GalaSHAPE 3D 100042-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00855920006140), received between Nov 2, 2022 and Nov 2, 2022 — classified as 2 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 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.

• InjuryNov 2, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(4): ON (B)(6) 2019, PATIENT UNDERWENT BILATERAL REVISION AUGMENTATION; IMPLANT MALPOSITION USING A HORIZONTAL INCISION IN IMF. 2 PIECES OF GALASHAPE (GALAFLEX 3D) (DEVICE1, DEVICE2) WERE USED. ON (B)(6) 2019, A SAE OF BREAST INFECTION WAS REPORTED. PATIENT HAD BEEN HOSPITALIZED THE PREVIOUS WEEK (NO DATE GIVEN). PATIENT WAS SEEN BY INFECTIOUS DISEASE AND DOCTOR PUT ON BROAD SPECTRUM ANTIBIOTIC MEDICATION (UNKNOWN MEDS). RESOLVED WITHOUT SEQUELAE ON (B)(6) 2019. ON THAT (B)(6) 2019 FOLLOW UP VISIT, IT WAS NOTED THAT THE PATIENT FELT THAT THE MESH HADN'T HELD THINGS UP IN THE RIGHT BREAST AND THE LEFT BREAST HAD CONTRACTED. REVISION RIGHT BREAST CAPSULORRHAPY UTILIZING STRATTICE MESH ON (B)(6) 2019. COMPLETED WITHOUT COMPLICATIONS. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE INFECTION AND CONTRACTURE AS LIKELY RELATED TO THE DEVICE AND SERIOUS. THIS FILE REPRESENTS THE DEVICE #1.

  Patient problems: Capsular Contracture; Unspecified Infection

  MAUDE report 15713684 ↗
• InjuryNov 2, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(4): ON (B)(6) 2017, PATIENT UNDERWENT BILATERAL AUGMENTATION MASTOPEXY USING A VERTICAL INCISION. TWO PIECES OF GALAFLEX 3D (DEVICE #1 AND DEVICE #2) WERE USED. ON (B)(6) 2017, NECROSIS; LEFT AREOLA WAS REPORTED. PATIENT WAS TREATED WITH MEDICATION (NITROBID, BETADINE WIPES). RESOLVED WITH SEQUELAE ON (B)(6) 2018. PATIENT IS REPORTED TO HAVE A LEFT AREOLAR SCAR. AS REPORTED THE PATIENT¿S AE WAS ASSESSED BY THE CLINICIAN AS SEVERE AND A SERIOUS ADVERSE EVENT. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED NECROSIS IS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Necrosis; Scar Tissue

  MAUDE report 15713373 ↗