GalaFLEX Scaffold 100035-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 90 adverse event reports that list this exact device (DI 00855920006041), received between Mar 14, 2019 and Aug 26, 2026 — classified as 2 deaths, 82 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (78 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 90 reports, in the reporter's own words as published by the FDA.

• InjuryAug 26, 2026Patient-Device Incompatibility

  Attorney alleges that the patient underwent breast reconstruction surgery on or about (b)(6)2021, during which a GalaFlex Mesh was implanted following which patient had additional surgery on (b)(6)2022 to repair and explant GalaFlex Mesh. As alleged, the patient experienced additional surgical intervention, mental anguish, severe 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 50449032 ↗
• InjuryJan 17, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, PATIENT WAS IMPLANTED WITH GALAFLEX MESH BY UNDERGOING BREAST AUGMENTATION MASTOPEXY ON (B)(6)2023. IT WAS REPORTED THAT PATIENT HAD A PERSISTENT ISSUE WITH PALPATION OF THE LATERAL ASPECT OF THE MESH ON THE RIGHT BREAST AND TENDERNESS IN THIS AREA. ON (B)(6)2024, PATIENT REPORTED PAIN DURING HOSPITAL VISIT FOR APPOINTMENT. HENCE, THE SURGEON RECOMMENDED A REVISION SURGICAL PROCEDURE TO REMOVE THE PALPABLE GALAFLEX AND REPLACE WITH GALAFLEX LITE. THE PROCEDURE IS SCHEDULED FOR (B)(6)2025.

  Patient problems: Pain

  MAUDE report 21178337 ↗
• InjuryNov 7, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, ON (B)(6) 2024 PATIENT UNDERWENT BILATERAL BREAST IMPLANT EXCHANGE NEOSUBPECTORAL POCKET PROCEDURE WITH IMPLANT OF GALAFLEX SCAFFOLD TO THE LOWER POLES. IT WAS REPORTED, THE MESH WAS CUT IN HALF, USED BILATERALLY AND 5 DAYS POST IMPLANT OF THE MESH PATIENT DIAGNOSED WITH INFECTION ONLY IN THE RIGHT BREAST. AS REPORTED ON (B)(6) 2024 THE MESH WAS REMOVED, AND PATIENT UNDERWENT SECOND SURGERY FOR EXPLORATION, WASHOUT AND DEBRIDEMENT ON (B)(6) 2024. PATIENT WAS ON ORAL AND IV ANTIBIOTICS BY INFECTIOUS DISEASE PHYSICIANS. ANTIBIOTICS STOPPED ON (B)(6) 2024 AND PICC LINE REMOVED (B)(6) 2024. IT WAS ALSO REPORTED THAT PATIENT IS SCHEDULED FOR A RIGHT BREAST AUGMENTATION, IMF INCISION, SUBPECTORAL POCKET AND RIGHT BREAST LOWER POLE SUPPORT WITH GALAFLEX ON (B)(6) 2024.

  Patient problems: Unspecified Infection

  MAUDE report 20630441 ↗
• MalfunctionJun 13, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, PATIENT UNDERWENT SURGICAL BREAST LIFT PROCEDURE WITH IMPLANT OF GALAFLEX ON (B)(6) 2021 AND REPORTED ¿IT¿S STILL FEELS HARD WHERE THE GALAFLEX WAS PLACED (3 YEARS LATER) AND NOT MUCH SUPPORT." IT WAS ALSO REPORTED THAT 240CC BREAST IMPLANTS EXCHANGE WAS ALSO PERFORMED.

  Patient problems: Ptosis

  MAUDE report 19527133 ↗
• InjuryMar 29, 2024Material Deformation; Material Deformation

  AS REPORTED, PATIENT UNDERWENT A MASTOPEXY PROCEDURE WITH IMPLANT EXCHANGE AND IMPLANT OF GALAFLEX MESH ON (B)(6) 2023. IT WAS REPORTED THAT PATIENT EXPERIENCED RIGHT BREAST BOTTOMING OUT THEREBY UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024 DURING WHICH SURGEON NOTICED THAT RIGHT BREAST LOWER POLE WAS SLIGHTLY TIGHT AND THE GALAFLEX MESH APPEARED TO HAVE SOME TYPE OF "DEFORMITY." IT WAS REPORTED THAT THE MESH WAS REMOVED AND NEW GALAFLEX MESH WAS IMPLANTED.

