An association of silicone-gel breast implant rupture and fibromyalgia.
Silicone-gel breast implant rupture is common. Silicone-gel from ruptured implants may escape the scar capsule that forms around breast implants and become "extracapsular silicone." Our previously published study found that women with extracapsular silicone gel were at higher risk of reporting that they were diagnosed with fibromyalgia. There has been a limited number of studies addressing this association in the literature. Some studies addressing the issue of silicone breast implants and connective tissue disease specifically exclude patients with fibromyalgia from the sample or do not include the syndrome in the analysis. Case series describing fibromyalgia in patients with implants have been published, but many of these papers lack information on extracapsular silicone and are not representative because the patients are typically from referral populations. In addition, most studies do not have control groups of women without implants for comparison or do not distinguish between saline and silicone implants. Additional observational studies of women from nonreferral populations are necessary to validate an association. These studies should provide information on how the rupture is diagnosed, state whether the rupture extended beyond the capsule, and provide an appropriate control group for comparison. The findings from such studies may be important to physicians as they describe potential risks associated with implants to their patients. These findings should also be important for regulatory decision making on silicone-gel breast implants.
US Food and Drug Administration, Epidemiology Branch, Center for Devices and Radiological Health, HFZ-541, 1350 Piccard Drive, Rockville, MD 20850, USA. syb@cdrh.fda.gov
S Lori
SL
Brown
Hesha Jani
HJ
Duggirala
Gene
G
Pennello
D018427:Breast Implants / Q000009:adverse effects*; D019544:Equipment Failure Analysis; D004869:Equipment Safety; D005260:Female; D005356:Fibromyalgia / Q000453:epidemiology / Q000209:etiology*; D005500:Follow-Up Studies; D005782:Gels / Q000009:adverse effects; D006801:Humans; D015994:Incidence; D011475:Prosthesis Failure; D012307:Risk Factors; D012828:Silicones / Q000009:adverse effects*
D005782:Gels; D012828:Silicones