GalaFLEX 3DRRecalls & reported problems across all models
Tepha, Inc. · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 27
- Deaths reported
- 0
- Injuries reported
- 22
- Recalls
- 0
We found 6 models of GalaFLEX 3DR by Tepha, Inc. in the FDA's device registry (GUDID). Together they are named in 27 adverse event reports in the FDA's MAUDE database, received between Mar 23, 2022 and Aug 27, 2026 — classified as 22 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (17 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported GalaFLEX 3DR problems
Device problems
- Patient-Device Incompatibility17
- Material Deformation3
- Material Split, Cut or Torn3
- Device Appears to Trigger Rejection2
- Incorrect, Inadequate or Imprecise Result or Readings2
- Migration2
- Deformation Due to Compressive Stress1
- Delivered as Unsterile Product1
Patient problems
- Ptosis6
- Pain5
- Breast Discomfort/Pain4
- No Clinical Signs, Symptoms or Conditions4
- Bacterial Infection3
- Neuralgia3
- Physical Asymmetry3
- Loss of Range of Motion2
GalaFLEX 3DR models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- GalaFLEX 3DR 100043-05Surgical Film8 reports
- GalaFLEX 3DR 100043-04Surgical Film7 reports
- GalaFLEX 3DR 100043-02Surgical Film5 reports
- GalaFLEX 3DR 100043-06Surgical Film5 reports
- GalaFLEX 3DR 100043-01Surgical Film1 report
- GalaFLEX 3DR 100043-03Surgical Film1 report
Recent GalaFLEX 3DR adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 27, 2026Patient-Device Incompatibility
Attorney alleges that the patient underwent surgery for bilateral breast reconstruction and bilateral inframammary fold reconstruction and soft tissue support on (b)(6) 2025, during which a GalaFlex 3DR mesh was implanted. Within weeks of implantation, the GalaFlex mesh was scheduled to surgically excised due to the reported severe nerve pain, scar tissue, limited range of motion in right arm and disability caused. Patient was injured severely and permanently. As alleged, the patient experienced mental anguish and 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: Loss of Range of Motion; Neuralgia; Scar Tissue
MAUDE report 50474381 ↗InjuryAug 27, 2026Patient-Device Incompatibility
Attorney alleges that the patient underwent surgery for bilateral breast reconstruction and bilateral inframammary fold reconstruction and soft tissue support on 18-Jun-2025, during which a GalaFlex 3DR mesh was implanted. Within weeks of implantation, the GalaFlex 3DR mesh was scheduled to surgically excised due to the reported severe nerve pain, scar tissue, limited range of motion in right arm and disability caused. Patient was injured severely and permanently. As alleged, the patient experienced mental anguish and 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: Loss of Range of Motion; Neuralgia; Scar Tissue
MAUDE report 50474380 ↗InjuryAug 27, 2026Patient-Device Incompatibility
