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GalaFORM 3D 100043-02Recalls & reported problems

Tepha, Inc. · GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold. The scaffold has a 3D curvature supported with a P4HB rim designed to promote better conformance with a patient's anatomy in locations in which a flat design does not easily conform. P4HB bioresorbs through a process of hydrolysis and hydrolytic enzymatic digestion. It has been developed to optimize resorption rate and prolong strength retention in order to provide support throughout the expected period of healing. Although the scaffold loses strength with time, its porous construction was designed to allow native tissue ingrowth and gradual transfer of load from the scaffold to the tissue. Pre-clinical implantation studies indicate that GalaFORM 3D scaffold retains approximately 70% of its strength at 12 weeks. Bioresorption of the scaffold material will be essentially complete within 18-24 months. · Class 2 · Implant

Quick summary

This Tepha GalaFORM 3D surgical scaffold is a resorbable mesh used to support tissue during healing. Reports mostly describe poor wound healing and other breast-surgery complications, along with reports that the scaffold did not dissolve or was not compatible with the patient. There are 41 reports, with 40 injuries and no deaths. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
41
Deaths reported
0
Injuries reported
40
Recalls naming it
0

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00855920006232), received between Sep 10, 2018 and Nov 1, 2022 — classified as 40 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (27 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

Device problems

  • Patient-Device Incompatibility27
  • Patient Device Interaction Problem4
  • Device Appears to Trigger Rejection3
  • Migration3
  • Contamination2
  • Adverse Event Without Identified Device or Use Problem1
  • Expulsion1
  • Incorrect, Inadequate or Imprecise Result or Readings1

Patient problems

  • Impaired Healing10
  • Unspecified Infection4
  • Unspecified Reproductive System or Breast Problem4
  • Breast Discomfort/Pain3
  • Hematoma3
  • Erythema2
  • Post Operative Wound Infection2
  • Seroma2

Recent adverse event reports

The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

  • InjuryNov 1, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

    PER CLINICAL TRIAL (B)(4): ON (B)(6) 2018, PATIENT UNDERWENT BILATERAL AUGMENTATION MASTOPEXY USING A VERTICAL INCISION. 2 PIECES OF GALAFORM (GALAFLEX 3DR) WERE USED. CONCOMITANT PROCEDURE WAS CAPSULORRHAPY. ON 8/31/18, LEFT NECROSIS WAS REPORTED. PATIENT TREATED WITH MEDICATION (NITROPASTE). RESOLVED WITHOUT SEQUELAE ON UNKNOWN DATE. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE NECROSIS AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

    Patient problems: Necrosis

    MAUDE report 15711865 ↗
  • InjuryNov 1, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

    PER CLINICAL TRIAL (B)(4): ON (B)(6) 2018, PATIENT UNDERWENT BILATERAL SUPERIOR PEDICLE MASTOPEXY USING A VERTICAL INCISION. 2 PIECES OF GALAFORM (GALAFLEX 3DR) WERE USED. CONCOMITANT PROCEDURES INCLUDED EARLOBE REDUCTION, FAT GRAFTING TO FACE, AUTOAUGMENTATION LIPOSUCTION TO ARMS, THIGHS, BACK. ON (B)(6) 2018, DELAYED WOUND HEALING OF LEFT BREAST WAS REPORTED. THERE WAS A SMALL OPEN WOUND AT THE MIDPOINT OF THE VERTICAL INCISION OF THE LEFT BREAST. ON (B)(6) 2018 (SAME DAY), THE AREA WAS DEBRIDED - THERE WAS EXPOSED MESH AT THE BASE OF THE OPENING. NO EVIDENCE OF ANY WOUND INFECTION. PATIENT PROBABLY HAD A SEROMA WHICH DRAINED SIMULTANEOUSLY. PATIENT TREATED WITH POLYSPORIN AND DRESSING CHANGES. RESOLUTION DATE AND OUTCOME UNKNOWN. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE DELAYED WOUND HEALING AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

    Patient problems: Impaired Healing; Seroma

    MAUDE report 15711863 ↗
  • InjuryAug 2, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