  Patient problems: Physical Asymmetry

  MAUDE report 19002938 ↗
• MalfunctionMar 10, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  AS REPORTED, UPON OPENING THE PRODUCT PACKAGE OF GALAFLEX, THERE WAS A SMALL PIN HOLE NOTED IN THE STERILE ENVELOPE. IT WAS REPORTED THAT THE MESH WAS NOT USED AND WAS DISCARDED. IT WAS ALSO REPORTED THAT ANOTHER MESH PIECE WAS USED AND THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16523420 ↗
• InjuryFeb 1, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT IN 1994 A FEMALE PATIENT WITH A MEDICAL HISTORY OF BREAST CANCER, MASTECTOMY UNDERWENT LEFT BREAST RECONSTRUCTION WITH A SILICONE IMPLANT AND AN AUGMENTATION IMPLANT ON RIGHT BREAST. OVER THE NEXT 24 YEARS SHE DEVELOPED PROGRESSIVE ASYMMETRY. ON (B)(6) 2018, THE PATIENT UNDERWENT REVISION SURGERY, DURING WHICH BOTH THE SILICONE IMPLANTS WERE REMOVED, AND IMPLANT OF GALAFLEX P4HB ON THE LEFT RECONSTRUCTION SIDE ONLY. THE PATIENT UNDERWENT MASTOPEXY ON RIGHT BREAST AND THREE FAT GRAFT SURGERIES OVER THE NEXT YEAR AND A HALF. AT THE END OF 2022, THE PATIENT WAS DIAGNOSED WITH THE MICRO CALCIFICATIONS AND 4 MM PRE-CANCER (DUCTAL CARCINOMA IN-SITU) IN RIGHT BREAST. ON (B)(6) 2022, THE PATIENT UNDERWENT RIGHT MASTECTOMY AND DIEP FLAP RECONSTRUCTION AND SILICONE TISSUE EXPANDERS WERE PLACED BILATERALLY. HER SURGERY WENT WELL. THE PATH REPORT SHOWED NO SIGN OF CANCER REMAINING AFTER THE NEEDLE BIOPSY. AS REPORTED, THE IMPLANTING SURGEON DID NOT CONSIDER THE PRE-CANCER DUCTAL CARCINOMA OCCURRENCE RIGHT BREAST TO BE AN OUTCOME OF THE USE OF GALAFLEX IN THE LEFT BREAST AND WAS REPORTED IN AN ABUNDANCE OF CAUTION TO DOCUMENT THE EVENT.

  Patient problems: Breast Cancer

  MAUDE report 16277294 ↗
• InjuryDec 22, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, THE PATIENT UNDERWENT BREAST RECONSTRUCTION PROCEDURE ON (B)(6) 2017 AND WAS IMPLANTED WITH GALAFLEX. IT WAS REPORTED THAT ABOUT 5-6 YEARS LATER, THE PATIENT WITH GALAFLEX (P4HB) IMPLANT MAY HAVE A BREAST CANCER RECURRENCE. IT WAS ALSO REPORTED THAT THE PATIENT IS CURRENTLY UNDERGOING DIAGNOSTIC TESTING TO CONFIRM POSSIBLE CANCER RECURRENCE.

  Patient problems: Breast Mass

  MAUDE report 16034987 ↗
• InjuryNov 9, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, ON (B)(6) 2018 SUBJECT 481-38 WAS TREATED WITH P4HB CONSTRUCT TO TREAT RIGHT BREAST CANCER MASTOPLEXY. DATE OF ONSET (B)(6) 2019 EXPERIENCED, MECHANICAL COLLAPSE OF THE P4HB CONSTRUCT, RIGHT BREAST. (B)(6) 2019 IDENTIFIES CONTINUATION OF TIGHTER SKIN ENVELOPE DUE TO RADIATION AND SCARRING PREVENTING SUFFICIENT PROJECTION FROM CHEST. ON (B)(6) 2019 REOPERATION PERFORMED WITH THE INITIAL CONSTRUCT THAT COLLAPSED BEING REMOVED AND REPLACED WITH A NEW CONSTRUCT USED.

