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. RiegerEmail author
Original Article Breast



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.


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


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.


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).


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


PIP implants Silicone Breast implants Implant rupture Clinical findings Capsular contracture 


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
    Email author
  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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