GalaSHAPE 3DRecalls & reported problems across all models
Tepha, Inc. · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 74
- Deaths reported
- 0
- Injuries reported
- 72
- Recalls
- 0
We found 7 models of GalaSHAPE 3D by Tepha, Inc. in the FDA's device registry (GUDID). Together they are named in 74 adverse event reports in the FDA's MAUDE database, received between Nov 13, 2017 and Nov 2, 2022 — classified as 72 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (57 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Most reported GalaSHAPE 3D problems
Device problems
- Patient-Device Incompatibility57
- Adverse Event Without Identified Device or Use Problem4
- Device Appears to Trigger Rejection4
- Migration3
- Patient Device Interaction Problem3
- Device Contamination With Biological Material2
- Microbial Contamination of Device2
- Contamination1
Patient problems
- Necrosis13
- Wound Dehiscence11
- Impaired Healing10
- Unspecified Infection8
- Bacterial Infection5
- Seroma5
- Breast Discomfort/Pain4
- Erythema4
GalaSHAPE 3D models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- GalaSHAPE 3D 100042-04Surgical Film37 reports
- GalaSHAPE 3D 100042-06Surgical Film18 reports
- GalaSHAPE 3D 100042-02Surgical Film7 reports
- GalaSHAPE 3D 100042-03Surgical Film5 reports
- GalaSHAPE 3D 100042-07Surgical Film3 reports
- GalaSHAPE 3D 100042-01Surgical Film2 reports
- GalaSHAPE 3D 100042-05Surgical Film2 reports
Recent GalaSHAPE 3D adverse event reports
The 15 most recent reports across all models, 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 ↗InjuryNov 2, 2022Patient-Device Incompatibility; Patient-Device Incompatibility
PER CLINICAL TRIAL (B)(4): ON (B)(6) 2019, PATIENT UNDERWENT BILATERAL REVISION AUGMENTATION; IMPLANT MALPOSITION USING A HORIZONTAL INCISION IN IMF. 2 PIECES OF GALASHAPE (GALAFLEX 3D) (DEVICE1, DEVICE2) WERE USED. ON (B)(6) 2019, A SAE OF BREAST INFECTION WAS REPORTED. PATIENT HAD BEEN HOSPITALIZED THE PREVIOUS WEEK (NO DATE GIVEN). PATIENT WAS SEEN BY INFECTIOUS DISEASE AND DOCTOR PUT ON BROAD SPECTRUM ANTIBIOTIC MEDICATION (UNKNOWN MEDS). RESOLVED WITHOUT SEQUELAE ON (B)(6) 2019. ON THAT (B)(6) 2019 FOLLOW UP VISIT, IT WAS NOTED THAT THE PATIENT FELT THAT THE MESH HADN'T HELD THINGS UP IN THE RIGHT BREAST AND THE LEFT BREAST HAD CONTRACTED. REVISION RIGHT BREAST CAPSULORRHAPY UTILIZING STRATTICE MESH ON (B)(6) 2019. COMPLETED WITHOUT COMPLICATIONS. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE INFECTION AND CONTRACTURE AS LIKELY RELATED TO THE DEVICE AND SERIOUS. THIS FILE REPRESENTS THE DEVICE #1.