  Patient problems: Pocket Erosion; Unspecified Reproductive System or Breast Problem

  MAUDE report 15763441 ↗
• InjuryNov 2, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(4): PATIENT UNDERWENT PRIMARY BILATERAL PRE-PEC RECONSTRUCTION PROCEDURE. THE PROCEDURE WAS FOR ONCOLOGICAL REASON AND PATIENT WAS HOSPITALIZED FOR PROCEDURE ON (B)(6) 2020 (WITH DISCHARGE ON (B)(6) 2020). A FULL VERTICAL AND HORIZONTAL T INCISION WAS USED WITH A CONCOMITANT PROCEDURE OF ADIPODERMAL FLAP PLACEMENT. 2 PIECES OF GALAFLEX WERE USED. ON (B)(6) 2020, LEFT BREAST EXTRUSION WAS REPORTED. PATIENT TREATED WITH MEDICATION (LEVOFLOXACIN, DOXYCYCLINE, CIPRO, CLINDAMYCIN). ON (B)(6) 2020- ERYTHEMA/REDNESS OF LEFT BREAST WAS REPORTED. THERE WAS SIGNIFICANT PARTIAL AND FULL THICKNESS INJURIES INVOLVING THE NAC, WORSE ON THE LEFT THAN ON THE RIGHT. THERE WAS REDNESS AND SWELLING OF THE LEFT BREAST WITH DRAINAGE. THE PATIENT TREATED WITH EXCISIONAL DEBRIDEMENT AND COMPLEX WOUND CLOSURE RIGHT BREAST. ON (B)(6) 2020, THE PATIENT UNDERWENT LEFT BREAST REVISION RECONSTRUCTION; LEFT EXTRUDING BREAST IMPLANT AND MESH WAS REMOVED AND REPLACED WITH A NEW SMALLER BREAST IMPLANT AND NEW MESH. 1 NEW PIECE OF GALAFLEX (LEFT BREAST ONLY) WAS USED IN THIS PROCEDURE. ADDITIONALLY, COMPLEX WOUND CLOSURE, REDNESS/SWELLING ON THIS PATIENT FOR THE RIGHT BREAST. REVIEW OF MEDICA

  Patient problems: Erythema; Swelling/ Edema

  MAUDE report 15713680 ↗
• InjuryNov 2, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(4): PATIENT UNDERWENT PRIMARY BILATERAL PRE-PEC RECONSTRUCTION PROCEDURE. THE PROCEDURE WAS FOR ONCOLOGICAL REASON AND PATIENT WAS HOSPITALIZED FOR PROCEDURE ON (B)(6) 2020 (WITH DISCHARGE ON (B)(6) 2020). A FULL VERTICAL AND HORIZONTAL T INCISION WAS USED WITH A CONCOMITANT PROCEDURE OF ADIPODERMAL FLAP PLACEMENT. 2 PIECES OF GALAFLEX WERE USED. ON (B)(6) 2020, LEFT BREAST EXTRUSION WAS REPORTED. PATIENT TREATED WITH MEDICATION (LEVOFLOXACIN, DOXYCYCLINE, CIPRO, CLINDAMYCIN). ON (B)(6) 2020 - ERYTHEMA/REDNESS OF LEFT BREAST WAS REPORTED. THERE WAS SIGNIFICANT PARTIAL AND FULL THICKNESS INJURIES INVOLVING THE NAC, WORSE ON THE LEFT THAN ON THE RIGHT. THERE WAS REDNESS AND SWELLING OF THE LEFT BREAST WITH DRAINAGE. THE PATIENT TREATED WITH EXCISIONAL DEBRIDEMENT AND COMPLEX WOUND CLOSURE RIGHT BREAST. ON (B)(6) 2020, THE PATIENT UNDERWENT LEFT BREAST REVISION RECONSTRUCTION; LEFT EXTRUDING BREAST IMPLANT AND MESH WAS REMOVED AND REPLACED WITH A NEW SMALLER BREAST IMPLANT AND NEW MESH. 1 NEW PIECE OF GALAFLEX (LEFT BREAST ONLY) WAS USED IN THIS PROCEDURE. ADDITIONALLY, COMPLEX WOUND CLOSURE, REDNESS/SWELLING ON THIS PATIENT FOR THE RIGHT BREAST. REVIEW OF MEDIC

