乳房再建術に用いられるブレスト・インプラント(ゲル充填人工乳房)関連製品(回収品の代替製品)を承認しました
https://www.mhlw.go.jp/stf/newpage_07152.htmlThe evidence pack includes HTML, screenshots, summaries, and metadata. It can be downloaded on Pro.
乳房再建術に用いられるブレスト・インプラント(ゲル充填人工乳房)関連製品(回収品の代替製品)を承認しました
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This page announces the approval of replacement breast implant products (gel-filled artificial breasts) used in breast reconstruction surgery. Following Allergan Japan's voluntary recall in July 2019, the distribution of insured products in Japan had stopped. In response to requests from medical professionals and patients, the Ministry of Health, Labour and Welfare requested expedited review of replacement products from the PMDA. After confirming effectiveness and safety, two products were approved: Natrel 133 Tissue Expander and Natrel Breast Implant, enabling resumption of breast reconstruction procedures.
