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GalaFORM 3D 100043-04Recalls & 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

All models of GalaFORM 3D (5)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Quick summary

This Tepha GalaFORM 3D surgical mesh is a biodegradable breast scaffold implant used during augmentation, revision, and breast reduction surgery. The 29 adverse event reports mostly describe healing problems in the breast — blood or fluid collections under the skin, tissue breakdown and necrosis, infection, and the implant or its covering shifting out of position — often requiring drainage, debridement, or a second operation. There were 28 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
29
Deaths reported
0
Injuries reported
28
Recalls naming it
0

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00855920006256), received between Mar 10, 2022 and Jul 12, 2022 — classified as 28 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (25 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 16, 2026.

Most reported problems

Device problems

  • Patient-Device Incompatibility25
  • Patient Device Interaction Problem2
  • Migration1
  • Migration or Expulsion of Device1

Patient problems

  • Impaired Healing6
  • Hematoma4
  • Bacterial Infection2
  • Breast Discomfort/Pain2
  • Cellulitis2
  • Necrosis2
  • Seroma2
  • Unspecified Reproductive System or Breast Problem2

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 12, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

    PER CLINICAL TRIAL (B)(6): ON (B)(6) 2019, PATIENT UNDERWENT BILATERAL REVISION AUGMENTATION; CAPSULAR CONTRACTURE, USING A VERTICAL INCISION. 2 PIECES OF GALAFORM (GALAFLEX 3DR) WERE USED. CONCOMITANT PROCEDURES INCLUDED CAPSULECTOMIES, MASTOPEXIES, AND FAT GRAFTING TO FACE. ON (B)(6) 2019, DELAYED WOUND HEALING; RIGHT AREOLA WAS REPORTED. PATIENT HAD DEBRIDEMENT ON (B)(6) 2019 AND WAS TREATED WITH MEDICATION (POLYSPORIN, SILVADENE CREAM). RESOLVED WITHOUT SEQUELAE ON (B)(6) 2019. REVIEW OF MEDICAL AFFAIRS IDENTIFIED THAT THE DELAYED WOUND HEALING IS LIKELY RELATED TO THE DEVICE AND SERIOUS.

    Patient problems: Impaired Healing

    MAUDE report 14985004 ↗
  • InjuryJul 6, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

    PER CLINICAL TRIAL (B)(6): ON (B)(6) 2018, PATIENT UNDERWENT REVISION LEFT INFERIOR BREAST CAPSULORRHAPHY USING A CRESCENT/PERI-AREOLAR INCISION. UNKNOWN IF CONCOMITANT PROCEDURE(S) WERE DONE. 1 PIECE OF GALAFORM (GALAFLEX 3DR) WAS USED - LEFT SIDE ONLY. ON (B)(6) 2018, LEFT MIGRATION, MALPOSITION, OR CONTRACTION WAS REPORTED - INFERIOR MALPOSITION. ON (B)(6) 2019, PATIENT HAD LEFT BREAST CAPSULORRHAPHY WITH CAPSULAR FLAP PROCEDURE. NO END DATE WAS GIVEN. ON (B)(6) 2019, LEFT BREAST REOPERATION WAS REPORTED (LEFT BREAST WAS MUCH LOWER THAN RIGHT). PATIENT HAD REVISION LEFT BREAST CAPSULORRHAPHY ON (B)(6) 2019. RESOLVED WITHOUT SEQUELAE ON (B)(6) 2019. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED EVENTS MIGRATION, MALPOSITION, OR CONTRACTION AND REOPERATION ARE LIKELY RELATED TO THE DEVICE AND SERIOUS.

