A long way.

What came first?
Symptoms reported by women OR the mediahype in America.

A different look on breast implants, a long way to registration, being heard, adequate treatment....and the question remains, are they really safe?

Introduction

Breast implants, used from the 60's, first in Amerika, then more and more worldwide. With time problems started . After a few years some women expirienced symptoms, non defined symptoms and illnesses.
Plastic surgeons also complained. They noticed something oily seeped through intact shells of the implants.

Dutch plastic surgeon Robert B. Bergman wrote to Dow Corning:
"An annoying experience induced this study. A silicone gel-filled breast prosthesis, occasionally shown to patients desiring augmentation, was laid aside in a cabinet on top of a pile of newly printed writing paper. Some time elapsed before this stationary was to be used and, on removing the prosthesis, I found a greasy patch exactly underneath. Respectfully, I counted the waste of 203 sheets and shortly afterwards I recalled that the total amount of the substance in the paper could hardly be derived from the sweaty hands which ever held the prosthesis. More likely, it had something to do with the filling but, when asked, none of the agencies (companies) distributing mammary implants could supply information." source.
A strange phenonemon, unwanted, often denied, after years they invented the term ‘gelbleed’.
Many did make the audience believe that it was a mass hysteria in America, hysterical women did it for the money.
But what was first? The health-issues or the hype in the media.
Here is a piece from that which played long before it ever appeared in the media.
The agency (FDA)announced, in November of 1988, that although manufacturers could continue to produce breast implants, they would have to provide more detailed information on the safety concern for a 1991 investigation. Unfortunately, the 1991 investigation proved uneventful. Although the FDA panel cited the overall lack of safety data, it did not move to ban the sale of breast implants. The panel noted testimony from breast cancer patients (and their psychological benefits from the implants) as an integral part of their decision. By 1991, “the FDA had received 2,500 reports of illnesses or injuries associated with the implants, which have been used in one million women. But the degree of risk was unclear because extensive research had not been done.” As pressures mounted regarding the product’s safety, DCC adamantly “denied any link between the implants and illness.” Moreover, “rather than wait for results from the [FDA] research, Dow undertook to determine the safety of silicone gel implants.” The Dow Corning study of silicone implants in March 1993 “reported that the silicone gel in the implants altered the immune systems of laboratory rats . . . but [rats] are more susceptible to inflammatory reactions than humans.”

Confidence Game: Burson-Marsteller's PR Plan for Silicone Breast Implants

The PR story begins in 1985, when Burson-Marsteller warned Dow Corning of "the potential for a corporate media crisis" after a federal jury in San Francisco ordered the company to pay $1.7 million to Maria Stern in Carson City, Nevada for what the court judged were "defectively designed and manufactured" breast implants. The jury judged Dow Corning guilty of fraud, based on internal corporate memos and studies showing that the company had failed to inform the public of health risks related to implants. Although the Stern case received slight media coverage, Burson-Marsteller wrote an analysis titled "Silicone Medical Implants as a Public Issue," in which the PR firm predicted that "the combination of human suffering, large financial awards, big business and big medicine . . . represent a potentially volatile media situation for the company." read more..

The next article was published in NEJM in june 1992 by David Kessler

The Basis of the FDA's Decision on Breast Implants

On April 16, 1992, the Food and Drug Administration announced that breast implants filled with silicone gel would be available only through controlled clinical studies and that women who need such implants for breast reconstruction would be assured of access to these studies. This decision was especially difficult because even after more than 30 years of use involving more than 1 million women, adequate data to demonstrate the safety and effectiveness of these devices do not exist. They had been allowed to remain on the market after the enactment of the 1976 Medical Device Amendments ("grandfathered") with the understanding that the FDA would later go back and require their manufacturers to submit data demonstrating safety and effectiveness.

Although the decision to limit access to breast implants was in step with the recommendations of an FDA advisory panel, it was one of the most controversial decisions ever made by the agency. It has left the FDA open to criticism on both flanks: from those who argue that the FDA should not let any women have breast implants as long as their safety and effectiveness have not been demonstrated, and from those who argue that women ought to be free to weigh the known risks against the personal benefits of an implant and make an independent choice about whether to have one.

