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Adverse events due to suspected nickel hypersensitivity in patients with essure micro-inserts

Zurawin, R.K.; Zurawin, J.L.

Journal of Minimally Invasive Gynecology 18(4): 475-482

2011

ISSN/ISBN: 1553-4650
PMID: 21777837
DOI: 10.1016/j.jmig.2011.04.009
Document Number: 224959
Review reported adverse events associated with suspected nickel hypersensitivity and subsequent clinical outcomes in patients with Essure implants and to evaluate the correlation of nickel allergy related adverse events with positive results of nickel patch testing. Case series (Canadian Task Force classification II-3). Measurements and Main Reports of suspected nickel hypersensitivity reported from 21 through July 21, 21, were collected from de-identified data obtained from the MAUDE (Manufacturer and User Facility Device Experience) database and reports to the manufacturer directly from treating physicians, and published results for the 65 patients in the Phase II and Pivotal trials. Clinical outcomes and symptom.

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Adverse events due to suspected nickel hypersensitivity in patients with essure micro-inserts

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