This appeared in the Salt Lake City Event. We were not provided with a date: If anyone can provide us with an orig. please forward.

TDN

It all started in the Baby Boomer era when Japanese prostitutes began searching for a way to enlarge their breasts, the better to appeal to American GIs stationed in Asia. Japanese physicians complied and they learned how to inject liquid silicone directly into their patients' breast tissue. Hollywood starlets and Las Vegas showgirls got wind of the technique, and (presumably for similar reasons) got their bosoms injected as well. Problems with silicone leaching into breast tissue and being marched around the body by blood and lymphatic fluid spurred physicians to new heights of creativity. Instead of simply dropping the technique, they began to add substances such as oil to the silicone mixture. Their reasoning? The foreign oil would precipitate a tissue reaction: the body would produce a capsule of scar tissue that would wall off the silicone and prevent its migration. About 50,000 women in this country underwent the procedure with its attendant side effects-migrating silicone and the scar-producing additives the mix contained produced lumps called granulomas, caused deformity (as well as asymmetry if the silicone migrated from one breast but not the other), illness, and death.

Using good old American know-how, the Dow Corning Company devised what it thought would be a better alternative, and in 1962, produced the first silicone gel breast implant. Although the injection of liquid silicone into a human body is now illegal, at that time neither the injections nor the implants were subject to government regulations. Which meant that in order to be marketed, no company producing the materials or practitioner providing them needed to produce data about their safety and effectiveness. Not until 1976 did legislation go into effect that would require the Food and Drug Administration to regulate medical devices, into which category the implants fell. And regulation would mean that the FDA might one day request safety data. Initially, however, the implants were "grandfathered" into the market along with other medical devices without their manufacturers being forced to provide safety data. The FDA's assumption was that, if these devices had been used for many years without incident, there was no reason to exclude them >from the market.

In the case of implants, this turned out to be a weak assumption. Reports began to surface about devastating local complications-leakage of silicone from an implanted woman's nipple, for instance, or severe scarring-as well as systemic effects-muscle and joint pain, granuloma formation, even neurological symptoms. The companies (Dow Corning had now been joined in this lucrative market by Mentor, McGhan, Surgitek, Bristol-Meyers-Squibb and others) responded not by examining these claims in any sort of systematic way but by trying to build an implant that would elicit fewer complaints. In their effort to build a better mousetrap, the competitors toyed with many approaches. They thinned and texturized the silicone shell that encloses the gel, toyed with the actual consistency of the gel, tried a saline filler or alternated layers of saline solution with silicone, even encased the gel in polyurethane foam-the stuff that fills the cushions on your couch-all in an effort to make the implants feel more "natural." Their objective became not to generate safety data about existing implants but to create an implant that would capture more than its fair market share. Enter the late Congressman Ted Weiss and his employee, epidemiologist Dr. Diana Zuckerman. "Ted chaired the Human Resources and Intergovernmental Relations Subcommittee," she explained in a recent interview. "It oversaw the functioning of such departments as the Department of Health and Human Services; the FDA was not an agency we usually dealt with. In 1990, I got a call from a young woman who served as an aide in the Senate. She asked me to come and talk to her mother, who had become very ill after having received silicone breast implants following a mastectomy for breast cancer. "I didn't believe there could be a connection. I went and talked to her, but my first question was, 'Well, what has the FDA said about this device?' And the daughter answered, 'It doesn't know about it.'" Zuckerman went to her boss Weiss and asked him to request the documents that outlined the FDA's involvement with the implants. "The more I looked," she commented, "the more horrified I became. There were no human studies on the safety of these implants and very few animal studies." Weiss ordered his staff to look into the matter. They launched an investigation in which many individuals, agencies and companies who had an interest in breast implants testified. The hearings and documents search that were concomitants of the investigation turned up several items of interest.

For example, in 1982, the FDA had published a proposal to classify implants as "Class III" medical devices, the most stringent level of regulation, and the one that would make it incumbent upon the implant manufacturers to provide safety data.

The rule, however, was not truly propagated until 1986; it was not until 1988 that the rule was enforced. At that time, the FDA allowed the companies an additional 30 months to produce data that would allow their implants to remain on the market. By 1990, when Zuckerman and her team launched their investigation, the FDA had not yet demanded that safety data be produced. (Eventually, the manufacturers would be given till July of 1991 to submit their research results.) During the course of their investigation, Zuckerman and her team uncovered some unsettling facts about the actual manufacture of the implants.

In one case, the ovens used to "cure" the gel were found to be faulty-quality assurance data had been falsified to make it appear the ovens were functioning normally. In another, the investigators learned that implants meant to be filled with saline solution through a valve had been test-inflated by the technicians, who inflated them by blowing into them as one would blow into a beach ball. No attention was given to resterilizing them before they were released to the market. While all this was going on, the courts decided several pricey lawsuits in favor of their defendants, women who had received implants, subsequently become ill, and now wanted their day in court. A large factor in the decisions seems to have been that the women were provided slim, faulty, or inaccurate data about the safety of the procedure they were about to undergo.