Patient problems: Capsular Contracture; Unspecified Infection
MAUDE report 15713684 ↗InjuryNov 2, 2022Patient-Device Incompatibility; Patient-Device Incompatibility
PER CLINICAL TRIAL (B)(4): ON (B)(6) 2019, PATIENT UNDERWENT BILATERAL REVISION AUGMENTATION; IMPLANT MALPOSITION USING A HORIZONTAL INCISION IN IMF. 2 PIECES OF GALASHAPE (GALAFLEX 3D) (DEVICE1, DEVICE2) (LOT #180283, #180384) WERE USED. ON (B)(6) 2019, A SAE OF BREAST INFECTION WAS REPORTED. PATIENT HAD BEEN HOSPITALIZED THE PREVIOUS WEEK (NO DATE GIVEN). PATIENT WAS SEEN BY INFECTIOUS DISEASE AND DOCTOR PUT ON BROAD SPECTRUM ANTIBIOTIC MEDICATION (UNKNOWN MEDS). RESOLVED WITHOUT SEQUELAE ON (B)(6) 2019. ON THAT (B)(6) 2019 FOLLOW UP VISIT, IT WAS NOTED THAT THE PATIENT FELT THAT THE MESH HADN'T HELD THINGS UP IN THE RIGHT BREAST AND THE LEFT BREAST HAD CONTRACTED. REVISION RIGHT BREAST CAPSULORRHAPY UTILIZING STRATTICE MESH ON (B)(6) 2019. COMPLETED WITHOUT COMPLICATIONS. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE INFECTION AND MALPOSITION AS LIKELY RELATED TO THE DEVICE AND SERIOUS. THIS FILE REPRESENTS THE DEVICE #2.
Patient problems: Unspecified Infection
MAUDE report 15713675 ↗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 REVISION AUGMENTATION MASTOPEXY USING A FULL VERTICAL AND HORIZONTAL T INCISION. TWO PIECES OF GALASHAPE (GALAFLEX 3D) WERE USED. CONCOMITANT PROCEDURES WERE LIPOSUCTION TO LOVE HANDLES AND ABDOMEN. ON (B)(6) 2017, DELAYED WOUND HEALING AND NECROSIS OF BILATERAL BREASTS WAS REPORTED. PATIENT HAD BILATERAL BREAST WOUND DEBRIDEMENT FOR FULL THICKNESS TISSUE LOSS ON (B)(6) 2017. PATIENT WAS TREATED WITH MEDICATION (SILVADENE, HYDROCORTISONE CREAM). DELAYED WOUND HEALING RESOLVED WITH SEQUELAE ON (B)(6) 2017. NECROSIS RESOLVED WITH SEQUELAE ON AN UNKNOWN DATE. WOUNDS HEALED SLOWLY. ON (B)(6) 2017, BILATERAL BREAST WOUND DEHISCENCE WAS REPORTED. PATIENT WAS TREATED WITH MEDICATION (HYDROCORTISONE CREAM). RESOLVED WITH SEQUELAE ON (B)(6) 2017. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED DELAYED WOUND HEALING, NECROSIS AND WOUND DEHISCENCE ARE LIKELY RELATED TO THE DEVICE AND SERIOUS.
Patient problems: Impaired Healing; Necrosis; Wound Dehiscence
MAUDE report 15713376 ↗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 ↗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 15713373 ↗InjuryAug 2, 2022Patient-Device Incompatibility; Patient-Device Incompatibility
PER CLINICAL TRIAL (B)(4): ON (B)(6) 2019, PATIENT UNDERWENT BILATERAL CENTRAL MOUND MASTOPEXY USING A FULL VERTICAL AND HORIZONTAL T INCISION. 2 PIECES OF GALASHAPE (GALAFLEX 3D) WERE USED. CONCOMITANT PROCEDURES INCLUDED BRACHIOPLASTY, ABDOMINOPLASTY. ON (B)(6) 2020, INFECTION; ONE BREAST WAS REPORTED. PATIENT TREATED WITH MEDICATION. RESOLVED WITHOUT SEQUELAE ON (B)(6) 2020. NO ADDITIONAL INFORMATION GIVEN. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED INFECTION IS LIKELY RELATED TO THE DEVICE AND SERIOUS.
Patient problems: Unspecified Infection
MAUDE report 15144999 ↗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 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 28, 2022Patient-Device Incompatibility; Patient-Device Incompatibility
PER CLINICAL TRIAL (B)(4): 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 9/16/20. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED WOUND DEHISCENCE IS LIKELY RELATED TO THE DEVICE AND SERIOUS.
Patient problems: Wound Dehiscence
MAUDE report 15123702 ↗InjuryJul 28, 2022Patient-Device Incompatibility; Patient-Device Incompatibility
PER CLINICAL TRIAL (B)(4): 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 15123686 ↗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 15123660 ↗
Other Tepha, Inc. products
All Tepha, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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