GalaSHAPE 3D 100042-06Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00855920006195), received between Nov 13, 2017 and Nov 2, 2022 — classified as 18 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (14 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 18 most recent of 18 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) 2019, PATIENT UNDERWENT BILATERAL AUGMENTATION MASTOPEXY USING A VERTICAL INCISION. TWO PIECES OF GALASHAPE (GALAFLEX 3D) WERE USED. ON (B)(6) 2019, RIGHT BREAST SEROMA WAS REPORTED. ON (B)(6) 2019, PATIENT HAD DEBRIDEMENT OF RIGHT BREAST WOUND AS WELL AS REMOVAL OF EXPOSED RIGHT BREAST IMPLANT AND EXPOSED GALASHAPE (GALAFLEX 3D) MESH. REPLACEMENT OF RIGHT BREAST IMPLANT AND PRIMARY CLOSURE OF RIGHT BREAST OPEN WOUND. PATIENT WAS TREATED WITH MEDICATION (KEFLEX 500MG, CIPRO 500MG). ON (B)(6) 2019, RIGHT BREAST INFECTION WAS REPORTED,(SERRATIA MARCESCENS AND PSEUDOMONAS AERUGINOSA.) PATIENT WAS TREATED WITH CONTINUED MEDICATION (KEFLEX 500MG, CIPRO 500MG). RESOLVED WITH SEQUELAE ON (B)(6) 2019. ON (B)(6) 2019, PATIENT HAD DEBRIDEMENT OF SMALL OPENING OF RIGHT BREAST INCISION. RESOLVED WITHOUT SEQUELAE ON (B)(6) 2019. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED SEROMA AND INFECTION ARE LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Bacterial Infection; Seroma

  MAUDE report 15713414 ↗
• InjuryNov 2, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(4): ON (B)(6) 2017, PATIENT UNDERWENT BILATERAL AUGMENTATION MASTOPEXY USING A VERTICAL INCISION. TWO PIECES OF GALAFLEX 3D (DEVICE #1 AND DEVICE #2) WERE USED. ON (B)(6) 2017, NECROSIS; LEFT AREOLA WAS REPORTED. PATIENT WAS TREATED WITH MEDICATION (NITROBID, BETADINE WIPES). RESOLVED WITH SEQUELAE ON (B)(6) 2018. PATIENT IS REPORTED TO HAVE A LEFT AREOLAR SCAR. AS REPORTED THE PATIENT¿S AE WAS ASSESSED BY THE CLINICIAN AS SEVERE AND A SERIOUS ADVERSE EVENT. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED NECROSIS IS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Necrosis; Scar Tissue

  MAUDE report 15713375 ↗
• InjuryJul 28, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(4): ON (B)(6) 2019, PATIENT UNDERWENT BILATERAL MASTOPEXY/REDUCTION; INFERIOR PEDICLE, USING A FULL VERTICAL AND HORIZONTAL T INCISION. 2 PIECES OF GALASHAPE (GALAFLEX 3D) WERE USED. NO CONCOMITANT PROCEDURES WERE DONE. ON (B)(6) 2019, WOUND DEHISCENCE; BILATERAL BREASTS WAS REPORTED. PATIENT TREATED WITH MEDICATION (TOPICAL AQUAPHOR). RESOLVED WITHOUT SEQUELAE ON (B)(6) 2019. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE WOUND DEHISCENCE IS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Wound Dehiscence

  MAUDE report 15123728 ↗
• InjuryJul 28, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(4): ON (B)(6) 2019, PATIENT UNDERWENT BILATERAL MASTOPEXY/REDUCTION; INFERIOR PEDICLE, USING A FULL VERTICAL AND HORIZONTAL T INCISION. 2 PIECES OF GALASHAPE (GALAFLEX 3D) WERE USED. NO CONCOMITANT PROCEDURES WERE DONE. ON (B)(6) 2019, EDEMA; BILATERAL BREASTS WAS REPORTED. PATIENT TREATED WITH MEDICATION (TOPICAL AQUAPHOR). RESOLVED WITHOUT SEQUELAE ON (B)(6) 2020. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE EDEMA IS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Swelling/ Edema

