GalaFORM 3D 100043-01Recalls & 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 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00855920006225), received between Mar 17, 2022 and Mar 17, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (1 report).
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
Device problems
- Patient-Device Incompatibility1
Patient problems
- Swelling/ Edema1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 17, 2022Patient-Device Incompatibility; Patient-Device Incompatibility
PER CLINICAL TRIAL (B)(4): ON (B)(6) 2019, PATIENT UNDERWENT RIGHT REVISION BREAST AUGMENTATION; INJURY OR TRAUMA TO THE BREAST, USING A FULL VERTICAL AND HORIZONTAL T INCISION. 1 PIECE OF GALAFORM (GALAFLEX 3DR) WAS USED. NO CONCOMITANT PROCEDURES DONE. ON (B)(6) 2020, BREAST SWELLING WAS REPORTED. THERE IS SOME PALPABILITY OF THE MESH IN THE AREA OF DISCOMFORT. ACTION TAKEN IS NOT KNOWN. REVIEW OF MEDICAL AFFAIRS IDENTIFIED THAT THE REPORTED AE OF SWELLING IS LIKELY RELATED AND NOT SERIOUS. OUTCOME UNKNOWN, NO END DATE GIVEN.
Patient problems: Swelling/ Edema
MAUDE report 13792139 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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