Journal Article

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

Billner, Moritz, Reif, Simon, Rieger, Ulrich M., Wirthmann, Anna

2016

Overview

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

• Publisher: Springer US,Springer Nature B.V
• Subject: Adult / Breast Implantation - adverse effects / Breast Implantation - methods / Breast Implants / Breast Neoplasms - etiology / Breast Neoplasms - prevention & control / Case-Control Studies / Device Removal / Female / Follow-Up Studies / Germany / Humans / Implant Capsular Contracture - diagnostic imaging / Implant Capsular Contracture - surgery / Linear Models / Medicine / Medicine & Public Health / Middle Aged / Multivariate Analysis / Original Article / Otorhinolaryngology / Plastic Surgery / Prosthesis Design / Prosthesis Failure / Reoperation - methods / Retrospective Studies / Risk Assessment / Rupture, Spontaneous - diagnostic imaging / Rupture, Spontaneous - surgery / Silicone Gels - adverse effects / Treatment Outcome