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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.
Protocol
* Three hundred and forty-four women with silicone gel breast implants responded
to an FDA questionnaire in which they were asked whether they had persistent
symptoms including joint pain, swelling, or stiffness; rash on the breast or
chest; or fatigue.
* Women were also asked whether a doctor diagnosed them with any of a list of
illnesses such as scleroderma, systemic lupus erythematosus (SLE), Sjogren’s
syndrome, Raynaud’s syndrome, fibromyalgia, chronic fatigue syndrome, or other
connective tissue disease not already listed.
* After the questionnaire was completed, women underwent a magnetic resonance
imaging (MRI) examination of their breasts to detect whether their current
implants were intact or ruptured. The MRI examination can also tell whether
silicone gel has leaked outside of the fibrous scar capsule that forms around
the breast implant.
Results
* 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 manufacturer.
Limitations of the Study
* Women who developed fibromyalgia before they had a breast implant could not be
distinguished from women who developed fibromyalgia after breast implant
surgery. This study does not show cause and effect, but a statistical
association between extracapsular silicone and fibromyalgia.
* Women in this study did not receive a medical examination to confirm their
self-reported diagnosis. When diseases are self-reported, some women may have a
disease and not report it, and others may not have the disease but incorrectly
report that they do have it.
Strengths of this Study
This is the first study in which the status of all women’s breast implants, with
respect to rupture, has been known.
Conclusions
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.
Source :
http://www.fda.gov/cdrh/breastimplants/extracapstudy.html