GalaSHAPE 3D 100042-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00855920006157), received between Apr 22, 2022 and Nov 2, 2022 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 2, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PER CLINICAL TRIAL (B)(4): ON (B)(6) 2017, PATIENT UNDERWENT BILATERAL REVISION AUGMENTATION MASTOPEXY USING A FULL VERTICAL AND HORIZONTAL T INCISION. 2 PIECES OF GALASHAPE (GALAFLEX 3D) WERE USED (LOT #160484). CONCOMITANT PROCEDURES INCLUDED: FAT GRAFTING TO FACE, UPPER/LOWER BLEPHAROPLASTY AND EXCISION OF MID CHEST SKIN LESION. ON (B)(6) 2017, LEFT BREAST NECROSIS WAS REPORTED. PATIENT HAD LEFT BREAST DEBRIDEMENT ON (B)(6) 2017. GALAFLEX BECAME EXPOSED BOTH VISUAL AND PALPABLE AT MEDIAL PORTION OF LEFT BREAST. PATIENT ALSO WAS TREATED WITH MEDICATION (SILVADENE, CARRINGTON WOUND GEL, UNNAMED ANTIBIOTIC). ON (B)(6) 2017, PATIENT HAD LOCAL CLOSURE OF LEFT BREAST WOUND AND WOUND VACUUM APPLICATION. PATIENT HAD ANOTHER P4HB PROCEDURE ON (B)(6) 2018 - REVISION LEFT BREAST CAPSULECTOMY WITH WOUND DEBRIDEMENT AND CLOSURE AND IMPLANT EXCHANGE, FOR FULL THICKNESS TISSUE LOSS AND INFECTION OF LEFT BREAST. PATIENT ON AN ANTIBIOTIC FOR SINUS INFECTION. PORTIONS OF ORIGINAL P4HB RESECTED. DRAIN PLACEMENT. 2 PIECES OF GALASHAPE (LOT # UNKNOWN) WERE USED IN THIS PROCEDURE. RESOLVED WITH SEQUELAE ON (B)(6) 2018. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED NECROSIS IS LIKELY RELATED TO TH

  Patient problems: Necrosis; Unspecified Infection

  MAUDE report 15713685 ↗
• InjuryJul 28, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(6): ON (B)(6) 2020, PATIENT WAS HOSPITALIZED AND UNDERWENT BILATERAL PRIMARY RECONSTRUCTION; PRE PECTORAL. THE INCISION TYPE WAS NOT RECORDED. MULTIPLE PIECES OF GALAFLEX MESH WERE IMPLANTED DURING THIS PROCEDURE. NO CONCOMITANT PROCEDURES WERE DONE. ON (B)(6) 2020, RIGHT BREAST WOUND DEHISCENCE WAS REPORTED. ON (B)(6) 2020, PATIENT HAD WASHOUT AND DEBRIDEMENT PROCEDURE AND WAS ALSO TREATED WITH MEDICATION (CEPHALEXIN). IT WAS NOTED THAT THERE WAS NO EVIDENCE OF EXPOSED MESH OR BREAST IMPLANTS. RESOLVED WITHOUT SEQUELAE ON (B)(6) 2020. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED WOUND DEHISCENCE IS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Wound Dehiscence

  MAUDE report 15123703 ↗
• InjuryJul 12, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(6): ON (B)(6) 2019, PATIENT UNDERWENT BILATERAL REVISION AUGMENTATION; OTHER (REMOVAL OF IMPLANTS) USING A FULL VERTICAL AND HORIZONTAL T INCISION. 2 PIECES OF GALASHAPE (GALAFLEX 3D) WERE USED. CONCOMITANT PROCEDURES INCLUDED MASTOPEXY/AUTOAUGMENTATION. ON (B)(6) 2019, CYANOSIS OF LEFT NIPPLE WAS REPORTED. PATIENT WAS TREATED WITH MEDICATION (NITRO PASTE). RESOLVED WITHOUT SEQUELAE ON (B)(6) 2019. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE CYANOSIS AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Cyanosis

