GalaFLEX LITE 100027-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00810054980575), received between Aug 31, 2022 and Oct 10, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (5 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 10, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, THE PATIENT UNDERWENT A BILATERAL SUBFASCIAL BREAST AUGMENTATION WITH IMPLANT OF A GALAFLEX LITE MESH THAT WAS CUT IN HALF AND USED BILATERALLY ON (B)(6) 2024. IT WAS REPORTED THAT THE PATIENT DEVELOPED A PUS INFECTION AT THE INCISION SITE ON THE LEFT BREAST STARTING ON (B)(6) 2024. ON (B)(6) 2024 PATIENT UNDERWENT RE-EXCISION OF OPEN AREA (WOUND TISSUE) AND CLOSURE AND STARTED ON KEFLEX (ANTIBIOTIC) AND THE INFECTION WAS CLEARED.

  Patient problems: Unspecified Infection

  MAUDE report 20424295 ↗
• InjuryOct 10, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, PATIENT UNDERWENT A BILATERAL SUBFASCIAL BREAST AUGMENTATION WITH IMPLANT OF A GALAFLEX LITE MESH THAT WAS CUT IN HALF AND USED BILATERALLY ON (B)(6) 2024. AS REPORTED, THE PATIENT DEVELOPED A PUS INFECTION AT THE INCISION SITE ON THE LEFT BREAST STARTING ON (B)(6) 2024. ON (B)(6) 2024 PATIENT UNDERWENT EXCISION OF WOUND TISSUE AND CLOSURE OF THE OPEN AREA.

  Patient problems: Unspecified Infection

  MAUDE report 20422938 ↗
• InjuryOct 10, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, PATIENT UNDERWENT A BILATERAL IMPLANT EXCHANGE, SUBMUSCULAR TO SUBFASCIAL, BILATERAL SUPERIOR PEDICLE MASTOPEXY, RE ATTACHMENT OF PEC MAJOR MUSCLE, BILATERAL BREAST FAT GRAFT AND GALAFLEX LITE MESH PLACEMENT WHICH WAS CUT IN HALF AND USED BILATERALLY ON (B)(6) 2024. AS REPORTED, THE PATIENT DEVELOPED CELLULITIS ON THE RIGHT BREAST STARTING ON (B)(6) 2024 AND PATIENT WAS TREATED WITH ANTIBIOTICS (DOXYCYCLINE AND RIFAMPIN) WITH RESOLUTION OF INFECTION.

  Patient problems: Cellulitis

  MAUDE report 20422886 ↗
• InjuryJun 18, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, DURING BREAST AUGMENTATION PROCEDURE ON (B)(6) 2024, THE PATIENT WAS IMPLANTED WITH GALAFLEX LITE SCAFFOLD. ABOUT TWO MONTHS POST-IMPLANT PATIENT DEVELOPED AN INFECTION ON RIGHT SIDE (LEFT SIDE WAS UNAFFECTED). IT WAS REPORTED THAT THE GALAFLEX LITE WAS SURGICALLY REMOVED TO TREAT THE INFECTION ON (B)(6) 2024. AS REPORTED BY THE OR NURSE, "WHEN THEY OPENED THE BREAST POCKET UP THEY REMOVED ¿THE GALAFLEX IN A PUS BALL¿.

  Patient problems: Unspecified Infection

  MAUDE report 19557164 ↗
• InjuryAug 31, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, ON (B)(6) 2022, THE PATIENT UNDERWENT BILATERAL BREAST AUGMENTATION WITH IMPLANT REMOVAL/REPLACEMENT AND A MASTOPEXY DURING WHICH A SEGMENT OF GALAFLEX LITE WAS IMPLANTED AT THE LOWER POLE AND APPROXIMATED WITH SUTURES. IT WAS REPORTED THAT ABOUT ONE-MONTH POST-IMPLANT, THE PATIENT'S BREASTS WERE ASYMMETRICAL AND ¿DO NOT LOOK GOOD.¿

  Patient problems: Physical Asymmetry

  MAUDE report 15326409 ↗