GalaFORM 3DRecalls & reported problems across all models
Tepha, Inc. · 5 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 76
- Deaths reported
- 0
- Injuries reported
- 74
- Recalls
- 0
We found 5 models of GalaFORM 3D by Tepha, Inc. in the FDA's device registry (GUDID). Together they are named in 76 adverse event reports in the FDA's MAUDE database, received between Sep 10, 2018 and Nov 1, 2022 — classified as 74 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (56 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 GalaFORM 3D problems
Device problems
- Patient-Device Incompatibility56
- Patient Device Interaction Problem7
- Migration4
- Device Appears to Trigger Rejection3
- Contamination2
- Migration or Expulsion of Device2
- Adverse Event Without Identified Device or Use Problem1
- Expulsion1
Patient problems
- Impaired Healing17
- Hematoma7
- Unspecified Reproductive System or Breast Problem6
- Breast Discomfort/Pain5
- Bacterial Infection4
- Seroma4
- Unspecified Infection4
- Wound Dehiscence4
GalaFORM 3D models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- GalaFORM 3D 100043-02Surgical Film41 reports
- GalaFORM 3D 100043-04Surgical Film29 reports
- GalaFORM 3D 100043-06Surgical Film4 reports
- GalaFORM 3D 100043-01Surgical Film1 report
- GalaFORM 3D 100043-07Surgical Film1 report
Recent GalaFORM 3D adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryNov 1, 2022Patient-Device Incompatibility; Patient-Device Incompatibility
PER CLINICAL TRIAL (B)(4): ON (B)(6) 2018, PATIENT UNDERWENT BILATERAL AUGMENTATION MASTOPEXY USING A VERTICAL INCISION. 2 PIECES OF GALAFORM (GALAFLEX 3DR) WERE USED. CONCOMITANT PROCEDURE WAS CAPSULORRHAPY. ON 8/31/18, LEFT NECROSIS WAS REPORTED. PATIENT TREATED WITH MEDICATION (NITROPASTE). RESOLVED WITHOUT SEQUELAE ON UNKNOWN DATE. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE NECROSIS AS LIKELY RELATED TO THE DEVICE AND SERIOUS.
Patient problems: Necrosis
MAUDE report 15711865 ↗InjuryNov 1, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PER CLINICAL TRIAL (B)(4): ON (B)(6) 2018, PATIENT UNDERWENT BILATERAL SUPERIOR PEDICLE MASTOPEXY USING A VERTICAL INCISION. 2 PIECES OF GALAFORM (GALAFLEX 3DR) WERE USED. CONCOMITANT PROCEDURES INCLUDED EARLOBE REDUCTION, FAT GRAFTING TO FACE, AUTOAUGMENTATION LIPOSUCTION TO ARMS, THIGHS, BACK. ON (B)(6) 2018, DELAYED WOUND HEALING OF LEFT BREAST WAS REPORTED. THERE WAS A SMALL OPEN WOUND AT THE MIDPOINT OF THE VERTICAL INCISION OF THE LEFT BREAST. ON (B)(6) 2018 (SAME DAY), THE AREA WAS DEBRIDED - THERE WAS EXPOSED MESH AT THE BASE OF THE OPENING. NO EVIDENCE OF ANY WOUND INFECTION. PATIENT PROBABLY HAD A SEROMA WHICH DRAINED SIMULTANEOUSLY. PATIENT TREATED WITH POLYSPORIN AND DRESSING CHANGES. RESOLUTION DATE AND OUTCOME UNKNOWN. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE DELAYED WOUND HEALING AS LIKELY RELATED TO THE DEVICE AND SERIOUS.
Patient problems: Impaired Healing; Seroma
MAUDE report 15711863 ↗InjuryAug 2, 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. 2 PIECES OF GALAFORM (GALAFLEX 3DR) WERE USED. CONCOMITANT PROCEDURES INCLUDED: BREAST IMPLANT REMOVAL, AUTOAUGMENTATION, LIPOSUCTION TO ABDOMEN, AXILLA, MID/LOWER BACK, HIPS. ON (B)(6) 2018, DELAYED WOUND HEALING; LEFT BREAST, WAS REPORTED. PATIENT HAD DEBRIDEMENT ON (B)(6) 2018 AND WET TO DRY DRESSING CHANGES. NO INDICATION OF INFECTION FROM CULTURES AND NO INDICATION OF MESH REMOVAL. RESOLVED WITH UNKNOWN SEQUELAE ON 11/13/18. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE DELAYED WOUND HEALING AS LIKELY RELATED TO THE DEVICE AND SERIOUS.
