GalaFLEX 3DR 100043-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00810054980018), received between Oct 11, 2023 and Feb 4, 2026 — classified as 5 injuries.

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

• InjuryFeb 4, 2026Material Deformation; Migration

  AS REPORTED DURING A PROCEDURE ON (B)(6) 2025, A GALAFLEX 3DR IMPLANT WAS IMPLANTED, POST IMPLANT THE IMPLANT DID NOT PERFORM AS INTENDED, RESULTING IN THE NEED FOR A REVISION SURGERY ON (B)(6) 2025, IN WHICH ANOTHER SHEET OF GALAFLEX IMPLANT WAS USED. ACCORDING TO THE REPORT, THE IMPLANT APPEARED TO BE FOLDED AND SHRIVELED, AND FOLLOW-UP EVALUATIONS INDICATED THAT THE LEFT IMPLANT APPEARED TO BE DROPPING.

  Patient problems: Physical Asymmetry

  MAUDE report 24260143 ↗
• InjuryApr 30, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, THE PATIENT HAD A BILATERAL BREAST IMPLANT EXCHANGE WITH CAPSULECTOMY AND PLACEMENT OF COHESIVE IMPLANTS ON (B)(6) 2025. PATIENT CAME IN FOR FOLLOW UP ON (B)(6) 2025 FOR BILATERAL SWELLING. NO REDNESS, WARMTH, OR BILATERAL SWELLING FOUND. IT WS REPORTED THAT ON (B)(6) 2025 THE PATIENT WENT INTO OR FPR WHAT WAS THOUGHT TO BE (R) BREAST HEMATOMA EVACUATION, BUT ONCE OPENED NO BLOOD WAS FOUND, ONLY A SIGNIFICANT AMOUNT OF SEROUS YELLOW FLUID; FOUND ON BOTH SIDES, BUT MORE SO ON THE (R) THAN THE (L). THE SURGEON REMOVED BOTH GALAFLEX MESHES.

  Patient problems: Seroma

  MAUDE report 21937464 ↗
• InjuryJan 17, 2025Material Deformation; Material Deformation

  AS REPORTED, THE PATIENT WITH THE HISTORY OF BILATERAL BREAST AUGMENTATION HAD CAPSULAR CONTRACTURE OF RIGHT BREAST WHICH WAS ATTEMPTED TO BE FIXED BY EXCHANGING IMPLANTS, MASTOPEXY AND IT WAS NOT SUCCESSFUL. IT WAS REPORTED THAT THE RIGHT IMPLANT WAS BOTTOMING OUT AND IT WAS DECIDED TO IMPLANT GALAFLEX 3DR TO ADD AN EXTRA LAYER BILATERALLY FOR EVENNESS. THE PROCEDURE WAS PERFORMED IN (B)(6)2024. IT WAS REPORTED THAT ¿BOTH HAVE ROLLED AND CAUSING PAIN¿. IN (B)(6) 2024, PATIENT WAS REFERRED TO ANOTHER SURGEON WHO CONFIRMED THAT ¿THE MESH HAD FAILED, IMPLANT IS BOTTOMING OUT AND MESH IS ROLLED AND FELT THROUGH MY SKIN.¿ AS REPORTED, PATIENT HAD EXTREME DISCOMFORT, CONSTANT PAIN AND SCHEDULED A REMOVAL SURGERY ON (B)(6)2025.

  Patient problems: Breast Discomfort/Pain; Ptosis

  MAUDE report 21179439 ↗
• InjuryJan 12, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AS REPORTED, DURING REVISION BILATERAL BREAST AUGMENTATION PROCEDURE ON (B)(6) 2023 PATIENT WAS IMPLANTED WITH GALAFLEX 3DR ON BOTH SIDES. IT WAS REPORTED THAT ABOUT 3 WEEKS POST IMPLANTS PATIENT WAS PRESENTED WITH SEROMA, INFECTION, IMPLANT EXTRUSION AND WOUND DEHISCENCE THEREBY UNDERWENT REVISION OF BREAST AUGMENTATION ON (B)(6) 2023 WITH BREAST IMPLANTS REMOVAL AND GALAFLEX PLACEMENT. SURGEON REPORTED THAT GALAFLEX 3DR INCREASED THE SEROMA RATE AFTER SURGERY AND THE SEROMA LEAKED INTO THE WOUND WHICH LIKELY GOT INFECTED CAUSING WOUND DEHISCENCE.

  Patient problems: Seroma; Unspecified Infection; Wound Dehiscence

  MAUDE report 18501649 ↗
• InjuryOct 11, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  AS REPORTED, THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023 WHICH INCLUDED BREAST IMPLANT EXCHANGE USING LOW PROFILE BREAST IMPLANTS AND A BREAST LIFT WITH IMPLANT OF THE GALAFLEX 3DR SCAFFOLD. AS REPORTED, PATIENT FOLLOWED UP WITH THE SURGEON DURING ROUTINE OFFICE VISIT AND THE NURSE DEMONSTRATED HOW TO MASSAGE HER BREAST. PATIENT REPORTS THE NURSE MASSAGED HER LEFT BREAST AND THE PATIENT FELT A TEARING SENSATION. PATIENT REPORTS SHORTLY AFTER THAT HER LEFT BREAST APPEARED TO BE LUMPY AND NOT SYMMETRICAL WITH HER RIGHT BREAST. PATIENT REPORTED HER CONCERNS TO HER SURGEON AND SHE REPORTS HE DOES NOT FEEL THERE IS ANY NEED FOR ANY INTERVENTION AT THIS TIME AS HE EXPLAINED TO HER THAT THE SCAFFOLD WILL RESORB AFTER 24 MONTHS. SHE ALSO REPORTS SHE HAS HAD IN THE PAST MONTH AN INCREASE OF PAIN IN HER LEFT BREAST.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 17912977 ↗