Magnetic resonance imaging screening results compared with explantation results in poly implant prothèse silicone breast implants, recalled from the European market in 2010.
BACKGROUND
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.


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.


CONCLUSIONS
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.


METHODS
Diagnostic, II.
Amsterdam, The Netherlands From the Department of Plastic and Reconstructive Surgery, VU University Medical Center; Jan van Goyen Clinic; and MRI Center Amsterdam.
Maria C
MC
Maijers
Francisus B
FB
Niessen
Jacob F H
JFH
Veldhuizen
Marco J P F
MJPF
Ritt
Radu A
RA
Manoliu
D000328:Adult; D018427:Breast Implants; D020878:Device Removal; D005060:Europe; D005260:Female; D006801:Humans; D008279:Magnetic Resonance Imaging; D057052:Medical Device Recalls; D011183:Postoperative Complications / Q000175:diagnosis*; D011446:Prospective Studies; D011474:Prosthesis Design; D011475:Prosthesis Failure; D020034:Silicone Gels; D055815:Young Adult
D020034:Silicone Gels