GalaFLEX Scaffold 100035-05Recalls & reported problems
Tepha, Inc. · GalaFLEX Scaffold, 2.5 cm x 7.6 cm, Rectangle · Class 2 · Implant
All models of GalaFLEX Scaffold (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00855920006003), received between Apr 5, 2022 and Apr 5, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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
- Device Appears to Trigger Rejection1
- Patient-Device Incompatibility1
Patient problems
- Erythema1
- Unspecified Reproductive System or Breast Problem1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 5, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PER CLINICAL TRIAL (B)(6): ON (B)(6) 2014, PATIENT UNDERWENT LEFT BREAST REVISION AUGMENTATION AND SCAR REVISION USING A SHORT SCAR INCISION. 1 PIECE OF GALAFLEX WAS USED. NO CONCOMITANT PROCEDURES WERE DONE. ON (B)(6) 2014, A SECOND AE OF LEFT BREAST EXTRUSION WAS REPORTED. PATIENT HAD ADDITIONAL SURGERY ON THAT DAY TO REMOVE THE LEFT BREAST IMPLANT AND MESH. RESOLVED ON (B)(6) 2014 WITHOUT SEQUELAE. ON (B)(6) 2014, FAT GRAFTING WAS DONE TO THE LEFT BREAST. REVIEW BY MEDICAL AFFAIRS IDENTIFIES AS RELATED TO THE DEVICE AND SERIOUS.
Patient problems: Unspecified Reproductive System or Breast Problem
MAUDE report 14012601 ↗InjuryApr 5, 2022Patient-Device Incompatibility; Patient-Device Incompatibility
PER CLINICAL TRIAL (B)(4): ON (B)(6) 2014, PATIENT UNDERWENT LEFT BREAST REVISION AUGMENTATION AND SCAR REVISION USING A SHORT SCAR INCISION. 1 PIECE OF GALAFLEX WAS USED. NO CONCOMITANT PROCEDURES WERE DONE. ON (B)(6) 2014, BREAST ERYTHEMA/REDNESS WAS REPORTED. PATIENT WAS TREATED WITH MEDICATION (CIPRO, DOXYCYCLINE, BACTROBAN). AE RESOLVED ON (B)(6) 2014 WITHOUT SEQUELAE. REVIEW BY MEDICAL AFFAIRS IDENTIFIES AS LIKELY RELATED TO THE DEVICE AND SERIOUS.
Patient problems: Erythema
MAUDE report 14012590 ↗
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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