[Poly Implant Prothèse (PIP®) incidence of complications in breast reconstructive surgery: A retrospective comparative analysis]

Ann Chir Plast Esthet. 2015 Dec;60(6):478-83. doi: 10.1016/j.anplas.2015.08.007. Epub 2015 Oct 21.
[Article in French]

Abstract

Introduction: On 29 March 2010, the Poly Implant Prothèse (PIP(®)) breast prosthesis was withdrawn from the market by the ANSM. In this study we review our experience with PIP(®) implants in breast reconstruction. We compare our complications with other types of breast implants used during the same period at our institution.

Patients and method: This is a retrospective study conducted at the Hospital René Huguenin of the Institut Curie (Paris, France). It includes 327 prostheses, from 268 patients who underwent surgery for breast reconstruction between February 2008 and February 2012: 69 PIP(®) (Group 1), 82 Mentor(®) (Group 2) and 179 Allergan(®) (Group 3). The objective of the study was to compare the rates of early and late complications for each prosthesis. Our results are compared with the current literature.

Results: With regard to the rate of early complications (hematoma, infection, seroma, wound dehiscence), no difference was observed between the three groups (P not significant). However, the study found that 100% of the 13 PIP(®) implants with early complications required surgical revision. There were too few late complications (capsular contracture, prosthetic rupture) in our cohort to allow statistical comparison between the three groups (P not significant). We compare our results with the current literature.

Conclusion: This study highlights the lack of significant difference in the occurrence of early adverse events between the three groups of implants. This may explain the time taken for surgeons to become aware there was a problem with the PIP(®) implants. The low rate of late complications in our series does not allow statistical analysis between the three groups of implants.

Keywords: Breast implant; Breast reconstruction; Complication précoce; Early complication; Implant mammaire; Infection; PIP(®); Reconstruction mammaire; Reprise chirurgicale; Revision surgery.

Publication types

  • Comparative Study

MeSH terms

  • Adult
  • Aged
  • Breast Implants / adverse effects*
  • Breast Implants / statistics & numerical data
  • Female
  • France
  • Humans
  • Mammaplasty*
  • Middle Aged
  • Postoperative Complications
  • Prosthesis Failure
  • Reoperation
  • Retrospective Studies
  • Safety-Based Medical Device Withdrawals