    Patient problems: Capsular Contracture; Unspecified Reproductive System or Breast Problem

    MAUDE report 14938407 ↗
  • InjuryJun 21, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

    PER CLINICAL TRIAL (B)(4): ON (B)(6) 2017, PATIENT UNDERWENT BILATERAL AUGMENTATION MASTOPEXY USING A FULL VERTICAL AND HORIZONTAL T INCISION. 2 PIECES OF GALAFORM (GALAFLEX 3DR) WERE USED. CONCOMITANT PROCEDURES INCLUDED ABDOMINOPLASTY, LIPOSUCTION, FAT GRAFTING TO BUTTOCKS. ON (B)(6) 2017, BREAST HEMATOMA WAS REPORTED. EVACUATION OF HEMATOMA, LOWER POCKET, WAS PERFORMED ON (B)(6) 2018. RESOLVED WITHOUT SEQUELAE ON (B)(6) 2018. RESOLVED WITHOUT SEQUELAE ON (B)(6) 2018. REVIEW BY MEDICAL AFFAIRS IDENTIFIES AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

    Patient problems: Hematoma

    MAUDE report 14756161 ↗
  • 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 ABDOMINOPLASTY, LIPOSUCTION, FAT GRAFTING TO BUTTOCKS. ON (B)(6) 2017, RIGHT BREAST HEMATOMA WAS REPORTED. HEMATOMA EVACUATED AND 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: Hematoma

    MAUDE report 14756115 ↗
  • InjuryJun 15, 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. 2 PIECES OF GALAFORM (GALAFLEX 3DR) WERE USED. CONCOMITANT PROCEDURES INCLUDED LIPOSUCTION TO LATERAL BREASTS AND REMOVAL OF ABDOMINAL LESIONS. ON (B)(6) 2018, BILATERAL BREAST NECROSIS WAS REPORTED. ON (B)(6) 2018, PATIENT HAD BILATERAL DEBRIDEMENT AND CLOSURE PROCEDURE. ALSO TREATED WITH MEDICATION (AVELOX 400MG). RESOLVED WITH SEQUELAE ON (B)(6) 2018. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED ADVERSE EVENT AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

    Patient problems: Necrosis

    MAUDE report 14693873 ↗
  • InjuryJun 8, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

    PER CLINICAL TRIAL (B)(4): ON (B)(6) 2018, PATIENT UNDERWENT BILATERAL SUPERIOR PEDICLE BREAST REDUCTION USING A FULL VERTICAL AND HORIZONTAL T INCISION. 2 PIECES OF GALAFORM (GALAFLEX 3DR) WERE USED. THERE WERE NO CONCOMITANT PROCEDURES DONE. ON (B)(6) 2018, RIGHT BREAST HEMATOMA WAS REPORTED. SAE. PATIENT HOSPITALIZED ON (B)(6) 2018 AND HAD RIGHT BREAST HEMATOMA EVACUATION THAT DAY. RESOLVED WITH SEQUELAE ON (B)(6) 2018. FAT NECROSIS OF THE RIGHT BREAST AND A LESS THAN IDEAL RESULT OCCURRED FROM THE HEMATOMA. REVIEW BY MEDICAL AFFAIRS IDENTIFIES AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

    Patient problems: Hematoma; Necrosis

    MAUDE report 14636550 ↗
  • InjuryJun 7, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

    PER CLINICAL TRIAL (B)(6). ON (B)(6) 2018 PATIENT UNDERWENT BILATERAL AUGMENTATION MASTOPEXY USING A VERTICAL INCISION. 2 PIECES OF GALAFORM (GALAFLEX 3DR) WERE USED. CONCOMITANT PROCEDURES INCLUDED ABDOMINOPLASTY, LIPOSUCTION, UMBILICAL HERNIA REPAIR. ON (B)(6) 2018 SEROMA, LOCATED SUPERIORLY, WAS REPORTED. ON (B)(6) 2018 PATIENT HAD ASPIRATION OF SEROMA. 20ML SEROSANGUINOUS FLUID ASPIRATED. OTHERWISE, HEALING UNEVENTFULLY. 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: Seroma

    MAUDE report 14621804 ↗
  • InjuryMay 27, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

    PER CLINICAL TRIAL (B)(6): ON (B)(6) 2017, THE PATIENT UNDERWENT BILATERAL BREAST REDUCTION; INFERIOR PEDICLE, USING A FULL VERTICAL AND HORIZONTAL T INCISION. 2 PIECES OF GALAFORM (GALAFLEX 3DR) WERE USED. NO CONCOMITANT PROCEDURES WERE DONE. ON (B)(6) 2017, RIGHT BREAST DRAINAGE WAS REPORTED. PATIENT TREATED WITH MEDICATION (CLINDAMYCIN, BACTROBAN). RESOLVED WITHOUT SEQUELAE ON (B)(6) 2018. REVIEW OF MEDICAL AFFAIRS IDENTIFIED THAT THE REPORTED AE IS LIKELY RELATED TO THE DEVICE AND SERIOUS.

