GalaSHAPE 3D 100042-04Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00855920006171), received between Jul 8, 2019 and Nov 2, 2022 — classified as 35 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (29 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 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• InjuryNov 2, 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. TWO PIECES OF GALASHAPE (GALAFLEX 3D) WERE USED. CONCOMITANT PROCEDURES WERE LIPOSUCTION TO LOVE HANDLES AND ABDOMEN. ON (B)(6) 2017, DELAYED WOUND HEALING AND NECROSIS OF BILATERAL BREASTS WAS REPORTED. PATIENT HAD BILATERAL BREAST WOUND DEBRIDEMENT FOR FULL THICKNESS TISSUE LOSS ON (B)(6) 2017. PATIENT WAS TREATED WITH MEDICATION (SILVADENE, HYDROCORTISONE CREAM). DELAYED WOUND HEALING RESOLVED WITH SEQUELAE ON (B)(6) 2017. NECROSIS RESOLVED WITH SEQUELAE ON AN UNKNOWN DATE. WOUNDS HEALED SLOWLY. ON (B)(6) 2017, BILATERAL BREAST WOUND DEHISCENCE WAS REPORTED. PATIENT WAS TREATED WITH MEDICATION (HYDROCORTISONE CREAM). RESOLVED WITH SEQUELAE ON (B)(6) 2017. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED DELAYED WOUND HEALING, NECROSIS AND WOUND DEHISCENCE ARE LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Impaired Healing; Necrosis; Wound Dehiscence

  MAUDE report 15713376 ↗
• MalfunctionJul 26, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B(4): ON (B)(6) 2018, PATIENT UNDERWENT BILATERAL MASTOPEXY; INFERIOR PEDICLE, USING A FULL VERTICAL AND HORIZONTAL T INCISION. 2 PIECES OF GALASHAPE (GALAFLEX 3D) WERE USED. CONCOMITANT PROCEDURE WAS VASER ASSISTED LIPOSUCTION TO POSTERIOR HIPS AND LATERAL THIGHS. ON (B)(6) 2018, LEFT BREAST NECROSIS WAS REPORTED. ¿PROBABLY TINY LEFT BREAST FAT NECROSIS¿. NO ACTION WAS TAKEN. RESOLVED WITHOUT SEQUELAE ON (B)(6) 2019. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED NECROSIS IS LIKELY RELATED TO THE DEVICE AND NOT SERIOUS.

  Patient problems: Necrosis

  MAUDE report 15101769 ↗
• InjuryJun 21, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(6): ON (B)(6) 2019, PATIENT UNDERWENT BILATERAL REVISION AUGMENTATION MASTOPEXY USING A VERTICAL INCISION. 2 PIECES OF GALASHAPE (GALAFLEX 3D) WERE USED. CONCOMITANT PROCEDURE INCLUDED CAPSULECTOMY. ON (B)(6) 2019, NECROSIS; VERTICAL LIMB AT BOTH JUNCTIONS, WAS REPORTED. REPORTED AS SAE. PATIENT TREATED WITH MEDICATION (SILVADENE CREAM, AUGMENTIN, DOXYCYCLINE, SSD 1% CREAM) . RESOLVED WITH SEQUELAE ON (B)(6) 2019. REVIEW BY MEDICAL AFFAIRS IDENTIFIES AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Necrosis

  MAUDE report 14756166 ↗
• InjuryJun 21, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(6): ON (B)(6) 2017, PATIENT UNDERWENT BILATERAL BREAST AUGMENTATION MASTOPEXY USING A FULL VERTICAL AND HORIZONTAL T INCISION. 2 PIECES OF GALASHAPE (GALAFLEX 3D) WERE USED. CONCOMITANT PROCEDURES INCLUDED LIPOSUCTION TO LATERAL BREASTS, UPPER BLEPHAROPLASTY, FAT GRAFTING TO FACIAL STRUCTURES. ON (B)(6) 2017, RIGHT BREAST NECROSIS WAS REPORTED. ON (B)(6) 2017, RIGHT BREAST WOUND DEBRIDEMENT AND CLOSURE WAS DONE. PATIENT WAS LATER TREATED WITH MEDICATION (Z PAK). REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED ADVERSE EVENT AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Necrosis