  Patient problems: Erythema

  MAUDE report 15713670 ↗
• InjuryNov 1, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(4): ON (B)(6) 2018, PATIENT UNDERWENT BILATERAL MASTOPEXY/REDUCTION; MEDIAL PEDICLE, USING A WISE PATTERN - SUPERIOMEDIAL PEDICLE. 2 PIECES OF GALAFLEX WERE USED. CONCOMITANT PROCEDURES INCLUDED: FAT GRAFTING TO BREASTS/ LIPOSUCTION TO FLANKS, UPPER BACK, BUFFALO HUMP, ABDOMEN, AXILLA. ON (B)(6) 2018, ERYTHEMA/REDNESS; RIGHT VERTICAL INCISION, WAS REPORTED. PATIENT TREATED WITH MEDICATION (CIPRO 500MG). BETADINE AND NON-STICK PAD. RESOLVED WITHOUT SEQUELAE ON (B)(6) 2018. REVIEW OF MEDICAL AFFAIRS IDENTIFIED THAT THE ERYTHEMA/REDNESS IS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Erythema

  MAUDE report 15711876 ↗
• DeathOct 19, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED ON (B)(6) 2018 PATIENT UNDERWENT REMOVAL OF SILICONE IMPLANTS, COMPLETE CAPSULECTOMY, INTERNAL AND EXTERNAL MASTOPEXY, LOTUS SCAFFOLD IMPLANT AND AUTOLOGOUS FAT TRANSFER TO BILATERAL BREASTS FROM ABDOMEN AND THIGHS. AS REPORTED GALAFLEX 15.3CM X 20.3CM MESH (DEVICE 1) WAS USED TO CREATE THE SCAFFOLD. ON (B)(6) 2019, PATIENT WAS IDENTIFIED WITH RIGHT BREAST INVASION DUCTAL CARCINOMA (CANCER OCCURRENCE) (ER NEG PR NEG HER-2 NEG (KI-67 78%, CK-5 15%). ON (B)(6) 2019, PATIENT UNDERWENT SKIN AND NIPPLE SPARING MASTECTOMY OF THE RIGHT BREAST WITH IMMEDIATE RECONSTRUCTION WITH INTERNAL MASTOPEXY AND P4HB LOTUS MESH IMPLANT. AS REPORTED GALAFLEX 15.3CM X 20.3CM MESH (DEVICE 2) WAS USED TO CREATE THE SCAFFOLD. ON (B)(6) 2020 MASS SUBDERMAL AT ¿T¿ FELT BY PHYSICIAN. ON (B)(6) 2020 EXCISIONAL BIOPSY DONE AND PATHOLOGY ON 6/19/2020 SHOWED RECURRENCE OF BREAST CANCER. ON (B)(6) 2020 PATIENT PASSES AWAY FROM TRIPLE NEGATIVE BREAST CANCER.

  Patient problems: Breast Cancer

  MAUDE report 15631493 ↗
• InjuryOct 19, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2016 PATIENT UNDERWENT INTERNAL AND EXTERNAL MASTOPEXY, LOTUS SCAFFOLD IMPLANT AND AUTOLOGOUS FAT TRANSFER TO BILATERAL BREASTS FROM ABDOMEN, HIPS AND THIGHS. AS REPORTED GALAFLEX 15.3CM X 20.3CM MESH WAS USED TO CREATE THE SCAFFOLD, TREAT THE PATIENT. ON (B)(6) 2021, THE PATIENT WAS DIAGNOSED WITH A LEFT BREAST INVASIVE DUCTAL CARCINOMA. ON (B)(6) 2021, THE PATIENT UNDERWENT BILATERAL NIPPLE SPARING MASTECTOMY WITH IMMEDIATE RECONSTRUCTION WITH INTERNAL MASTOPEXY AND USE OF P4HB LOTUS WITH PHASIX MESH. SURGEON REPORTS THE PATIENT IS DOING WELL AND CONTINUES TO FOLLOW UP WITH CANCER SPECIALISTS AND IS ON ADJUVANT ENDOCRINE THERAPY WITH ANASTROZOLE. PER THE PHYSICIAN, THE PATIENT HAD A COMMON BREAST CARCINOMA DEVELOP IN HER LEFT BREAST GLAND (CORPUS MAMMAE), ON THE INFERIOR AND LATERAL EDGE. THE CANCER WAS SHOWN ON PATHOLOGIC EXAM UNDER THE MICROSCOPE TO BE WITHIN THE BREAST GLAND, WHICH COVERED THE NEARBY REMNANTS OF THE MESH IMPLANT. THERE WAS NO CANCER CELLS WITHIN THE MESH FIBERS OR IMPLANT. THE CANCER WAS DETECTED AND DIAGNOSED THROUGH ANNUAL RADIOLOGIC SURVEILLANCE. IN THE FALL OF 2021, THE PATIENT WENT FOR A MAMMOGRAM THAT FOUND SOME NEW CALCIFICATIONS IN THE LEFT B

