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. METHODS ONE HUNDRED TWELVE: 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. CLINICAL QUESTION/LEVEL OF EVIDENCE: Diagnostic, II.

The clinical and diagnostic consequences of Poly Implant Prothèse silicone breast implants, recalled from the European market in 2010.

BACKGROUND: Recently, Poly Implant Prothèse silicone breast implants were recalled from the European market. The authors studied 112 women and previously published data on rupture prevalence. Women are presenting with symptoms they feel may be a result of ruptured implants. The authors' aim was to study the clinical consequences of Poly Implant Prothèse implants. METHODS: One hundred twelve women with 224 proven Poly Implant Prothèse implants after 10 years of implantation were enrolled in this study. All women underwent physical examination and magnetic resonance imaging and were interviewed regarding symptoms. Details of the explantations of 35 women with at least one ruptured implant were documented. Tissue from 10 women was sent for pathologic investigation. RESULTS: Of 112 women, 34 (30.4 percent) had symptoms attributable to their implants. Physical examination showed that 12 of the 121 women (10.7 percent) had findings suggestive of rupture, most commonly pain. Three had lymphadenopathy that seemed to correlate with implant rupture or excessive "gel bleed." Pathologic findings showed no malignancies. Eight women who underwent explantation had no implant rupture. Excessive gel bleed was documented in half of them. CONCLUSIONS: Clinical consequences of women with Poly Implant Prothèse implants are comparable to those reported in the literature of other manufacturers. Neither complaints nor findings at physical examination had a significant correlation with implant rupture at explantation. Magnetic resonance imaging is still the preferred method compared with physical examination for diagnosing rupture. The low specificity was probably caused by the difficulty in differentiating between rupture and excessive gel bleed in these implants.

Prevalence of rupture in poly implant Prothèse silicone breast implants, recalled from the European market in 2010.

BACKGROUND: Known complications of silicone breast implants are rupture and silicone leakage, complications that are related not only to generation and implant age but also to the manufacturer. Implants from the French manufacturer Poly Implant Prothèse showed more rupture than expected and were banned from the European market in 2010. Clinics in Europe recalled their patients, but prevalence of rupture in these implants has not been previously reported. METHODS: All women who underwent breast augmentation in 2000 and 2001 in the Jan van Goyen Clinic, Amsterdam, The Netherlands, were informed about concerns regarding the quality of their implants. Medical records were used to trace manufacturer and implantation specifics. One hundred twelve women with proven Poly Implant Prothèse implants were enrolled in this study. All women underwent physical examination and magnetic resonance imaging and were interviewed for complaints to determine the prevalence of symptomatic and asymptomatic rupture. RESULTS: Two hundred twenty-four Poly Implant Prothèse implants were evaluated with a mean implant age of 122 months. Of these 224 implants, 54 had ruptured. Magnetic resonance imaging showed that 33 percent of women had at least one ruptured implant. There was no significant difference in rupture rate of implants manufactured in 2000 and 2001. CONCLUSIONS: One third of the women who had undergone breast augmentation with Poly Implant Prothèse implants were shown to have at least one ruptured implant after 10 years; 45.9 percent had bilateral rupture and 13.5 percent had extracapsular leakage. These were mostly asymptomatic ruptures. The rupture prevalence rate for Poly Implant Prothèse implants after 10 years is 24 percent. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.