    PER CLINICAL TRIAL (B)(4): ON (B)(6) 2018, PATIENT UNDERWENT BILATERAL MASTOPEXY; SUPERIOR PEDICLE, USING A VERTICAL INCISION. 2 PIECES OF GALAFORM (GALAFLEX 3DR) WERE USED. CONCOMITANT PROCEDURES INCLUDED: BREAST IMPLANT REMOVAL, AUTOAUGMENTATION, LIPOSUCTION TO ABDOMEN, AXILLA, MID/LOWER BACK, HIPS. ON (B)(6) 2018, DELAYED WOUND HEALING; LEFT BREAST, WAS REPORTED. PATIENT HAD DEBRIDEMENT ON (B)(6) 2018 AND WET TO DRY DRESSING CHANGES. NO INDICATION OF INFECTION FROM CULTURES AND NO INDICATION OF MESH REMOVAL. RESOLVED WITH UNKNOWN SEQUELAE ON 11/13/18. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE DELAYED WOUND HEALING AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

    Patient problems: Impaired Healing

    MAUDE report 15144884 ↗
  • InjuryAug 2, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

    PER CLINICAL TRIAL (B)(6): ON (B)(6) 2018, PATIENT UNDERWENT BILATERAL AUGMENTATION MASTOPEXY USING A FULL VERTICAL AND HORIZONTAL T INCISION. 2 PIECES OF GALAFORM (GALAFLEX 3DR) WERE USED. NO CONCOMITANT PROCEDURES WERE DONE. ON (B)(6) 2018, DELAYED WOUND HEALING; LEFT BREAST T REGION, WAS REPORTED. PATIENT HAD DRESSING CHANGES AND HYPERBARIC CHAMBER TREATMENT. RESOLVED WITHOUT SEQUELAE ON AN UNKNOWN DATE. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED DELAYED WOUND HEALING IS LIKELY RELATED TO THE DEVICE AND SERIOUS.

    Patient problems: Impaired Healing

    MAUDE report 15144883 ↗
  • InjuryAug 2, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

    PER CLINICAL TRIAL (B)(4): ON (B)(6) 2019 PATIENT UNDERWENT BILATERAL AUGMENTATION MASTOPEXY USING A FULL VERTICAL AND HORIZONTAL T INCISION. 2 PIECES OF GALAFORM (GALAFLEX 3DR) WERE USED. NO CONCOMITANT PROCEDURES WERE DONE. ON (B)(6) 2019, DELAYED WOUND HEALING; RIGHT T REGION WAS REPORTED. PATIENT HAD WOUND DEBRIDEMENT AND DRESSING CHANGES. RESOLVED WITHOUT SEQUELAE ON (B)(6) 2019. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE DELAYED WOUND HEALING AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

    Patient problems: Impaired Healing

    MAUDE report 15144882 ↗
  • InjuryJul 28, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

    PER CLINICAL TRIAL (B)(4): ON (B)(6) 2019, PATIENT UNDERWENT BILATERAL AUGMENTATION MASTOPEXY USING A FULL VERTICAL AND HORIZONTAL T INCISION. 2 PIECES OF GALAFORM (GALAFLEX 3DR) WERE USED. NO CONCOMITANT PROCEDURES WERE DONE. ON (B)(6) 2020, AN AE OF: GALAFORM DID NOT DISSOLVE; LEFT LATERAL BREAST, WAS REPORTED. GALAFORM WAS EXCISED ON 6/18/20. RESOLVED WITHOUT SEQUELAE ON (B)(6) 2020. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED AE IS RELATED TO THE DEVICE AND SERIOUS.

    Patient problems: Insufficient Information

    MAUDE report 15123639 ↗
  • InjuryJul 19, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

    PER CLINICAL TRIAL (B)(4): ON (B)(6) 2019, PATIENT UNDERWENT BILATERAL AUGMENTATION MASTOPEXY USING A VERTICAL INCISION. 2 PIECES OF GALAFORM (GALAFLEX 3DR) WERE USED. NO CONCOMITANT PROCEDURES WERE DONE. ON (B)(6) 2019, LEFT BREAST HEMATOMA WAS REPORTED. ON (B)(6) 2019, HEMATOMA WAS EVACUATED. RESOLVED WITHOUT SEQUELAE ON (B)(6) 2019. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE LEFT BREAST HEMATOMA IS LIKELY RELATED TO THE DEVICE AND SERIOUS.