  MAUDE report 14754180 ↗
• MalfunctionJun 15, 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 GALASHAPE (GALAFLEX 3D) WERE USED. NO CONCOMITANT PROCEDURES WERE DONE. ON (B)(6) 2020, LEFT BREAST DELAYED WOUND HEALING WAS REPORTED. WOUND HEALED ON ITS OWN. NO INTERVENTION OR MEDICATION NEEDED. RESOLVED WITHOUT SEQUELAE ON (B)(6) 2020. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED DELAYED WOUND HEALING IS LIKELY RELATED TO THE DEVICE AND NOT SERIOUS.

  Patient problems: Impaired Healing

  MAUDE report 14693857 ↗
• InjuryJun 15, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(4): ON (B)(6) 2020, PATIENT UNDERWENT BILATERAL REVISION AUGMENTATION MASTOPEXY USING A FULL VERTICAL AND HORIZONTAL T INCISION. 2 PIECES OF GALASHAPE (GALAFLEX 3D) WERE USED. CONCOMITANT PROCEDURES INCLUDED LIPOSUCTION TO LOWER ABDOMEN AND SCAR REVISION OF ABDOMINOPLASTY SCAR. ON (B)(6) 2020, PATIENT'S LEFT BREAST IMPLANT BOTTOMED OUT AND A LEFT 'DOUBLE BUBBLE' WAS REPORTED. PROGRESSIVELY GOTTEN WORSE WITH TIME. PATIENT IS WAITING ON REVISION. LAST DOCUMENTED PATIENT FOLLOW UP VISIT IS (B)(6) 2020. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED DOUBLE BUBBLE IS LIKELY RELATED TO THE DEVICE AND NOT SERIOUS.

  Patient problems: Physical Asymmetry

  MAUDE report 14693849 ↗
• InjuryJun 15, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(4): ON (B)(6) 2019, PATIENT UNDERWENT BILATERAL BREAST REVISION MASTOPEXY/REDUCTION; SUPERIOR PEDICLE, USING A FULL VERTICAL AND HORIZONTAL T INCISION. 2 PIECES OF GALASHAPE (GALAFLEX 3D) WERE USED. CONCOMITANT PROCEDURE WAS LIPOSUCTION TO BILATERAL BREASTS. ON (B)(6) 2019, LEFT BREAST NECROSIS WAS REPORTED. PATIENT WAS TREATED WITH MEDICATION (HYDROCORTISONE CREAM, GABAPENTIN 300MG). ON (B)(6) 2019, THE LAST DOCUMENTED FOLLOW UP VISIT ON THIS PATIENT, NOTES INDICATE THAT BREAST INCISIONS HEALING WELL. FAT NECROSIS OF LOWER LEFT POLE OF BREAST CAUSING PUCKERED LOOK. RESOLUTION DATE NOT GIVEN. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED ADVERSE EVENT AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Necrosis

  MAUDE report 14693660 ↗
• InjuryJun 15, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL CP-1060: ON (B)(6) 2018, PATIENT UNDERWENT BILATERAL SUPERIOR PEDICLE MASTOPEXY USING A FULL VERTICAL AND HORIZONTAL T INCISION. 2 PIECES OF GALASHAPE (GALAFLEX 3D) WERE USED. NO CONCOMITANT PROCEDURES WERE DONE. ON (B)(6) 2018, DELAYED WOUND HEALING; BILATERAL BREASTS, WAS REPORTED. PATIENT HAD HYPERBARIC OXYGEN TREATMENT AND WAS TREATED WITH BIOCORNEUM AND LOCAL WOUND CARE. 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: Impaired Healing

