Unplanned Implant Removal after Multimodality Therapy for Breast Cancer

Abstract

The purpose of this study is to determine the frequency and timing of unplanned surgical implant removal after mastectomy with immediate implant-based reconstruction and RT. From 2010-2017, 52 patients underwent RT following mastectomy and immediate reconstruction for primary or recurrent invasive cancer at a single institution. Implant removal was defined as any unplanned removal of an implant or tissue expander outside of immediate, one-stage (direct to implant) or two-stage (tissue expander followed by implant placement) reconstruction. Time to removal was measured from the date of initial surgery. Implant removal rates were compared before and after radiation for all 52 patients. In 34 patients with bilateral mastectomies with reconstruction, we compared the breast cancer side to the contralateral side. For bilateral reconstructions, implant removal was assigned to the side responsible for the event. Statistical analysis was performed using Fisher’s Exact Test and a Two Sample Test for Proportions. Baseline patient and tumor characteristics include: median age of 45.5 years, 42% pathologic stage II, 44% pathologic stage III, 77% ER positive, 25% HER-2 positive, and 15% were triple negative. At a median follow-up of 3.1 years (range 0.6 – 8.8 years), implant removal occurred in 23 patients (44%; 23/52). The median time to implant removal was 5.5 months (0.3 – 60.6 months). Implant removal occurred in 14 patients within 6 months of surgery and in 9 after 6 months (p = 0.24). In 3 patients, implant removal occurred >2 years after surgery. Implant removal rates were similar after one-stage (45%; 10/23) and two-stage reconstructions (45%; 13/29, p = 0.98). Implant removal occurred in 9 patients before starting RT and 14 patients after starting RT. Implant removal rates were similar after unilateral reconstruction (39%; 7/18) or bilateral reconstruction (47%; 16/34, p = 0.77). In bilaterally reconstructed patients, implant removal was more frequently due to a complication in the breast with invasive cancer (33%; 11/34) than in the contralateral breast (15%; 5/34, p = 0.04). The rates of implant removal on the affected versus contralateral breast were more different for the period before RT (Δ12%, p = 0.07) than the period after (Δ6%, p = 0.23). Unplanned implant removal is a risk for women undergoing mastectomy and reconstruction with post-operative RT. This complication is more common in the affected than the contralateral breast, but the differential between these is larger before than after RT. These events can occur months to years after initial reconstruction emphasizing the importance of long-term follow-up.