    Patient problems: Hematoma

    MAUDE report 15057490 ↗
  • InjuryJul 12, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

    PER CLINICAL TRIAL CP-1060: ON (B)(6) 18, PATIENT UNDERWENT BILATERAL AUGMENTATION MASTOPEXY USING A FULL VERTICAL AND HORIZONTAL T INCISION. 2 PIECES OF GALAFORM (GALAFLEX 3DR) WERE USED. NO CONCOMITANT PROCEDURES WERE DONE. ON (B)(6) 18, RIGHT BREAST SEROMA AND INFECTION WAS REPORTED. PATIENT HAD CULTURE TAKEN AND WAS TREATED WITH MEDICATION (BACTRIM). RESOLVED WITHOUT SEQUELAE ON (B)(6) 18. ON (B)(6) 18, DELAYED WOUND HEALING; RIGHT T REGION, WAS REPORTED. PATIENT TREATED WITH DRESSING CHANGES. RESOLVED WITHOUT SEQUELAE ON (B)(6) 18. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE SEROMA, INFECTION AND DELAYED WOUND HEALING ARE LIKELY RELATED TO THE DEVICE AND SERIOUS.

    Patient problems: Impaired Healing; Seroma; Unspecified Infection

    MAUDE report 14984998 ↗
  • InjuryJul 6, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

    PER CLINICAL TRIAL (B)(4): ON (B)(6) 2018, PATIENT UNDERWENT BILATERAL REVISION AUGMENTATION MASTOPEXY USING A FULL VERTICAL AND HORIZONTAL T INCISION. 1 PIECE OF GALAFORM (GALAFLEX 3DR) WAS USED. NO CONCOMITANT PROCEDURES WERE DONE. ON (B)(6) 2018, DOG EAR: MEDIAL FOLD OF BREASTS WAS REPORTED. PATIENT HAD DOG EAR REMOVAL PROCEDURE ON (B)(6) 2018. A PIECE OF MESH WAS REMOVED FROM LEFT BREAST. BILATERAL BREAST SCAR REVISION ALSO DONE. RESOLVED WITHOUT SEQUELAE ON (B)(6) 2018. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED ADVERSE EVENT AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

    Patient problems: Physical Asymmetry

    MAUDE report 14938450 ↗
  • InjuryJul 6, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

    PER CLINICAL TRIAL (B)(6): ON (B)(6) 2018, PATIENT UNDERWENT BILATERAL REVISION AUGMENTATION MASTOPEXY USING A FULL VERTICAL AND HORIZONTAL T INCISION. 1 PIECE OF GALAFORM (GALAFLEX 3DR) WAS USED. CONCOMITANT PROCEDURES INCLUDED BL SUPERIOR CAPSULOTOMY AND BL INFERIOR CAPSULORRHAPHY. ON (B)(6) 2018, RIGHT BREAST INCISION SITE COMPLICATION WAS REPORTED. SMALL ESCHAR ON INCISION. PATIENT WAS TREATED WITH MEDICATION (TOPICAL BETADINE). RESOLVED WITHOUT SEQUELAE ON (B)(6) 2018. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED INCISION SITE COMPLICATION IS LIKELY RELATED TO THE DEVICE AND SERIOUS.

    Patient problems: Unspecified Tissue Injury

    MAUDE report 14938446 ↗
  • InjuryJun 21, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

    PER CLINICAL TRIAL (B)(6): ON (B)(6) 2017, PATIENT UNDERWENT BILATERAL MASTOPEXY; INFERIOR PEDICLE, USING A FULL VERTICAL AND HORIZONTAL T INCISION. 2 PIECES OF GALAFORM (GALAFLEX 3DR) WERE USED. CONCOMITANT PROCEDURES INCLUDED FAT GRAFTING OF LEFT BREAST AND LIPOSUCTION. ON (B)(6) 2017, RIGHT DELAYED WOUND HEALING WAS REPORTED. PATIENT TREATED WITH MEDICATION (BACTROBAN). RESOLVED WITHOUT SEQUELAE ON (B)(6) 2017. REVIEW BY MEDICAL AFFAIRS IDENTIFIES AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

    Patient problems: Impaired Healing

    MAUDE report 14757067 ↗
  • InjuryJun 21, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

