Date: Mon, 14 Aug 2000 02:39:34 -0700

To: Recipient List Suppressed:;

~~~ thanks to Kathy Nye for digging this one up for us ~~~

Reality check: Can 400,000 women be wrong?

Ms

New York

Mar 1996

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Authors: Washburn, Jennifer

Abstract:

More than 100,000 of the approximately one million women who have received silicone breast implants are currently ill. Medical research regarding the health hazards of breast implants and the lack of regulation and testing of the implants before they are used are discussed. Copyright Lang Communications, Inc. Mar 1996

Full Text:

In September 1993, Charlotte Mahlum, a waitress from Elko, Nevada, and the mother of two children, sued the Dow Corning Corporation and one of its parent companies, the Dow Chemical Company, alleging that silicone breast implants manufactured by Dow Corning had made her sick. Mahlum, 44 years old, had had the implants put in after a double mastectomy in 1985. Six years later, she developed joint and muscle aches, full-body rashes, and chronic fatigue. Soon afterward, she began to suffer tremors and seizures, and was diagnosed with axonal polyneuropathy, a condition that prevents brain signals from reaching the outermost nerves. At times she suffered fits of uncontrollable shaking, and she eventually lost control of her bowels.

When Mahlum had her implants taken out in 1993, silicone breast implants had been off the market for a year (for all but mastectomy patients), removed by the Food and Drug Administration (FDA), whose commissioner, David Kessler, said at the time, "We know more about the life span of automobile tires than we do about the longevity of breast implants." When Mahlum's surgeon opened up her chest, he discovered that one implant had ruptured, but he was unable to remove all of the gel that had seeped into surrounding tissue. Today, Charlotte Mahlum is still extremely ill.

In May 1995, Dow Corning declared bankruptcy, placing itself beyond the reach of the trial courts. The bankruptcy was announced days after the collapse of the Breast Implant Global Settlement (see page 57), in which implant manufacturers had agreed to compensate the members of a class action suit who claimed to have--or feared the development of--illnesses associated with silicone implants. At least 400,000 women had signed up for the suit, and their numbers were growing.

Mahlum proceeded with her case against Dow Chemical, which owns 50 percent of Dow Corning's stock. Although Dow Chemical never manufactured silicone breast implants, it performed much of the original research and testing on liquid silicone, which makes up 80 to 85 percent of the gel used in Dow Corning implants. On October 30, 1995, a Nevada jury ruled in Mahlum's favor, awarding $14.1 million to her and her husband, $10 million of it in punitive damages. It was one of the highest awards ever granted in a breast implant case. Dow Chemical plans to appeal this ruling.

Although the Mahlum jury had reviewed internal documents that showed that both companies knew liquid silicone was dangerous inside the body, the verdict outraged implant manufacturers, who insist that there is no proven link between silicone implants and disease. It also sparked an outpouring of criticism in the media. "It's the judges' fault," blasted a Wall Street Journal editorial, lamenting that breast implant companies are "paying billions in damages despite a mountain of evidence they didn't do anything wrong." Even advocates of legal reform got into the act, insisting that the case proved that the U.S. legal system is in desperate need of fixing.

More than 100,000 of the approximately one million U.S. women who have received silicone breast implants are currently ill. But the companies and many commentators insist that the autoimmune diseases thousands of women suffer from don't exist. For proof they point to two studies published in the New England Journal of Medicine. The first, by the Mayo Clinic, appeared in 1994. The second came out a year later, reporting on research performed by Harvard University and Brigham and Women's Hospital, which is affiliated with Harvard's medical school. Both say there is no link between silicone breast implants and autoimmune diseases. The studies have been held up as proof that lawyers like Mahlum's are using "junk science" to win large awards at the expense of innocent corporations.

Is that true? Or could two such respected institutions as the Mayo Clinic and Harvard University actually be guilty of practicing shoddy science themselves? Ms. has found, through speaking with doctors, researchers, plaintiffs' lawyers, and the two institutions as well, that there is a great deal wrong with these studies.