  MAUDE report 15123717 ↗
• InjuryJul 28, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(4): ON (B)(6) 2019, PATIENT UNDERWENT BILATERAL MASTOPEXY/REDUCTION; INFERIOR PEDICLE, USING A FULL VERTICAL AND HORIZONTAL T INCISION. 2 PIECES OF GALASHAPE (GALAFLEX 3D) WERE USED. NO CONCOMITANT PROCEDURES WERE DONE. ON (B)(6) 2019, ERYTHEMA/REDNESS; BILATERAL BREASTS WAS REPORTED. PATIENT WAS TREATED WITH MEDICATION (TOPICAL AQUAPHOR). RESOLVED WITHOUT SEQUELAE ON (B)(6) 2020. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE ERYTHEMA/REDNESS IS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Erythema

  MAUDE report 15123711 ↗
• InjuryJul 26, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(4): ON (B)(6) 2019, PATIENT UNDERWENT BILATERAL MASTOPEXY; INFERIOR PEDICLE, USING A FULL VERTICAL AND HORIZONTAL T INCISION. 2 PIECES OF GALASHAPE (GALAFLEX 3D) WERE USED. CONCOMITANT PROCEDURE INCLUDED VASER ASSISTED LIPOSUCTION TO POSTERIOR HIPS AND ABDOMEN. ON (B)(6) 2019, BILATERAL NIPPLE NECROSIS WAS REPORTED. PATIENT HAD DEBRIDEMENT PROCEDURE ON (B)(6) 2019. RESOLVED WITHOUT SEQUELAE ON (B)(6) 2019. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED NECROSIS IS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Necrosis

  MAUDE report 15101770 ↗
• InjuryJul 12, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(6): ON (B)6) 2017, PATIENT UNDERWENT BILATERAL AUGMENTATION MASTOPEXY USING A VERTICAL INCISION. 2 PIECES OF GALASHAPE (GALAFLEX 3D) WERE USED. CONCOMITANT PROCEDURE WAS LIPOSUCTION. ON (B)(6) 2017, LEFT BREAST HEMATOMA WAS REPORTED. HEMATOMA WAS MILKED THROUGH SMALL OPENING OF INCISION. RESOLVED WITHOUT SEQUELAE ON (B)(6) 2017. RESOLVED WITH SEQUELAE ON AN UNKNOWN DATE. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED HEMATOMA IS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Hematoma

  MAUDE report 14988488 ↗
• InjuryJul 12, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(4): ON (B)(6) 2017, PATIENT UNDERWENT BILATERAL AUGMENTATION MASTOPEXY USING A VERTICAL INCISION. 2 PIECES OF GALASHAPE (GALAFLEX 3D) WERE USED. CONCOMITANT PROCEDURE WAS LIPOSUCTION. ON (B)(6) 2017, LEFT BREAST SEROMA WAS REPORTED. PATIENT TREATED WITH PLACEMENT OF PENROSE DRAIN, WET TO DRY DRESSING, WOUND VAC. AND WITH MEDICATION (CIPRO). RESOLVED WITH SEQUELAE ON (B)(6) 2017. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED SEROMA IS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Seroma

  MAUDE report 14988342 ↗
• InjuryJul 12, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(6): ON (B)(6) 2017, PATIENT UNDERWENT BILATERAL AUGMENTATION MASTOPEXY USING A VERTICAL INCISION. 2 PIECES OF GALASHAPE (GALAFLEX 3D) WERE USED. CONCOMITANT PROCEDURE WAS LIPOSUCTION. ON (B)(6) 2017, BILATERAL WOUND DEHISCENCE WAS REPORTED. PATIENT UNDERWENT DELAYED PRIMARY CLOSURE OF BREAST WOUNDS ON (B)(6) 2017 AND WAS TREATED WITH MEDICATION (KEFLEX, CIPRO). RESOLVED WITH SEQUELAE ON AN UNKNOWN DATE. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED WOUND DEHISCENCE IS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Wound Dehiscence

