PURPOSE: In 2020, the FDA updated its surveillance recommendations for breast implant rupture to an ultrasound or MRI 5 to 6 years following silicone implant placement, with repeat screening every 2 to 3 years after. As new generations of silicone gel implants are continuously developed, the definitive lifespan of an implant is unknown. Furthermore, iatrogenic damage and trauma can lead to implant rupture. This study aims to assess the risk of implant rupture in a single-surgeon cohort and evaluate the utility of routine surveillance MRIs in accurately diagnosing implant rupture.
METHODS: We performed a retrospective review of patients who underwent implant-based reconstruction for breast cancer with a single surgeon between 2012-2017. Inclusion criteria included implant-based reconstruction and a minimum follow-up period of five years. Clinical notes and imaging records were reviewed. Univariate analysis was performed to elucidate implant rupture rate and bivariate analysis was performed to identify factors associated with rupture.
RESULTS: A total of 376 patients underwent breast reconstruction with implants. 13% of reconstructions were with saline implants and 87% with silicone implants. 105 (28%) patients underwent at least one routine screening MRI to assess implant integrity. Implant rupture occurred in 26 patients, with an overall rupture rate of 7%. The average time from implant placement to rupture was 5.9 ± 4.0 years, with patients being 55 years old, on average, when diagnosed with implant rupture. 58% of all ruptures were diagnosed by routine MRI screening, and 4% were diagnosed incidentally on chest CT. 38% of all silicone implant ruptures presented without any clinical symptoms and were found incidentally on routine MRI screening, while all saline implant ruptures presented with clinical symptoms. 81% of all ruptures were identified as intracapsular on imaging and 12% were classified as extracapsular. 73% of ruptures were confirmed intraoperatively while patients underwent implant replacement. All patients with saline implants opted for new saline implants and 88% of patients with silicone implants opted for new silicone implants. 23% of all patients with breast implant rupture elected for implant removal, without replacement. The median time for implant removal or replacement after rupture was 3 months (average of 4.8 months) and ranged from 0.5-21 months.
CONCLUSION: Implant rupture occurs on average 5.9 years after placement. Many patients with implant rupture may not present with clinical symptoms, and the true rate at which patients undergo routine MRI screening is low. Routine screening every 5 years is accurate in detecting implant rupture. Patients should be counseled on the risk of implant rupture and the potential for additional operations for implant replacement.