Breast Implant Imaging Surveillance among U.S. Plastic Surgeons: U.S. Food and Drug Administration Recommendations versus Clinical Reality.

BACKGROUND: Device rupture is considered a major complication associated with breast implants. The U.S. Food and Drug Administration recommends magnetic resonance imaging (MRI) surveillance 3 years after implantation and then every 2 years, but adherence to these recommendations is poor. The authors identified current practice management for breast implant rupture surveillance by surveying practicing U.S. plastic surgeons. METHODS: An online survey of all active members of the American Society of Plastic Surgeons was performed. Questions analyzed imaging practice patterns related to breast implants. Logistic regression models were used to analyze determinants for radiographic imaging in breast implant patients. RESULTS: The survey had a response rate of 16.5 percent. For patients with breast implants, 37.7 percent of respondents recommended MRI at the recommended intervals. Fifty-five percent perform imaging only if there is a problem with the implant. Academic surgeons more frequently recommended MRI (56.3 percent and 39.3 percent; p = 0.0002). Surgeons with less than 5 years of experience are four times more likely to order MRI than surgeons with over 25 years' experience (60.8 percent and 28.1 percent; p < 0.0001). Furthermore, lower volume surgeons recommend significantly more MRI (45.2 percent and 27.3 percent; p = 0.001). Respondents are almost two times more likely to recommend MRI in reconstructive versus cosmetic patients (51.2 percent and 35.6 percent; p = 0.0004). CONCLUSIONS: MRI limitations include high costs, time commitments, and equipment constraints. Fewer than 40 percent of survey respondents suggest the recommended screening frequency to their patients; however, academic, low-volume, early-career surgeons are more likely to recommend MRI implant monitoring. Screening recommendations need to be evidence based and align with common practices to prevent undue system, provider, and patient burden.

Biopsy Feasibility Trial for Breast Cancer Pathologic Complete Response Detection after Neoadjuvant Chemotherapy: Imaging Assessment and Correlation Endpoints.

PURPOSE: This study was designed to present the secondary imaging endpoints of the trial for evaluating mammogram (MMG), ultrasound (US) and image guided biopsy (IGBx) assessment of pathologic complete response (pCR) in breast cancer (BC) patients undergoing neoadjuvant chemotherapy (NAC). METHODS: Patients with T1-3, N0-3, M0 triple-negative or HER2-positive BC who received NAC were enrolled in an Institutional Review Board-approved prospective, clinical trial. Patients underwent US and MMG at baseline and after NAC. Images were evaluated for residual abnormality and to determine modality for IGBx [US-guided (USG) or stereotactic guided (SG)]. Fine-needle aspiration and 9-G, vacuum-assisted core biopsy (VACBx) of tumor bed was performed after NAC and was compared with histopathology at surgery. RESULTS: Forty patients were enrolled. Median age was 50.5 (range 26-76) years; median baseline tumor size was 2.4 cm (range 0.8-6.3) and 1 cm (range 0-5.5) after NAC. Nineteen patients had pCR: 6 (32%) had residual Ca2+ presurgery, 5 (26%) residual mass, 1 (5%) mass with calcifications, and 7 (37%) no residual imaging abnormality. Sensitivity, specificity, and accuracy of US, MMG, and IGBx for pCR were 47/95/73%, 53/90/73%, and 100/95/98%, respectively. Twenty-five (63%) patients had SGBx and 15 (37%) had US-guided biopsy (USGBx). Median number of cores was higher with SGBx (12, range 6-14) than with USGBx (8, range 4-12), p < 0.002. Positive predictive value for pCR was significantly higher for SG VACBx than for USG VACBx (100 vs. 60%, p < 0.05). CONCLUSIONS: SG VACBx is the preferred IGBx modality for identifying patients with pCR for trials testing the safety of eliminating surgery.