Although plastic surgeons have been promising their patients that silicone breast implants are perfectly safe ever since the products became available in 1963, implants were put on the market without long-term testing. But that doesn't mean that no testing was done at all. In a letter to the New York Times, Fredric Ellis and Ernest Hornsby, lawyers for Charlotte Mahlum, stated that "Dow Chemical found out in the 1960s that liquid silicone affected the immune system and central nervous system and could even be effective as an insecticide. Instead of disclosing this research to the scientific community, Dow Chemical concealed the results and entered into secret development agreements with Dow Corning to develop silicone as a drug and as an insecticide." When Dow Corning did report the results of research, it was often far from truthful. In a 1973 article in Medical Instrumentation, Dow reported on a study of four dogs that had been implanted with miniature silicone breast implants. The article only reported the six-month results--that the dogs had suffered some inflammation, but no other adverse effects--since Dow said the results at the end of the study's full two years were the same. But in fact, lawyers for a woman who was suing Dow proved in court that after two years, one dog had died and the others suffered from severe chronic inflammation, thyroiditis, autoimmune response, and spots on the spleen.

Doctors soon began seeing the effects of Dow's decision not to fully disclose the results of silicone testing. Women came to them describing debilitating pain, often in the chest and shoulder. As we now know, within two to four years of receiving a silicone implant, nearly 70 percent of patients suffer capsular contracture, a hardening of the scar tissue around the implant, which squeezes the implant into a hard disk. But as painful and disfiguring as capsular contracture can be, it is not nearly as serious as the danger women face when silicone enters their bodies, either through leakage or implant rupture. In its early literature, Dow Corning said that the implants would last a lifetime, but in reality, many don't make it past 15 years. A study published in Annals of Plastic Surgery in 1994 reported that among women surveyed who had implants for five years or less, 93 percent of the implants were intact. But only 30 percent of implants that were six to 15 years old remained intact. And in 1995, the same journal reported on a study of 300 breast implant patients: 71.3 percent of them had experienced rupture or severe silicone leakage.

Dow Corning knew that gel could leak from its implants and that they had a high rupture rate. In a 1983 company memo, a researcher points out that the safety of implants is based upon the assumption that "ruptures do not occur or are removed quickly when they do occur by additional surgery. Experience has shown this latter assumption to not be accurate...some physicians have noted ruptures...that may go undetected for unknown time periods."

Yet Dow Corning failed to investigate the long-term health consequences of liquid silicone leaking into the body. Other researchers have, and although their research is still in progress, there are some things we do know. Donors have found proof that silicone can travel to internal organs and can settle there. Dr. Douglas Shanklin, a professor of medicine at the University of Tennessee, who has been studying what he believes to be silicone-related disorders for ten years, says he recently saw an implant patient with silicone fluid in her brain and spinal fluid; This woman cannot feel where her feet and hands are, has lost her memory, and cannot keep her balance because her nerve sensors are impaired. "They have been grounded out, just like an electrical wire," says Dr. Shanklin.

According to Shanklin, silicone leaking into the body causes a "cellular immune reaction,' which shows up initially as inflammation. "The body's immune system is trying to get rid of this stuff, but it can't. We can't metabolize silicone." Our immune system doesn't know that and keeps on fighting. "Eventually, after 10, 12, or 14 years, this primary attack...is exhausted. Then the body begins attacking its own cell tissue and organs," resulting in autoimmune disease, says Shanklin. Traditional autoimmune, or connective tissue, diseases include rheumatoid arthritis and lupus.

But Dr. Shanklin and the majority of doctors treating women with implants have found that the women primarily suffer not from traditional autoimmune diseases, but from a specific constellation of problems--including joint pains, skin rashes, numbness, and fatigue--that medicine has never before seen grouped together in this way. Rather than analyze and define what this new syndrome might be, most large-scale studies have concentrated on looking for previously identified diseases--and have rarely found them.

The Harvard/Brigham study, also known as the "Nurses' Study," and the Mayo Clinic study should have changed all that. Considering how much was riding on this research, it is surprising to discover that both studies are full of holes--thanks to problems in design as well as to conflicts of interest.

Neither the Mayo nor the Harvard/Brigham study focused on "atypical" symptoms; The Mayo Clinic looked at 14 isolated symptoms, although researchers believe it is the clustering of these symptoms that indicates silicone disease. The researchers relied on information on medical charts, where symptoms like skin rashes are less likely to have been noted than are firm disease diagnoses. Women in the study were never examined or interviewed by Mayo's researchers, and no attempt was made to inquire about symptoms that weren't on the charts.

