GalaFLEX 3DR 100043-06Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00810054980056), received between Nov 2, 2023 and Jun 9, 2026 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2026Material Split, Cut or Torn

  AS REPORTED, ON (B)(6) 2026, TWO PIECES OF GALAFLEX 3DR SCAFFOLD WERE USED BY THE SURGEON. UPON CLOSURE, IT WAS OBSERVED THAT THE RIM HAD DETACHED FROM A PORTION OF THE MESH ON ONE SIDE. IT WAS FURTHER REPORTED THAT WHEN THE MESH WAS GENTLY FOLDED, THE RIM NEARLY DETACHED. A SECOND PIECE OF MESH WAS OPENED, AND THE RIM WAS NOTED TO HAVE DETACHED AT SEVERAL LOCATIONS; DESPITE THIS, THE SURGEON OPTED TO PROCEED WITH IMPLANTATION. ADDITIONALLY, IT WAS OBSERVED THAT THE MESH WAS LESS STRETCHY AND FELT DIFFERENT. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25447551 ↗
• InjuryJun 4, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT BREAST AUGMENTATION REVISION SURGERY ON (B)(6) 2025, DURING WHICH A GALAFLEX 3DR MESH WAS IMPLANTED. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED PAIN AT THE IMPLANTATION SITE AND ON (B)(6) 2025, THE PATIENT UNDERWENT AN ADDITIONAL SURGICAL PROCEDURE TO REMOVE THE IMPLANTED MESH. AS ALLEGED, THE PATIENT EXPERIENCED ADDITIONAL SURGICAL INTERVENTION, MENTAL ANGUISH AND PAIN. ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT." IT IS ALSO ALLEGED THAT THE DEVICE WAS DEFECTIVE.

  Patient problems: Pain

  MAUDE report 25391487 ↗
• MalfunctionNov 21, 2025Migration; Migration

  AS REPORTED, PATIENT UNDERWENT A BREAST REPAIR PROCEDURE WITH GALAFLEX IMPLANT ON (B)(6) 2025. IT WAS REPORTED THAT THE PATIENT FELT THE MESH WAS POSITIONED DIFFERENTLY ON EACH SIDE. PLACEMENT ON THE RIGHT WAS FELT TO BE POSITIONED MORE BELOW THE BREAST, IN CONTRAST TO THE LEFT, WHERE IT WAS ALONG THE SIDE. THE RIGHT SIDE IS REPORTED TO BE SAGGING SIGNIFICANTLY. PER THE PATIENT "I AM DEFINITELY NOT HAPPY WITH THE LOOK, AND THE REASON I GOT THE MESH WAS SO THAT THEY WOULDN¿T SAG¿AT LEAST NOT SO QUICKLY. THESE ARE ONLY 7 MONTHS OLD. THE MESH ON THE LEFT COMES MORE UP THE SIDE, BUT THE MESH ON THE RIGHT IS MORE UNDER THE BREAST SO THE RIGHT BREAST IS FALLING TO THE SIDE AND DOWN."

  Patient problems: Physical Asymmetry

  MAUDE report 23618677 ↗
• InjuryJun 18, 2024Incorrect, Inadequate or Imprecise Result or Readings; Patient-Device Incompatibility; Incorrect, Inadequate or Imprecise Result or Readings; Patient-Device Incompatibility

  AS REPORTED, DURING BILATERAL BREAST REVISION AUGMENTATION SURGERY, THE PATIENT WAS IMPLANTED WITH 775 IMPLANTS AND GALAFLEX 3DR (DEVICE #1 & #2) FOR SOFT TISSUE SUPPORT ON (B)(6) 2022. IT WAS REPORTED THAT SURGEON CONFIRMS THAT THERE WAS MESH LUMPS ON BOTH SIDES. THE GALAFLEX WAS NOT SUTURED IN PLACE. THE PATIENT HAS ¿BOTTOMED OUT ¿ AND CAN STILL FEEL THE GALAFLEX "VERY EASILY.¿ IT WAS REPORTED THAT THE PATIENT AND THE SURGEON ARE CONCERNED THAT THE PRODUCT DID NOT INTEGRATE AS EXPECTED AND PLANS TO REMOVE THE MESHES SOON.

  Patient problems: Ptosis

  MAUDE report 19557231 ↗
• InjuryNov 2, 2023Patient-Device Incompatibility; Material Deformation; Patient-Device Incompatibility; Material Deformation

  AS REPORTED, PATIENT UNDERWENT A BREAST LIFT WITH NO IMPLANT PROCEDURE IN 2021. ABOUT A YEAR LATER IN 2022, PATIENT UNDERWENT ANOTHER BREAST LIFT WITH BREAST IMPLANTS THAT WERE 400 CC. THE FOLLOWING YEAR ON (B)(6) 2023 PATIENT UNDERWENT A THIRD REVISION PROCEDURE WITH AN IMPLANT EXCHANGE TO 310 CC IMPLANTS AND A BREAST LIFT IMPLANTING THE GALAFLEX 3DR. SHORTLY AFTER THE IMPLANT OF GALAFLEX 3DR, PATIENT STARTED TO EXPERIENCE BREASTS BILATERALLY MOVING TO THE SIDE WITH VERY LITTLE TO NO SUPPORT. PATIENT REPORTS GOING TO SURGEON NUMEROUS TIMES WITH DIRECTION TO WEAR A COMPRESSION BRA AND TAPING HER BREASTS TO HOLD THEM IN PLACE. AS THE SURGEON REPORTED PATIENT'S BREAST DID NOT HOLD, IT IS MORE NOTICEABLE WITH THE RIGHT BREAST THAN THE LEFT AND THE GALAFLEX 3DR DID NOT WORK AND WILL NEED A REVISION PROCEDURE. IT WAS FURTHER REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2023.

  Patient problems: Ptosis

  MAUDE report 18053377 ↗