    PER CLINICAL TRIAL (B)(4): ON (B)(6) 2017 PATIENT UNDERWENT BILATERAL MASTOPEXY; INFERIOR PEDICLE, USING A FULL VERTICAL AND HORIZONTAL T INCISION. 2 PIECES OF GALAFORM (GALAFLEX 3DR) WERE USED. CONCOMITANT PROCEDURES INCLUDED FAT GRAFTING OF LEFT BREAST AND LIPOSUCTION. ON (B)(6) 2017 BREAST HEMATOMA WAS REPORTED. HEMATOMA EVACUATED ON (B)(6) 2017. RESOLVED WITHOUT SEQUELAE ON (B)(6) 2017. REVIEW BY MEDICAL AFFAIRS IDENTIFIES AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

    Patient problems: Hematoma

    MAUDE report 14756851 ↗
  • MalfunctionJun 21, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

    PER CLINICAL TRIAL (B)(4): ON (B)(6) 2017, PATIENT UNDERWENT BILATERAL REVISION AUGMENTATION MASTOPEXY USING A FULL VERTICAL AND HORIZONTAL T INCISION. 2 PIECES OF GALAFORM (GALAFLEX 3DR) WERE USED. CONCOMITANT PROCEDURE INCLUDED LIPOSUCTION. ON (B)(6) 2017, HEMATOMA; BREAST WAS REPORTED. NO TREATMENT WAS GIVEN OR ACTION TAKEN. RESOLVED WITHOUT SEQUELAE ON (B)(6) 2017. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED HEMATOMA IS LIKELY RELATED TO THE DEVICE AND NOT SERIOUS.

    Patient problems: Hematoma

    MAUDE report 14756183 ↗
  • InjuryJun 21, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

    PER CLINICAL TRIAL (B)(6): ON (B)(6) 2017, PATIENT UNDERWENT BILATERAL MASTOPEXY; INFERIOR PEDICLE, USING A FULL VERTICAL AND HORIZONTAL T INCISION. 2 PIECES OF GALAFORM (GALAFLEX 3DR) WERE USED. CONCOMITANT PROCEDURES INCLUDED FAT GRAFTING TO BILATERAL BREASTS, ABDOMINOPLASTY, LIPOSUCTION, FAT GRAFTING TO BUTTOCKS. ON (B)(6) 2017, RIGHT BREAST DELAYED WOUND HEALING WAS REPORTED. PATIENT HAD DEBRIDEMENT AND APPLICATION OF WET TO DRY DRESSING CHANGES. ALSO TREATED WITH MEDICATION (AQUAPHOR). RESOLVED WITHOUT SEQUELAE ON (B)(6) 2018. REVIEW BY MEDICAL AFFAIRS IDENTIFIES AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

    Patient problems: Impaired Healing

    MAUDE report 14756176 ↗
  • InjuryJun 21, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

    PER CLINICAL TRIAL (B)(4): ON (B)(6) 2017, PATIENT UNDERWENT BILATERAL BREAST REDUCTION; INFERIOR PEDICLE, USING A FULL VERTICAL AND HORIZONTAL T INCISION. 2 PIECES OF GALAFORM (GALAFLEX 3DR) WERE USED. CONCOMITANT PROCEDURES INCLUDED LIPOSUCTION AND FAT GRAFTING TO BUTTOCKS. ON (B)(6) 2017, INFECTION; BREAST WAS REPORTED. PATIENT TREATED WITH MEDICATION (BACTROBAN, KEFLEX, ULTRAM, BACTRIM). RESOLVED WITHOUT SEQUELAE ON (B)(6) 2017. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED ADVERSE EVENT AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

    Patient problems: Unspecified Infection

    MAUDE report 14756160 ↗
  • InjuryJun 21, 2022Migration; Migration

    PER CLINICAL TRIAL CP-(B)(6): ON (B)(6) 2017, PATIENT UNDERWENT BILATERAL REVISION AUGMENTATION MASTOPEXY USING A FULL VERTICAL AND HORIZONTAL T INCISION. 2 PIECES OF GALAFORM (GALAFLEX 3DR) WERE USED. CONCOMITANT PROCEDURE INCLUDED LIPOSUCTION. ON (B)(6) 2017 MIGRATION, MALPOSITION OR CONTRACTION WAS REPORTED. PATIENT HAD PROCEDURE TO LOWER BREAST POCKET ON (B)(6) 2017. RESOLVED WITHOUT SEQUELAE ON (B)(6) 2017. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED MIGRATION IS LIKELY RELATED TO THE DEVICE AND SERIOUS.