The legal basis for the FDA's decision was straightforward. The 1976 Medical Device Amendments to the Food, Drug and Cosmetic Act require that medical devices be shown by their manufacturers to be safe and effective before they may be distributed and used. 1 The legal standard is not that devices must be proved unsafe before the FDA can protect patients against their use. Rather, the law requires a positive demonstration of safety — and the burden of proof rests squarely with the manufacturer. What many participants in this debate have failed to recognize is that under the law, "grandfathered" devices such as breast implants must eventually meet the same requirements as new devices: they must be shown to be safe.

Thirty years after silicone breast implants appeared on the market, the list of unanswered questions about their safety remains long. It is not known how long these devices last, nor is it known what percentage of them will rupture — though it is known that some do rupture. Although manufacturers' reports suggest a frequency of asymptomatic rupture between 0.2 and 1.1 percent, preliminary findings presented at the FDA advisory panel's meeting in February suggested that in 4 to 6 percent of asymptomatic women with implants the devices have ruptured. It is never possible to predict with certainty how a device will function 10, 20, or 30 years after its implantation; however, even basic characteristics that have some value in predicting future performance, such as tensile strength and fatigue resistance tested through cyclic loading, are lacking in this case.

The chemical composition of the gel that leaks into the body when a breast implant ruptures is unknown. And the link, if any, between these implants and immune-related disorders and other systemic diseases is also unknown. Serious questions remain about the ability of manufacturers to produce the device reliably and under strict quality controls. Until these questions are answered, the FDA cannot legally approve the general use of breast implants filled with silicone gel.

Nevertheless, to answer these questions once and for all and to preserve the option of access to silicone breast implants for patients whose need is greatest, the FDA has decided to make these devices available under controlled conditions. In the first stage, already in effect, silicone-gel implants will be available to women whose need for them is most urgent. This group includes patients with temporary breast-tissue expanders — whether they were put in place before or during the recent moratorium on the use of silicone breast implants — who are awaiting permanent reconstructive surgery; patients who undergo reconstructive surgery at the time of mastectomy; and those who require the device for urgent medical reasons, as in the case of the rupture of a device already in place. During the second stage, women who desire implants for breast reconstruction will be able to obtain them through extended-availability protocols under the public-health-need provisions of the Food, Drug and Cosmetic Act.

Under these protocols, siliconegel implants will be made available to patients with certified medical need for these devices; their registration will be required for the purpose of long-range data collection and follow-up. In the third stage, which includes more intensive research protocols enrolling a limited number of women, the FDA will offer implants for purposes of reconstruction or augmentation in carefully controlled clinical trials. The number of subjects in these studies will be limited to the minimum needed to answer the scientific questions at issue.

Some who criticize the FDA's decision argue that no one should be exposed to a risk that he or she cannot assess. Because we lack information, and because the information we do have arouses concern, the argument goes, no woman should be allowed to take the risk of having a silicone breast implant. This argument claims that women cannot provide valid informed consent when so much information about silicone implants is lacking.

It is true that women who receive implants under the new protocols will be taking a risk of unknown magnitude. It is equally true that, henceforth, any woman entering the clinical trials will be told that implants are not risk-free — a decided improvement over the previous state of "informed consent." The authors of the Medical Device Amendments of 1976 anticipated precisely this type of situation when they included in the law a special exception to the requirement that devices already in use before 1976 had to be demonstrated to be safe and effective in order to remain on the market. The law gives the FDA the prerogative to decide that there is a legitimate public health need for the continued availability of a particular device and, thus, that it may be allowed to remain on the market until studies of its safety and effectiveness are completed.

In allowing patients with cancer and others with a need for breast reconstruction access to silicone breast implants as part of such studies, the FDA has judged that, for these patients, the risk—benefit ratio permits the use of the implant under carefully controlled conditions. In reaching this decision, the FDA carefully weighed whether any alternatives to silicone-gel breast implants existed. Saline implants remain on the market, and for some patients they provide a good alternative to silicone implants. But two additional factors influenced the decision. First, for a small number of patients, silicone implants may be more desirable than saline implants, and second, the safety of saline implants has also not yet been established.

Some argue, however, that it is inconsistent for the FDA to allow the use of a medical device in some situations and not in others. In their view, healthy women who have poor body images because they have small or asymmetrical breasts have as great a need for the device as women who have breast cancer. This contention has a superficial appeal. Although one can legitimately argue for a continuum of need, in the end the needs of the patient who desires reconstructive surgery differ from those of the patient who desires augmentation. One can argue that for both groups the benefit is ultimately cosmetic, yet for women with breast cancer who undergo mastectomy, the option of reconstructive surgery is viewed as an integral part of the treatment of the disease.

