March 15, 2000 (New York) -- Women with silicone breast implants do not appear to have a higher risk of developing connective-tissue diseases and diseases of the immune system such as rheumatoid arthritis and lupus, a new report says. The report, in Thursday's issue of The New England Journal of Medicine, is one of several in recent years to refute the theory that the implants can cause these diseases.
"There was no evidence of an association between breast implants ... and any of the individual connective-tissue diseases, all definite connective-tissue diseases combined, or other autoimmune or rheumatic conditions," say Esther C. Janowsky, MD, PhD, and colleagues at the University of North Carolina at Chapel Hill. Last year, an expert panel of the Institute of Medicine came to a similar conclusion after reviewing about 3,000 published studies and hearing from women with implants and experts.
The FDA banned sales of silicone-filled breast implants in 1992, following reports of high rates of rupture as well as diseases such as rheumatoid arthritis, lupus, scleroderma, and the "dry-eye" condition known as Sjögren's syndrome. Since then, there have been intense medical and legal debates over the relationship between the implants and such diseases. Dow Corning Corp. has agreed to pay $3.2 billion to breast implant recipients who have become ill, and has filed for bankruptcy as a result of litigation relating to the implants. Other manufacturers have collectively agreed to a settlement of approximately $3 billion to be paid out to women who believe they have become ill from their implants.
Janowsky and her colleagues analyzed data from 20 published reports of associations between silicone breast implants and connective-tissue disease. In addition to finding no evidence of excessive risk of these diseases in women with silicone implants, the researchers estimated that such women account for less than 1% of all new cases of rheumatoid arthritis, lupus, Sjögren's syndrome, and similar diseases diagnosed in U.S. women each year.
But the researchers say that many of the studies they looked at did not address factors other than implants that could account for increased risk of these diseases. They also note that most studies fail to include the participants' reasons for getting the implants -- whether cosmetic or for reconstruction after breast cancer -- which they say may have affected their symptoms.
The analysis also could not draw firm conclusions about any connection between ruptures or leakage of the implants and connective-tissue diseases, since many of the studies did not provide adequate information on these occurrences. Some researchers say that the outer shell of the implants, not just the silicone gel inside, may be making women sick.
The controversy over the implants is unlikely to end here. Supporters of women who believe implants have made them ill say that it's not possible to conclude there is no connection between the implants and these diseases based on published scientific studies -- some of which were financed by implant manufacturers.
Sidney Wolfe, MD, medical director of the Public Citizen Health Research Group and one of the first to petition the FDA in the late 1980s to ban silicone implants, tells WebMD that the latest analysis is interesting, but doesn't add much to previous findings.
"There has not yet been a properly designed and large enough study to answer the question of whether there is a significantly increased risk of [immune-system] disease in women with breast implants," Wolfe says. He says analyses such as Janowsky's are interesting, but are simply rehashing old information, some of which was based on studies that were inadequate to begin with.
Wolfe says that while he is not convinced silicone implants cause immune-system or other diseases, he believes there are enough questions about their effects that the investigations must continue. The National Cancer Institute is conducting a large-scale study of women who developed breast cancer after getting implants, and Wolfe says its results should provide more answers.
- According to an analysis of 20 published studies on silicone breast implants, there seems to be no association between the implants and diseases of the immune system or connective tissue.
- Silicone breast implants were banned in 1992, and manufacturers of the devices have settled lawsuits with women who became ill.
- The analysis did not examine why the women had breast implants, whether for cosmetic or reconstructive reasons, and could not determine a possible relationship between rupture or leakage and serious health problems.