Aesthetic Plastic Surgery

, Volume 40, Issue 4, pp 507–513 | Cite as

Poly Implant Prothèse and Rofil Substandard Breast Implant Explantations from a Large German Single Centre from 2011 to 2014: A Comparative Study

  • Moritz Billner
  • Anna Wirthmann
  • Simon Reif
  • Ulrich M. Rieger
Original Article Breast
First Online:
Received:
Accepted:

Abstract

Background

Following a Europe-wide scandal, substandard breast implants containing silicone for industry purposes produced by Poly Implant Prothèse (PIP&Rofil) were explanted due to its potential health risks.

Objective

We investigated whether these implants actually imposed a threat to patients’ health.

Methods

In this retrospective single-centre case–control study, we compared patients with breast augmentation receiving implant explantation (01/2011–01/2015). Data were collected retrospectively from the patients’ records. Patients were split into two groups: PIP&Rofil and implants of other manufacturers.

Results

A total of 307 patients with 495 breast implants met the inclusion criteria, 64 patients with 115 PIP&Rofil implants and 243 patients with 380 implants of other manufacturers. Comparison of descriptive statistics between the two groups revealed that for a variety of indicators (e.g. patient age, breast cancer, aesthetic vs. reconstructive indication, implant volume, submuscular vs. subglandular implant position) PIP implants differ from non-PIP implant patients. Raw mean comparison showed higher rupture rates for non-PIP implants, 28.42 % (PIP 23.48 %). However, when controlling for implant indwelling time, PIP implants had shown higher rupture rates. Both groups had similar rates of capsular contracture (PIP: 71.30 %, Others: 72.63 %) with different distribution of Baker Scores (Baker 2/3/4: PIP 5/8/13 and non-PIP 3/24/135).

Conclusion

Concerning patient symptoms, we did not find any objective reason to justify implant explantation of PIP&Rofil implants as a solely precautionary measure. As PIP&Rofil implants showed shorter retention periods until rupture and ruptured implants can cause symptoms or health problems, PIP&Rofil implants should be regularly monitored and explanted if there is evidence of rupture.

Level of Evidence III

This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266

Keywords

PIP implants Silicone Breast implants Implant rupture Clinical findings Capsular contracture 
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Notes

Compliance with Ethical Standards

Conflict of interest

None of the authors have anything to disclose.

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Copyright information

© Springer Science+Business Media New York and International Society of Aesthetic Plastic Surgery 2016

Authors and Affiliations

  • Moritz Billner
    • 1
    • 2
  • Anna Wirthmann
    • 1
  • Simon Reif
    • 3
  • Ulrich M. Rieger
    • 1
  1. 1.Department of Plastic & Aesthetic, Reconstructive & Hand Surgery, AGAPLESION Markus HospitalAcademic Teaching Hospital of the Johann Wolfgang von Goethe UniversityFrankfurt am MainGermany
  2. 2.Department of Plastic, Reconstructive & Aesthetic Surgery, Burn Unit, Klinikum Nuremberg HospitalParacelsus Medical University (PMU)NurembergGermany
  3. 3.University of Erlangen-NurembergNurembergGermany

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