GalaFLEX Scaffold 100035-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00855920006010), received between May 20, 2022 and Jun 4, 2026 — classified as 4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 4, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT BILATERAL BREAST PTOSIS BREAST MASTOPEXY PROCEDURE ON (B)(6) 2024, DURING WHICH A GALAFLEX MESH WAS IMPLANTED. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED PAIN AT THE IMPLANTATION SITE, WHICH LED TO A SUBSEQUENT SURGICAL INTERVENTION. ON OR ABOUT (B)(6) 2024, PLAINTIFF REQUIRED A PROCEDURE TO REMOVE THE GALAFLEX MESH. ON OR ABOUT (B)(6) 2026, PLAINTIFF UNDERWENT AN ADDITIONAL SURGERY TO REMOVE THE GALAFLEX MESH. PLAINTIFF WAS INJURED SEVERELY AND PERMANENTLY. AS ALLEGED, THE PATIENT EXPERIENCED ADDITIONAL SURGICAL INTERVENTION, MENTAL ANGUISH AND CHRONIC 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 25390570 ↗
• InjuryApr 23, 2026Material Deformation

  AS REPORTED, ON (B)(6) 2025 DURING A BREAST AUGMENTATION PROCEDURE THE PATIENT WAS IMPLANTED WITH GALAFLEX IMPLANT. REPORTEDLY, ONE (1) MESH WAS DIVIDED INTO TWO (2) AND IMPLANTED BILATERALLY IN THE PATIENT. POST ONE (1) YEAR OF IMPLANTATION THE PATIENT HAD DISCOMFORT, PULLING SENSATIONS BILATERALLY FROM THE BOTTOM OF HER BREASTS, FEELING LIKE HER IMPLANTS ARE 'STUCK' IN HER MESH THAT HASN'T DISSOLVED IN A YEAR'S TIME, IRRITATING SENSATION MAKING PATIENT WANT TO "CRAWL OUT OF HER SKIN". IT WAS ALSO REPORTED THAT, THE AFFECTED SIDE IS BILATERALLY, MORE PRONOUNCED ON THE RIGHT. FOR THE POST-OPERATIVE COMPLICATIONS A REVISION SURGERY HAS BEEN SCHEDULED ON (B)(6) 2026. AS PER THE CLINICAL FINDINGS, THE PATIENT HAS GRADE ONE (1) PTOSIS AND THE MESH IS FOLDED IN THE RIGHT BREAST. PATIENT HAS BEEN ADVISED TO GET A MAMMOGRAM PRIOR TO HER UPCOMING SURGERY.

  Patient problems: Discomfort; Physical Asymmetry; Ptosis; Skin Inflammation/ Irritation

  MAUDE report 24967617 ↗
• InjuryJun 21, 2022Migration; Migration

  PER CLINICAL TRIAL CP-(B)(6): ON (B)(6) 2017 PATIENT UNDERWENT BILATERAL BREAST AUGMENTATION USING A SHORT SCAR INCISION. 1 PIECE OF GALAFLEX WAS USED, CUT IN HALF. NO CONCOMITANT PROCEDURES WERE DONE. ON (B)(6) 2018 MIGRATION, MALPOSITION, OR CONTRACTION; BREAST, WAS REPORTED. ON (B)(6) 2018 PATIENT HAD BILATERAL CAPSULORRHAPHIES AND LATERAL CAPSULOTOMIES, FAT GRAFTING. RESOLVED WITHOUT SEQUELAE ON (B)(6) 2018. REVIEW BY MEDICAL AFFAIRS IDENTIFIES AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Unspecified Reproductive System or Breast Problem

  MAUDE report 14756124 ↗
• InjuryMay 20, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(6): ON (B)(6) 2017, PATIENT UNDERWENT BILATERAL COSMETIC AUGMENTATION MASTOPEXY USING A FULL VERTICAL AND HORIZONTAL T INCISION. 1 PIECE OF GALAFLEX WAS USED. THERE WERE NO CONCOMITANT PROCEDURES DONE. ON (B)(6) 2018, AN AE OF 'REOPERATION' WAS REPORTED. ON (B)(6) 2019, PATIENT HAD BILATERAL CAPSULOTOMY WITH BREAST IMPLANT REPLACEMENT. RESOLVED WITHOUT SEQUELAE ON (B)(6) 2019. REVIEW BY MEDICAL AFFAIRS IDENTIFIES REOPERATION AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Capsular Contracture

  MAUDE report 14460903 ↗