GALAFLEX 3DR

Description of Event or Problem

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 LIKE DRAINAGE ON ONE SIDE IS MORE RED THAN THE OTHER. THE DRAINAGE IN THE TUBE DOESN¿T LOOK LIKE BLOOD OR BLEEDING. THERE WAS SEVERE PAIN IN TWO HARD LUMPS. (B)(6) 2024 - THE LEFT DRAIN HAS TURNED INTO A THICK RED THAT LOOKS LIKE BLOOD AND HAS INCREASED OUTPUT. (B)(6) 2024 - RIGHT IMPLANT SHOWED MASSIVE INFECTION THAT TOOK PATIENT INTO EMERGENCY SURGERY. ON LEFT SIDE, PATIENT HAD INFECTION AND ELECTED TO REMOVE THE IMPLANT. THIS FILE REPRESENTS GALAFLEX 3DR (LEFT).

Additional Manufacturer Narrative

AS REPORTED, THE PATIENT HAD DEVELOPED INFECTION, SWELLING AND EXTREME PAIN POST IMPLANT OF GALAFLEX 3DR IMPLANT. THESE COMPLICATIONS REQUIRED FURTHER SURGICAL PROCEDURES TO REMOVE THE IMPLANT. BASED ON THE INFORMATION PROVIDED THE DEGREE TO WHICH THE GALAFLEX 3DR IMPLANT USED MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S POSTOPERATIVE COURSE IS UNKNOWN. REVIEW OF MANUFACTURING RECORDS CONFIRMS PRODUCT WAS MANUFACTURED TO SPECIFICATION. PAIN AND INFECTION ARE LISTED AS POSSIBLE COMPLICATIONS IN THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE, PROVIDED WITH THE DEVICE. REGARDING INFECTION THE WARNING SECTION STATES, "IF AN INFECTION DEVELOPS, TREAT THE INFECTION AGGRESSIVELY. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE SCAFFOLD." THIS SUPPLEMENTAL EMDR REPRESENTS THE GALAFLEX 3DR (LEFT). AN ADDITIONAL EMDR WAS SUBMITTED TO REPRESENT THE GALAFLEX 3DR (RIGHT). 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.