GALAFLEX
Received Jul 14, 2026 · Event occurred Jun 24, 2026
Report 1213643-2026-00916 · MDR key 25818119
Device
Generic name
Breast - Absorbable Mesh
Manufacturer
Tepha, Inc. - 3005670760Model number
NICatalog number
UNKAA128
Lot number
NI
Product problems
- Material Integrity Problem
Patient
NA · Female
- Insufficient Information
Narrative
Description of Event or Problem
AS REPORTED, POST IMPLANT OF GALAFLEX "SEVERAL PATIENTS WITH POOR RESORPTION AND PERSISTENTLY PALPABLE PRODUCTS >2 YEARS OUT."
Additional Manufacturer Narrative
AS REPORTED, POST IMPLANT OF GALAFLEX "SEVERAL PATIENTS WITH POOR RESORPTION AND PERSISTENTLY PALPABLE PRODUCTS >2 YEARS OUT." THE INFORMATION PROVIDED IS LIMITED, MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION HOWEVER, THERE HAS BEEN NO RESPONSE. BASED ON THE INFORMATION PROVIDED, NO CONCLUSIONS CAN BE MADE AS TO IF/WHY THE DEVICE DID RESORB AS EXPECTED. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORD IS NOT POSSIBLE. THE IFU PROVIDED WITH THE DEVICE STATES; BIORESORPTION OF THE SCAFFOLD MATERIAL WILL BE ESSENTIALLY COMPLETE WITHIN 18-24 MONTHS. NOTE, THE DATE OF EVENT (24-JUN-2026) IS CONSIDERED TO BE THE BEST ESTIMATE BASED ON THE DATE OF AWARENESS. NOTE: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.