MAY BE PARAPHRASED BUT NOT QUOTED UNTIL PUBLISHED
CONSENSUS STATEMENT ON THE
BREAST IMPLANTS TO CONNECTIVE
A few recent publications have raised the possibility that silicone breast implants may be a stimulus for a variety
of systemic connective tissue disorders, especially systemic sclerosis (scleroderma). Between one and two million U.S. women
have received these implants, so that any proven relationship could represent a significant public health issue. To address these concerns, a task force was assembled on June 25, 1990 which included plastic surgical
and rheumatological communities, epidemiology and the AMA. The following comments
represent a consensus based on published observations plus the experience and expertise of the members of this task force.
The recent explosion of concern in the media and Congress makes this document especially pertinent and timely.
In addition to the estimated one to two million women who have received medically appropriate silicone breast implants,
another large but indeterminate number have had their breasts injected with silicone (of uncertain origin, composition and
adulteration), paraffin, or other unknown substances. Silicone injections by
unscrupulous practitioners were common in the U.S. during the late 1960s and 1970s until they were curtailed by public awareness
of the hazards and, in some states, by enjoining legislation. Breast enlargement
by injection is still occasionally performed clandestinely in the United States and remains popular in Asia and certain countries
in South America.
A literature review reveals that breast enlargement from surgically implanted medical grade silicone breast implants
as well as the injected silicone and paraffin from uncertain sources, have been implicated as possibly associated with autoimmune
disorders. Patients with classical scleroderma, scleroderma-like disorders and
other more poorly defined symptom complexes termed “human adjuvant disease” constitute the bulk of reported cases.
‘Scleroderma-like disorder’ describes a variety of systemic illnesses characterized by skin thickening
which have been causally linked to identifiable environmental agents (drugs, industrial chemicals, etc.) It is not known whether
this environmentally precipitate disease is the same as idiopathic scleroderma.
Scleroderma is an uncommon disease with an estimated incidence of less than 20 new cases per million population at
risk per year. There is a male to female incidence ration of 1:4 over the age of 18.
At this writing, the number of reported cases of connective tissue disorders in women following breast enlargement
is 69; 12 injected with paraffin, 31 injected with silicone of uncertain origin or purity; and 26 receiving silicone gel implants. Analysis of the 69 cases suggests that 24 could be classified as scleroderma or scleroderma-like
disease. Given the vary small number of cases reported, no statistically or epidemiologically
valid conclusions can be drawn from the available data about co-incident connective tissue disease of any sort and breast
enlargement with silicone. A more informed answer to this question awaits further investigation and documentation. Premature speculation is unwarranted.
Unlike certain other connective tissue disorders, evidence for a genetic predisposition to scleroderma is weak. Therefore
there is little justification to recommend that women with these HLA types reported to be associated with scleroderma should
avoid silicone breast implantation. Also, there are no data to suggest that women with Raynaud’s phenomenon alone or
any other connective tissue disorders are at increased risk for exacerbation of their disease following silicone implantation.
The term “human adjuvant disease” defies valid definition and therefore its use should be discouraged. While the immunologic concept of adjuvant stimulation may prove to be relevant, classical
adjuvant disease is actually a disorder of rodents without direct analogy to a specific human connective tissue disease. These symptom complex descriptions are vague, and could potentially lead to their
overuse, and diagnosis and unwarranted associations. This would be unfortunate
and could lead to unnecessary and inappropriate anxiety and insecurity in implanted women.
The task force urges that established disease terminology be used unless and until a unique new clinical entity is
Among the cases reporter, removal of the silicone or other foreign material with or without the surrounding scar capsule,
was not consistently followed by remission of the disease manifestations. This
suggests that, at least in some patients, immune cell activation of the disease process may be established and cannot be surgically
reversed. Silicone is ubiquitous and it is probable that all humans have acquired some silicone in their body. Silicone is absorbed through the lungs from such products as hair spray, from the digestive tract in certain
foods, from medications such as proprietary remedies for indigestion and even in FDA approved infant anti-gas preparations. All needles and syringes are coated with silicone so that microscopic quantities must
enter the body with each injection. It is therefore surgically impossible to
totally remove all microscopic silicone from the body.
In the light of these observations, the task force makes the following recommendations:
1. There is insufficient information
available at this time to determine whether silicone in the form of a breast implant can be implicated as a cause of scleroderma-like
disorders or any other auto-immune disease. Judging from the paucity of reported
cases in the very large population of implanted women, if a causal associated was to be established, the statistical risk
would likely be very low. The presence of risk and magnitude thereof can only
be determined by appropriate epidemiological research.
2. At present there is no reason to
discourage women from considering breast augmentation on the basis of the risk of acquiring or exacerbating a connective tissue
disorder. Until the question is answered by further research, patients should
be informed that a theoretic risk might exist especially if they already had a connective tissue disorder, idiopathic Raynaud’s
phenomenon or an affected first degree relative.
3. There is currently insufficient evidence
to state that the removal of implants and their surrounding scar capsule will alter the course of existing disease or prevent
the occurrence of new disease.
4. The term “human adjuvant disease”
is imprecise and its use should be avoided.
The task force has initiated research projects to study
The members of the task force were:
Garry S. Brody, M.D. – Plastic Surgery (convener)
Donald P. Conway, M.D. – Internal Medicine
Dennis M. Deapen, PhD. – Epidemiology
Jack C. Fisher, M.D. – Plastic Surgery
Marc C. Hochbert, M.D. – Rheumatology
E. Carwile LeRoy, M.D. – Rheumatology
Thomas A. Medsger, Jr. M.D. – Rheumatology
Martin C. Robson, M.D. – Plastic Surgery
Alan R. Shons, M.D. – Plastic Surgery
Michael H. Weisman, M.D. – Rheumatology
Refer all queries or comments to:
Garry S. Brody.
11411 Brookshire Ave. #504
Downey, CA 90241