Statement on Silicone Breast Implants
American College of Rheumatology
October 22, 1995

The American College of Rheumatology recognizes that many women who have received silicone breast implants have musculoskeletal complaints that are also very common in the general population. Many rheumatologists have examined women with implants who have scleroderma, lupus, fibromyalgia, or other well-defined disorders. The problem has been to determine whether any cause and effect relationship exists between silicone implants and the musculoskeletal symptoms. Previous data were solely based on anecdotal evidence. In 1994, the American College of Rheumatology stated the importance and great need for scientific analysis of this question.

Two large studies now have been completed. The first was conducted on all women in a single county in Minnesota who received implants between 1964 and 1991. At a mean follow-up of 7.8 years, there was no association between breast implants and connective tissue or rheumatic disease. (NEJM 330:1697-702, 1994). The second study was a follow-up of the Nurses Health Study. Among this very large cohort, after 14 years of follow-up, no evidence existed for an association between silicone breast implants and connective tissue diseases. (NEJM 332:1666-70, 1995).

The American College of Rheumatology believes that these studies provide compelling evidence that silicone implants expose patients to no demonstrable additional risk for connective tissue or rheumatic disease. Anecdotal evidence should no longer be used to support this relationship in the courts or by the FDA. Clinicians, scientists, academicians, and editors who have been harassed by plaintiffs' attorneys for their involvement in scientific research efforts related to silicone implants deserve the continued support of their institutions and professional societies.

In future cases involving rheumatic diseases possibly associated with an environmental agent, we call upon the FDA and other regulatory agencies to allow professional societies, such as the American College of Rheumatology, to foster appropriate and scientifically developed epidemiological studies. Anecdotal reports, while of importance to call attention to a potential problem, should not be utilized to formulate decisions and regulations.

The American College of Rheumatology is the professional organization of rheumatologists. It includes practicing physicians, research scientists, and health professionals who are dedicated to healing, preventing disability, and eventually curing the more than 100 types of arthritis and related disabling and sometimes fatal disorders of the joints, muscles, and bones.

Laboratory Testing for Monitoring Patients with Silicone Breast Implants

College of American Pathologists
Appendix CC

It is the position of the College of American Pathologists that laboratory tests measuring blood, urine, or tissue silicon, silicone, toluenediamines, or related substances are not currently indicated or useful for purposes of medical management of individual breast implant recipients. Research interests may be served by investigation of the measurement of these materials in controlled studies. Serum autoantibody tests or panels are useful in the evaluation of individual patients suspected of having collagen vascular disease, whether or not they have received breast implants, but such tests provide no findings uniquely indicative or supportive of purported silicone induced autoimmune disease in implant recipients. Interpretation of such panels as " consistent with silicone reaction" for example, is not supported by the current medical literature.

The sale or distribution in commerce of in-vitro diagnostic tests, instruments, or test systems intended for use in evaluating patients with silicone implants would require prior approval by the FDA. To date, the FDA has not approved any such tests, instruments, or systems. If FDA were to give approval, the approval would likely be for investigational purposes only until sufficient data were available to justify approval for general use. Without approval by FDA, the use of diagnostic tests, instruments, or test systems intended for the evaluation of patients with silicone implants would be excluded from coverage under the Medicare program and could subject the use to an increased risk of medical malpractice liability.

Adopted 5/93

Silicone Breast Implants and Multiple Sclerosis-like Disorder

National Multiple Sclerosis Society

Summary

A settlement has recently been proposed between manufacturers of silicone breast implants and a group of women who brought suit seeking compensation for what they believe are adverse medical consequences on the implants, including a condition called "atypical neurological disease syndrome," that in some respects resembles MS. This document summarizes some of the specified proposed criteria that must be met for a person to be considered for compensation. It is important to note that there are no valid scientific data indicating that silicone implants are related to the onset of typical multiple sclerosis.

Media attention has focused on the possible contribution of silicone breast implants to the development of immune system problems, including autoimmune neurological disease. Litigation relating to silicone breast implant product liability has resulted in a proposed negotiated settlement between representatives of women who believe they have suffered adverse consequences from such implants and manufacturers of the devices. This proposed settlement will be reviewed by the United States District Court (Northern District of Alabama) on August 18, 1994, after which a settlement will be considered final.

While most media attention has focused on the role of such implants in arthritis-like and connective tissue disorders, an "atypical neurological disease syndrome" (ANDS), with characteristics similar to MS, has also been reported. The proposed negotiated settlement details very specific medical criteria that must be met for a person with ANDS to be considered for compensation from the damages pool to be created by the product manufacturer group. These include:

• primary symptoms characteristic of a neurological disease diagnosed by a board-certified neurologist or internal medicine specialist;
  
• clinical and laboratory characteristics of the disease will be atypical and must include additional neuromuscular, rheumatic or nonspecific autoimmune signs and symptoms;
  
• for the "multiple sclerosis-like syndrome" which is included in the proposed settlement agreement, there must be objective physician-documented evidence of central nervous sytem disease, with a history and physical findings compatible with MS or "MS-like syndrome" AND additional objectively documented evidence of at least three signs of atypical connective tissue disease which might include, among others: polyarthritis; keratoconjuctivitis sicca (dry eyes/mouth with additional objective findings); immune-mediated skin changes or rash; pulmonary abnormalities; pericariditis; neuropsychiatric symptoms characteristic of systemic lupus erythematosus or mixed connective tissue disease; peripheral neuropathies; fatigue; and others.

For the many immunological disorders which have been linked to silicone breast implants, the theory is that leaking silicone from the devices may serve as an "adjuvant" which can trigger immune system responses in the body and may result in the development or worsening of inflammatory, immune-mediated and autoimmune disorders of many kinds. Since it is clear that there are many hundreds of thousands of people with such disorders who have never had silicone breast implants, silicone cannot be a sole, or even primary, cause of such conditions.

Valid scientific evidence linking silicone to typical MS is lacking. It is notable that the proposed legal settlement requires that "MS-like syndrome" be accompanied by additional signs of atypical connective tissue disease. The possibility of an association between such a syndrome and silicone implants has only recently been reported, in a series of public presentations at scientific meetings. From these reports, it is not clear if the incidence of "MS-like syndrome" among women with implants is any different than the incidence of MS among a similar age-matched group of women. A population-based study of the association of silicone breast implants with immunological disorders is underway, which should help to answer such questions.