  MAUDE report 14693652 ↗
• InjuryJun 15, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(4): ON (B)(6) 2018, PATIENT UNDERWENT RIGHT BREAST REVISION AUGMENTATION MASTOPEXY USING A FULL VERTICAL AND HORIZONTAL T INCISION. 2 PIECES OF GALASHAPE (GALAFLEX 3D) WERE USED. NO CONCOMITANT PROCEDURES WERE DONE. ON (B)(6) 2018, BILATERAL BREAST INFECTION WAS REPORTED. PATIENT WAS TREATED WITH MEDICATION (CIPRO 500MG). 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: Unspecified Infection

  MAUDE report 14693636 ↗
• InjuryJun 15, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(4): ON (B)(6) 2019, PATIENT UNDERWENT BILATERAL BREAST MASTOPEXY; SUPERIOR PEDICLE, USING A FULL VERTICAL AND HORIZONTAL T INCISION. 2 PIECES OF GALASHAPE (GALAFLEX 3D) WERE USED. CONCOMITANT PROCEDURES INCLUDED RIGHT AXILLARY DOG EAR REVISION AND LIPOSUCTION TO LATERAL BREASTS. ON (B)(6) 2019, SEROMA OF BILATERAL BREASTS WAS REPORTED. PATIENT HAD SEROMA ASPIRATION (X2) ON (B)(6) 2019 AND (B)(6) 2019. PATIENT ALSO TREATED WITH MEDICATION (BACTRIM). RESOLVED WITHOUT SEQUELAE ON (B)(6) 2019. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED ADVERSE EVENT AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Seroma

  MAUDE report 14693582 ↗
• InjuryJun 10, 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 GALASHAPE (GALAFLEX 3D) WERE USED. CONCOMITANT PROCEDURE INCLUDED LIPOSUCTION TO LATERAL BREASTS. ON (B)(6) 2017, MILD NECROSIS OF RIGHT BREAST WAS REPORTED. PATIENT TREATED WITH MEDICATION (SILVADENE, ALSO AN ORAL ANTIBIOTIC - UNKNOWN). ON (B)(6) 2017, PATIENT HAD RIGHT BREAST WOUND DEBRIDEMENT FOR FULL THICKNESS TISSUE LOSS. END DATE (B)(6) 2017, WITH OUTCOME NOT KNOWN AS PATIENT HAD NOT RETURNED FOR FOLLOW UP. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED ADVERSE EVENT AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Necrosis

  MAUDE report 14657813 ↗
• InjuryJun 8, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL CP-1060: ON (B)(6) 2018, PATIENT UNDERWENT BILATERAL SUPERIOR PEDICLE MASTOPEXY USING A FULL VERTICAL AND HORIZONTAL T INCISION. 2 PIECES OF GALASHAPE (GALAFLEX 3D) WERE USED. NO CONCOMITANT PROCEDURES WERE DONE. ON (B)(6) 2018, DERMATITIS OF RIGHT BREAST WAS REPORTED. PATIENT WAS TREATED WITH MEDICATION (AVELOX 400MG). RESOLVED WITHOUT SEQUELAE ON (B)(6) 2018. REVIEW BY MEDICAL AFFAIRS IDENTIFIED THAT THE DERMATITIS IS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 14638268 ↗
• InjuryJun 8, 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. 2 PIECES OF GALASHAPE (GALAFLEX 3D) WERE USED. CONCOMITANT PROCEDURE INCLUDED EXCISION OF SMALL MOLE NASOLABIAL LINE. ON (B)(6) 2018 RIGHT NIPPLE NECROSIS WAS REPORTED. PATIENT HAD WOUND CLOSURE AND DEBRIDEMENT ON (B)(6) 2018. ATTENDED HYPERBARIC OXYGEN TREATMENT TO HELP WITH NECROSIS. ANOTHER ARELOAR DEBRIDEMENT OF RIGHT BREAST WAS DONE ON 4/3/18. PATIENT ALSO TREATED WITH MEDICATION (SILVADENE OINTMENT). REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED ADVERSE EVENT AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Necrosis

