Breast implants and connective tissue disease formal reviews

At the time of the Panel meeting in 1992, there were no epidemiologic studies on the association of connective tissue disease with breast implants. Starting in 1994, there were a series of studies published. The first of these studies raised considerable criticism, since the study was funded by breast implant manufacturers [58,59]. Many subsequent studies were also funded by implant manufacturers. The FDA reviewed these studies on breast implant association with connective tissue disease in several publications [60-62]. The conclusions were similar to those reached by others, such as the Institute of Medicine on the Safety of Silicone Breast Implants and the National Science Panel on Silicone Implants [56,63], who formally reviewed these studies: the studies had some flaws and were not large enough to definitively rule out a small increased risk of connective tissue disease in women with breast implants. However, it can be concluded from these studies that there is not a large association between breast implants and individual connective tissue diseases that were studied or all connective tissue diseases combined. To rule out a small increase in various connective tissue diseases would require a large, well-designed study. It is unlikely that such a massive study would be undertaken, given the mostly negative findings from smaller studies.

There were some investigators who believed that women with breast implants were prone to an 'atypical connective tissue disease', based on the observation that women with breast implants reported fatigue, myalgias, and arthralgias. However, the search for a silicone-specific syndrome did not reveal a consistent pattern of signs and symptoms that could be attributed to breast implants. A related issue, over which there has been a continuing controversy, is whether there is an increase in other difficult-to-diagnose syndromes in women with implants, specifically fibromyalgia or chronic fatigue syndrome. FDA's study on breast implant rupture (described above) indicated that women who had extracapsular silicone gel were 3.8 times more likely to self-report doctor-diagnosed fibromyalgia than were other women with implants but without extracapsular silicone spread [64,65]. This study differed from other studies in that the implant rupture status for every woman in the study cohort was known at a single moment in time. These women had responded to a questionnaire about their current health status weeks prior to their MRI examination for implant rupture.

This study was not definitive because it was essentially a cross-sectional study. It was not known whether implantation occurred before or after the onset of the fibromyalgia. In addition, the FDA study was subject to all the biases of self-reports, since patients may incorrectly report a diagnosis (over- or underreporting may occur). The ideal study would be prospective and longitudinal, would include implant status, medical record review for date of diagnosis (and implantation), and current physician's diagnosis, as well as a comparable comparison group without implants.

A recent manufacturer's study in support of approval for silicone gel-filled breast implants reported a statistically significant increase, from baseline (before implantation) to 3 years postimplantation for augmentation patients, of fatigue, exhaustion, joint swelling, frequent muscle cramps, joint pain, combined fatigue, combined pain, and combined (symptoms of) fibromyalgia [66]. Unfortunately, there was no comparable control group to compare the findings with, so it is difficult to interpret these findings and the question of an association of breast implants with fibromyalgia is left unresolved.

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