GalaFLEX Scaffold 100035-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00855920006027), received between Mar 30, 2022 and Dec 13, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Migration” (2 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. How this data works · Data updated Oct 13, 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.

• InjuryDec 13, 2024Material Deformation; Material Deformation

  AS REPORTED, FOLLOWING BREAST IMPLANT SURGERY IN 2020, THE PATIENT UNDERWENT IMPLANT OF GALAFLEX AND REPLACEMENT OF BREAST IMPLANTS WITH SMALLER ONES IN (B)(6) 2022. IT WAS REPORTED THAT POST IMPLANT OF GALAFLEX, PATIENT HAD PAIN, DEVELOPED "IRON BREAST SYNDROME" AND ALSO A "LUMP" ON THE RIGHT LATERAL BREAST. IT WAS ALSO REPORTED THAT DURING LAST WEEK, THE PATIENT UNDERWENT REMOVAL OF THE "WADDED UP GALAFLEX".

  Patient problems: Breast Discomfort/Pain; Foreign Body In Patient

  MAUDE report 20925148 ↗
• InjuryJul 19, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(4): ON (B)(6) 2018, PATIENT UNDERWENT BILATERAL MASTOPEXY; SUPERIOR PEDICLE, USING A VERTICAL INCISION. 1 PIECE OF GALAFLEX CUT INTO RECTANGLE. CONCOMITANT PROCEDURE WAS AFG TO BILATERAL BREASTS FROM ABDOMEN. ON (B)(6) 2018, DELAYED WOUND HEALING; LEFT BREAST WAS REPORTED. PATIENT TREATED WITH MEDICATION (KEFLEX). WASHED WITH SALINE, POLYSPORIN APPLIED. CULTURE TAKEN, BUT NO FURTHER MENTION OF RESULTS. RESOLVED WITHOUT SEQUELAE ON (B)(6) 2018. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE DELAYED WOUND HEALING AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Impaired Healing

  MAUDE report 15056970 ↗
• InjuryJun 15, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(4): ON (B)(6) 2018, PATIENT UNDERWENT BILATERAL MASTOPEXY; SUPERIOR PEDICLE, USING A VERTICAL INCISION. 1 PIECE GALAFLEX WAS USED AND CUT INTO RECTANGLE. THERE WERE NO CONCOMITANT PROCEDURES DONE. ON (B)(6) 2019, BILATERAL BREAST UPPER POLE NECROSIS WAS REPORTED. PATIENT WAS TREATED WITH ULTRASOUND TREATMENT AND MEDICATION (SINGULAIR). RESOLVED WITHOUT SEQUELAE ON (B)(6) 2019. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED ADVERSE EVENT AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Necrosis

  MAUDE report 14693856 ↗
• InjuryApr 12, 2022Migration; Migration

  PER CLINICAL TRIAL (B)(6): ON (B)(6) 2018, PATIENT UNDERWENT BILATERAL AUGMENTATION MASTOPEXY USING A FULL VERTICAL AND HORIZONTAL T INCISION. ONE PIECE OF GALAFLEX WAS USED AND CUT INTO A RECTANGLE. NO CONCOMITANT PROCEDURES WERE PERFORMED. ON (B)(6) 2019, LEFT MIGRATION, MALPOSITION OR CONTRACTION WAS REPORTED. NOTE STATES THAT PHYSICIAN CAN DO LEFT LATERAL CAPSULORRAPHY TO MAKE BREASTS MORE EVEN. NO DOCUMENTATION OF FURTHER PROCEDURE BEING DONE. NO FURTHER INFORMATION GIVEN AND RESOLUTION DATE NOT GIVEN. REVIEW BY MEDICAL AFFAIRS IDENTIFIES AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Unspecified Reproductive System or Breast Problem

  MAUDE report 14086795 ↗
• InjuryMar 30, 2022Migration; Migration

  PER CLINICAL TRIAL (B)(4): ON (B)(6) 2018, PATIENT UNDERWENT BILATERAL REVISION AUGMENTATION; LOWER POLE BOTTOMING OUT(LOWER POLE STRETCH DEFECT) USING A FULL VERTICAL AND HORIZONTAL T INCISION. 1 PIECE OF GALAFLEX WAS USED AND CUT INTO A RECTANGLE SHAPE. CONCOMITANT PROCEDURE - LESION REMOVAL UNDER LEFT ARM. ON (B)(6) 2018, LEFT BREAST MIGRATION, MALPOSITION OR CONTRACTION WAS REPORTED. ON (B)(6) 2019, PATIENT HAD ADDITIONAL SURGERY OF LEFT CAPSULORRAPHY. NO ADDITIONAL DETAILS WERE GIVEN. RESOLVED WITHOUT SEQUELAE ON (B)(6) 2019. REVIEW OF MEDICAL AFFAIRS IDENTIFIED THAT THE REPORTED AE IS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Unspecified Reproductive System or Breast Problem

  MAUDE report 13953776 ↗