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Article from Plastic Surgery News is part of the legal evidence stored at the National Breast Implant Depository. 

Whenver reading the documents, the industry repeatedly misrepresents the number of women who had received silicone gel breast implants.  Evidentiary documents show that the manufacturers could not prove more than 800,000 of all types of silicone implants, including those used for orthopedic surgeries. One can only ask why the misrepresentation.  And one can only conclude that by misrepresenting the numbers of women with implants, the reported disease categories would not look so bad for them.

The Plastic Surgery News indicates the New York University undertook two studies, funded by implant manufacturers.  The first study was of 10,000 women in the state of New York to determine a connection between breast implants and cancer. The other was to determone a connection between silicone breast implants and connective-tissue disease.  In fact, from what I can determine, there was only one study, which was a questionnaire and I have found no mention of examining any women on the evidentiary CDs.

In 2004, when I requested a copy of the New York study from FDA, they did not have the study, nor knew of its existance.

Evidentiary CD 1002


July 1991

Plastic Surgery News

ASPRS task force examines implants and scleroderma

Editor’s note: In June of 1990, a task force of plastic surgeons, rheumatologists and epidemiologists—as well as a representative of the AMA—was convened by ASPRS to address the concern that silicone breast implants may be a stimulus for a variety of connective-tissue disorders.  Although the group’s conclusions will be published in a fall issue of Plastic and Reconstructive Surgery, permission has been granted to print a summary here, in light of the issue’s timeliness.

An estimated 1 million to 2 million American women have had silicone breast implants inserted.  As of May 1991, an extensive literature search identified 80 probable cases of women who developed connective tissue disorders following breast enlargement:  12 who were injected with paraffin, 31 who were injected with silicone of uncertain original and purity, and 28 who had silicone-gel implants inserted.  In the remaining nine, the materials used for enlargement was undocumented.

Further analysis suggests the disease involved in the majority of these cases is scleroderma or scleroderma-like disorder.  The latter condition, the most likely to be associated with exogenous etiological agents, describes a variety of systemic illnesses that are characterized by skin thickening and that have been causally linked to environmental elements (drugs, industrial chemicals, etc.). It is not known whether this environmentally precipitated disease is the same as idiopathic scleroderma.

In any case, scleroderma and scleroderma-like disorder are uncommon diseases with an estimated incidence of fewer than 20 new cases per million population per year.  The conditions occur most often in individuals older than 18, and females are four times more likely to be stricken than males.  Unlike some connective-tissue disorders, evidence of a genetic predisposition to scleroderma is weak.

The term “human adjuvant disease” (HAD), which has been popularized in the press, defies valid definition.  While the immunologic concept of adjuvant stimulation may prove to be relevant, classical adjuvant disease is actually a rodent disorder, without direct analogy to a specific human connective-tissue disease.  The symptoms ascribed to HAD are vague, and could therefore lead to over-diagnosis and unnecessary anxiety among implanted women. Established disease terminology should be used in place of “human adjuvant disease” unless and until a unique, new clinical entity is described.

Based on public findings and the collective experience of the task-force participants, the following observations are offered.

1)    Given the small number of documented cases of connective-tissue disease among implanted women, no statistically or epidemiologically valid conclusions can be drawn concerning whether silicone breast implants cause scleroderma-like disorders or any other conditions.  If such a relationship does exist, the risk is likely very low.

2)    In addition, there is currently no reliable evidence that silicone breast implants pose any special risk for women who have a first degree relative—or a personal history of—scleroderma, idiopathic Raynaud’s phenomenon or any other connective-tissue disease.

3)    However, until further research resolves all uncertainties (see related this page), prospective patients should be advised that a theoretic risk of acquiring or exacerbating such a disorder might exist.

4)    Finally, there is insufficient evidence to support the removal of breast implants and their surrounding scar tissue in the hopes of altering the course of existing disease or prevent a new condition.  Among the cases reported, removal was not consistently followed by disease remission.  This suggests that if immune-cell activation occurs in some patients, it cannot be reversed by surgical removal of the implants.


Breast implant manufacturers have agreed to forge ahead with a three-year, $2 million study to settle the debate over whether breast implants increase a woman’s risk of cancer.

The study is designed to be the most comprehensive research on the subject to date.  Of particular importance is the fact that it will examine women who have had implants for 12-21 years, says Richard Bennett, vice-president of Regulatory Affairs and Quality Assurance for Bioplasty, Inc., and acting spokesman for the five participating manufacturers.

Researchers at New York University will look at 5,000 women who have had the devices inserted for cosmetic reasons between 1960 and 1979.  Another 5,000 women who don’t have implants will be examined for comparison.  The researchers will choose women who had their augmentations performed in New York.

Women who had implants for breast reconstruction are not included in the study because their risks of getting cancer is greater than the normal population, Bennett explains.  On the average, one out of ever nine women will develop breast cancer in her lifetime.

The researchers will examine each patient’s medical records and conduct extensive interviews to determine her risk factors, such as smoking and a family history of breast cancer.

At press time, the manufacturers hoped to begin the study by July 9.  Dow Corning Wright Bioplasty, Mentor, McGhan and Surgitek are funding the research.

Those same manufacturers are also in the midst of negotiations concerning a study of the relationship between implants and connective-tissue disorders.  A decision on who will participate in that study and details on how it will be conducted are expected in July.

While manufacturers were prepared at press time to file thousands of documents on time on July 9—the deadline for risk/benefit data on silicone gel-filled devices—the FDA is aware that information from ongoing studies won’t be submitted until they are completed and the data becomes available, says Ron Dieck, Dow’s vice-president of research development.

Polyurethane Update

Meanwhile, Surgitek officials are confident that reports that the carcinogen TDA had been found in the breast milk of a woman augmented with polyurethane-covered breast implants will have no effect on the Food and Drug Administration’s decision on whether the devices should go back on the market.

“We had a response for the FDA prepared the morning of the (New York Times) article came out that refuted the charges and showed the TDA was created as an artificial result of placing the milk in hydrochloric acid,” says Lynda Walker, senior product manager for Surgitek’s plastic surgery division.

The FDA’s General and Plastic Surgery Devices Panel will hold a public hearing on the safety of polyurethane-covered implants on July 31.

Wanted:  deposition and trial statements

To assist ASPRS Risk Management Committee in collecting expert testimony given in medical malpractice cases, the Society’s Executive Office will serve as a clearinghouse for all depositions and trial statements.

Members who are currently being sued, as well as those who have already had their cases litigated, are urged to submit copies of testimony by expert witnesses to Lousanne Lofgren, ASPRS, 444 East Algonquin Road, Arlington Heights, IL 60005.

As the collection grows, members will be able to request copies of testimony for a nominal fee.

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