  Patient problems: Breast Cancer

  MAUDE report 15631404 ↗
• InjuryAug 31, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, PATIENT WAS IMPLANTED WITH TWO GALAFLEX DEVICES (DEVICE #1 AND DEVICE #2) ON (B)(6) 2019. ON (B)(6) 2019 PATIENT WAS DIAGNOSED WITH RIGHT BREAST SEROMA (DEVICE #1) . ON (B)(6) 2019 A SMALL AMOUNT TISSUE ASPIRATED AND SENT FOR CULTURE/SENSITIVITY; NEGATIVE FOR INFECTION. ON (B)(6) 2019 A DRAIN WAS PLACED IN-OFFICE, CULTURE TAKEN OF FLUID 30-40CC; CULTURE/SENSITIVITY NEGATIVE. ON (B)(6) 2019 DRAIN WAS REMOVED. AS REPORTED, THE TREATING SURGEON IDENTIFIED THE CONDITION OF THE SEROMA AS NOT CAUSED BY THE USE OF THE GALAFLEX (P4HB) IMPLANT USED TO TREAT THE PATIENT.

  Patient problems: Seroma

  MAUDE report 15326345 ↗
• InjuryAug 31, 2022Patient-Device Incompatibility; Patient Device Interaction Problem; Patient-Device Incompatibility; Patient Device Interaction Problem

  AS REPORTED, PATIENT WAS IMPLANTED WITH GALAFLEX ON (B)(6) 2020. ON (B)(6) 2020 PATIENT WAS DIAGNOSED WITH LEFT BREAST INFECTION . NOTE: SUBJECT HAD GEL FOAM USED WITH LOTUS (B)(6)2020: 4MM INCISION FOUND OPEN AT THE T AND LEAKING TEA-COLORED FLUID. NO SIGNIFICANT VOLUME DRAINED, BUT IRRIGATED WITH ANTIBIOTIC SOLUTION. DRAIN PLACED AND POSITIVE CULTURE/SENSITIVITY. AS REPORTED, THE TREATING SURGEON IDENTIFIED THE CONDITION OF THE INFECTION AS NOT CAUSED BY THE GALAFLEX (P4HB) IMPLANT USED TO TREAT THE PATIENT.

  Patient problems: Bacterial Infection

  MAUDE report 15326343 ↗
• InjuryAug 31, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, PATIENT WAS IMPLANTED WITH A GALAFLEX MESH ON (B)(6) 2017. ON (B)(6) 2018 PATIENT WAS DIAGNOSED WITH LEFT BREAST IMPLANT FAILURE TO INTEGRATE AND DIMENSIONAL COLLAPSE . ON (B)(6) 2018 30 CC YELLOW THICK FLUID WAS ASPIRATED IN THE OFFICE. ON (B)(6) 2018 10 CC YELLOW LIPID FLUID WAS ASPIRATED. AS REPORTED THE GALAFLEX SCAFFOLD WAS COLLAPSED AND NOT ATTACHED TO SKIN FLAP ANTERIORLY THAT INCISION AND DRAINAGE PERFORMED. AS REPORTED, THE TREATING SURGEON IDENTIFIED THE CONDITION OF THE LEFT BREAST DEVICE FAILURE TO INTEGRATE AND DIMENSIONAL COLLAPSE AS NOT CAUSED BY THE USE OF THE GALAFLEX (P4HB) IMPLANT USED TO TREAT THE PATIENT.

