GalaSHAPE 3D 100042-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00855920006164), received between Mar 17, 2022 and Nov 2, 2022 — classified as 5 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (5 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 5 most recent of 5 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) (LOT #180283, #180384) 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 MALPOSITION AS LIKELY RELATED TO THE DEVICE AND SERIOUS. THIS FILE REPRESENTS THE DEVICE #2.

  Patient problems: Unspecified Infection

  MAUDE report 15713675 ↗
• InjuryJul 28, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(4): ON (B)(6) 2020, PATIENT WAS HOSPITALIZED AND UNDERWENT BILATERAL PRIMARY RECONSTRUCTION; PRE PECTORAL. THE INCISION TYPE WAS NOT RECORDED. MULTIPLE PIECES OF GALAFLEX MESH WERE IMPLANTED DURING THIS PROCEDURE. NO CONCOMITANT PROCEDURES WERE DONE. ON (B)(6) 2020, RIGHT BREAST WOUND DEHISCENCE WAS REPORTED. ON (B)(6) 2020, PATIENT HAD WASHOUT AND DEBRIDEMENT PROCEDURE AND WAS ALSO TREATED WITH MEDICATION (CEPHALEXIN). IT WAS NOTED THAT THERE WAS NO EVIDENCE OF EXPOSED MESH OR BREAST IMPLANTS. RESOLVED WITHOUT SEQUELAE ON 9/16/20. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED WOUND DEHISCENCE IS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Wound Dehiscence

  MAUDE report 15123702 ↗
• InjuryJul 28, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(4): ON (B)(6) 2020, PATIENT WAS HOSPITALIZED AND UNDERWENT BILATERAL PRIMARY RECONSTRUCTION; PRE PECTORAL. THE INCISION TYPE WAS NOT RECORDED. MULTIPLE PIECES OF GALAFLEX MESH WERE IMPLANTED DURING THIS PROCEDURE. NO CONCOMITANT PROCEDURES WERE DONE. ON (B)(6) 2020, RIGHT BREAST WOUND DEHISCENCE WAS REPORTED. ON (B)(6) 2020, PATIENT HAD WASHOUT AND DEBRIDEMENT PROCEDURE AND WAS ALSO TREATED WITH MEDICATION (CEPHALEXIN). IT WAS NOTED THAT THERE WAS NO EVIDENCE OF EXPOSED MESH OR BREAST IMPLANTS. RESOLVED WITHOUT SEQUELAE ON (B)(6) 2020. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED WOUND DEHISCENCE IS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Wound Dehiscence

  MAUDE report 15123686 ↗
• InjuryMar 23, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(4): ON (B)(6)2016, PATIENT UNDERWENT BILATERAL REVISION INFERIOR PEDICLE MASTOPEXY USING A FULL VERTICAL AND HORIZONTAL T INCISION. 2 BREAST IMPLANTS WERE REMOVED. 2 PIECES OF GALASHAPE (GALAFLEX 3D) WERE PLACED. A REFINE SUTURE SUSPENSION WAS USED AND NO CONCOMITANT PROCEDURES WERE DONE. ON (B)(6) 2016, BREAST PAIN WAS REPORTED. MEDICATION (MARCAINE INJECTION AND NEURONTIN) WAS GIVEN AND AE WAS RESOLVED ON (B)(6) 2016 WITHOUT SEQUELAE. REVIEW BY MEDICAL AFFAIRS IDENTIFIES AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 13859426 ↗
• InjuryMar 17, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL CP-1060: ON (B)(6) 2020, PATIENT UNDERWENT RIGHT BREAST REVISION RECONSTRUCTION USING AN IMF INCISION. PATIENT WAS HOSPITALIZED AND WAS DISCHARGED THE FOLLOWING DAY (B)(6) 2020. ONE PIECE OF GALAFLEX AND ONE PIECE OF GALASHAPE (GALAFLEX 3D) WERE BOTH USED. NO CONCOMITANT PROCEDURES WERE DONE. ON (B)(6) 2020, RIGHT BREAST INFECTION WAS REPORTED. PATIENT WAS HOSPITALIZED ON (B)(6) 2020, WHERE WASHOUT AND DEBRIDEMENT WITH REMOVAL OF BREAST IMPLANT WAS PERFORMED ON THAT DATE. PER NOTES, THERE WAS SOME EVIDENCE OF NONADHERENT P4HB MATRIX JUST INFERIOR TO THE NIPPLE AREOLAR COMPLEX THAT WAS SHARPLY DEBRIDED. THERE WAS OPACITY OF ADEQUATE SOFT TISSUE JUST BELOW THE INVERTED NIPPLE WITH A DEFINITIVE TRACK TO THE BREAST POCKET. A SMALL AMOUNT OF NONADHERENT P4HB WAS REMOVED FROM THE PATIENT USING CURETTES. ALSO TREATED WITH MEDICATION (CIPRO AND CLINDAMYCIN). RESOLVED WITH SEQUELAE ON UNKNOWN DATE. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED ADVERSE EVENT IS RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Unspecified Infection

  MAUDE report 13800594 ↗