The Harvard/Brigham study claims to have looked at a broad range of atypical symptoms, but only women who reported being diagnosed with a traditional connective-tissue disease were given the questionnaire on atypical symptoms. Many women who are severely ill would inevitably have been excluded with this method. (The final count included only 32 women with implants and connective tissue disease.) During questioning under oath, the study's authors admitted that, despite earlier claims, they had, in fact, only examined traditional diseases.

"We're dealing with atypical disorders. Anyone who read the literature going back to the 1970s would have known that you need to look beyond classical diseases," says Dr. Gary Solomon, who is the associate director of rheumatology at the Hospital for Joint Diseases Orthopaedic Institute in New York City. "It is frankly disturbing that these medical studies did not consider this. One can only suspect that this was intentional."

Critics also say that the studies look at too few women to find an increased risk of even the traditional diseases that they were looking for. The Mayo Clinic studied the health records of 749 women with implants (and 1,498 controls). The Harvard researchers chose 1,183 women with implants (876 of them silicone) for their study. But since a traditional autoimmune disease like scleroderma--a fibrotic thickening of skin and vital organs--occurs in only .02 to .04 percent of the population, "to detect even a doubling of the baseline rate of scleroderma, you would need to have at least 30,000 women in your study," explains Dr. Solomon.

And neither study considered a long enough "latency period." Doctors estimate that the average length of time it takes for a woman with implants to begin showing symptoms of illness is eight to ten years. In the Mayo study, women were tracked for a mean of 7.8 years after implantation. The Harvard researchers interviewed women who had had implants for a mean of 9.9 years, but they included women whose implants were only 30 days old. (Even more astonishing, the researchers included one woman who said she'd had her silicone implants nearly 40 years, even though the first implants were not available until 1963--29 years before the study began.) "This is not unlike R. J. Reynolds funding a study that examines people in their thirties, and finding no increased risk of lung cancer," says Dr. Shanna Swan, an epidemiologist at the University of California at Berkeley's School of Public Health. Many doctors believe it may take decades for the full effects of silicone poisoning to appear.

Both studies have also been plagued with conflict of interest charges. Dr. Matthew Liang, for instance, a coauthor of the Harvard study, was paid $2,525 by law firms representing Dow Corning and other manufacturers, for consulting work. Meanwhile, the Mayo study was funded by the National Institutes of Health (NIH) and the Plastic Surgery Educational Foundation (PSEF), which receives funding from implant manufacturers. Part of the $174,000

that PSEF gave the Mayo Clinic came from Dow Corning and two other manufacturers, McGhan Medical and Bristol-Meyers Squibb. The companies say this isn't a problem, that they have "no input on what research the foundation chooses to fund." But documents show that they do influence which studies get money, and sometimes they oversee research. In an August 31, 1990, letter to Abt Associates, a research firm that was hoping to study atypical diseases, foundation president Barrett Noone wrote: "The manufacturer's group in general and Dow Corning in specific were disinclined to behave in a collaborative manner....My colleagues and I are disappointed by their decision not to fund your study." On November 24, 1992, the vice president for research and development at Mentor Corporation, also an implant manufacturer, wrote to the foundation concerning a different study, one the company did want to fund: 'We are in direct contact with these authors and discussing the various aspects of these study plans. As the protocols are finalized, these authors will directly send the final protocol to your organization."

Dow Corning may have had an even more direct hand in the Harvard study. Three months before a questionnaire was sent to participants, researcher Dr. Jorge Sanchez Guerrero provided a copy of the questionnaire to Dow Corning epidemiologists. At press time, Matthew Liang had refused to release information to the courts that could reveal whether the questionnaire was altered to suit Dow Corning.

Given the problems with these studies, is there any research that can clarify the relation between silicone implants and disease? There are, in fact, hundreds of peer-reviewed medical studies that have found that silicone breast implants and their components are dangerous to human health. But these studies, like those of Harvard and Mayo, are not definitive. Nevertheless, they point to areas for concern. At an NIH workshop a year ago, several studies showed evidence of autoimmune problems linked to silicone. One, by Dr. Michael Potter of the National Cancer Institute, found that after being injected with silicone gel as many as 80 percent of mice developed the equivalent of multiple myeloma, a rare cancer that attacks immune system cells.