    Patient problems: Fluid Discharge

    MAUDE report 14521628 ↗
  • InjuryMay 23, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

    PER CLINICAL TRIAL CP-1060: ON (B)(6) 2019, PATIENT UNDERWENT BILATERAL REVISION AUGMENTATION; CAPSULAR CONTRACTION, USING A VERTICAL INCISION. 2 PIECES OF GALAFORM (GALAFLEX 3DR) WERE USED. CONCOMITANT PROCEDURES INCLUDED REVISION MASTOPEXY AND HALO TREATMENT TO THE FACE. AT A FOLLOW UP VISIT, PATIENT REPORTED RECENT ADMISSION TO HOSPITAL (UNKNOWN DATES) WITH CELLULITIS OF LEFT BREAST. SAE START DATE OF (B)(6) 2019. PATIENT TREATED WITH CLINDAMYCIN AND KEFLEX AND STABLE AFTER 2 WEEKS OF TREATMENT. RESOLVED (B)(6) 2019 WITHOUT SEQUELAE. REVIEW BY MEDICAL AFFAIRS IDENTIFIES AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

    Patient problems: Cellulitis

    MAUDE report 14476776 ↗
  • InjuryMay 9, 2022Migration; Migration

    PER CLINICAL TRIAL (B)(4): ON (B)(6) 2018, PATIENT UNDERWENT BILATERAL COSMETIC 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, MIGRATION, MALPOSITION, OR CONTRACTION WAS REPORTED. PATIENT WAS TREATED WITH MEDICATION (SINGULAIR). ON (B)(6) 2019, PATIENT HAD RIGHT LOWERING CAPSULOTOMY, REVISION BILATERAL MASTOPEXY, LEFT POPCORN CAPSULORRAPHY. THE AE RESOLVED WITHOUT SEQUELAE ON (B)(6) 2019. REVIEW OF MEDICAL AFFAIRS IDENTIFIED THAT THE REPORTED AE IS LIKELY RELATED TO THE DEVICE AND SERIOUS.

    Patient problems: Unspecified Reproductive System or Breast Problem

    MAUDE report 14341675 ↗
  • InjuryMay 7, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

    PER CLINICAL TRIAL (B)(4): ON (B)(6) 2018, PATIENT UNDERWENT BILATERAL COSMETIC BREAST REDUCTION; INFERIOR PEDICLE, 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 WOUND DEHISCENCE WAS REPORTED. PATIENT TREATED WITH MEDICATION (CLINDAMYCIN, CIPRO, BACTROBAN), WET TO DRY DRESSING, WOUND CLOSURE/MINOR DEBRIDEMENT AND PREVENA NEGATIVE PRESSURE SYSTEM. RESOLVED WITH SEQUELAE ON (B)(6) 2018. REVIEW BY MEDICAL AFFAIRS IDENTIFIES ADVERSE EVENT AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

    Patient problems: Wound Dehiscence

    MAUDE report 14319455 ↗
  • InjuryMay 7, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

    PER CLINICAL TRIAL CP-1060: ON (B)(6) 2018, PATIENT UNDERWENT BILATERAL COSMETIC BREAST REDUCTION; INFERIOR PEDICLE, 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 CELLULITIS WAS REPORTED. TREATED WITH MEDICATION (CLINDAMYCIN, CIPRO, BACTROBAN). RESOLVED WITH SEQUELAE ON (B)(6) 2018. REVIEW BY MEDICAL AFFAIRS IDENTIFIES AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

    Patient problems: Cellulitis

    MAUDE report 14319129 ↗
  • InjuryApr 22, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

