Magnetic Resonance Imaging Screening Results Compared with Explantation Results in Poly Implant Prothèse Silicone Breast Implants, Recalled from the European Market in 2010
| Autor: | Jacob F. H. Veldhuizen, Marco J.P.F. Ritt, Francisus B. Niessen, Maria C. Maijers, Radu A. Manoliu |
|---|---|
| Přispěvatelé: | Plastic, Reconstructive and Hand Surgery, Radiology and nuclear medicine, MOVE Research Institute |
| Rok vydání: | 2014 |
| Předmět: |
Adult
Medical Device Recalls medicine.medical_specialty Breast Implants Prosthesis Design Silicone Gels Young Adult chemistry.chemical_compound Postoperative Complications Silicone Humans Medicine European market Prospective Studies Prospective cohort study Device Removal medicine.diagnostic_test business.industry Magnetic resonance imaging equipment and supplies Magnetic Resonance Imaging Prosthesis Failure Surgery Europe chemistry Female Radiology Implant business human activities |
| Zdroj: | Plastic and reconstructive surgery, 133(2), 114E-120E. Lippincott Williams and Wilkins Maijers, M C, Niessen, F B, Veldhuizen, J F H, Ritt, M J P F & Manoliu, R A 2014, ' Magnetic Resonance Imaging Screening Results Compared with Explantation Results in Poly Implant Prothese Silicone Breast Implants, Recalled from the European Market in 2010 ', Plastic and reconstructive surgery, vol. 133, no. 2, pp. 114E-120E . https://doi.org/10.1097/01.prs.0000436853.32527.c3 |
| ISSN: | 0032-1052 |
| DOI: | 10.1097/01.prs.0000436853.32527.c3 |
| Popis: | In a prospective cohort study, the authors followed 112 women whose Poly Implant Prothèse silicone breast implants were recalled. Magnetic resonance imaging results and clinical consequences were previously published. The authors compared magnetic resonance imaging screening with explantation results to study the diagnostic value of magnetic resonance imaging in this unique unselected and nonbiased group.women with 224 proven Poly Implant Prothèse implants after a mean implantation time of 10 years were enrolled in 2011. All women underwent magnetic resonance imaging screening and were offered explantation. The explantation details of 107 women could be compared with magnetic resonance imaging results.Of 107 women, 29 (27 percent) had at least one ruptured implant at explantation, and 44 of 214 explanted implants (21 percent) were ruptured. The magnetic resonance imaging results correctly diagnosed 154 intact and 35 ruptured implants. Sensitivity and specificity were 80 percent and 91 percent, respectively. The positive predictive value was 69 percent, and the negative predictive value was 95 percent.The accuracy of magnetic resonance imaging is comparable to previously published data from other manufacturers of modern silicone implants but lower than that of some recent validation studies in selected symptomatic women. The authors believe that this study is representative of common daily practice as they followed normal day-to-day magnetic resonance imaging protocol without using multiple independent readers. The authors hope that this study will contribute to the ongoing discussion to screen asymptomatic women with modern silicone breast implants.Diagnostic, II. |
| Databáze: | OpenAIRE |
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