Another study (not presented at the NIH workshop) that has caused concern is one led by Dr. Shanklin at the University of Tennessee, and a colleague, Dr. David Smalley. Their research indicates that children born to symptomatic women with silicone implants sometimes have the same silicone-specific cellular immune activity as their mothers--i.e., their bodies are fighting a foreign substance that appears to be silicone.

The NIH is finally putting together a large-scale investigation of "atypical disease symptoms," using 18,000 women, 13,000 of whom have implants. In addition, a "Silicone-Related Syndrome Study Group" has been created by members of the American College of Rheumatology (ACR) to define and describe the diseases that some women with implants are suffering from. (The ACR itself is caught in a battle over silicone. At the college's annual meeting in October 1995, its directors announced that implants do not cause rheumatic diseases, claiming that the courts that had ruled in favor of women with implants were relying on "anecdotal evidence." Members of the ACR were furious and demanded that the directors retract their statement, pointing out that 16 out of 18 studies presented at the conference indicated links between implants and certain diseases.)

Some doctors are pinning their hopes on Harvard's "Women's Health Cohort Study," of nearly 400,000 women, but others worry that Dow Corning has also funded this study--to the tune of its full $6.8 million. As it turns out, interim findings from the cohort study (that were leaked to the press in 1995) indicate a 45 to 49 percent increased risk of rheumatoid arthritis among women with silicone implants. Despite these findings, which admittedly could change when the data are fully analyzed, Matthew Liang publicly insists that implants are safe.

Meanwhile, claiming that Americans sue each other too much, the Republican Congress seeks to make it more difficult for the women who have yet to go to court to win their cases against silicone implant manufacturers. Advocates claim they are trying to curb a litigation explosion that is burdening the courts. Yet, according to the National Center for State Courts, tort suits (cases concerning injury or damages) are just 9 percent of all state court filings, and product liability suits are only 4 percent of that. To many analysts, today's tort reform is another case of corporations using their political clout to escape potential liability. And liability is certainly a big issue for both Dow Chemical and Dow Corning.

The Manhattan Institute, a conservative think tank and long-time lobbyer for tort reform, held a conference in Washington last June, featuring Dow Corning's CEO, Richard Hazleton, who took the opportunity to deliver Dow's wish list on reform. First came the "exclusion of biomaterials suppliers from litigation brought against medical device manufacturers." Dow, of course, is a supplier to many implant manufacturers. Next was a cap on punitive damages; under the cap proposed by the Republicans, Charlotte Mahlum--who will be sick for the rest of her life--would not have received much more than $250,000.

Despite Dow's obvious interest in legal reform, much of the media has bought into the company's analysis of the implant crisis. Marcia Angell, the executive editor of the New England Journal of Medicine, wrote an article in The New Republic last year in which she blasted "rapacious attorneys," "well-paid doctors who stretch the science and ethical limits of their profession," and "healthy women" for "responding to the lure of big financial awards."

The New York Times also promotes this interpretation. Gina Kolata, a Times science reporter, pronounced the Harvard study "so compelling...that some leading rheumatologists contend that the issue of whether implants cause these diseases can now be considered closed." What about the women who have been diagnosed with illnesses? Kolata told Ms. that some of them might be responding to "the power of suggestion."

We have been down this road before. Women in real pain going to doctors and being told that it is all in their heads. Women being encouraged to use medical devices that don't function properly and being told these devices are perfectly safe when they aren't. What we haven't had before, certainly not on this scale, is tens of thousands of women who were perfectly healthy being given something that has jeopardized their health. At the same time, women who are in the midst of fighting one devastating disease--breast cancer--are being asked to risk other illnesses. And the time bomb is still ticking. Only about 300,000 women have passed the latency period (half of all women who have received breast implants got them after 1988). There are approximately 700,000 more women who, if they are not sick yet, must wait and watch to see if they will be.

Jennifer Washburn is a Brooklyn-based freelance writer.

