Utilization of BioZorb implantable device in breast-conserving surgery.

Abstract

BioZorb fiducial marker is an implantable device made of six clips to mark the surgical site of tissue removal in three dimensions. The marker facilitates focused radiation therapy, while allowing for tissue ingrowth during the healing process with resorption by the body overtime. Current literature investigating the use of the BioZorb is limited and focused on its value for radiation treatment. Our objective was to investigate the feasibility and surgical complications associated with the BioZorb in breast-conserving surgery. From April 2015 to June 2018, 89 patients who underwent 91 partial mastectomies with planned adjuvant radiation therapy and placement of the BioZorb. Demographics, type of BioZorb used, complication rate, and postoperative examinations were analyzed. A total of 89 patients who were a median age of 59years (range 34-84) underwent 91 operations with BioZorb placement-86.8% underwent a partial mastectomy (n=79), and 13.2% underwent a breast wide re-excision for margins at the time of BioZorb placement (n=12). Of the 79 partial mastectomies, 21.5% (n=17) were palpable tumors. Location of the tumor and subsequent BioZorb placement was most often in the upper outer quadrant (40.7%), followed by upper inner (27.5%), lower outer (20.9%), and lower inner quadrants (10.9%). 92.3% (n=84) had a single BioZorb placed, 5.5% (n=5) had two BioZorbs placed in a single lumpectomy cavity, and 2.2% (n=2) had two BioZorbs placed in separate lumpectomy cavities of the same breast. Of the 10 different tissue marker sizes used, a 2×3cm BioZorb was most commonly used (37/98, 37.8%), followed by 3×4cm (25/98, 25.5%) and 1×3×2 (9/98, 9.2%). A total of five patients underwent immediate bilateral breast reduction following placement of the BioZorb. Of the 91 operations, 22 patients had a subsequent reoperation for positive margins after initial placement of the BioZorb, of which 86.4% retained the BioZorb. During these reoperations, only 1 patient had the BioZorb removed due to discomfort (4.5%) and two had it removed due to subsequent mastectomy (9.1%). At a median time of 1.1years, the BioZorb continued to be palpable on clinical breast examination in 63.6% of patients. The longest time that the BioZorb continued to be palpable was 2.8years. Additional imaging was ordered because a clinician palpated a mass, unaware it was the BioZorb 8.8% of the time (n=8). Thirty-day complications include 3.3% of patients with an infection requiring antibiotics (n=3) and 2.2% with an abscess requiring aspiration and antibiotics without removal of the BioZorb. One patient had migration of the BioZorb from the breast to the axilla which resulted in surgical explant at 9months post-op. BioZorb is feasible to use in breast-conserving surgery with few short- and long-term complications, but will result in a palpable mass that may persist for more than 1year. Explantation is rare.