    Patient problems: Unspecified Reproductive System or Breast Problem

    MAUDE report 14756137 ↗
  • InjuryMay 7, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

    PER CLINICAL TRIAL CP-1060: ON (B)(6) 2018, PATIENT UNDERWENT REVISION BILATERAL MASTOPEXY/REDUCTION; INFERIOR PEDICLE, USING A FULL VERTICAL AND HORIZONTAL T INCISION. 2 PIECES OF GALAFORM (GALAFLEX 3DR) WERE USED. CONCOMITANT PROCEDURES INCLUDE FAT GRAFTING TO LEFT BREAST AND LIPOSUCTION. ON (B)(6) 2018, INFECTION OF LEFT BREAST WAS REPORTED. TREATED WITH MEDICATION (BACTRIM AND BACTROBAN). RESOLVED WITHOUT SEQUELAE ON (B)(6) 2018. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE ADVERSE EVENT AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

    Patient problems: Unspecified Infection

    MAUDE report 14319361 ↗
  • InjuryApr 22, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

    PER CLINICAL TRIAL CP-(B)(4): ON (B)(6) 2019, PATIENT UNDERWENT BILATERAL AUGMENTATION MASTOPEXY USING A FULL VERTICAL AND HORIZONTAL T INCISION. 2 PIECES OF GALAFORM (GALAFLEX 3DR) WERE USED. CONCOMITANT PROCEDURES INCLUDED FAT GRAFTING TO BOTH BREASTS, ABDOMINAL SCAR REVISION AND REDUCTION LABIAPLASTY. ON (B)(6) 2019, BREAST BLISTER WAS REPORTED. SAE. ON (B)(6) 2019, PATIENT HAD BILATERAL DEBRIDEMENT AND BREAST IMPLANT/MESH REMOVAL. PATIENT WAS TREATED WITH WOUND VAC AND MEDICATION (BACTROBAN OINTMENT). RESOLVED WITH SEQUELAE ON (B)(6) 2019. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE BLISTER AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

    Patient problems: Blister

    MAUDE report 14190205 ↗
  • InjuryApr 22, 2022Migration; Migration

    PER CLINICAL TRIAL (B)(4): ON (B)(6) 2018, PATIENT UNDERWENT BILATERAL BREAST AUGMENTATION MASTOPEXY USING A SHORT SCAR INCISION. 2 PIECES OF GALAFORM (GALAFLEX 3DR) WERE USED. NO CONCOMITANT PROCEDURES WERE DONE. ON (B)(6) 2018, BILATERAL MIGRATION, MALPOSITION OR CONTRACTION WAS REPORTED. ON (B)(6) 2019, BILATERAL CAPSULORRHAPHIES WERE DONE. RESOLVED WITHOUT SEQUELAE ON (B)(6) 2019. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED MIGRATION AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

    Patient problems: Unspecified Reproductive System or Breast Problem

    MAUDE report 14190081 ↗
  • InjuryApr 22, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

    PER CLINICAL TRIAL (B)(4): ON (B)(6) 2018, PATIENT UNDERWENT BILATERAL AUGMENTATION MASTOPEXY USING A FULL VERTICAL AND HORIZONTAL T INCISION. 2 PIECES OF GALAFORM (GALAFLEX 3DR) WERE USED. NO CONCOMITANT PROCEDURES WERE DONE. ON (B)(6) 2018, LEFT BREAST DELAYED WOUND HEALING WAS REPORTED. PATIENT TREATED WITH MEDICATION (AQUAPHOR). RESOLVED WITHOUT SEQUELAE ON (B)(6) 2018. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED DELAYED WOUND HEALING AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

    Patient problems: Impaired Healing

    MAUDE report 14189955 ↗
  • InjuryApr 22, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

