GalaFLEX 3DR 100043-04Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00810054980032), received between Mar 23, 2022 and Jun 9, 2026 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2026Patient-Device Incompatibility

  AS REPORTED, DURING A BILATERAL BREAST REDUCTION SURGERY THE PATIENT WAS IMPLANTED WITH GALAFLEX 3DR ON (B)(6) 2024. REPORTEDLY, POST ONE (1) WEEK OF IMPLANTATION, THE PATIENT REPORTED PAIN AND PINCHING SENSATION AND FELT LIKE THE GALAFLEX WAS FOLDED OVER. THE PATIENT HAS BEEN EXPERIENCING CONSTANT PAIN ON THE LEFT BREAST WITH POSITIONING SINCE IMPLANT, ALSO REPORTED IT ALMOST FEELS LIKE THE GALAFLEX IS PINCHING A NERVE. AS REPORTED THE RIGHT BREAST IS NOT AS PAINFUL BUT DOES ACHE FROM TIME TO TIME AND THE OUTLINE OF THE GALAFLEX CAN BE FELT. THE TREATING PHYSICIAN STATED, "ITS "NORMAL" AND REFUSES TO TAKE IT OUT AND HAS TOLD THE PATIENT TO WAIT FOR IT TO ABSORB." THE PATIENT IS HAVING A BREAST MRI ON (B)(6) 2026 FOR ROUTINE BREAST CANCER SCREENING.

  Patient problems: Breast Discomfort/Pain; Neuralgia

  MAUDE report 25447556 ↗
• InjuryNov 6, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, DURING BILATERAL BREAST IMPLANT EXCHANGE, BILATERAL REVISION OF RECONSTRUCTED BREASTS, THE PATIENT WAS IMPLANTED WITH GALAFLEX 3DR BILATERALLY ON (B)(6) 2024. IT WAS REPORTED THAT THE PATIENT DEVELOPED STAPH INFECTION ON THE RIGHT BREAST THEREBY GIVING ORAL ANTIBIOTICS AND THE INFECTION RESOLVED.

  Patient problems: Bacterial Infection

  MAUDE report 20621699 ↗
• InjuryNov 6, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, DURING BILATERAL BREAST CAPSULECTOMY, BILATERAL BREAST IMPLANT REPLACEMENT AND BILATERAL SECONDARY MASTOPEXY, THE PATIENT WAS IMPLANTED WITH GALAFLEX 3DR BILATERALLY ON (B)(6) 2024. IT WAS REPORTED THAT THE PATIENT DEVELOPED STAPH INFECTION ON THE LEFT BREAST THEREBY GIVEN ORAL ANTIBIOTICS AND THE INFECTION RESOLVED.

  Patient problems: Bacterial Infection

  MAUDE report 20621509 ↗
• InjurySep 12, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, THE PATIENT UNDERWENT IMPLANT EXCHANGE WITH GALAFLEX 3DR BILATERAL TO SUPPORT AN IMF ON (B)(6) 2024 AND IN LESS THAN 6 MONTHS PATIENT HAD ALREADY BOTTOMED OUT THROUGH THE CAPSULORRHAPHY AND THE GALAFLEX 3DR BILATERAL. AS REPORTED, SURGEON PLANNED TO HAVE A REVISION SURGERY ON (B)(6) 2024 TO DO MORE CAPSULORRHAPHY (SUTURE AND THERMAL) AS WELL AS SECURE MORE GALAFLEX INTO PLACE SO IT DOESN¿T ROTATE.

  Patient problems: Ptosis

  MAUDE report 20200853 ↗
• MalfunctionSep 5, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  AS REPORTED, DURING AN AUGMENTATION MASTOPEXY PROCEDURE, IT WAS FOUND THAT STERILE PACKAGING OF GALAFLEX 3DR WAS RIPPED/COMPROMISED WHEREAS THE PRODUCT BOX WAS INTACT. IT WAS REPORTED THAT THE MESH WAS NOT USED AND ANOTHER GALAFLEX MESH WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20152969 ↗
• InjuryNov 4, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, THE PATIENT UNDERWENT A BILATERAL BREAST MASTOPEXY WITH BREAST IMPLANTS AUGMENTATION AND IMPLANT OF A GALAFLEX 3DR SCAFFOLD ON (B)(6) 2021. AS REPORTED, THE PATIENT STARTED EXPERIENCING SIGNIFICANT DROPPING OF BOTH BREASTS WITH PAIN AND DISCOMFORT ABOUT 3 MONTHS LATER. IT WAS REPORTED THAT PRIOR TO THE PROCEDURE RECOMMENDED TO HAVE THE BREAST IMPLANTS AS WELL AS THE GALAFLEX 3DR SCAFFOLD TO SUPPORT THE BREAST LIFT. IT WAS ALSO REPORTED THAT THE RESULTS ARE NOT WHAT THE SURGEON DISCUSSED DURING HER CONSULTATION. AS REPORTED, THE PATIENT FRUSTRATED AND CONSULTED WITH ANOTHER SURGEON ON (B)(6) 2022. THE SURGEON NOW RECOMMENDING SHE HAVE THE IMPLANTS REMOVED AND ANOTHER BREAST LIFT PROCEDURE. AS REPORTED, THE PATIENT CONTINUES TO HAVE PAIN AND DISCOMFORT IN BOTH HER BREASTS SINCE THE PROCEDURE IN (B)(6) 2021.

  Patient problems: Breast Discomfort/Pain; Unspecified Reproductive System or Breast Problem

  MAUDE report 15729519 ↗
• InjuryMar 23, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(4): ON (B)(6) 2017, PATIENT UNDERWENT BILATERAL REVISION AUGMENTATION MASTOPEXY. A FULL VERTICAL AND HORIZONTAL T INCISION WAS DONE. 2 PIECES OF GALAFORM (GALAFLEX 3DR) WERE USED. ON (B)(6) 2018, PTOSIS OF BILATERAL BREASTS WAS REPORTED. ON 9/5/18, REVISION BILATERAL CAPSULLOROPHIES WERE DONE USING SHORT SCAR INCISION AND USING 2 NEW PIECES OF GALASHAPE (GALAFLEX 3D). AE RESOLVED ON (B)(6) 2019 WITH NO SEQUELAE. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THIS AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Ptosis

  MAUDE report 13862483 ↗