Article Figures & Data
Figures
- Figure.
Complications associated with BioZorb placement.
Tables
- Table.
Follow-Up Periods, Complications, Management, and Outcomes Associated With BioZorb Placement
Patient Time From Placement to Complication Device Removed? Time From First Complication to Removal Time From Placement to Removal/Time From Removal To Last Clinical Follow-Up Complications Management Outcomes 1 <1 month Yes 2 months 2 months/32 months Sinus tract in surgical wound Dehiscence Debridement Device removal Wound healed 2 <1 month Yes 36 months 36 months/11 months Chronic seroma Abscess Percutaneous aspiration ×5 IV antibiotics Incision and drainage with device removal Mastectomy with rotational flap, surgical site infection, wound debridement with areas of fat necrosis, left open, wound VAC, hyperbaric O2 therapy with Hydrofera (wound closing) 3 <1 month Yes 6 months 6 months/36 months Seroma Surgical site infection Dehiscence Percutaneous aspiration ×2 Oral antibiotics Debridement Device removal Developed nodules possibly indicating local recurrence Lost to follow-up 4 <1 month Yes 3 days 1 month/62 months Surgical site infection Dehiscence Incision and drainage Oral antibiotics Device removal Nonhealing wound after 3 months; additional debridement and tissue rearrangements by Plastic Surgery 5 1 month No NA 40 months Surgical site infection Chronic pain Percutaneous aspiration Oral antibiotics Infection resolved BioZorb site still abnormally palpable 6 3 months Yes 2 days 3 months/64 months Dehiscence Device removal Nonhealing wound; tissue rearrangement and closure by Plastic Surgery 7 6 months No NA 74 months Chronic pain Sensation of device movement No specific treatment Pain resolved 24 months after surgery 8 7 months No NA 43 months Chronic pain No specific treatment Chronic pain 9 31 months No NA 43 months Chronic pain No specific treatment Chronic pain 10 36 months Yes 5 months 45 months/8 months Surgical site infection Chronic pain Oral antibiotics Device removal and debridement Wound healed 11 36 months Yes 2 months 41 months/37 months Chronic pain Palpable massa Device removal Pain resolved 12 72 months Yes 15 days 69 months/5 months Surgical site infection Abscess Oral antibiotics Percutaneous drainage ×2 Incision and drainage with device removal Cavitary wound left open followed by Plastic Surgery; plan for abdominal flap reconstruction of right breast 13 108 months No NA 105 months Chronic pain No specific treatment Chronic pain ↵aDuring the reoperation, the device was found to have been reabsorbed despite complaints of palpable abnormality.
IV, intravenous; NA, not applicable; O2, oxygen; VAC, vacuum-assisted closure.
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