Evidentiary CD 1002
DCCKKA028980
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.
STUDY TO FOCUS ON BREAST
IMPLANTS AND CANCER
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.