Patient problems: Impaired Healing
MAUDE report 15144884 ↗InjuryAug 2, 2022Patient-Device Incompatibility; Patient-Device Incompatibility
PER CLINICAL TRIAL (B)(6): ON (B)(6) 2018, PATIENT UNDERWENT BILATERAL AUGMENTATION MASTOPEXY USING A FULL VERTICAL AND HORIZONTAL T INCISION. 2 PIECES OF GALAFORM (GALAFLEX 3DR) WERE USED. NO CONCOMITANT PROCEDURES WERE DONE. ON (B)(6) 2018, DELAYED WOUND HEALING; LEFT BREAST T REGION, WAS REPORTED. PATIENT HAD DRESSING CHANGES AND HYPERBARIC CHAMBER TREATMENT. RESOLVED WITHOUT SEQUELAE ON AN UNKNOWN DATE. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED DELAYED WOUND HEALING IS LIKELY RELATED TO THE DEVICE AND SERIOUS.
Patient problems: Impaired Healing
MAUDE report 15144883 ↗InjuryAug 2, 2022Patient-Device Incompatibility; Patient-Device Incompatibility
PER CLINICAL TRIAL (B)(4): ON (B)(6) 2019 PATIENT UNDERWENT BILATERAL AUGMENTATION MASTOPEXY USING A FULL VERTICAL AND HORIZONTAL T INCISION. 2 PIECES OF GALAFORM (GALAFLEX 3DR) WERE USED. NO CONCOMITANT PROCEDURES WERE DONE. ON (B)(6) 2019, DELAYED WOUND HEALING; RIGHT T REGION WAS REPORTED. PATIENT HAD WOUND DEBRIDEMENT AND DRESSING CHANGES. RESOLVED WITHOUT SEQUELAE ON (B)(6) 2019. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE DELAYED WOUND HEALING AS LIKELY RELATED TO THE DEVICE AND SERIOUS.
Patient problems: Impaired Healing
MAUDE report 15144882 ↗InjuryJul 28, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
PER CLINICAL TRIAL (B)(4): ON (B)(6) 2019, PATIENT UNDERWENT BILATERAL AUGMENTATION MASTOPEXY USING A FULL VERTICAL AND HORIZONTAL T INCISION. 2 PIECES OF GALAFORM (GALAFLEX 3DR) WERE USED. NO CONCOMITANT PROCEDURES WERE DONE. ON (B)(6) 2020, AN AE OF: GALAFORM DID NOT DISSOLVE; LEFT LATERAL BREAST, WAS REPORTED. GALAFORM WAS EXCISED ON 6/18/20. RESOLVED WITHOUT SEQUELAE ON (B)(6) 2020. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED AE IS RELATED TO THE DEVICE AND SERIOUS.
Patient problems: Insufficient Information
MAUDE report 15123639 ↗InjuryJul 19, 2022Patient-Device Incompatibility; Patient-Device Incompatibility
PER CLINICAL TRIAL (B)(4): ON (B)(6) 2019, PATIENT UNDERWENT BILATERAL AUGMENTATION MASTOPEXY USING A VERTICAL INCISION. 2 PIECES OF GALAFORM (GALAFLEX 3DR) WERE USED. NO CONCOMITANT PROCEDURES WERE DONE. ON (B)(6) 2019, LEFT BREAST HEMATOMA WAS REPORTED. ON (B)(6) 2019, HEMATOMA WAS EVACUATED. RESOLVED WITHOUT SEQUELAE ON (B)(6) 2019. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE LEFT BREAST HEMATOMA IS LIKELY RELATED TO THE DEVICE AND SERIOUS.