  MAUDE report 14638178 ↗
• InjuryJun 8, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL CP-(B)(6) : ON (B)(6) 2018, PATIENT UNDERWENT BILATERAL MASTOPEXY/REDUCTION; SUPERIOR PEDICLE USING A FULL VERTICAL AND HORIZONTAL T INCISION. 2 PIECES OF GALASHAPE (GALAFLEX 3D) WERE USED. CONCOMITANT PROCEDURE WAS LIPOSUCTION LATERAL BREASTS. ON (B)(6) 2018 RIGHT BREAST DELAYED WOUND HEALING WAS REPORTED. PATIENT TREATED WITH MEDICATION (SILVADENE 1% TOPICAL ANTIBACTERIAL CREAM AND CARRINGTON WOUND GEL). NO DEBRIDEMENT WAS NECESSARY. PER NOTES: GALASHAPE (GALAFLEX 3D) MAY HAVE BEEN EXPOSED SLIGHTLY AT A POINT IN RECOVERY. REVIEW OF MEDICAL AFFAIRS IDENTIFIED THAT THE DELAYED WOUND HEALING IS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Impaired Healing

  MAUDE report 14638174 ↗
• InjuryJun 8, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL CP-1060: ON (B)(6) 2018, PATIENT UNDERWENT BILATERAL REVISION AUGMENTATION MASTOPEXY USING A FULL VERTICAL AND HORIZONTAL T INCISION. 2 PIECES OF GALASHAPE WERE USED. CONCOMITANT PROCEDURE INCLUDED TRANS-AXILLARY PLACEMENT OF IMPLANTS. ON (B)(6) 2018, DERMATITIS OF BILATERAL BREASTS WAS REPORTED. PATIENT WAS TREATED WITH MEDICATION (HYDRO-CORTISONE CREAM). 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: Contact Dermatitis

  MAUDE report 14637231 ↗
• InjuryJun 8, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(6) : ON (B)(6) 2017 PATIENT UNDERWENT BILATERAL SUPERIOR PEDICLE MASTOPEXY USING A FULL VERTICAL AND HORIZONTAL T INCISION. 2 PIECES OF GALASHAPE (GALAFLEX 3D) WERE USED. CONCOMITANT PROCEDURE WAS LIPOSUCTION TO LATERAL BREASTS. ON (B)(6) 2017, ERYTHEMA/REDNESS OF BILATERAL BREAST INFRAMAMMARY CREASES WAS REPORTED. PATIENT WAS TREATED WITH MEDICATION (HYDROCORTISONE CREAM). RESOLVED WITHOUT SEQUELAE ON (B)(6) 2017. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE ERYTHEMA AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Erythema

  MAUDE report 14636532 ↗
• InjuryMay 25, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(6): ON (B)(6) 2017, PATIENT UNDERWENT BILATERAL AUGMENTATION MASTOPEXY USING A VERTICAL INCISION. 2 PIECES OF GALASHAPE (GALAFLEX 3D) WERE USED. NO CONCOMITANT PROCEDURES WERE DONE. ON (B)(6) 2017, LEFT BREAST PAIN WAS REPORTED. THE AE BEGAN WITH A SPITTING SUTURE OF LEFT INFRAMAMMARY SUTURE LINE AND INFLAMMATION OF THE LEFT INFERIOR INCISION. PATIENT TREATED WITH MEDICATIONS (SINGULAIR, KEFLEX, ADVIL). RESOLVED WITH SEQUELAE ON UNKNOWN DATE. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED AE AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Breast Discomfort/Pain; Impaired Healing; Skin Inflammation/ Irritation

  MAUDE report 14493194 ↗
• InjuryMay 24, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(4): ON (B)(6) 2018, PATIENT UNDERWENT BILATERAL REVISION AUGMENTATION MASTOPEXY USING A VERTICAL INCISION. 2 PIECES OF GALASHAPE (GALAFLEX 3D) WERE USED. NO CONCOMITANT PROCEDURES WERE PERFORMED. ON (B)(6) 2018, WOUND DEHISCENCE, RIGHT BREAST, WAS REPORTED. PATIENT WAS TREATED WITH MEDICATION (SILVADENE CREAM). RESOLVED WITHOUT SEQUELAE ON (B)(6) 2018. REVIEW BY MEDICAL AFFAIRS IDENTIFIES AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Wound Dehiscence