  Patient problems: Purulent Discharge

  MAUDE report 15326342 ↗
• InjuryAug 31, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, PATIENT WAS IMPLANTED WITH GALAFLEX ON (B)(6) 2017. ON (B)(6) 2019 THE PATIENT WAS DIAGNOSED WITH RIGHT BREAST CANCER RECURRENCE . ON (B)(6) 2019, THE PATIENT UNDERWENT TUMOR RESECTION PROCEDURE FOLLOWED BY CHEMOTHERAPY AND RADIATION. AS REPORTED, THE TREATING SURGEON IDENTIFIED THE CONDITION OF THE RECURRING CANCER WAS NOT CAUSED BY THE USE OF THE GALAFLEX (P4HB) IMPLANT TO TREAT THE PATIENT.

  Patient problems: Breast Cancer

  MAUDE report 15326337 ↗
• DeathAug 31, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, ON (B)(6) 2019 PATIENT WAS IMPLANTED WITH GALAFLEX. ON (B)(6) 2020 A NODULE FOUND ON BREAST. BIOPSY PERFORMED AND PATIENT WAS DIAGNOSED WITH RIGHT BREAST CANCER RECURRENCE. ON (B)(6) 2020 IDENTIFIED CLEAR MARGINS, BUT BREAST CANCER REOCCURRENCE WITH VASCULAR INVASION CONFIRMED ON IMMUNO-STAINS. SUBJECT UNDERWENT CHEMO POST RECURRENT DIAGNOSIS WITH RAPID DECLINE IN HEALTH. ON (B)(6) 2020 PATIENT PASSED AWAY. AS REPORTED, THE TREATING SURGEON IDENTIFIED THE CONDITION OF THE RECURRING CANCER AS NOT CAUSED BY THE USE OF THE GALAFLEX (P4HB) IMPLANT USED TO TREAT THE PATIENT.

  Patient problems: Breast Cancer

  MAUDE report 15326335 ↗
• InjuryAug 31, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, ON (B)(6) 2020 PATIENT WAS IMPLANTED WITH TWO GALAFLEX DEVICES (DEVICE#1, DEVICE #2) (GEL FOAM USED WITH LOTUS). ON (B)(6) 2020 PATIENT WAS DIAGNOSED WITH RIGHT BREAST INFECTION (AE1). ERYTHEMA NOTED INITIALLY AND PRESCRIBED KEFLEX BY GENERAL SURGEON WITHOUT IMPROVEMENT. ON (B)(6) 2020 INCISION, 50-70CC THICK FLUID DRAINED, DRAIN PLACED, AND POSITIVE CULTURE/SENSITIVITY, CONTINUED ANTIBIOTICS. INFECTION RESOLVED (B)(6) 2020. ON (B)(6) 2021 PATIENT WAS DIAGNOSED WITH RIGHT BREAST SMALL WEEPING SINUS (AE2). NO FLUID COLLECTION PERFORMED, HOWEVER THREE PUNCTUATE "PINHOLE" OPENINGS IN SKIN BETWEEN NIPPLE AND SITE OF CANCER. ON (B)(6) 2021 EXPLANT PERFORMED OF RIGHT LOTUS WITH SPECIMEN NEGATIVE FOR PATHOLOGY. AS REPORTED, THE TREATING SURGEON IDENTIFIED THE CONDITIONS OF THE INFECTION AND SMALL WEEPING SINUS AS NOT CAUSED BY THE USE OF THE P4HB IMPLANTS USED TO TREAT THE PATIENT.

  Patient problems: Bacterial Infection; Fluid Discharge

  MAUDE report 15326333 ↗
• InjuryAug 31, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, PATIENT WAS IMPLANTED WITH TWO GALAFLEX DEVICES (DEVICE #1 AND DEVICE #2) ON (B)(6) 2019. ON (B)(6) 2020 PATIENT WAS DIAGNOSED WITH LEFT BREAST AREA OF SWELLING AND DRAINAGE (DEVICE #2) . PATIENT SELF-TREATED FOR 2 WEEKS WITH ANTIBIOTICS ON-HAND (CEPHALEXIN). AS REPORTED, THE TREATING SURGEON IDENTIFIED THE CONDITION OF THE SWELLING AND DRAINAGE AS NOT CAUSED BY THE USE OF THE GALAFLEX (P4HB) IMPLANT USED TO TREAT THE PATIENT.