  MAUDE report 14988298 ↗
• InjuryJun 21, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(4): ON (B)(6) 2017, PATIENT UNDERWENT BILATERAL REVISION AUGMENTATION MASTOPEXY USING A VERTICAL INCISION. 2 PIECES OF GALASHAPE (GALAFLEX 3D) WERE USED. CONCOMITANT PROCEDURES INCLUDED CAPSULORRAPHIES AND PIXIE EAR CORRECTION. ON (B)(6) 2018, BILATERAL CAPSULAR CONTRACTURE WAS REPORTED. EVIDENCE OF GRADE II/III CAP CON BILATERALLY. PATIENT WAS TREATED WITH SINGULAIR. PATIENT WAS TO FOLLOW UP IN 5 MONTHS HOWEVER, LAST DOCUMENTED FOLLOW UP ON CASE REPORT FORMS IS ON (B)(6) 2018. UNKNOWN END DATE. REVIEW BY MEDICAL AFFAIRS IDENTIFIES CAPSULAR CONTRACTURE AS LIKELY RELATED TO THE DEVICE AND NOT SERIOUS.

  Patient problems: Capsular Contracture

  MAUDE report 14756148 ↗
• InjuryJun 15, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(4): ON (B)(6) 2017, PATIENT UNDERWENT BILATERAL REVISION AUGMENTATION; PTOSIS, USING A VERTICAL INCISION. 2 PIECES OF GALASHAPE WERE USED. CONCOMITANT PROCEDURE WAS MASTOPEXY. ON (B)(6) 2017, DELAYED WOUND HEALING; LEFT MID VERTICAL BREAST WOUND, WAS REPORTED. PATIENT WAS TREATED WITH MEDICATION (SILVADENE, SILVER NITRATE). 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 14693606 ↗
• InjuryJun 15, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(4): ON (B)(6) 2017, PATIENT UNDERWENT BILATERAL AUGMENTATION MASTOPEXY USING A VERTICAL INCISION. 2 PIECES OF GALASHAPE (GALAFLEX 3D) WERE USED. THERE WERE NO CONCOMITANT PROCEDURES DONE. ON (B)(6) 2017, NECROSIS; BILATERAL AREOLAR COMPLEXES, WAS REPORTED. REPORTED AS SAE. PATIENT HAD SKIN GRAFTING PROCEDURE ON (B)(6) 2017 AND WAS ALSO TREATED WITH MEDICATION (SILVADENE, KEFLEX 500MG, NITRO-BID). RESOLVED WITHOUT SEQUELAE ON (B)(6) 2017. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED NECROSIS IS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Necrosis

  MAUDE report 14693571 ↗
• InjuryJun 7, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(4): ON (B)(6) 2017, PATIENT UNDERWENT BILATERAL AUGMENTATION MASTOPEXY USING A VERTICAL INCISION. 2 PIECES OF GALASHAPE (GALAFLEX 3D) WERE USED. CONCOMITANT PROCEDURES WERE BRACHIOPLASTY AND LIPOSUCTION TO ARMS, AXILLA AND CHEST. ON 5/15/17, CELLULITIS OF LEFT BREAST WAS REPORTED. SAE. WOUND CULTURE REVEALED ACINETOBACTER. PATIENT HAD INCISION AND DRAINAGE IN THE OPERATING ROOM ON (B)(6) 2017. AREAS OF UNINCORPORATED SCAFFOLD WERE REMOVED. THERE WERE AREAS OF WELL INCORPORATED MESH THAT WERE LEFT IN PLACE. PATIENT WAS ALSO TREATED WITH MEDICATION (SILVADENE, IV VANCOMYCIN, IV CEFEPIME, CIPRO). INFECTIOUS DISEASE REFERRAL AND TREATMENT. RESOLVED WITH SEQUELAE ON (B)(6) 2017. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED CELLULITIS IS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Bacterial Infection; Cellulitis

