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

Beitrag in einer Fachzeitschrift


Details zur Publikation

Autorinnen und Autoren: Billner M, Wirthmann A, Reif S, Rieger U
Zeitschrift: Aesthetic Plastic Surgery
Jahr der Veröffentlichung: 2016
Band: 40
Heftnummer: 4
Seitenbereich: 507-513
ISSN: 0364-216X
Sprache: Englisch


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


FAU-Autorinnen und Autoren / FAU-Herausgeberinnen und Herausgeber

Reif, Simon Dr.
Professur für Gesundheitsökonomie


Zitierweisen

APA:
Billner, M., Wirthmann, A., Reif, S., & Rieger, U. (2016). Poly Implant Prothèse and Rofil Substandard Breast Implant Explantations from a Large German Single Centre from 2011 to 2014: A Comparative Study. Aesthetic Plastic Surgery, 40(4), 507-513. https://dx.doi.org/10.1007/s00266-016-0666-1

MLA:
Billner, Moritz, et al. "Poly Implant Prothèse and Rofil Substandard Breast Implant Explantations from a Large German Single Centre from 2011 to 2014: A Comparative Study." Aesthetic Plastic Surgery 40.4 (2016): 507-513.

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Zuletzt aktualisiert 2018-18-10 um 06:10