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.