FDA, Journal of Rheumatology, May 28, 2001
The FDA has recently completed a study on the health effects of ruptured silicone gel breast
implants. The study was published in the May 2001 Journal of Rheumatology.
FDA conducted this study because of concerns about the frequency and results of rupture.
Rupture is a concern because:
• Rupture of silicone gel-filled implants may allow silicone to migrate through the tissues.
The relationship of free silicone to development or progression of disease is unknown.
• Implant rupture is a device failure – the implant is no longer performing as intended. […]
• Women with MRI diagnosed breast implant rupture were no more likely than women with
intact implants to report that they had either persistent symptoms or doctor-diagnosed
illnesses that were listed.
• Women with MRI-diagnosed extracapsular silicone gel (that is silicone that had migrated
outside the fibrous scar around the implant) were 2.8 times more likely to report that they had
the soft tissue syndrome, fibromyalgia. This association remained statistically significant
after taking into account other factors including whether women thought their implants were
ruptured, implant age, and implant manufacturer. Fibromyalgia is a syndrome characterized
by widespread pain, fatigue, and sleep disturbance.
• Women with MRI-diagnosed extracapsular silicone gel were 2.7 times more likely to report
that they had “other connective tissue disease,” a category that included a diverse group of
illnesses such as dermatomyositis, polymositis, and mixed connective tissue disease. This
association did not remain statistically significant after taking into account other factors
including whether women thought their implants were ruptured, implant age, and implant
The data suggest an association between extracapsular silicone gel and fibromyalgia. If other
studies are consistent with these findings, women should be informed of the potential risk of
developing fibromyalgia if their breast implants rupture and silicone gel escapes the fibrous scar capsule.
Read original article here.
Funding and Authors
• Funding for this study came from: the Office of Women’s Health, FDA; the Office of the
Commissioner; the National Cancer Institute, NIH; the Office of Research on Women’s
Health, NIH; and the U.S. Department of Health and Human Services.
• Authors were S. Lori Brown, PhD, MPH, Gene Pennello PhD, Wendie A. Berg, MD,
PhD, Mary Scott Soo, MD, Michael S. Middleton, PhD, MD