I was 29 and had just finished nursing my third child when I found a lump in my right breast. My doctor said, "It's a milk duct." It turned out to be malignant and I had a modified radical mastectomy in September 1987. I had been married for six years. We'd just bought a house. I had gone back to college and my husband had just started a new job. It was a perfect time in our lives, then the cancer came and changed everything. Thoughts run through your mind like, Am I going to see my children grow up?" Cancer is part of my life now. Every time I get a pain, or there's something off with a blood test, it takes me back to 1987. In 1988 I had a prophylactic

mastectomy on my left breast and had silicone implants put in. I love to swim and run, and I knew an external prosthesis was not for me. I wanted to wake up like everybody else and not have to be reminded of that horrible time in my life. My husband said, You don't have to do this." I said, "I know. I'm doing it for me." After the reconstruction, I looked down and there were two again. It was like a present.

The scars never go away, but the reconstruction lessens the impact. You get up and put your clothes on and do thing with the best of them. Nothing in life is perfect People ere allergic to aspirin, penicillin. I believe that women have allergic reactions. I've had the implants in for many years, and something would have happened by now. The life expectancy of an implant is 10 to 15 years. I'm not going to go to the doctor now and say, "Take them out if I don't have any problems. If it ain't broke, don't fix it.

Sylvia Mercado, 38 years old, lives in Fort Worth, Texas

In 1980 I got a divorce after about 20 years of marriage. My husband had made comments after the years about how flat-chested I was. When I met the man I'm now living with, we weren't intimate because I was very self-conscious. As the relationship progressed and I realized we were going to have a life together, I had these

Silicone Implants put in. In no time I was deformed, and that was the end of any intimacy I was going to have. When my boyfriend touched my breasts and they were rock-hard, that did something to him and to me, too. We've hardly had s since. It makes me feel like crying. The second month, the right one started mine up toward mg clavice. The doctor said it was a capsule and tried to break it. He put a fist on either side of my breast and squeezed, but it didn't work. I didn't have any money, so for two years, I wore big sweatshirts to hide the disfigurement I went to a new doctor who said I had to have the implants out I couldn't afford to have both, so he took one out and put in another silicone inplant. He said it would take a car accident to break an implant. But in no time, the new one broke. I tied a bathrobe belt under mg armpits to beep the silicone down, because I didn't have money to get it explanted, but it moved up and stayed there. I went to a doctor who removed the implant, put in another one, and six weeks later it was hard as a brick. I was so despondent, I stopped going back. Eventually I went another surgeon. I had a golf ball-size silicone tumor in my lymph nodes. They told me they would put in silicone implants that would not rupture, but when I woke up, my boyfriend told me they used saline. That was when I figured something was wrong with silicone. The left breast looks like a half-empty water balloon, rippled and pendulous. They don't want to do surgery because the muscles have atrophied. I have nerve damage in both arms. To drive, I can only use one arm, and I had to cut my hair short because I can't handle a blow-dryer because of the pain. I never thought my life could feel so limited. Doris Winn, 53, lives in San Pedro, California

As the number of women who appeared to be suffering complications from silicone breast implants grew, many of their claims were consolidated into a class action suit. To settle the suit, Dow Corning and other manufacturers (including Baxter Healthcare, Bristol-Meyers Squibb, Mentor Corporation, and 3M) agreed in 1994 to establish a fund of $4.25 billion (known as the Breast Implant Global Settlement) that would be used to pay off the approximately 400,000 claims in the suit. But U.S. District Judge Sam C. Pointer announced that the fund was substantially underfunded and would need to be renegotiated.

Faced with the prospect of putting out even more money, Dow Corning declared bankruptcy on May 15, 1995. That declaration froze all litigation against Dow and halted compensation to women who had already won settlements. Yet Dow Corning is hardly broke. In the first quarter of 1995, profits were up 33 percent, to $49.5 million on record sales of $612 million.

Because Dow had manufactured about 80 percent of the gel used in all silicone breast implants, its bankruptcy stopped almost all the implant litigation dead in its tracks until the other manufacturers agreed to create their own settlement with the women who had used their implants. Neither the women nor the courts have yet decided whether to accept this offer.

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Sandy Bussières, Amqui

Membre I.I.M. Inc.

We want to say "Thanks Sandy" for your wonderful work.