  Patient problems: Fluid Discharge; Swelling/ Edema

  MAUDE report 15326332 ↗
• InjuryAug 31, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, ON (B)(6) 2020 PATIENT WAS IMPLANTED WITH TWO GALAFLEX DEVICES (DEVICE#1, DEVICE #2) (GEL FOAM USED WITH LOTUS). ON (B)(6) 2020 PATIENT WAS DIAGNOSED WITH RIGHT BREAST INFECTION (AE1). ERYTHEMA NOTED INITIALLY AND PRESCRIBED KEFLEX BY GENERAL SURGEON WITHOUT IMPROVEMENT. ON (B)(6) 2020 INCISION, 50-70CC THICK FLUID DRAINED, DRAIN PLACED, AND POSITIVE CULTURE/SENSITIVITY, CONTINUED ANTIBIOTICS. INFECTION RESOLVED (B)(6) 2020. ON (B)(6) 2021 PATIENT WAS DIAGNOSED WITH RIGHT BREAST SMALL WEEPING SINUS (AE2). NO FLUID COLLECTION PERFORMED, HOWEVER THREE PUNCTUATE "PINHOLE" OPENINGS IN SKIN BETWEEN NIPPLE AND SITE OF CANCER. ON (B)(6) 2021 EXPLANT PERFORMED OF RIGHT LOTUS WITH SPECIMEN NEGATIVE FOR PATHOLOGY. AS REPORTED, THE TREATING SURGEON IDENTIFIED THE CONDITIONS OF THE INFECTION AND SMALL WEEPING SINUS AS NOT CAUSED BY THE USE OF THE P4HB IMPLANTS USED TO TREAT THE PATIENT.

  Patient problems: Bacterial Infection; Fluid Discharge

  MAUDE report 15326331 ↗
• InjuryAug 31, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, PATIENT WAS IMPLANTED WITH GALAFLEX ON (B)(6) 2018. ON (B)(6) 2021 PATIENT WAS DIAGNOSED WITH RIGHT BREAST CANCER RECURRENCE . ANNUAL MAMMOGRAM SHOWED A NEW MASS IN SAME LOCATION AS INITIAL CANCER OCCURRENCE. DX: INVASIVE DUCTAL CARCINOMA (SAME DX AS INITIAL OCCURRENCE). ON (B)(6) 2021 BIOPSY ADDENDUM NOTED HYPOECHOIC NODULE IS AT THE INTERFACE BETWEEN THE SUPERFICIAL TISSUES AND THE SHADOWING ALONG THE FAT GRAFTING POSTSURGICAL CHANGE. AS REPORTED, THE TREATING SURGEON IDENTIFIED THE CONDITION OF THE RECURRING CANCER AS NOT CAUSED BY THE USE OF THE GALAFLEX (P4HB) IMPLANT USED TO TREAT THE PATIENT.

  Patient problems: Breast Cancer

  MAUDE report 15326325 ↗
• InjuryAug 2, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(4): ON (B)(6) 2018, PATIENT UNDERWENT BILATERAL CENTRAL MOUND MASTOPEXY USING A FULL VERTICAL AND HORIZONTAL T INCISION. 1 PIECE OF GALAFLEX WAS USED CUT INTO RECTANGLE SHAPE. NO CONCOMITANT PROCEDURES WERE DONE. ON (B)(6) 2018, DELAYED WOUND HEALING; BILATERAL IMF, 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 15145002 ↗
• InjuryJul 28, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER CLINICAL TRIAL (B)(4): ON (B)(6) 2020, PATIENT WAS HOSPITALIZED AND UNDERWENT BILATERAL PRIMARY RECONSTRUCTION; PRE PECTORAL. THE INCISION TYPE WAS NOT RECORDED. MULTIPLE PIECES OF GALAFLEX MESH WERE IMPLANTED DURING THIS PROCEDURE. NO CONCOMITANT PROCEDURES WERE DONE. ON (B)(6) 2020, RIGHT BREAST WOUND DEHISCENCE WAS REPORTED. ON 9/10/20, PATIENT HAD WASHOUT AND DEBRIDEMENT PROCEDURE AND WAS ALSO TREATED WITH MEDICATION (CEPHALEXIN). IT WAS NOTED THAT THERE WAS NO EVIDENCE OF EXPOSED MESH OR BREAST IMPLANTS. RESOLVED WITHOUT SEQUELAE ON (B)(6) 2020. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED WOUND DEHISCENCE IS LIKELY RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Wound Dehiscence

  MAUDE report 15123694 ↗