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The Clinical and Diagnostic Consequences of Poly Implant Prothèse Silicone Breast Implants, Recalled from the European Market in 2010

Maijers, Maria C. M.D.; Niessen, Francisus B. M.D., Ph.D.

Plastic & Reconstructive Surgery:
doi: 10.1097/PRS.0b013e31827c70aa
Cosmetic: Original Articles
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.

Author Information

Rotterdam and Amsterdam, The Netherlands

From the Department of Surgical Oncology, Erasmus Medical Center/Daniel den Hoed Cancer Center; the Department of Plastic and Reconstructive Surgery, VU University Medical Center; and the Medical Center Jan van Goyen.

Received for publication May 29, 2012; accepted August 30, 2012.

Disclosure: The authors have no financial interest to declare in relation to the content of this article. No external funding was received.

Francisus B. Niessen, M.D., Ph.D.; Department of Plastic, Reconstructive and Hand Surgery, VU University Medical Centre, De Boelelaan 1117, P.O. Box 7057, 1007 MB Amsterdam, The Netherlands, fb.niessen@vumc.nl

©2013American Society of Plastic Surgeons