Attorney alleges that the patient underwent breast augmentation surgery on (b)(6) 2022, during which a GalaFLEX 3DR was implanted. On (b)(6) 2023 and/or (b)(6) 2024 and/or (b)(6) 2026, the GalaFlex mesh was surgically excised due to the reported pain and injury. Patient was injured severely and permanently. As alleged, the patient experienced surgical intervention, mental anguish and 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 50471322 ↗MalfunctionJun 16, 2026Material Split, Cut or Torn
AS REPORTED ON (B)(6) 2026, ONE PIECE OF GALAFLEX 3DR SCAFFOLD WAS USED BY THE SURGEON. WHILE FOLDING, IT WAS OBSERVED THAT THE RIM ALMOST CAME OFF. DUE TO THIS, ANOTHER PIECE WAS OPENED BY THE SURGEON, AND THE RIM CAME OFF IN FEW SPOTS, AND THE SURGEON OPTED TO PROCEED WITH THE IMPLANTATION WITH IT. ADDITIONALLY, IT WAS OBSERVED THAT THE MESH WAS LESS STRETCHY AND FELT DIFFERENT. THERE WAS NO PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25518454 ↗InjuryJun 9, 2026Patient-Device Incompatibility
AS REPORTED, DURING A BILATERAL BREAST REDUCTION SURGERY THE PATIENT WAS IMPLANTED WITH GALAFLEX 3DR ON (B)(6) 2024. REPORTEDLY, POST ONE (1) WEEK OF IMPLANTATION, THE PATIENT REPORTED PAIN AND PINCHING SENSATION AND FELT LIKE THE GALAFLEX WAS FOLDED OVER. THE PATIENT HAS BEEN EXPERIENCING CONSTANT PAIN ON THE LEFT BREAST WITH POSITIONING SINCE IMPLANT, ALSO REPORTED IT ALMOST FEELS LIKE THE GALAFLEX IS PINCHING A NERVE. AS REPORTED THE RIGHT BREAST IS NOT AS PAINFUL BUT DOES ACHE FROM TIME TO TIME AND THE OUTLINE OF THE GALAFLEX CAN BE FELT. THE TREATING PHYSICIAN STATED, "ITS "NORMAL" AND REFUSES TO TAKE IT OUT AND HAS TOLD THE PATIENT TO WAIT FOR IT TO ABSORB." THE PATIENT IS HAVING A BREAST MRI ON (B)(6) 2026 FOR ROUTINE BREAST CANCER SCREENING.
Patient problems: Breast Discomfort/Pain; Neuralgia
MAUDE report 25447556 ↗MalfunctionJun 9, 2026Material Split, Cut or Torn
AS REPORTED, ON (B)(6) 2026, TWO PIECES OF GALAFLEX 3DR SCAFFOLD WERE USED BY THE SURGEON. UPON CLOSURE, IT WAS OBSERVED THAT THE RIM HAD DETACHED FROM A PORTION OF THE MESH ON ONE SIDE. IT WAS FURTHER REPORTED THAT WHEN THE MESH WAS GENTLY FOLDED, THE RIM NEARLY DETACHED. A SECOND PIECE OF MESH WAS OPENED, AND THE RIM WAS NOTED TO HAVE DETACHED AT SEVERAL LOCATIONS; DESPITE THIS, THE SURGEON OPTED TO PROCEED WITH IMPLANTATION. ADDITIONALLY, IT WAS OBSERVED THAT THE MESH WAS LESS STRETCHY AND FELT DIFFERENT. THERE WAS NO PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25447551 ↗InjuryJun 4, 2026Patient-Device Incompatibility
PER INFORMATION PROVIDED: ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT BREAST AUGMENTATION REVISION SURGERY ON (B)(6) 2025, DURING WHICH A GALAFLEX 3DR MESH WAS IMPLANTED. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED PAIN AT THE IMPLANTATION SITE AND ON (B)(6) 2025, THE PATIENT UNDERWENT AN ADDITIONAL SURGICAL PROCEDURE TO REMOVE THE IMPLANTED MESH. AS ALLEGED, THE PATIENT EXPERIENCED ADDITIONAL SURGICAL INTERVENTION, MENTAL ANGUISH AND 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 25391487 ↗InjuryJun 3, 2026Patient-Device Incompatibility