The upshot of Zuckerman's investigation was that the FDA had been wildly ineffective in regulating breast implants. "They are an agency," observed Zuckerman, "who live in terror of having their already meager budget cut further. They listen to Congress, and at that time, Congress had as many members coercing them into taking the implants off the market as members encouraging to keep the implants available."What followed is what Zuckerman called "the grand compromise." It was, she noted, politically impossible to take the implants off the market. So the FDA would permit them to remain available, but under limited conditions. Mentor Corporation, by mid-1992 the only company still in the market, proposed to undertake a five-year study that would carefully track implant patients and record what untoward events, if any, stemmed from the implant procedure.

From 1992 till the present, silicone gel breast implants have been available only through controlled clinical trials conducted by physicians who agreed to become a part of the study. Under the terms of the research protocol, physicians would be permitted to insert gel implants only if their patients needed reconstructive surgery following surgical treatment of breast cancer, or if their breasts were deformed due to disease, injury or birth defects. However, a woman who had received gel implants before the decision and subsequently had them rupture could get them replaced with gel implants under the protocol.

Instead of settling the matter, the institution of the research protocol stirred a mound of already glowing embers. A number of plastic surgeons had gone on record as categorizing small breasts as a disease. Women who had previously received saline implants and now wanted to try silicone gel were slipped into the study. The most disturbing news, though, comes from a number of women who, seven years after Mentor initiated its study, allege that the company obfuscated its data results in order to make its implants appear safer than they truly are. "I had an experience similar to Lisa's," says Kim Hoffman (see sidebar). "Like her, I tried to report my illness to my doctor, and he refused to pass my symptoms on to Mentor in his report of my case. Then I tried to report them to Mentor directly and was told that Mentor could only accept a report of complications from the plastic surgeon involved in the study. I had symptoms like Lisa's, but I also had the implants replaced due to rupture after the study protocol was initiated-and any replacement of an implant for any reason whatsoever was supposed to be reported automatically. I was 29 when I had my original implant surgery. I ran my own business; I made $60,000 a year. I became totally disabled afterwards. My insurance premiums rose to $700 a month. I had to apply for Medicare to cover the cost of my explantation."

What really spurred Hoffman on to become an activist in the field was determining that her own data, including the mandatory, clear-cut complication of requiring re-implantation surgery, had been reported incorrectly. The source of her information is several "whistle-blowers" who work for Mentor and are surreptitously sympathetic to the cause. They are the "Deep Throats" of the medical device industry. "I got a copy of my own report form from Mentor," she continued. "I was reported as having 'no complaint.' With the help of my 'whistle-blowers,' I have found 13 other women, including Lisa, who are in the same situation. When Mentor reported in July 1998, to the Institute of Medicine, it reported on only 7,000 women. The study included more than 20,000." Zuckerman viewed the reporting this way: "You could say a 10 percent return was acceptable if you were sending out questionnaires. But for a clinical trial that included 23,000 women, a return of 7,000-less than 30 percent-is ridiculous."

Hoffman describes really having to search to find someone with clout to listen to her allegations. She found an ally in retired Congresswoman Elizabeth Furse. The main office of the FDA brushed her concerns aside, but workers in the Office of Women's Health at last connected her to the FDA's Office of Criminal Investigations in Austin, Texas. The investigation of Mentor has gained momentum and is now being conducted by the Office of Special Prosecutions in the Washington, D.C., area.

The controversy over the safety of breast implants has, in the past, centered around two major areas of concern. One is the localized phenomena-contracture of the scar tissue capsule that forms around the implant, bleeding, infection, and leakage of the gel into the breast tissue. The other-the systemic complications-centers around what might be broadly termed rheumatological and connective tissue disease. These include scleroderma, lupus, and rheumatoid arthritis. On July 17, 1998, the American Society of Plastic and Reconstructive Surgeons and the American Society of Aesthetic Plastic Surgery released a joint position statement clarifying their view on the safety of implants. Citing more than 20 epidemiologic studies of the relationship of connective-tissue disease to breast implants, they present their position as being one of confidence.

"The overwhelming consensus . . .," says the document, "is that there is no scientific proof of an association between breast implants and the development of CTD Findings regarding breast implants and cancer have been equally reassuring The major area of concern over breast implants is local complications."

The document reaffirms the curious finding that researchers who have studied the incidence of implant rupture have concluded that the rupture rate is anywhere from 5.7 percent to greater than 50 percent (depending on population studied and methods utilized). Dr. Renato Saltz, MD, FACS, a plastic surgeon whose University of Utah practice brings him to Park City once a week, serves as media spokesperson for the ASAPS. "A joint committee representing associations of plastic surgeons and rheumatologists and the FDA," he reports, "has just released a statement concluding that there is no connection between the implants and connective tissue disorders. We feel we have good data on their safety."

