GalaSHAPE 3D 100042-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00855920006188), received between Feb 2, 2021 and Jun 24, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 24, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  PER CLINICAL TRIAL CP-1060: ON (B)(6) 2016, PATIENT UNDERWENT RIGHT BREAST MASTOPEXY; INFERIOR PEDICLA, USING A FULL VERTICAL AND HORIZONTAL T INCISION. 1 PIECE OF GALASHAPE (GALAFLEX 3D) WAS USED. CONCOMITANT PROCEDURES INCLUDED FAT GRAFTING TO BILATERAL BREASTS AND LIPOSUCTION. ON (B)(6) 2016, ERYTHEMA/REDNESS OF BREAST (NO INDICATION WHICH BREAST) WAS REPORTED. PATIENT TREATED WITH MEDICATION (BACTRIM). RESOLVED WITHOUT SEQUELAE ON (B)(6) 2016. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED ADVERSE EVENT AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Erythema

  MAUDE report 14799523 ↗
• InjuryFeb 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED THAT ON (B)(6) 2020 SHE UNDERWENT CORRECTIVE RECONSTRUCTION WITH IMPLANT EXCHANGE. HER IMPLANTS WERE CHANGED TO THE SAME ALLERGAN NATRELLE IMPLANTS. HER PHYSICIAN ALSO USED GALASHAPE 3D SCAFFOLD (NOW KNOWN AS GALAFLEX 3D). ON (B)(6) 2020 SHE FINISHED HER ANTIBIOTICS (WHICH WAS AN ANTIBIOTIC SHE HAD PREVIOUSLY TAKEN). SHE DID NOT MAKE ANY CHANGES TO SOAPS OR DETERGENTS AND REVIEWED THAT WITH HER PHYSICIANS. ON (B)(6) 2020 SHE BEGAN HAVING SYSTEMATIC ITCHY HIVES. IT BEGAN WITH HER HANDS AND THE INSIDE OF HER EARS AND THROAT. NO SWELLING. SINCE THEN, SHE CONTINUES TO HAVE HIVES EVERY DAY, OFF AND ON. THE HIVES APPEAR EVERYDAY ON HER UNDERARMS AND ARMS. THE HIVES HAVE ALSO APPEARED ON HER BREASTS, BACK, STOMACH, FEET, ANKLES OFF AND ON. THE ONLY AREA THAT HAS NOT SHOWN ANY HIVES OR ITCHING IS HER FACE. SHE HAS VISITED WITH HER PRIMARY CARE PHYSICIAN, A DERMATOLOGIST AND AN ALLERGIST. CURRENTLY SHE IS BEING TREATED FOR URTICARIA. AT THE TIME OF HER REPORT SHE WAS TAKING PREDNISONE AND A REGIMEN OF VARIOUS ALLERGY MEDICATIONS.

  Patient problems: Urticaria

  MAUDE report 11269581 ↗