Fw: Implant Rupture & Fibromyalgia ~ Journal of Rheumatology

[Guest guest]

From: " ilena rose " <ilena@...>

Sent: Thursday, May 31, 2001 10:43 AM

Subject: Implant Rupture & Fibromyalgia ~ Journal of Rheumatology

> Abstract: Silicone gel breast implant rupture, extracapsular silicone, and

> health status in a population of women.

>

>

> by Brown SL, Pennello G, Berg WA, Soo MS, Middleton MS.

>

> ImmuneSupport.com

> 05-31-2001

>

> Office of Surveillance and Biometrics, Center for Devices and Radiological

> Health, Food and Drug Administration, Rockville, MD, USA.

>

> Summary

>

> This study found a 'statistically significant' association between the

> development of fibromyalgia and the rupture of silicone breast implants.

>

> Objective

>

> To assess whether breast implant rupture or extracapsular silicone are

> associated with selected symptoms of self-reported physician-diagnosed

> connective tissue disease (CTD).

>

> Methods

>

> Women with silicone gel breast implants responded to a questionnaire that

> included questions on health status, satisfaction with implants, symptoms

> of CTD, and physician-diagnosed disease. These women then had magnetic

> resonance imaging (MRI) of their breasts to determine the status of the

> implants with respect to rupture and extracapsular silicone.

>

> Results

>

> Women with breast implant rupture diagnosed by MRI were no more likely to

> report a diagnosis of selected CTD than those with intact implants or

those

> with implants of indeterminate status.

>

> Women with extracapsular silicone (silicone gel outside of the fibrous

scar

> that forms around breast implants) were more likely to report having

> fibromyalgia (FM, p = 0.004) or other CTD, which included dermatomyositis,

> polymyositis, Hashimoto's thyroiditis, mixed CTD, pulmonary fibrosis,

> eosinophilic fasciitis, and polymyalgia (p = 0.008) than other women in

the

> study.

>

> The association with FM remained statistically significant when adjusted

> for multiple comparisons (7 diagnoses) and implant age, implant location,

> or implant manufacturer (p < 0.05 in all cases), but became of borderline

> statistical significance when adjusted for multiple comparisons and

> self-perceived health status (p = 0.094) or self-perceived rupture status

> (p = 0.051). The association with other CTD remained statistically

> significant when adjusted for multiple comparisons and implant location or

> implant manufacturer, but became borderline or insignificant when adjusted

> for multiple comparisons and for implant age (p = 0.051), self-perceived

> health status (p = 0.434), or self-perceived rupture status (p = 0.145).

>

> Logistic regression was used to compute odds ratios of self-reported

> diagnoses comparing women with and without extracapsular silicone. The

odds

> ratios were 2.8 (95% CI 1.2 to 6.3) for FM, and 2.6 (95% CI 0.8 to 8.5)

for

> other CTD after adjustment for implant age, implant location, implant

> manufacturer, implant type, self-perceived health, self-perceived rupture

> status, and site of surgery practice.

>

> Conclusion

>

> These data suggest an association between extracapsular silicone from

> ruptured silicone breast implants and FM. If this association persists in

> other studies, women with silicone gel breast implants should be informed

> of the potential risk of developing fibromyalgia if their breast implants

> rupture and the silicone gel escapes the fibrous scar capsule.

>

> J Rheumatol 2001 May;28(5):996-1003

> PMID: 11361228 [PubMed - in process]

>

>

>