BIOZORB

Additional Manufacturer Narrative

HOLOGIC HAS RECEIVED CORRESPONDENCE ARISING FROM LITIGATION. THE LITIGATION ALLEGES THAT A 58-YEAR-OLD PATIENT WAS IMPLANTED ON (B)(6) 2018 WITH A BIOZORB MARKER FOLLOWING A SURGICAL PROCEDURE FOR A LEFT BREAST LUMPECTOMY. THE PATIENT PRESENTED INFLAMMATORY CHANGES AND FIRMNESS AT THE SURGICAL PROCEDURE SITE. AT A MAMMOGRAM EXAMINATION IN (B)(6) 2021, IT WAS FOUND THE PATIENT PRESENTED SKIN THICKENING IN THE AREA OF CUTANEOUS REDNESS, PROMPTING A RECOMMENDATION FOR PUNCH BIOPSY. ON (B)(6) 2021 THE PATIENT UNDERWENT ADDITIONAL SURGICAL INTERVENTION FOR BIOPSY EXAM. SUBSEQUENT PATHOLOGY FROM A LEFT BREAST PUNCH BIOPSY REVEALED FAT NECROSIS AND INFLAMMATION, WITH FINDINGS INDICATING A CHRONIC INFLAMMATORY AND DEGENERATIVE PROCESS AT THE LUMPECTOMY SITE. ON (B)(6) 2022, THE TREATING PHYSICIANS DOCUMENTED CONCERN THAT THE BIOZORB DEVICE COULD BE CONTRIBUTING TO THE INFLAMMATORY SKIN CHANGES AND FIRMNESS AT THE SURGICAL SITE. GIVEN THESE FINDINGS, THE SAME DAY, THE PATIENT UNDERWENT A LEFT PARTIAL MASTECTOMY WITH EXCISION OF THE OVERLYING SKIN, REMOVAL OF RESIDUAL BIOZORB, AND TISSUE REARRANGEMENT. DESPITE REMOVAL OF THE BIOZORB, THE PATIENT CONTINUED TO EXPERIENCE RESIDUAL BREAST DEFORMITY AND ASYMMETRY. ON (B)(6) 2023, DUE TO LEFT BREAST CONTOUR IRREGULARITIES AND ASYMMETRY FOLLOWING LUMPECTOMY AND RADIATION THERAPY, PATIENT UNDERWENT FAT GRAFTING OF THE LEFT BREAST. PATIENT CONTINUED TO SUFFER PAIN AND DEFORMITY, REQUIRING AN ADDITIONAL LIPOSCULPTURE PROCEDURE WITH FAT INJECTION TO THE LEFT BREAST FROM ABDOMINAL DONOR TISSUE ON (B)(6) 2023. ON (B)(6) 2024, THE PATIENT UNDERWENT YET ANOTHER LEFT BREAST REVISION WITH FAT GRAFTING FOR CORRECTION OF THE PERSISTENT RESIDUAL DEFORMITY. PATIENT¿S CLINICAL COURSE DEMONSTRATES THAT FOLLOWING BIOZORB IMPLANTATION, SHE DEVELOPED SIGNIFICANT POSTOPERATIVE COMPLICATIONS INCLUDING CHRONIC INFLAMMATION, FAT NECROSIS, AND SKIN CHANGES, ULTIMATELY NECESSITATING SURGICAL REMOVAL OF THE DEVICE AND MULTIPLE SUBSEQUENT RECONSTRUCTIVE PROCEDURES. PATIENT¿S INJURIES INCLUDE PROLONGED INFLAMMATORY CHANGES AT THE SURGICAL SITE, BREAST DEFORMITY AND ASYMMETRY, CHRONIC PAIN, AND THE NEED FOR AT LEAST FOUR ADDITIONAL SURGICAL INTERVENTIONS DIRECTLY ATTRIBUTABLE TO COMPLICATIONS ASSOCIATED WITH THE BIOZORB IMPLANT. NO OTHER RELEVANT INFORMATION WAS PROVIDED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE REPORTED LOT NUMBER. THE DEVICE WAS RELEASED MEETING ALL QA SPECIFICATIONS. THIS REPORT IS BEING SUBMITTED PURSUANT TO 21 CFR PART 803 BASED ON INFORMATION MADE AVAILABLE TO HOLOGIC THROUGH LITIGATION. CONSISTENT WITH 21 CFR 803.16, THE SUBMISSION OF THIS REPORT IS NOT INTENDED, AND SHALL NOT BE CONSTRUED, AS AN ADMISSION, ACKNOWLEDGMENT, OR CONFIRMATION BY HOLOGIC THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.