PER INFORMATION PROVIDED: ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT BREAST RECONSTRUCTION REVISION SURGERY ON (B)(6) 2021, DURING WHICH A GALAFLEX 3DR WAS IMPLANTED. ON (B)(6) 2026, THE GALAFLEX MESH WAS SURGICALLY EXCISED DUE TO THE REPORTED PAIN AND INJURY. PATIENT WAS INJURED SEVERELY AND PERMANENTLY. AS ALLEGED, THE PATIENT EXPERIENCED SURGICAL INTERVENTION, MENTAL ANGUISH AND 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 25376214 ↗MalfunctionMay 13, 2026Material Split, Cut or Torn
AS REPORTED, DURING A SURGERY, THE EDGES OF GALAFLEX 3DR FELL OFF, WITHOUT THE CUSTOMER CUTTING THEM. THERE WAS NO PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25160277 ↗InjuryMar 19, 2026Patient-Device Incompatibility
PER INFORMATION PROVIDED: A 33-YEAR-OLD FEMALE PATIENT HAD IMPLANT MALPOSITION THEREBY UNDERWENT BILATERAL IMPLANT CONVERSION TO SUBGLANDULAR POCKET, BILATERAL WISE PATTERN MASTOPEXY WITH THE BILATERAL IMPLANT OF TWO GALAFLEX 3DR SCAFFOLD (DEVICE 1 AND 2) AND TWO ALLERGEN STYLE SSX NATRELLE INSPIRA SOFT TOUCH ON (B)(6) 2024. PER OP NOTES, ¿PATIENT DID TEST POSITIVE ON A URINE NICOTINE TEST. PREVIOUSLY PLACED IMPLANT WAS REMOVED. ON THE RIGHT SIDE, THE IMPLANT WAS IN A FLIPPED POSITION, THE CAPSULE DID EXTEND BENEATH AND OVER THE PECTORALIS MAJOR MUSCLE. AT THIS POINT, PERFORMED A CAPSULECTOMY OFF THE CHEST WALL, THE GALAFLEX 3DR SCAFFOLD (DEVICE 1) AND SOFT TOUCH XTRA IMPLANT WERE PLACED. ON THE LEFT SIDE, THE PECTORALIS MAJOR MUSCLE WAS SLIGHTLY MORE ADVANCED, ALTHOUGH THERE WAS STILL A SMOOTH CAPSULE ABOVE THE PECTORALIS MAJOR MUSCLE. PERFORMED A CAPSULECTOMY, CAPSULORRHAPHY, AND CAPSULOTOMY IN A SYMMETRICAL FASHION AS THE RIGHT SIDE. SECURED GALAFLEX 3DR SCAFFOLD (DEVICE 2) TO THE CHEST WALL ALONG ITS INFERIOR BORDER. A SYMMETRICAL MASTOPEXY AND IMPLANT PLACEMENT WERE PERFORMED ON THE CONTRALATERAL SIDE.¿ (B)(6) 2024 ¿ PATIENT HAD EXTREME PAIN. (B)(6) 2024 ¿ IN CT SCAN, IT LOOKS
Patient problems: Bacterial Infection; Fever; Pain; Swelling/ Edema
MAUDE report 24641108 ↗InjuryFeb 4, 2026Material Deformation; Migration
AS REPORTED DURING A PROCEDURE ON (B)(6) 2025, A GALAFLEX 3DR IMPLANT WAS IMPLANTED, POST IMPLANT THE IMPLANT DID NOT PERFORM AS INTENDED, RESULTING IN THE NEED FOR A REVISION SURGERY ON (B)(6) 2025, IN WHICH ANOTHER SHEET OF GALAFLEX IMPLANT WAS USED. ACCORDING TO THE REPORT, THE IMPLANT APPEARED TO BE FOLDED AND SHRIVELED, AND FOLLOW-UP EVALUATIONS INDICATED THAT THE LEFT IMPLANT APPEARED TO BE DROPPING.
Patient problems: Physical Asymmetry
MAUDE report 24260143 ↗MalfunctionNov 21, 2025Migration; Migration
AS REPORTED, PATIENT UNDERWENT A BREAST REPAIR PROCEDURE WITH GALAFLEX IMPLANT ON (B)(6) 2025. IT WAS REPORTED THAT THE PATIENT FELT THE MESH WAS POSITIONED DIFFERENTLY ON EACH SIDE. PLACEMENT ON THE RIGHT WAS FELT TO BE POSITIONED MORE BELOW THE BREAST, IN CONTRAST TO THE LEFT, WHERE IT WAS ALONG THE SIDE. THE RIGHT SIDE IS REPORTED TO BE SAGGING SIGNIFICANTLY. PER THE PATIENT "I AM DEFINITELY NOT HAPPY WITH THE LOOK, AND THE REASON I GOT THE MESH WAS SO THAT THEY WOULDN¿T SAG¿AT LEAST NOT SO QUICKLY. THESE ARE ONLY 7 MONTHS OLD. THE MESH ON THE LEFT COMES MORE UP THE SIDE, BUT THE MESH ON THE RIGHT IS MORE UNDER THE BREAST SO THE RIGHT BREAST IS FALLING TO THE SIDE AND DOWN."
