Evaluating Breast Implant Screening Guidelines in Breast Cancer Reconstruction.

Abstract

Introduction: In 2020, the US Food and Drug Administration updated its surveillance recommendations for breast implant rupture to ultrasound screening or magnetic resonance imaging (MRI) 5-6 years following silicone implant placement, with repeat screening every 2-3 years thereafter. This study evaluates the risk of implant rupture and assesses the utility of routine surveillance MRIs in diagnosing implant rupture.

Methods: We performed a retrospective review of patients with implant-based reconstruction for breast cancer with a single surgeon between 2012 and 2017. Inclusion criteria included a 5-year minimum follow-up period. Analysis was performed to elucidate rupture rate and associated factors.

Results: A total of 376 patients underwent reconstruction with saline (13%) and silicone implants (87%). Seventy-five (20%) underwent routine MRI screening within 5-6 years of surgery. Implant rupture occurred in 26 patients (7%). Average time from implant placement to rupture was 5.9 ± 4.0 years. Fifty-nine percent of silicone implant ruptures were diagnosed by MRI screening. Thirty-eight percent of silicone implant ruptures presented without clinical symptoms and were identified on routine MRI screening. All saline implant ruptures presented with clinical symptoms. On imaging, ruptures were classified as intracapsular (81%) or extracapsular (12%). Seventy-three percent of ruptures were confirmed intraoperatively during implant replacement. Median time for rupture diagnosis to implant removal/replacement was 3 months (range, 0.5-21 months).

Conclusions: MRI screening for silicone implant rupture in implant-based breast reconstruction had a 59% detection rate, with relatively low patient adherence (20% within 5-6 years after surgery), highlighting the challenges of screening. Patients should be counseled on the risk of implant rupture and the likelihood of needing replacement during their lifetime.