    PER CLINICAL TRIAL (B)(4): ON (B)(6) 2019, PATIENT UNDERWENT LEFT REVISION AUGMENTATION; IMPLANT RUPTURE, USING A FULL VERTICAL AND HORIZONTAL T INCISION. 2 PIECES OF GALAFORM (GALAFLEX 3DR) WERE USED. CONCOMITANT PROCEDURES INCLUDED BILATERAL CAPSULECTOMIES, BLEPH, FACIAL FAT GRAFTING & LASER. ON (B)(6) 2019, LEFT BREAST HEMATOMA WAS REPORTED. ON (B)(6) 2019, PATIENT HAD PROCEDURE WHERE HEMATOMA WAS EVACUATED. RESOLVED WITHOUT SEQUELAE ON (B)(6) 19. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED HEMATOMA AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

    Patient problems: Hematoma

    MAUDE report 14190207 ↗
  • InjuryApr 22, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

    PER CLINICAL TRIAL (B)(4): ON (B)(6) 2018, PATIENT UNDERWENT BILATERAL BREAST REDUCTION; INFERIOR PEDICLE 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 WAS TREATED WITH MEDICATION (TOPICAL AQUAPHOR). RESOLVED WITHOUT SEQUELAE ON 6/28/18. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED DELAYED WOUND HEALING AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

    Patient problems: Impaired Healing

    MAUDE report 14190204 ↗
  • MalfunctionApr 20, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

    PER CLINICAL TRIAL (B)(6): ON (B)(6) 2018, PATIENT UNDERWENT LEFT BREAST CENTRAL MOUND REDUCTION AND RIGHT BREAST 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 ERYTHEMA/REDNESS WAS REPORTED. NO TREATMENT WAS GIVEN. RESOLVED ON (B)(6) 2018 WITHOUT SEQUELAE. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE ERYTHEMA AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

    Patient problems: Erythema

    MAUDE report 14159822 ↗
  • InjuryApr 20, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

    PER CLINICAL TRIAL (B)(4): ON (B)(6) 2018, PATIENT UNDERWENT BILATERAL AUGMENTATION MASTOPEXY USING A VERTICAL INCISION. 1 PIECE OF GALAFLEX (DEVICE #1) AND 2 PIECES OF GALAFORM (GALAFLEX 3DR) (DEVICE #2) WERE USED. CONCOMITANT PROCEDURE WAS CAPSULORRHAPHY. ON (B)(6) 2018, LEFT BREAST SEROMA WAS REPORTED. PATIENT TREATED WITH SEROSANGUINOUS FLUID ASPIRATIONS OVER SEVERAL DAYS AND PLACEMENT OF A SEROMA CATHETER. ALSO TREATED WITH MEDICATION (CIPRO). DRAIN REMOVED (B)(6) 2018. RESOLVED (B)(6) 2018 WITHOUT SEQUELAE. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED SEROMA IS LIKELY RELATED TO THE DEVICE AND SERIOUS.

    Patient problems: Seroma

    MAUDE report 14159816 ↗
  • InjuryApr 20, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

    PER CLINICAL TRIAL (B)(6): ON (B)(6) 2019, PATIENT UNDERWENT BILATERAL BREAST AUGMENTATION MASTOPEXY USING A FULL VERTICAL AND HORIZONTAL T INCISION. TWO PIECES OF GALAFORM (GALAFLEX 3DR) WERE USED. THERE WERE NOT ANY CONCOMITANT PROCEDURES. ON (B)(6) 2019, INCISION SITE COMPLICATION OF RIGHT BREAST WAS REPORTED. PATIENT TREATED WITH MEDICATION (BACTRIM, BACTROBAN, CIPRO, DOXYCYCLINE) AND ON (B)(6) 2019, VERTICAL SCAR WAS EXCISED. ON (B)(6) 2019, WOUND WAS EXCISED (AGAIN) AND CLOSED. RESOLVED WITHOUT SEQUELAE ON (B)(6) 2019. REVIEW OF MEDICAL AFFAIRS IDENTIFIED THAT THE REPORTED AE IS LIKELY RELATED TO THE DEVICE AND SERIOUS.