Certainly, as a society, we are far from according cosmetic interventions the same importance as a matter of public health that we accord to cancer treatments. The clearest demonstration of this social consensus comes from our policies regarding health insurance. In almost any context, the treatment of cancer — and usually reconstruction after mastectomy — is covered as a medical benefit by insurers. But in almost no context is cosmetic surgery, including primary breast augmentation, covered by insurance. It makes little sense for the FDA to consider breast augmentation of equivalent importance with an accepted component of cancer therapy

These restrictions on the use of silicone-gel implants for breast augmentation are not based on any judgment about values. Rather, the FDA has concluded that women who desire breast augmentation are at higher risk than patients with breast cancer who have had a mastectomy. Unlike patients who have undergone mastectomy, they still have breast tissue, and the presence of an implant complicates the use of mammography for the detection of breast cancer. Although special techniques for more complete mammography have been developed, many experts continue to believe that breast implants can preclude full visualization of the breast. In addition, we are concerned about "silent rupture," the undetected failure of the device in women who have no symptoms of rupture. Mammography is the only reliable procedure for detecting silent rupture, but mammography is not advisable for young women with breast tissue because it entails incremental exposure to radiation. In the end, it comes down to this: in our opinion the risk—benefit ratio does not at this time favor the unrestricted use of silicone breast implants in healthy women.

It has become fashionable in some quarters to argue that women ought to be able to make such decisions on their own. If members of our society were empowered to make their own decisions about the entire range of products for which the FDA has responsibility, however, then the whole rationale for the agency would cease to exist. People could simply communicate directly with manufacturers to design their own drug regimens or select medical devices. The rule governing intervention would be "caveat emptor."

The FDA was established as a result of a social mandate. Caveat emptor has never been — and will never be — the philosophy at the FDA. Manufacturers have vested interests. Between those interests and the interests of patients, the FDA must be the arbiter. To argue that people ought to be able to choose their own risks, that government should not intervene, even in the face of inadequate information, is to impose an unrealistic burden on people when they are most vulnerable to manufacturers' assertions: when they are desperately ill, when they are hoping against hope for a cure, or when they are seeking to enhance their physical appearance. Those are precisely the situations in which the legal and ethical justification for the FDA's existence is greatest, however. The decision about breast implants reflects that need.

Another factor carries equal weight. Had the FDA failed to intervene, the uncontrolled and widespread availability of breast implants would probably have continued for another 30 years — without producing any meaningful clinical data about their safety and effectiveness. Such a situation is obviously unacceptable. Once and for all, we need to gather information about the safety and effectiveness of these medical devices that have been so widely used for so many years. Source Information Food and Drug Administration Rockville, MD 20857
FDA has decided to make these devices available under controlled conditions. In the first stage, already in effect, silicone-gel implants will be available to women whose need for them is most urgent. This group includes patients with temporary breast-tissue expanders — whether they were put in place before or during the recent moratorium on the use of silicone breast implants — who are awaiting permanent reconstructive surgery; patients who undergo reconstructive surgery at the time of mastectomy; and those who require the device for urgent medical reasons, as in the case of the rupture of a device already in place.

During the second stage, women who desire implants for breast reconstruction will be able to obtain them through extended-availability protocols under the public-health-need provisions of the Food, Drug and Cosmetic Act. 2 Under these protocols, siliconegel implants will be made available to patients with certified medical need for these devices; their registration will be required for the purpose of long-range data collection and follow-up. In the third stage, which includes more intensive research protocols enrolling a limited number of women, the FDA will offer implants for purposes of reconstruction or augmentation in carefully controlled clinical trials. The number of subjects in these studies will be limited to the minimum needed to answer the scientific questions at issue.

Some who criticize the FDA's decision argue that no one should be exposed to a risk that he or she cannot assess. Because we lack information, and because the information we do have arouses concern, the argument goes, no woman should be allowed to take the risk of having a silicone breast implant. This argument claims that women cannot provide valid informed consent when so much information about silicone implants is lacking.