  MAUDE report 14621861 ↗
• InjuryApr 1, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(4): ON (B)(6) 2017, PATIENT UNDERWENT BILATERAL REVISION AUGMENTATION; CAPSULAR CONTRACTURE USING A VERTICAL INCISION. 2 PIECES OF GALASHAPE (GALAFLEX 3D) WERE USED. CONCOMITANT PROCEDURES INCLUDED CAPSULORRAPHY, CAPSULECTOMIES AND MASTOPEXY. ON 9/5/17, CULTURES FROM THE VERTICAL INCISION SHOWED STAPHYLOCOCCUS AUREUS PLUS A GRAM NEGATIVE BACTERIA. PATIENT HAD ADDITIONAL SURGERY ON (B)(6) 2017 CONSISTING OF INCISION AND DRAINAGE OF LEFT BREAST. LEFT BREAST IMPLANT AND LEFT BREAST MESH WERE REMOVED. MEDICATION (LOTRISONE CREAM, KEFLEX, DIFLUCAN, AUGMENTIN) WAS ALSO GIVEN AS TREATMENT. ON (B)(6) 2018, PATIENT HAD A SUBSEQUENT NON P4HB SURGERY - LEFT BREAST IMPLANT WAS REPLACED AND RIGHT PERIAREOLAR SCAR WAS REVISED. NO MENTION OF LEFT BREAST MESH BEING REPLACED, JUST LEFT BREAST IMPLANT. COMPLETED WITHOUT COMPLICATIONS. AE RESOLVED WITHOUT SEQUELAE ON (B)(6) 2018. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE AE OF INFECTION IS LIKELY RELATED AND SERIOUS.

  Patient problems: Bacterial Infection

  MAUDE report 13977880 ↗
• InjuryApr 1, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(6): ON (B)(6) 2017, PATIENT UNDERWENT BILATERAL REVISION AUGMENTATION; CAPSULAR CONTRACTURE USING A VERTICAL INCISION. 2 PIECES OF GALASHAPE (GALAFLEX 3D) WERE USED. CONCOMITANT PROCEDURES INCLUDED CAPSULORRAPHY, CAPSULECTOMIES AND MASTOPEXY. ON (B)(6) 2017, LEFT BREAST SEROMA/HEMATOMA WAS REPORTED. AE RESOLVED WITHOUT SEQUELAE ON (B)(6) 2018. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE AE OF SEROMA HEMATOMA IS LIKELY RELATED AND SERIOUS.

  Patient problems: Hematoma; Seroma

  MAUDE report 13977762 ↗
• InjuryOct 24, 2018Contamination; Contamination

  PHYSICIAN REPORTED THAT 9 DAYS AFTER THE SURGERY; RE-AUGMENTATION OF LEFT BREAST WITH IMPLANT AND MESH LOCATED AT THE INFERIOR POLE (LEFT BREAST ONLY), THE PATIENT PRESENTED AN ELEVATED WHITE BLOOD CELL COUNT AND SHOWED SIGNS AND SYMPTOMS OF AN INFECTION - REDNESS, FEVER, MALAISE AND ACHES. THE PATIENT WAS SENT TO THE HOSPITAL, THE BREAST IMPLANT AND MESH WERE REMOVED, THE AREA FLUSHED AND A NEW IMPLANT WAS PLACED. NO MESH WAS USED IN THE SECOND SURGERY.

  Patient problems: Unspecified Infection

  MAUDE report 8000102 ↗
• InjuryNov 13, 2017Microbial Contamination of Device; Device Contamination With Biological Material; Microbial Contamination of Device; Device Contamination With Biological Material

  INFECTED LEFT BREAST SEROMA / HEMATOMA INVOLVING MESH.

  Patient problems: Bacterial Infection

  MAUDE report 7025447 ↗
• InjuryNov 13, 2017Microbial Contamination of Device; Device Contamination With Biological Material; Microbial Contamination of Device; Device Contamination With Biological Material

  INFECTION OF BREAST, REQUIRING REMOVAL.

  Patient problems: Bacterial Infection

  MAUDE report 7024727 ↗