  MAUDE report 14493080 ↗
• InjuryMay 23, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL CP-(B)(4): ON (B)(6) 2017, PATIENT UNDERWENT BILATERAL AUGMENTATION MASTOPEXY USING A VERTICAL INCISION. 2 PIECES OF GALASHAPE (GALAFLEX 3D) WERE USED. CONCOMITANT PROCEDURES INCLUDED NECK LIFT, FX LASER CHEEKS AND UPPER LIP. ON (B)(6) 2017, HEMATOMA LEFT BREAST WAS REPORTED. SAE. ON 5/1/17, PATIENT HAD DRAINAGE OF HEMATOMA AND WAS TREATED WITH MEDICATION (KEFLEX). END DATE WAS 5/2/17 WITHOUT NOTED OUTCOME. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED HEMATOMA IS LIKELY RELATED TO THE DEVICE AND SERIOUS. ON (B)(6) 2017, A RUPTURED LEFT BREAST IMPLANT (NON-TEPHA) WAS REPORTED. SAE. ON (B)(6) 2017, PATIENT HAD LEFT BREAST IMPLANT (NON-TEPHA) AND LEFT TEPHA MESH REMOVED. PATIENT ALSO RECEIVED MEDICATION (KEFLEX, CIPRO). RESOLVED WITH SEQUELAE ON (B)(6) 2017. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED RUPTURED IMPLANT IS LIKELY RELATED TO THE DEVICE AND SERIOUS. ON (B)(6) 2019 PATIENT DID HAVE ANOTHER BILATERAL REVISION AUGMENTATION, AND 2 PIECES OF GALAFLEX WERE USED. NO AES DURING THE PROCEDURE OR DOCUMENTED AFTERWARDS.

  Patient problems: Unspecified Reproductive System or Breast Problem

  MAUDE report 14478879 ↗
• InjuryMay 23, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(4): ON (B)(6) 2017, PATIENT UNDERWENT BILATERAL AUGMENTATION MASTOPEXY USING A VERTICAL INCISION. 2 PIECES OF GALASHAPE (GALAFLEX 3D) WERE USED. CONCOMITANT PROCEDURES INCLUDED NECK LIFT, FX LASER CHEEKS AND UPPER LIP. ON (B)(6) 2017, HEMATOMA LEFT BREAST WAS REPORTED. SAE. ON (B)(6) 2017, PATIENT HAD DRAINAGE OF HEMATOMA AND WAS TREATED WITH MEDICATION (KEFLEX). END DATE WAS (B)(6) 2017 WITHOUT NOTED OUTCOME. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED HEMATOMA IS LIKELY RELATED TO THE DEVICE AND SERIOUS. ON (B)(6) 2017, A RUPTURED LEFT BREAST IMPLANT (NON-TEPHA) WAS REPORTED. SAE. ON (B)(6) 2017, PATIENT HAD LEFT BREAST IMPLANT (NON-TEPHA) AND LEFT TEPHA MESH REMOVED. PATIENT ALSO RECEIVED MEDICATION (KEFLEX, CIPRO). RESOLVED WITH SEQUELAE ON (B)(6) 2017. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED RUPTURED IMPLANT IS LIKELY RELATED TO THE DEVICE AND SERIOUS. ON (B)(6) 2019 PATIENT DID HAVE ANOTHER BILATERAL REVISION AUGMENTATION, AND 2 PIECES OF GALAFLEX WERE USED. NO AES DURING THE PROCEDURE OR DOCUMENTED AFTERWARDS.

