Ann Epidemiol. 2000 May;10(4):197-9. [/B]
A retrospective cohort study of implanted medical devices and selected chronic diseases in Medicare claims data.Greenland S, Finkle WD.
Department of Epidemiology, UCLA School of Public Health, Topanga, CA, USA.

PURPOSE Several case-control studies have observed associations of implanted medical devices and certain connective-tissue and neurologic diseases. We reexamined these and other associations using cohort comparisons.

[COLOR="black"]METHODS:[/COLOR] We compared the incidence of 52 diseases in several retrospective cohorts constructed from Medicare claims data. Six cohorts were defined by implantation of medical devices (silicone, metal bone or joint implants, breast implants, penile implants, pacemakers, artificial heart valves), and four comparison cohorts were defined by surgeries not involving implants.

RESULTS: We observed associations that were generally consistent with previous reports, including associations of bone and joint implants with connective-tissue diseases, and an association of penile implants with idiopathic progressive neuropathy. We also observed associations of breast implants and pacemakers with connective-tissue diseases.

CONCLUSIONS For the most part, our study confirms our previous case-control results. Although confounding by presurgical conditions (such as diabetes) remains a plausible explanation of the findings, several associations are worthy of more detailed research.

PMID: 10854955 [PubMed - indexed for MEDLINE]

: Ann Epidemiol. 1998 Jul;8(5):319-26. Links
A case-control study of prosthetic implants and selected chronic diseases in Medicare claims data.• Greenland S,
• Finkle WD.
Department of Epidemiology, UCLA School of Public Health, Los Angeles, CA 90095-1772, USA.

PURPOSE: In an exploratory case-control study of a private insurance-claims database, Greenland and Finkle (Ann Epidemiol. 1996;6:530-540) observed associations of certain prosthetic nonbreast implants with certain connective-tissue and neurologic conditions. We wished to test these associations using the same design with new data.

METHODS: We examined these associations in a case-control analysis of Medicare claims data. To control for possible confounding effects of surgery, our analysis examined nonimplant surgeries of severity similar to implant surgeries. RESULTS: We again found associations of silicone and metal implants with connective-tissue and neurologic conditions, but we also found similar associations of carpal-tunnel surgery with those conditions.
CONCLUSIONS: Possible explanations for these findings include confounding by presurgical conditions. Therefore, we recommend further studies be done in which such conditions can be measured and controlled.
PMID: 9669614 [PubMed - indexed for MEDLINE

1: Ann Epidemiol. 1996 Nov;6(6):530-40. Links

A case-control study of prosthetic implants and selected chronic diseases.
• Greenland S,
• Finkle WD.
Department of Epidemiology, UCLA School of Public Health 90095-1772, USA.
We examined the association between prosthetic nonbreast implants and selected malignant neoplasms, connective tissue disorders, and neurologic diseases. We conducted a case-control study from an insurance claims database. We selected controls who had diseases for which no association with implants have been claimed or reported. Data were analyzed using both tabular and polytomous regression analysis methods, including methods to account for the large number of comparisons. All analyses exhibited positive associations between implants (both silicone and metal) and neurologic conditions, especially idiopathic progressive neuropathy and Meniere syndrome, as well as the expected associations with arthritic conditions. There also was an unexpected negative association between metal implants and brain tumors.


Conclusion, further studies of prosthetic implants and neurologic diseases appear warranted. These studies should obtain medical histories to control for possible confounding effects of drug treatments associated with implant surgery.
PMID: 8978883 [PubMed - indexed for MEDLINE]


: Rheumatology (Oxford). 2002 Feb;41(2):129-35; discussion 123-4. Links
Silicone breast implants: correlation between implant ruptures, magnetic resonance spectroscopically estimated silicone presence in the liver, antibody status and clinical symptoms.
• Gaubitz M, • Jackisch C,

Department of Medicine B, University of Munster, Munster, Germany.

OBJECTIVE: To determine the impact of implant integrity on clinical symptoms and antibody status in women with silicone breast implants (SBIs). METHODS: Ninety consecutive women were examined by means of magnetic resonance imaging (MRI) to assess the integrity of their silicone breast implants. The presence of silicone in the liver was estimated by (1)H localized stimulated echo acquisition mode (STEAM) magnetic resonance spectroscopy (MRS). Results were correlated with patients' complaints, as evaluated by a standardized questionnaire, physical examination by a rheumatologist and antibody screening.

RESULTS: Breast MRI revealed defects in 24 patients (26.6%); in 13 (54.2%) of these women, silicone was detected in the liver by MRS. Of the 66 patients with MRI-estimated intact implants, 15 (22.7%) had apparent silicone in their liver, arguing for gel bleeding. Clinically, two patients had had rheumatoid arthritis before SBIs, whereas the other patients revealed no typical symptoms of arthritis or connective tissue disease (CTD). The patients with MRS evidence of silicone in the liver had no statistically significant differences in their complaints with the exception of the most frequent symptom, tingling/numbness of the fingers (82.1 vs 51.6%, P=0.006). A positive pattern of antinuclear antibodies (ANA) was obtained in 13 of the 28 MRS-positive patients (46.4%) and in 15 of the 62 MRS-negative patients (24.2%, P=0.033). However, in only one of these 28 ANA-positive patients was a specific weak antibody titre against SS-A detected by ELISA.

CONCLUSION: Implant integrity has no major impact on rheumatic symptoms of women with SBIs. This finding supports the standpoint that silicone does not cause either a specific CTD or any other distinct disease entity. However, the moderately increased incidences of ANA-positivity and neuropathy-associated symptoms require explanation.
PMID: 11886959 [PubMed - indexed for MEDLINE]