    PER CLINICAL TRIAL (B)(4): ON (B)(6) 2019, PATIENT UNDERWENT BILATERAL AUGMENTATION MASTOPEXY USING A FULL VERTICAL AND HORIZONTAL T INCISION. 2 PIECES OF GALAFORM (GALAFLEX 3DR) WERE USED. CONCOMITANT PROCEDURES INCLUDED BILATERAL NIPPLE REDUCTION, EARLOBE REPAIR, EXCISE FOREHEAD LESION. ON 2/26/19, BILATERAL CAPSULAR CONTRACTURE WAS REPORTED. ON (B)(6) 2019, PATIENT HAD OPEN BILATERAL CAPSULECTOMIES, REMOVAL OF BREAST IMPLANTS AND FAT GRAFTING TO BREASTS. RESOLVED WITHOUT SEQUELAE ON (B)(6) 2019. REVIEW BY MEDICAL AFFAIRS IDENTIFIES CAPSULAR CONTRACTURE AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

    Patient problems: Capsular Contracture

    MAUDE report 14189951 ↗
  • InjuryApr 22, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

    PER CLINICAL TRIAL CP-1060: ON (B)(6) 2019, PATIENT UNDERWENT BILATERAL AUGMENTATION MASTOPEXY USING A FULL VERTICAL AND HORIZONTAL T INCISION. 2 PIECES OF GALAFORM (GALAFLEX 3DR) WERE USED. CONCOMITANT PROCEDURES INCLUDED BILATERAL NIPPLE REDUCTION, EARLOBE REPAIR, EXCISE FOREHEAD LESION. ON (B)(6) 2019, DRAINAGE BILATERAL BREASTS WAS REPORTED. PATIENT TREATED WITH MEDICATION (BACTROBAN, BACTRIM). RESOLVED WITHOUT SEQUELAE ON (B)(6)2019. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE WOUND DRAINAGE AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

    Patient problems: Fluid Discharge

    MAUDE report 14189946 ↗
  • InjuryApr 20, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

    PER CLINICAL TRIAL (B)(6): ON (B)(6) 2018, PATIENT UNDERWENT BILATERAL AUGMENTATION MASTOPEXY USING A FULL VERTICAL AND HORIZONTAL T INCISION. 2 PIECES OF GALAFORM (GALAFLEX 3DR) WERE USED. NO CONCOMITANT PROCEDURES WERE DONE. ON (B)(6) 2019, RIGHT BREAST PTOSIS WAS REPORTED. NO ACTION WAS TAKEN. PATIENT MAY NEED SKIN EXCISION ON RIGHT BREAST. REVIEW OF MEDICAL AFFAIRS IDENTIFIED THAT THE REPORTED AE IS LIKELY RELATED TO THE DEVICE AND NOT SERIOUS.

    Patient problems: Ptosis

    MAUDE report 14159254 ↗
  • InjuryApr 20, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

    PER CLINICAL TRIAL (B)(6): ON (B)(6) 2018, PATIENT UNDERWENT BILATERAL MASTOPEXY; INFERIOR PEDICLE USING A FULL VERTICAL AND HORIZONTAL T INCISION. TWO PIECES OF GALAFORM (GALAFLEX 3DR) WERE USED. CONCOMITANT PROCEDURES INCLUDED ABDOMINOPLASTY, LIPO SUCTION, FAT GRAFTING TO BUTTOCKS, FAT GRAFTING TO RIGHT BREAST. ON (B)(6) 2018, LEFT BREAST ERYTHEMA/REDNESS WAS REPORTED. PATIENT WAS TREATED WITH MEDICATION (BACTROBAN, BACTRIM). RESOLVED WITHOUT SEQUELAE ON (B)(6) 2018. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE ERYTHEMA/REDNESS AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

    Patient problems: Erythema

    MAUDE report 14159250 ↗
  • InjuryApr 20, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

    PER CLINICAL TRIAL (B)(4): ON (B)(6) 2019, PATIENT UNDERWENT BILATERAL AUGMENTATION MASTOPEXY USING A FULL VERTICAL AND HORIZONTAL T INCISION. 2 PIECES OF GALAFORM (GALAFLEX 3DR) WERE USED. CONCOMITANT PROCEDURE WAS ABDOMINOPLASTY. ON (B)(6) 2019, SWELLING OF RIGHT BREAST WAS REPORTED. ON (B)(6) 2019, PATIENT HAD BILATERAL REVISION MASTOPEXY. NO RESOLUTION DATE WAS GIVEN. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE ADVERSE EVENT AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

    Patient problems: Swelling/ Edema

    MAUDE report 14159249 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.