  MAUDE report 14985000 ↗
• InjuryJun 24, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(4): ON (B)(6) 2017, PATIENT UNDERWENT BILATERAL REVISION AUGMENTATION MASTOPEXY USING A FULL VERTICAL AND HORIZONTAL T INCISION. 2 PIECES OF GALASHAPE (GALAFLEX 3D) WERE USED. CONCOMITANT PROCEDURE WAS NIPPLE REDUCTION. ON (B)(6) 2017, DELAYED WOUND HEALING; BREAST, WAS REPORTED. ON (B)(6) 2017, MINIMAL DEBRIDEMENT WAS PERFORMED AND PATIENT WAS TREATED WITH MEDICATION (BACTROBAN). RESOLVED WITHOUT SEQUELAE ON (B)(6) 2017. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED DELAYED WOUND HEALING IS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Impaired Healing

  MAUDE report 14799517 ↗
• InjuryMay 9, 2022Migration; Migration

  PER CLINICAL TRIAL (B)(4): ON (B)(6) 2019, PATIENT UNDERWENT BILATERAL REVISION AUGMENTATION; CAPSULAR CONTRACTURE, USING AN IMF INCISION. ONE PIECE OF GALASHAPE (GALAFLEX 3D) WAS USED. NO CONCOMITANT PROCEDURES WERE DONE. ON (B)(6) 2019, MIGRATION, MALPOSITION OR CONTRACTION WAS REPORTED. BAKER GRADE 4 BILATERALLY. ON (B)(6) 2020, PATIENT HAD BILATERAL BREAST IMPLANT REMOVAL (NOT REPLACED) WITH TOTAL CAPSULECTOMIES, AND BREAST FAT GRAFTING. PATIENT HAD Z WAVE TREATMENT X3 PRIOR TO IMPLANT REMOVAL SURGERY. RESOLVED WITHOUT SEQUELAE ON (B)(6) 2020. REVIEW BY MEDICAL AFFAIRS IDENTIFIES AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Unspecified Reproductive System or Breast Problem

  MAUDE report 14341634 ↗
• InjuryMay 7, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  (B)(4): ON (B)(6) 2018, PATIENT UNDERWENT BILATERAL AUGMENTATION MASTOPEXY USING A FULL VERTICAL AND HORIZONTAL T INCISION. 2 PIECES OF GALASHAPE (GALAFLEX 3D) WERE USED. NO CONCOMITANT PROCEDURES WERE DONE. ON (B)(6) 2018, ERYTHEMA/REDNESS, DRAINAGE AND DELAYED WOUND HEALING OF LEFT BREAST WERE REPORTED. PATIENT WAS TREATED WITH MEDICATION (BACTRIM) AND WET TO DRY DRESSING CHANGES. RESOLVED WITHOUT SEQUELAE ON (B)(6) 2018. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED ADVERSE EVENT AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Erythema; Fluid Discharge; Impaired Healing

  MAUDE report 14319140 ↗
• InjuryApr 22, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL CP-(B)(4): ON (B)(6) 2018, PATIENT UNDERWENT BILATERAL MASTOPEXY; INFERIOR PEDICLE USING A FULL VERTICAL AND HORIZONTAL T INCISION. 2 PIECES OF GALASHAPE (GALAFLEX 3D) WERE USED. THERE WERE NO CONCOMITANT PROCEDURES. ON (B)(6) 2018, DELAYED WOUND HEALING OF LEFT BREAST WAS REPORTED. A DEBRIDEMENT AND APPLICATION OF DUODERM WAS PERFORMED. RESOLVED (B)(6) 2018 WITHOUT SEQUELAE. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THAT THE REPORTED DELAYED WOUND HEALING IS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Impaired Healing

  MAUDE report 14190288 ↗