Patient problems: Hematoma
MAUDE report 15057490 ↗InjuryJul 12, 2022Patient-Device Incompatibility; Patient-Device Incompatibility
PER CLINICAL TRIAL (B)(6): ON (B)(6) 2019, PATIENT UNDERWENT BILATERAL REVISION AUGMENTATION; CAPSULAR CONTRACTURE, USING A VERTICAL INCISION. 2 PIECES OF GALAFORM (GALAFLEX 3DR) WERE USED. CONCOMITANT PROCEDURES INCLUDED CAPSULECTOMIES, MASTOPEXIES, AND FAT GRAFTING TO FACE. ON (B)(6) 2019, DELAYED WOUND HEALING; RIGHT AREOLA WAS REPORTED. PATIENT HAD DEBRIDEMENT ON (B)(6) 2019 AND WAS TREATED WITH MEDICATION (POLYSPORIN, SILVADENE CREAM). RESOLVED WITHOUT SEQUELAE ON (B)(6) 2019. REVIEW OF MEDICAL AFFAIRS IDENTIFIED THAT THE DELAYED WOUND HEALING IS LIKELY RELATED TO THE DEVICE AND SERIOUS.
Patient problems: Impaired Healing
MAUDE report 14985004 ↗InjuryJul 12, 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. 1 PIECE OF GALAFORM (GALAFLEX 3DR) WAS USED, CUT INTO OVAL SHAPE. NO CONCOMITANT PROCEDURES WERE DONE. ON (B)(6) 2019, EROSION; RIGHT BREAST WAS REPORTED. PER NOTES: ON (B)(6) 2019, THE RIGHT SIDE IS DEFINITELY FLAT REQUIRES SHORTENING AND TIGHTENING OF THE RIGHT INFRAMAMMARY FOLD MEDIALLY AND MEDIAL MOVEMENT OF THE RIGHT NIPPLE. UNKNOWN ACTION/TREATMENT WAS TAKEN. NO ADDITIONAL DETAILS GIVEN. RESOLVED WITHOUT SEQUELAE ON (B)(6) 2020. REVIEW OF MEDICAL AFFAIRS IDENTIFIED THAT THE EROSION IS LIKELY RELATED TO THE DEVICE AND SERIOUS.
Patient problems: Erosion
MAUDE report 14985003 ↗InjuryJul 12, 2022Patient-Device Incompatibility; Patient-Device Incompatibility
PER CLINICAL TRIAL CP-1060: ON (B)(6) 18, PATIENT UNDERWENT BILATERAL AUGMENTATION MASTOPEXY USING A FULL VERTICAL AND HORIZONTAL T INCISION. 2 PIECES OF GALAFORM (GALAFLEX 3DR) WERE USED. NO CONCOMITANT PROCEDURES WERE DONE. ON (B)(6) 18, RIGHT BREAST SEROMA AND INFECTION WAS REPORTED. PATIENT HAD CULTURE TAKEN AND WAS TREATED WITH MEDICATION (BACTRIM). RESOLVED WITHOUT SEQUELAE ON (B)(6) 18. ON (B)(6) 18, DELAYED WOUND HEALING; RIGHT T REGION, WAS REPORTED. PATIENT TREATED WITH DRESSING CHANGES. RESOLVED WITHOUT SEQUELAE ON (B)(6) 18. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE SEROMA, INFECTION AND DELAYED WOUND HEALING ARE LIKELY RELATED TO THE DEVICE AND SERIOUS.
Patient problems: Impaired Healing; Seroma; Unspecified Infection
MAUDE report 14984998 ↗InjuryJul 6, 2022Patient-Device Incompatibility; Patient-Device Incompatibility
PER CLINICAL TRIAL (B)(4): ON (B)(6) 2018, PATIENT UNDERWENT BILATERAL REVISION AUGMENTATION MASTOPEXY USING A FULL VERTICAL AND HORIZONTAL T INCISION. 1 PIECE OF GALAFORM (GALAFLEX 3DR) WAS USED. NO CONCOMITANT PROCEDURES WERE DONE. ON (B)(6) 2018, DOG EAR: MEDIAL FOLD OF BREASTS WAS REPORTED. PATIENT HAD DOG EAR REMOVAL PROCEDURE ON (B)(6) 2018. A PIECE OF MESH WAS REMOVED FROM LEFT BREAST. BILATERAL BREAST SCAR REVISION ALSO DONE. 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: Physical Asymmetry
MAUDE report 14938450 ↗InjuryJul 6, 2022Patient-Device Incompatibility; Patient-Device Incompatibility
PER CLINICAL TRIAL (B)(6): ON (B)(6) 2018, PATIENT UNDERWENT BILATERAL REVISION AUGMENTATION MASTOPEXY USING A FULL VERTICAL AND HORIZONTAL T INCISION. 1 PIECE OF GALAFORM (GALAFLEX 3DR) WAS USED. CONCOMITANT PROCEDURES INCLUDED BL SUPERIOR CAPSULOTOMY AND BL INFERIOR CAPSULORRHAPHY. ON (B)(6) 2018, RIGHT BREAST INCISION SITE COMPLICATION WAS REPORTED. SMALL ESCHAR ON INCISION. PATIENT WAS TREATED WITH MEDICATION (TOPICAL BETADINE). RESOLVED WITHOUT SEQUELAE ON (B)(6) 2018. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED INCISION SITE COMPLICATION IS LIKELY RELATED TO THE DEVICE AND SERIOUS.
