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# New Safety-Related Hernia Mesh Label Recommendations
- URL: https://www.fdaweb.com/new-safety-related-hernia-mesh-label-recommendations/
- Published: 2025-06-05T12:00:00.000Z
- Updated: 2026-09-14T15:13:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159310

FDA has released a [draft guidance](https://www.fda.gov/media/186797/download?ref=fdaweb.com) entitled “Hernia Mesh — Package Labeling Recommendations.” The recommendations are being issued to address “suboptimal device selection associated with these devices has resulted in serious adverse events, including deaths,” the guidance says. They are intended to supplement labeling recommendations in Section XI of the agency’s “[Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh](https://www.google.com/url?sa=t&source=web&rct=j&opi=89978449&url=https://www.fda.gov/media/71828/download&ved=2ahUKEwiL9OWhhNuNAxXhv4kEHYUMK-MQFnoECAoQAQ&usg=AOvVaw3FwWOJKB1nqGz7mLVtqhMG).”