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

Abstract：

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.

journal_name

Plast Reconstr Surg

journal_title

Plastic and reconstructive surgery

authors

Maijers MC,Niessen FB

doi

10.1097/PRS.0b013e31827c70aa

subject

Has Abstract

pub_date

2013-03-01 00:00:00

pages

394e-402e

issue

eissn

0032-1052

issn

1529-4242

pii

00006534-201303000-00034

journal_volume

131

pub_type

杂志文章

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