Description of Event or Problem

HOLOGIC HAS RECEIVED CORRESPONDENCE ARISING FROM LITIGATION. THE LITIGATION ALLEGES THAT A 58-YEAR-OLD PATIENT WAS IMPLANTED ON (B)(6) 2018 WITH A BIOZORB MARKER FOLLOWING A SURGICAL PROCEDURE FOR A LEFT BREAST LUMPECTOMY. THE PATIENT PRESENTED INFLAMMATORY CHANGES AND FIRMNESS AT THE SURGICAL PROCEDURE SITE. AT A MAMMOGRAM EXAMINATION IN (B)(6) 2021, IT WAS FOUND THE PATIENT PRESENTED SKIN THICKENING IN THE AREA OF CUTANEOUS REDNESS, PROMPTING A RECOMMENDATION FOR PUNCH BIOPSY. ON (B)(6) 2021 THE PATIENT UNDERWENT ADDITIONAL SURGICAL INTERVENTION FOR BIOPSY EXAM. SUBSEQUENT PATHOLOGY FROM A LEFT BREAST PUNCH BIOPSY REVEALED FAT NECROSIS AND INFLAMMATION, WITH FINDINGS INDICATING A CHRONIC INFLAMMATORY AND DEGENERATIVE PROCESS AT THE LUMPECTOMY SITE. ON (B)(6) 2022, THE TREATING PHYSICIANS DOCUMENTED CONCERN THAT THE BIOZORB DEVICE COULD BE CONTRIBUTING TO THE INFLAMMATORY SKIN CHANGES AND FIRMNESS AT THE SURGICAL SITE. GIVEN THESE FINDINGS, THE SAME DAY, THE PATIENT UNDERWENT A LEFT PARTIAL MASTECTOMY WITH EXCISION OF THE OVERLYING SKIN, REMOVAL OF BIOZORB IMPLANT, AND TISSUE REARRANGEMENT. DESPITE REMOVAL OF THE BIOZORB, THE PATIENT CONTINUED TO EXPERIENCE RESIDUAL BREAST DEFORMITY AND ASYMMETRY. ON (B)(6) 2023, DUE TO LEFT BREAST CONTOUR IRREGULARITIES AND ASYMMETRY FOLLOWING LUMPECTOMY AND RADIATION THERAPY, PATIENT UNDERWENT FAT GRAFTING OF THE LEFT BREAST. PATIENT CONTINUED TO SUFFER PAIN AND DEFORMITY, REQUIRING AN ADDITIONAL LIPOSCULPTURE PROCEDURE WITH FAT INJECTION TO THE LEFT BREAST FROM ABDOMINAL DONOR TISSUE ON (B)(6) 2023. ON (B)(6) 2024, THE PATIENT UNDERWENT YET ANOTHER LEFT BREAST REVISION WITH FAT GRAFTING FOR CORRECTION OF THE PERSISTENT RESIDUAL DEFORMITY. PATIENT¿S CLINICAL COURSE DEMONSTRATES THAT FOLLOWING BIOZORB IMPLANTATION, SHE DEVELOPED SIGNIFICANT POSTOPERATIVE COMPLICATIONS INCLUDING CHRONIC INFLAMMATION, FAT NECROSIS, AND SKIN CHANGES, ULTIMATELY NECESSITATING SURGICAL REMOVAL OF THE DEVICE AND MULTIPLE SUBSEQUENT RECONSTRUCTIVE PROCEDURES. PATIENT¿S INJURIES INCLUDE PROLONGED INFLAMMATORY CHANGES AT THE SURGICAL SITE, BREAST DEFORMITY AND ASYMMETRY, CHRONIC PAIN, AND THE NEED FOR AT LEAST FOUR ADDITIONAL SURGICAL INTERVENTIONS DIRECTLY ATTRIBUTABLE TO COMPLICATIONS ASSOCIATED WITH THE BIOZORB IMPLANT. NO OTHER RELEVANT INFORMATION WAS PROVIDED.