 had developed an immune response to silicone not found in women without implants. Dr. Nir Kossovsky, at the University of California at Los Angeles, has found anti-silicone-specific antibodies in women with implants. Dr. Kossovsky, who has been studying silicone since 1981, has researched how silicone reacts with proteins in the body and causes a change in their structure. These abnormal proteins stimulate the antibody. Kossovsky believes that Òwe have enough data to state that silicone causes disease in women.Ó But he admits that the research is still incomplete. ÒThe science is rudimentary in connecting clinical conditions to the expected epidemiological phenomenon. It is on that basis that the debate falls.Ó Even so, a workshop on silicone immunology sponsored by the National Institutes of Health in March disclosed results that seemed to bear out the findings of Shanklin and Kossovsky. Ninety percent of the studies presented at the workshop found evidence of immunological problems linked to the implantation of silicone devices. The risks suggested by these studies become explosive for implant manufacturers when viewed alongside research indicating that implants leak much more frequently than their makers have maintained. The 1972 insert for Dow Corning breast implants claimed that the implants should last a lifetime. ÒHowever,Ó the insert warned, Òsince no mammary prosthesis has been implanted for a full lifespan it is impossible to give an unequivocal answer.Ó Currently, Dow Corning is reporting that the rupture rate for implants is less than 5 percent. However, Dr. Gordon Robinson, a plastic surgeon from Birmingham, Ala., recently conducted a study examining the removed breast implants from 300 patients. In this sample, a remarkable 71.3 percent of the patients had either a full rupture or partial leak or both, in one or both of their implants. Of the 592 implants removed from the 300 patients, 63.5 percent had severely ruptured or begun leaking. ÒWe found that the implants wear out, and in a very predictable time frame,Ó Dr. Robinson says. ÒI think thereÕs no question about it. At eight years, roughly 80 percent of them are OK. At 14 years, roughly 80 percent of them had a disruption on one side or the other. After 20 years, basically everybody has problems.Ó Similar studies have produced similar results. A 1993 study in the journal Plastic and Reconstructive Surgery found that women who had implants for 1 to 9 years experienced a 35.7 percent rupture rate, and in implants that had been in place for 10 to 17 years, 95.7 percent had either ruptured or were leaking silicone. Another study in 1994, published in the Annals of Plastic Surgery, found that 25 percent had ruptured in the first 10 years, and 53 percent in the first 25 years. Even Stephanie Burns, Dow CorningÕs scientific liaison to the FDA, admits that once the silicone leaks, it Òcan migrate.Ó Dr. Shanklin has autopsied women where he found remnants of silicone in the brain, the wrist and even the knee. Some the most damning studies concerning silicone implants have come from within the implant industry itself. According to recent court documents, Dow Chemical conducted hundreds of tests on laboratory animals in the Õ50s proving that silicone causes adverse health effects. Unpublished Dow Corning studies uncovered by the FDA in the late Õ80s showed cancerous tumors appearing in rats when implanted with silicone. This research, like all the other Dow Corning and Dow Chemical studies, was never published. Rep. James Traficant (D-OH) noted many of these internal studies when he called on the Justice Department in June to investigate whether Dow Corning officials had perjured themselves during testimony before Congress in December 1990. Company officials had claimed under oath that Dow Corning had not suppressed information on the dangers of silicone implants. The Justice Department is currently looking at TraficantÕs allegations, although they have not officially opened an investigation. A five-year statute of limitations governs the charge of perjury before Congress, so the Justice Department will have to take action by December.Action on the scientific front, however, may be picking up. The National Cancer Institute has just begun the biggest epidemiological study to date, involving some 9,000 women who have had their implants for at least 10 years. The study will look at a number of health effects, including connective-tissue disease. And the American College of Rheumatology (ACR), a professional group of doctors who study and treat connective-tissue disorders, has set up a special ÒSilicone-Related Disorders Study GroupÓ to better define what symptoms these women are experiencing. Once this set of criteria is established, it will provide a guide for future epidemiological studies of silicone implants. Even within the college, however, many researchers remain hostile to the idea that implants are causing illness. In late October at the collegeÕs annual meeting in San Francisco, the ACRÕs directors issued a statement claiming that existing evidence clearly shows that implants do not cause rheumatic diseases. The directors blasted the FDA and the court system for relying on anecdotal evidence. But other rheumatologists at the conference blasted back. Critics noted that 16 of 18 implant studies presented at the conference indicated that there are links between implants and certain illnesses in women. But many women with implants are not waiting for the results from future scientific studies. Using a number of unorthodox tactics, they have banded together to fight Dow Corning and other implant manufacturers. In a September meeting with Justice Department officials concerning TraficantÕs allegations, one woman stood up and lifted up her shirt to show a group of stunned Justice Department lawyers the criss-cross of scars that disfigured her chest after her ruptured implants were removed. On September 18, hundreds of women rallied outside Congress and called for a boycott of products manufactured by implant makers. The women urged the public to boycott all products made by Dow Chemical and Corning Inc., 3M and Bristol-Myers Squibb. ÒThis is about corporate responsibility,Ó said Suzie Cunningham, an Ohio breast implant activist. ÒWe are going to use our consumer voice until [implant manufacturers] accept that.Ó According to Christy Warshaw, of the Silicone Alliance Network for Education, an estimated 150 support groups involving some 70,000 American women are building a network to put pressure on the implant industry. Representatives from many of these groups are going to meet in Chicago next month to try and better coordinate their efforts. So far, Dow Corning has tried to avoid open confrontation with these organizations. As Hazelton told Oprah, ÒWe are sensitive to women who are ill, and to their concerns, to their sincerely held beliefs about our product, and, yes, to their anger. At the same time we believe, based on sound science, in our product. ... It becomes very difficult to try to communicate that, particularly in an atmosphere driven by fear and anger.Ó But Peggy Pardo, of the Breast Implant Information Network, says, ÒWe have every right to be angry and fearful of the future. ... There are tons and tons of women who are sick, and are continuing to get sick. He wants us to go away, and weÕre not.Ó

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