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 59 years (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 × 3 cm BioZorb was most commonly used (37/98, 37.8%), followed by 3 × 4 cm (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 1.1 years, 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 2.8 years. Additional imaging was ordered because a clinician palpated a mass, unaware it was the BioZorb 8.8% of the time 2 × 3 37/98 (37.8) 3 × 3 7/98 (7.1) 3 × 4 25/98 (25.5) 4 × 4 3/98 (3.1) 4 × 5 4/98 (4.1) Low-profile device sizes 1 × 3 × 2 9/98 (9.2) 1 × 3 × 3 3/98 (3.1) 2 × 1 × 1 1/98 (1.0) 2 × 2 × 1 4/98 (4.1) Abbreviation: cm, centimeters.

Surgical excision of BioZorb device eroding through the nipple‐areolar complex one year postoperatively: A case report

“…There is currently a paucity of data related to the surgical complications secondary to use of a BioZorb. Reported complications seem to be minor and occur rarely 3,4 . However, our patient went on to complete post‐lumpectomy radiation for her DCIS, and nearly 9 months later presented with chronic symptoms of breast infection, pain, erythema, and ultimate erosion of the BioZorb through her skin 1 year after initial surgery.…”

“…Another single‐institution study from Chung and Srour concluded that the BioZorb was safe to use due to the rarity of complications. In this series, only 2 of 91 patients had the BioZorb removed (one at time of re‐excision of positive margins secondary to discomfort and one that had migrated to the axilla, requiring explant) 4 . To date, there have been no reported events of postoperative erosion of the BioZorb device into the NAC requiring removal and debridement of the breast.…”

Current Surgical Innovations in the Treatment of Breast Cancer

“…There is a "learning curve" for effective use of this device. The re-absorption can take up to two years with persistence of a palpable presence of the device at the tumor site, but with careful sizing of the implant this has rarely been an issue (55). Most of our patients have In some cases, we found the partial restoration in lost tissue volume to markedly improve the cosmetic outcome (e.g., upper inner and medial breast).…”

A Three-Dimensional Bioabsorbable Tissue Marker for Volume Replacement and Radiation Planning: A Multicenter Study of Surgical and Patient-Reported Outcomes for 818 Patients with Breast Cancer

“…A recent single-center study of 89 patients implanted with the BZ found that the BZ still was palpable at the time of the last clinical breast exam (performed at a median 1.1 years) for 63.6 % of the patients, with palpability observed to persist as late as 2.8 years after implantation. 36 Followup datapoints collected in the registry with relevance to device palpability are limited to the event-reporting of pain, which occurred for 1.1 % of the patients and was concentrated in the first 3 months after BCS, with reported reasons for device removal. Only two patients (0.2 %) requested device removal due to pain or anxiety.…”

“…This marker has been associated with positive cosmetic and overall patient outcomes as well as reduced RT volumes in the few reported studies to date. [36][37][38][39][40][41][42] These studies have been small, focused on RT planning outcomes or limited to short-term follow-up evaluation. This is the first report of 24-month outcomes after BCS with BioZorb Ò (BZ) implantation in a large U.S. registry of data collected across an array of clinical settings.…”