Patient problems: Unspecified Tissue Injury
MAUDE report 14938446 ↗InjuryJul 6, 2022Migration or Expulsion of Device; Migration or Expulsion of Device
PER CLINICAL TRIAL (B)(6): ON (B)(6) 2018, PATIENT UNDERWENT REVISION LEFT INFERIOR BREAST CAPSULORRHAPHY USING A CRESCENT/PERI-AREOLAR INCISION. UNKNOWN IF CONCOMITANT PROCEDURE(S) WERE DONE. 1 PIECE OF GALAFORM (GALAFLEX 3DR) WAS USED - LEFT SIDE ONLY. ON (B)(6) 2018, LEFT MIGRATION, MALPOSITION, OR CONTRACTION WAS REPORTED - INFERIOR MALPOSITION. ON (B)(6) 2019, PATIENT HAD LEFT BREAST CAPSULORRHAPHY WITH CAPSULAR FLAP PROCEDURE. NO END DATE WAS GIVEN. ON (B)(6) 2019, LEFT BREAST REOPERATION WAS REPORTED (LEFT BREAST WAS MUCH LOWER THAN RIGHT). PATIENT HAD REVISION LEFT BREAST CAPSULORRHAPHY ON (B)(6) 2019. RESOLVED WITHOUT SEQUELAE ON (B)(6) 2019. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED EVENTS MIGRATION, MALPOSITION, OR CONTRACTION AND REOPERATION ARE LIKELY RELATED TO THE DEVICE AND SERIOUS.
Patient problems: Capsular Contracture; Unspecified Reproductive System or Breast Problem
MAUDE report 14938407 ↗InjuryJun 21, 2022Patient-Device Incompatibility; Patient-Device Incompatibility
PER CLINICAL TRIAL (B)(6): ON (B)(6) 2017, PATIENT UNDERWENT BILATERAL MASTOPEXY; INFERIOR PEDICLE, USING A FULL VERTICAL AND HORIZONTAL T INCISION. 2 PIECES OF GALAFORM (GALAFLEX 3DR) WERE USED. CONCOMITANT PROCEDURES INCLUDED FAT GRAFTING OF LEFT BREAST AND LIPOSUCTION. ON (B)(6) 2017, RIGHT DELAYED WOUND HEALING WAS REPORTED. PATIENT TREATED WITH MEDICATION (BACTROBAN). RESOLVED WITHOUT SEQUELAE ON (B)(6) 2017. REVIEW BY MEDICAL AFFAIRS IDENTIFIES AS LIKELY RELATED TO THE DEVICE AND SERIOUS.
Patient problems: Impaired Healing
MAUDE report 14757067 ↗InjuryJun 21, 2022Patient-Device Incompatibility; Patient-Device Incompatibility
PER CLINICAL TRIAL (B)(4): ON (B)(6) 2017 PATIENT UNDERWENT BILATERAL MASTOPEXY; INFERIOR PEDICLE, USING A FULL VERTICAL AND HORIZONTAL T INCISION. 2 PIECES OF GALAFORM (GALAFLEX 3DR) WERE USED. CONCOMITANT PROCEDURES INCLUDED FAT GRAFTING OF LEFT BREAST AND LIPOSUCTION. ON (B)(6) 2017 BREAST HEMATOMA WAS REPORTED. HEMATOMA EVACUATED ON (B)(6) 2017. RESOLVED WITHOUT SEQUELAE ON (B)(6) 2017. REVIEW BY MEDICAL AFFAIRS IDENTIFIES AS LIKELY RELATED TO THE DEVICE AND SERIOUS.
Patient problems: Hematoma
MAUDE report 14756851 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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