DCCKKA031162

FINAL COPY

MAY BE PARAPHRASED BUT NOT QUOTED UNTIL PUBLISHED

CONSENSUS STATEMENT ON THE RELATIONSHIOP OF

BREAST IMPLANTS TO CONNECTIVE TISSUE DISORDERS

            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 described.

            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 these issues.

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. M.D.

11411 Brookshire Ave. #504

Downey, CA 90241