Study of Silicone Gel Breast Implant Rupture, Extracapsular Silicone, and
Health Status in a Population of Women
|
|
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.
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, MPH1, Gene Pennello PhD1, Wendie A. Berg,
MD, PhD2 , Mary Scott Soo, MD3 , Michael S. Middleton, PhD, MD4
1Office of Surveillance and Biometrics, Center for Devices and Radiological
Health, Food and Drug Administration, Rockville, MD 20850
2Division of Breast Imaging, Department of Radiology and Greenebaum Cancer
Center, University of Maryland School of Medicine, Baltimore, MD 21201
3Department 92103 of Radiology, Duke South Hospital, Duke University
Medical Center, Durham, NC 27710
4Department of Radiology, University of California at San Diego School of
Medicine, San Diego, CA
Return to the Breast Implant Information Page
Uploaded May 29, 2001
CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page
Center for Devices and Radiological Health / CDRH