It is true that women who receive implants under the new protocols will be taking a risk of unknown magnitude. It is equally true that, henceforth, any woman entering the clinical trials will be told that implants are not risk-free — a decided improvement over the previous state of "informed consent." The authors of the Medical Device Amendments of 1976 anticipated precisely this type of situation when they included in the law a special exception to the requirement that devices already in use before 1976 had to be demonstrated to be safe and effective in order to remain on the market. The law gives the FDA the prerogative to decide that there is a legitimate public health need for the continued availability of a particular device and, thus, that it may be allowed to remain on the market until studies of its safety and effectiveness are completed.

In allowing patients with cancer and others with a need for breast reconstruction access to silicone breast implants as part of such studies, the FDA has judged that, for these patients, the risk—benefit ratio permits the use of the implant under carefully controlled conditions. In reaching this decision, the FDA carefully weighed whether any alternatives to silicone-gel breast implants existed. Saline implants remain on the market, and for some patients they provide a good alternative to silicone implants. But two additional factors influenced the decision. First, for a small number of patients, silicone implants may be more desirable than saline implants, and second, the safety of saline implants has also not yet been established.

Some argue, however, that it is inconsistent for the FDA to allow the use of a medical device in some situations and not in others. In their view, healthy women who have poor body images because they have small or asymmetrical breasts have as great a need for the device as women who have breast cancer. This contention has a superficial appeal. Although one can legitimately argue for a continuum of need, in the end the needs of the patient who desires reconstructive surgery differ from those of the patient who desires augmentation. One can argue that for both groups the benefit is ultimately cosmetic, yet for women with breast cancer who undergo mastectomy, the option of reconstructive surgery is viewed as an integral part of the treatment of the disease. Certainly, as a society, we are far from according cosmetic interventions the same importance as a matter of public health that we accord to cancer treatments. The clearest demonstration of this social consensus comes from our policies regarding health insurance. In almost any context, the treatment of cancer — and usually reconstruction after mastectomy — is covered as a medical benefit by insurers. But in almost no context is cosmetic surgery, including primary breast augmentation, covered by insurance. It makes little sense for the FDA to consider breast augmentation of equivalent importance with an accepted component of cancer therapy

These restrictions on the use of silicone-gel implants for breast augmentation are not based on any judgment about values. Rather, the FDA has concluded that women who desire breast augmentation are at higher risk than patients with breast cancer who have had a mastectomy. Unlike patients who have undergone mastectomy, they still have breast tissue, and the presence of an implant complicates the use of mammography for the detection of breast cancer. Although special techniques for more complete mammography have been developed, many experts continue to believe that breast implants can preclude full visualization of the breast. In addition, we are concerned about "silent rupture," the undetected failure of the device in women who have no symptoms of rupture. Mammography is the only reliable procedure for detecting silent rupture, but mammography is not advisable for young women with breast tissue because it entails incremental exposure to radiation. In the end, it comes down to this: in our opinion the risk—benefit ratio does not at this time favor the unrestricted use of silicone breast implants in healthy women.

It has become fashionable in some quarters to argue that women ought to be able to make such decisions on their own. If members of our society were empowered to make their own decisions about the entire range of products for which the FDA has responsibility, however, then the whole rationale for the agency would cease to exist. People could simply communicate directly with manufacturers to design their own drug regimens or select medical devices. The rule governing intervention would be "caveat emptor."

The FDA was established as a result of a social mandate. Caveat emptor has never been — and will never be — the philosophy at the FDA. Manufacturers have vested interests. Between those interests and the interests of patients, the FDA must be the arbiter. To argue that people ought to be able to choose their own risks, that government should not intervene, even in the face of inadequate information, is to impose an unrealistic burden on people when they are most vulnerable to manufacturers' assertions: when they are desperately ill, when they are hoping against hope for a cure, or when they are seeking to enhance their physical appearance. Those are precisely the situations in which the legal and ethical justification for the FDA's existence is greatest, however. The decision about breast implants reflects that need.

Another factor carries equal weight. Had the FDA failed to intervene, the uncontrolled and widespread availability of breast implants would probably have continued for another 30 years — without producing any meaningful clinical data about their safety and effectiveness. Such a situation is obviously unacceptable. Once and for all, we need to gather information about the safety and effectiveness of these medical devices that have been so widely used for so many years.

Source Information Food and Drug Administration Rockville, MD 20857




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