    Patient problems: Unspecified Tissue Injury

    MAUDE report 14159244 ↗
  • 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. TWO PIECES OF GALAFORM (GALAFLEX 3DR) WERE USED. CONCOMITANT PROCEDURES INCLUDED ABDOMINOPLASTY, LIPO SUCTION, FAT GRAFTING TO BUTTOCKS. ON (B)(6) 2019, LEFT BREAST INFECTION ( (B)(6)) WAS REPORTED. ON (B)(6) 2019, PATIENT HAD ADDITIONAL SURGERY AS TREATMENT - LEFT BREAST EXPLORATION AND DEBRIDEMENT WITH REMOVAL OF BREAST IMPLANT AND MESH PER PRIOR NOTES, WITH PLACEMENT OF BLAKE DRAIN. PATIENT ALSO TREATED WITH MEDICATIONS FROM (B)(6) 2019, AT DIFFERENT TIMEPOINTS. (IV BETA LACTAM, IV CEFTRIAXONE SODIUM. ALSO, CIPRO, BACTRIM, PROBIOTICS, GABAPENTIN, PERCOCET, TORADOL). RESOLVED ON UNKNOWN DATE AFTER (B)(6) 2019. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED AE AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

    Patient problems: Bacterial Infection

    MAUDE report 14159238 ↗
  • InjuryApr 20, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

    PER CLINICAL TRIAL (B)(4): ON (B)(6) 2019, PATIENT UNDERWENT BILATERAL BREAST REDUCTION; INFERIOR PEDICLE, USING A FULL VERTICAL AND HORIZONTAL T INCISION. TWO PIECES OF GALAFORM (GALAFLEX 3DR) WERE USED. CONCOMITANT PROCEDURE WAS ABDOMINOPLASTY. ON (B)(6) 2019, LEFT BREAST DELAYED WOUND HEALING WAS REPORTED. ON (B)(6) 2019, PATIENT HAD TREATMENT OF DEBRIDEMENT AND CLOSURE OF LEFT BREAST WOUND. ALSO TREATED WITH MEDICATIONS (LEVAQUIN, DOXYCYCLINE). RESOLVED ON (B)(6) 2019 WITH NO SEQUELAE. REVIEW BY MEDICAL AFFAIRS IDENTIFIES AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

    Patient problems: Impaired Healing

    MAUDE report 14159237 ↗
  • InjuryMar 30, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

    PER CLINICAL TRIAL (B)(6). ON (B)(6) 2019, PATIENT UNDERWENT BILATERAL REVISION AUGMENTATION; PTOSIS USING A VERTICAL INCISION. 2 PIECES OF GALAFORM (GALAFLEX 3DR) WERE USED. CONCOMITANT PROCEDURES INCLUDED MASTOPEXY, BLEPHAROPLASTY - UPPER EYELIDS AND NECK-LIFT. ON (B)(6) 2019, INFECTION RIGHT BREAST WAS REPORTED. IDENTIFIED AS SERRATIA. PATIENT WAS TREATED WITH MEDICATIONS (CIPRO, AUGMENTIN) FOR SWELLING, ERYTHEMA, RECURRENT DRAINAGE, ALL OF THE RIGHT BREAST DURING THE TIMEFRAME OF THE AE. ON (B)(6) 2020, ADDITIONAL SURGERY WAS PERFORMED REVISE RIGHT MASTOPEXY AND DEBRIDEMENT OF NON INTEGRATED MESH. RESOLVED WITHOUT SEQUELAE ON (B)(6) 2020. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THAT THE REPORTED AE IS RELATED TO THE DEVICE AND SERIOUS.