Patient problems: Physical Asymmetry
MAUDE report 23618677 ↗InjuryApr 30, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
AS REPORTED, THE PATIENT HAD A BILATERAL BREAST IMPLANT EXCHANGE WITH CAPSULECTOMY AND PLACEMENT OF COHESIVE IMPLANTS ON (B)(6) 2025. PATIENT CAME IN FOR FOLLOW UP ON (B)(6) 2025 FOR BILATERAL SWELLING. NO REDNESS, WARMTH, OR BILATERAL SWELLING FOUND. IT WS REPORTED THAT ON (B)(6) 2025 THE PATIENT WENT INTO OR FPR WHAT WAS THOUGHT TO BE (R) BREAST HEMATOMA EVACUATION, BUT ONCE OPENED NO BLOOD WAS FOUND, ONLY A SIGNIFICANT AMOUNT OF SEROUS YELLOW FLUID; FOUND ON BOTH SIDES, BUT MORE SO ON THE (R) THAN THE (L). THE SURGEON REMOVED BOTH GALAFLEX MESHES.
Patient problems: Seroma
MAUDE report 21937464 ↗InjuryJan 17, 2025Material Deformation; Material Deformation
AS REPORTED, THE PATIENT WITH THE HISTORY OF BILATERAL BREAST AUGMENTATION HAD CAPSULAR CONTRACTURE OF RIGHT BREAST WHICH WAS ATTEMPTED TO BE FIXED BY EXCHANGING IMPLANTS, MASTOPEXY AND IT WAS NOT SUCCESSFUL. IT WAS REPORTED THAT THE RIGHT IMPLANT WAS BOTTOMING OUT AND IT WAS DECIDED TO IMPLANT GALAFLEX 3DR TO ADD AN EXTRA LAYER BILATERALLY FOR EVENNESS. THE PROCEDURE WAS PERFORMED IN (B)(6)2024. IT WAS REPORTED THAT ¿BOTH HAVE ROLLED AND CAUSING PAIN¿. IN (B)(6) 2024, PATIENT WAS REFERRED TO ANOTHER SURGEON WHO CONFIRMED THAT ¿THE MESH HAD FAILED, IMPLANT IS BOTTOMING OUT AND MESH IS ROLLED AND FELT THROUGH MY SKIN.¿ AS REPORTED, PATIENT HAD EXTREME DISCOMFORT, CONSTANT PAIN AND SCHEDULED A REMOVAL SURGERY ON (B)(6)2025.
Patient problems: Breast Discomfort/Pain; Ptosis
MAUDE report 21179439 ↗InjuryNov 6, 2024Patient-Device Incompatibility; Patient-Device Incompatibility
AS REPORTED, DURING BILATERAL BREAST IMPLANT EXCHANGE, BILATERAL REVISION OF RECONSTRUCTED BREASTS, THE PATIENT WAS IMPLANTED WITH GALAFLEX 3DR BILATERALLY ON (B)(6) 2024. IT WAS REPORTED THAT THE PATIENT DEVELOPED STAPH INFECTION ON THE RIGHT BREAST THEREBY GIVING ORAL ANTIBIOTICS AND THE INFECTION RESOLVED.
Patient problems: Bacterial Infection
MAUDE report 20621699 ↗
Other Tepha, Inc. products
All Tepha, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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