  Patient problems: Hematoma

  MAUDE report 14478515 ↗
• InjuryMay 23, 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 GALASHAPE (GALAFLEX 3D) WERE USED. NO CONCOMITANT PROCEDURES WERE DONE. ON (B)(6) 2019, DRAINAGE AND WOUND DEHISCENCE; INVERTED T INCISION ON THE LEFT BREAST, WAS REPORTED. PATIENT WAS TREATED WITH MEDICATIONS (CIPRO, SILVADENE CREAM). ALSO, ON (B)(6) 2020, PATIENT HAD DEBRIDEMENT AND CLOSURE OF LEFT WOUND WITH PARTIAL GALASHAPE MESH EXCISION. RESOLVED WITHOUT SEQUELAE ON (B)(6) 2020. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED DRAINAGE AND WOUND DEHISCENCE IS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Purulent Discharge; Wound Dehiscence

  MAUDE report 14478440 ↗
• InjuryApr 20, 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. TWO PIECES OF GALASHAPE (GALAFLEX 3D) WERE USED. THERE WERE NO CONCOMITANT PROCEDURES DONE. ON (B)(6) 2018, RIGHT DELAYED WOUND HEALING WAS REPORTED. PATIENT HAD SMALL WOUND DEBRIDEMENT OF RIGHT BREAST SCAR. PATIENT WAS TREATED WITH MEDICATION (SILVADENE). RESOLVED WITH SEQUELAE ON (B)(6) 2019. WILL NEED MINOR SCAR REVISION IN FUTURE. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE DELAYED WOUND HEALING IS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Impaired Healing

  MAUDE report 14159819 ↗
• InjuryApr 20, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(6): ON (B)(6) 2018, PATIENT UNDERWENT BILATERAL REVISION REDUCTION; SUPERIOR PEDICLE USING A FULL VERTICAL AND HORIZONTAL T INCISION. TWO PIECES OF GALASHAPE (GALAFLEX 3D) WERE USED. NO CONCOMITANT PROCEDURES WERE DONE. ON (B)(6) 2018, RIGHT BREAST INFECTION WAS REPORTED. ADDITIONAL DETAILS INCLUDE RIGHT BREAST SWELLING AND FEVER WITH DRAIN PLACEMENT. TREATMENT WAS MEDICATION (AUGMENTIN, CIPRO, BACTRIM, MEDROL) RESOLVED WITHOUT SEQUELAE ON UNKNOWN DATE. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE INFECTION AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Unspecified Infection

  MAUDE report 14159815 ↗
• InjuryApr 12, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(6): ON (B)(6) 2020, PATIENT UNDERWENT BILATERAL REVISION BREAST RECONSTRUCTION (ONCOLOGICAL) USING AN IMF INCISION. 2 PIECES OF GALASHAPE (GALAFLEX 3D) WERE USED. CONCOMITANT PROCEDURE WAS FAT GRAFTING. ON (B)(6) 2020, BILATERAL BREAST RIPPLING (UPPER POLE OF EACH BREAST) WAS REPORTED. NO ACTION WAS TAKEN. PATIENT MAY PURSUE A SECOND STAGE OF FAT GRAFTING AND/OR EXCHANGE OF IMPLANT SIZE IN THE FUTURE. RESOLVED WITHOUT SEQUELAE ON UNKNOWN DATE. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED BILATERAL BREAST RIPPLING AS LIKELY RELATED TO THE DEVICE AND NOT SERIOUS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14086821 ↗
• InjuryApr 12, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(6): ON (B)(6) 2019, PATIENT UNDERWENT BILATERAL REVISION AUGMENTATION MASTOPEXY USING A FULL VERTICAL AND HORIZONTAL T INCISION. TWO PIECES OF GALASHAPE (GALAFLEX 3D) WERE USED. THERE WERE NO CONCOMITANT PROCEDURES DONE. ON (B)(6) 2020, BILATERAL INVERTED NIPPLES WERE REPORTED. PATIENT NOTICED THAT HER NIPPLES BEGAN INVERTING AT ABOUT 8 MONTHS POST OP. NO ACTION WAS TAKEN. NO FURTHER FOLLOW UP NOTED; HOWEVER, SURGICAL PLAN IS SET FOR WHEN PATIENT IS READY FOR NIPPLE REVISION. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED BILATERAL INVERTED NIPPLES AS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14086784 ↗