    Patient problems: Bacterial Infection

    MAUDE report 13954301 ↗
  • InjuryMar 30, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

    PER CLINICAL TRIAL CP-(B)(4): ON (B)(6) 2018, PATIENT UNDERWENT BILATERAL AUGMENTATION MASTOPEXY USING A VERTICAL INCISION. TWO PIECES OF GALAFORM (GALAFLEX 3DR) WERE USED. THERE WERE NO CONCOMITANT PROCEDURES DOCUMENTED. ON (B)(6) 2019, BILATERAL PTOSIS WAS REPORTED. ON (B)(6) 2019, ADDITIONAL SURGERY WAS DONE - REVISE BILATERAL MASTOPEXIES WITH REPLACEMENT OF LEFT BREAST IMPLANT WITH A NEW ONE. NO INDICATION OF REMOVAL OF ANY MESH. RESOLVED WITHOUT SEQUELAE ON UNKNOWN DATE. REVIEW BY MEDICAL AFFAIRS IDENTIFIES AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

    Patient problems: Ptosis

    MAUDE report 13953795 ↗
  • InjuryMar 30, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

    PER CLINICAL TRIAL CP-1060: ON (B)(6) 2018, PATIENT UNDERWENT BILATERAL AUGMENTATION MASTOPEXY USING A VERTICAL INCISION. TWO PIECES OF GALAFORM (GALAFLEX 3DR) WERE USED. THERE WERE NO CONCOMITANT PROCEDURES DOCUMENTED. ON (B)(6) 2018, WOUND DEHISCENCE OF RIGHT BREAST INCISION WAS REPORTED. PATIENT WAS TREATED WITH MEDICATION (POLYSPORIN AND SILVER NITRATE). RESOLVED WITH SEQUELAE ON UNKNOWN DATE. REVIEW BY MEDICAL AFFAIRS IDENTIFIES AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

    Patient problems: Wound Dehiscence

    MAUDE report 13953519 ↗
  • InjuryMar 23, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

    PER CLINICAL TRIAL (B)(6): ON (B)(6) 2017, PATIENT UNDERWENT BILATERAL REVISION AUGMENTATION MASTOPEXY. A FULL VERTICAL AND HORIZONTAL T INCISION WAS USED. 2 PIECES OF GALAFORM (GALAFLEX 3DR) WERE USED. CONCOMITANT PROCEDURES INCLUDED REVISION OF TUMMY TUCK, LIPOSUCTION FAT GRAFTING TO BUTTOCKS. ON (B)(6) 2017, LEFT DELAYED WOUND HEALING WAS REPORTED. PATIENT HAD BREAST WOUND CLOSURE PROCEDURE ON (B)(6) 2018 AND RECEIVED MEDICATION (HYPOCHLOROUS ACID AND AQUAPHOR). RESOLVED (B)(6) 2018 WITH NO SEQUELAE. REVIEW BY MEDICAL AFFAIRS IDENTIFIES AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

    Patient problems: Impaired Healing

    MAUDE report 13860601 ↗
  • 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 USED. 2 PIECES OF GALAFORM (GALAFLEX 3DR) WERE USED. CONCOMITANT PROCEDURES INCLUDED REVISION OF TUMMY TUCK, LIPOSUCTION FAT GRAFTING TO BUTTOCKS. ON (B)(6) 2017, BILATERAL BREAST PAIN WAS REPORTED. PATIENT TREATED WITH MEDICATION (CELEBREX AND TRAMADOL). RESOLVED (B)(6) 2017 WITH NO SEQUELAE. REVIEW BY MEDICAL AFFAIRS IDENTIFIES AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

    Patient problems: Breast Discomfort/Pain

    MAUDE report 13860499 ↗
  • InjuryMar 23, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

    PER CLINICAL TRIAL (B)(4): ON (B)(6) 2017, PATIENT UNDERWENT BILATERAL INFERIOR PEDICLE REDUCTION. A FULL VERTICAL AND HORIZONTAL T INCISION WAS USED. 2 PIECES OF GALAFORM (GALAFLEX 3DR) WERE USED. ON (B)(6) 2017, RIGHT BREAST PAIN WAS REPORTED. PATIENT WAS TREATED WITH MEDICATION (BACTROBAN AND NSAIDS) AND AE RESOLVED ON (B)(6) 2017 WITHOUT SEQUELAE. REVIEW BY MEDICAL AFFAIRS IDENTIFIES AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

    Patient problems: Breast Discomfort/Pain

    MAUDE report 13860370 ↗

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