The office of Douglas Altschuler, a vice-president of Mentor and the company's chief counsel, made an appointment with this reporter so he could comment on the safety of his company's product and on the clinical trial results. He did not call at the arranged time and was unable to make himself available before the article deadline.

However, Mentor's website gives the company's take on all of this, explaining that Mentor has underwritten research, has studied more than 5,000 women in the past and is just reporting on a clinical trial that included not 23,000 but 30,000 women. It even has a patient-response line staffed by women and managed by a registered nurse: on that line, a woman contemplating breast implant surgery can receive the answers to all of her questions and have her fears allayed. ,

It reads like a nightmare straight out of a thriller by Robin Cook. A young woman sees a plastic surgeon about recontouring her figure after she has borne and nursed a child. She gets a new figure-but she also gets systemic joint inflammation, visual and motor impairment, and strange lumps appearing all over her body.

The protagonist in this little drama is local resident Lisa Hickey. Hickey feels that, after living this nightmare for eight years, she finally has her life back. And she has joined a crusade to keep her nightmare from becoming the experience of women the world over. It all began in the late '80s when Hickey, who was living in Phoenix at the time, went to see a plastic surgeon about breast implants. He recommended silicone gel implants over saline implants as the better option for her situation.

"When I asked about their safety," says Hickey, recalling a pre-operative discussion with him that, in retrospect, should have raised some red flags, "he told me I was asking too many questions. He said, 'You're gonna love them.' He also told me they would last 30 years." They didn't. She experienced multiple problems with them from the outset. Leakage of the silicone inside the gel capsule left her with lumps far distant from the breast-lumps called granulomas that required surgical excision. In addition to lumps in such areas as her calf, wrist, and groin, Hickey experienced local leakage in the area of the implant. Her physician's solution was not to excise the existing implants but to redo the implant-three times.

"I got sicker with each replacement," she recalls. "I began getting neurological symptoms as well as systemic joint inflammation. I had visual and motor impairment that became so bad that I couldn't even drive. My blood showed elevated levels of anti-IgG and anti-polymer antibodies, signs of autoimmune disease."

She at last sought help from a different surgeon, a woman in California who specialized in hand surgery-and breast implant explantation. "She told me," says Hickey, "that she would not be responsible for side effects I had even from saline implants-she felt that strongly about the danger of implants in general. She did a complete explant. The surgery itself was terrible. The recovery was similar to what a woman undergoing a complete mastectomy experiences with the surgical drains and pumps." But Hickey feels her outcome was worth the experience of the explantation surgery. It took two years, but most of her symptoms resolved. She has intermittent flare-ups of deranged muscle enzymes with disabling muscle pain and slight breathing problems.

Last summer, Hickey was invited to testify before the National Academy of Science's Institute of Medicine. There she met Missouri resident Kim Hoffman and became acquainted with the work of Dr. Michael Harbut. Hoffman, who had had a similar experience with breast implants to Hickey's own, has become a crusader for reform in the industry. Harbut, a clinical assistant professor in internal medicine at Wayne State University, had done independent research on the subject of side effects of breast implants. Where much of the controversy about silicone gel breast implants has been centered around questions of rheumatological and other autoimmune dysfunction, Hickey and Hoffman's experiences had included motor and neurological difficulties. Harbut's work described the latter and brought an entirely new entity into play: heavy metal poisoning. Oh, my. Heavy metals and silicon? Are silicon and lead anywhere near each other on the periodic table?

"What I learned from Dr. Harbut's work," explains Hickey, "is that the silicone gel is treated with platinum to polymerize it. (See main article.) The gel is left with a platinum residue. It was not until the Institutes of Medicine hearing that I realized every symptom Dr. Harbut described for platinum poisoning were those I had experienced all the time I had had the implants in my body. "I had instituted a lawsuit against the manufacturer of the implants I had received. It had been pending for six years. When I brought up the subject of my symptoms being related to platinum poisoning, they settled with me a week later. I think platinum poisoning may be easier to prove than some of the other effects related to the implants. "What's frightening is many women with symptoms are tested by their doctors for such things as AIDS and lupus. They find nothing, because they're doing the wrong tests."

Standing behind her convictions, Hickey has become part of a national effort to bring the issue of the side effects of the implants to greater public awareness.

"I don't see this as a women's issue as much as a consumer issue," she asserts. "Women who have been disabled from the effects of their implants are now collecting Supplemental Social Security Income. That makes the problem a more general one because it represents our tax dollars going into supporting people who might not have become ill had they been given adequate information about the procedure they were about to undergo.

"Women who have implants," she concludes, "are not my allies. They don't want to hear what I have to say. The message I hope to get out is not only the danger of these effects, but how widespread the implants are. This is not something only Hollywood stars get. It's something the girl next door has. My passion is to discourage use of this product. Maybe by hearing my story, one woman will reconsider having the surgery done. I know what it can do. I lived it."