GalaFORM 3D 100043-06Recalls & reported problems
Tepha, Inc. · GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. The scaffold has a 3D curvature supported with a P4HB rim designed to promote better conformance with a patient's anatomy in locations in which a flat design does not easily conform. P4HB bioresorbs through a process of hydrolysis and hydrolytic enzymatic digestion. It has been developed to optimize resorption rate and prolong strength retention in order to provide support throughout the expected period of healing. Although the scaffold loses strength with time, its porous construction was designed to allow native tissue ingrowth and gradual transfer of load from the scaffold to the tissue. Pre-clinical implantation studies indicate that GalaFORM 3D scaffold retains approximately 70% of its strength at 12 weeks. Bioresorption of the scaffold material will be essentially complete within 18-24 months. · Class 2 · Implant
All models of GalaFORM 3D (5)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00855920006270), received between Mar 22, 2019 and Jun 7, 2022 — classified as 4 injuries.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Patient-Device Incompatibility2
- Insufficient Device Problem Information1
- Patient Device Interaction Problem1
Patient problems
- Bacterial Infection1
- Impaired Healing1
- Rash1
- Wound Dehiscence1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJun 7, 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 GALAFLEX 3DR WERE USED. CONCOMITANT PROCEDURE WAS CAPSULECTOMY. ON (B)(6) 2017, BILATERAL DELAYED WOUND HEALING NOTED AT THE TRIFURCATIONS, WAS REPORTED. PATIENT WAS TREATED WITH NON-ADHERENT DRESSING AND POLYSPORIN APPLICATION TO THE AREAS. RESOLVED WITHOUT SEQUELAE ON (B)(6) 2017. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE ADVERSE EVENT AS LIKELY RELATED TO THE DEVICE AND SERIOUS.
Patient problems: Impaired Healing
MAUDE report 14622067 ↗InjuryMay 7, 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. 2 PIECES OF GALAFORM (GALAFLEX 3DR) WERE USED. CONCOMITANT PROCEDURES INCLUDED ABDOMINOPLASTY WITH FAT GRAFTING TO BUTTOCKS. ON (B)(6) 2018, OPEN AREA, LEFT BREAST WAS REPORTED. TREATMENT WAS DEBRIDEMENT AND APPLICATION OF PRISMA DRESSING. RESOLVED WITHOUT SEQUELAE ON (B)(6) 2018. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE ADVERSE EVENT AS LIKELY RELATED TO THE DEVICE AND SERIOUS.
Patient problems: Wound Dehiscence
MAUDE report 14319374 ↗InjuryJul 8, 2019Patient Device Interaction Problem; Patient Device Interaction Problem
PHYSICIAN REPORTED TO SALES REP ON (B)(6) 2018 THAT A PATIENT WHO UNDERWENT A SILICONE IMPLANT (ALLERGAN SMOOTH) EXCHANGE WITH A REVISION MASTOPEXY AND POCKET REINFORCEMENT USING GALAFORM 3D MESH ON (B)(6) 2018 HAS BEEN HAVING SEVERE URTICARIAL RASHES THAT WERE NOT SEEN AT THE TIME OF THE PLACEMENT OF THE MESH AS FAR AS HE WAS AWARE. THE PHYSICIAN HAS INDICATED THAT THE PATIENT "NOW HAS WIDESPREAD, DIFFUSE AND CONFLUENT URTICARIAL RASHES THROUGHOUT HER BODY, WHICH INITIALLY INVOLVED THE HEAD, NECK CHEST AND BREAST AREA." THE PATIENT HAS A HISTORY OF HYPERSENSITIVITIES AND DERMATOGRAPHIA.
Patient problems: Rash
MAUDE report 8767967 ↗InjuryMar 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
DOCTOR STATED THE PATIENT DEVELOPED A "MYCOBACTERIUM ABSCESSUS" INFECTION AFTER THE INITIAL SURGERY AND HAD TO BE ON STEROIDS AND ANTIBIOTICS FOR 6 MONTHS. HE REMOVED THE MESH AND THE INFECTION CAME BACK AGAIN. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: Bacterial Infection
MAUDE report 8445508 ↗
Other Surgical Film devices
- GalaFLEX Scaffold 100035-09Tepha, Inc. · Surgical Film2 deaths90 reports
- GalaFLEX Scaffold 100035-15Tepha, Inc. · Surgical Film64 reports
- GalaFORM 3D 100043-02Tepha, Inc. · Surgical Film41 reports
- Phasix 1190500Davol Inc. · surgical film39 reports
- GalaSHAPE 3D 100042-04Tepha, Inc. · Surgical Film37 reports
- GalaFORM 3D 100043-04Tepha, Inc. · Surgical Film29 reports
- Phasix 1190400Davol Inc. · surgical film26 reports
- Phasix 1190200Davol Inc. · surgical film22 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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