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


CONCLUSIONS
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.


METHODS
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Department of Plastic & Aesthetic, Reconstructive & Hand Surgery, AGAPLESION Markus Hospital, Academic Teaching Hospital of the Johann Wolfgang von Goethe University, Wilhelm-Epstein-Str. 4, 60431, Frankfurt am Main, Germany.|Department of Plastic, Reconstructive & Aesthetic Surgery, Burn Unit, Klinikum Nuremberg Hospital, Paracelsus Medical University (PMU), Breslauer Str. 201, 90471, Nuremberg, Germany.
Moritz
M
Billner
Department of Plastic & Aesthetic, Reconstructive & Hand Surgery, AGAPLESION Markus Hospital, Academic Teaching Hospital of the Johann Wolfgang von Goethe University, Wilhelm-Epstein-Str. 4, 60431, Frankfurt am Main, Germany.
Anna
A
Wirthmann
University of Erlangen-Nuremberg, Findelgasse 7, 90402, Nuremberg, Germany.
Simon
S
Reif
Department of Plastic & Aesthetic, Reconstructive & Hand Surgery, AGAPLESION Markus Hospital, Academic Teaching Hospital of the Johann Wolfgang von Goethe University, Wilhelm-Epstein-Str. 4, 60431, Frankfurt am Main, Germany. dr.ulrich.rieger@gmail.com.
Ulrich M
UM
Rieger
D000328:Adult; D019928:Breast Implantation / Q000009:adverse effects* / Q000379:methods; D018427:Breast Implants; D001943:Breast Neoplasms / Q000209:etiology / Q000517:prevention & control; D016022:Case-Control Studies; D020878:Device Removal; D005260:Female; D005500:Follow-Up Studies; D005858:Germany; D006801:Humans; D057910:Implant Capsular Contracture / Q000000981:diagnostic imaging / Q000601:surgery*; D016014:Linear Models; D008875:Middle Aged; D015999:Multivariate Analysis; D011474:Prosthesis Design; D011475:Prosthesis Failure; D012086:Reoperation / Q000379:methods; D012189:Retrospective Studies; D018570:Risk Assessment; D012422:Rupture, Spontaneous / Q000000981:diagnostic imaging / Q000601:surgery*; D020034:Silicone Gels / Q000009:adverse effects*; D016896:Treatment Outcome
D020034:Silicone Gels
Breast implants; Capsular contracture; Clinical findings; Implant rupture; PIP implants; Silicone