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The Importance of Registries in the Postmarketing Surveillance of Surgical Meshes

OBJECTIVE: To assess the role of registries in the postmarketing surveillance of surgical meshes. BACKGROUND: To date, surgical meshes are classified as group II medical devices. Class II devices do not require premarket clearance by clinical studies. Ethicon initiated a voluntary market withdrawal...

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Detalhes bibliográficos
Publicado no:Ann Surg
Main Authors: Köckerling, Ferdinand, Simon, Thomas, Hukauf, Martin, Hellinger, Achim, Fortelny, Rene, Reinpold, Wolfgang, Bittner, Reinhard
Formato: Artigo
Idioma:Inglês
Publicado em: Lippincott, Williams, and Wilkins 2018
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC6250300/
https://ncbi.nlm.nih.gov/pubmed/28594740
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1097/SLA.0000000000002326
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