Poly Implant Prothèse and Rofil Substandard Breast Implant Explantations from a Large German Single Centre from 2011 to 2014: A Comparative Study
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
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KeywordsPIP implants Silicone Breast implants Implant rupture Clinical findings Capsular contracture
- 1.SCENIHR (2014) The safety of Poly Implant Prothèse (PIP) silicone breast implants: update of the opinion of February 2012. http://ec.europa.eu/health/scientific_committees/emerging/docs/scenihr_o_043.pdf. Accessed 9 June 2016
- 2.afssaps Topical report PIP silicone gel pre-filled implants. http://ansm.sante.fr/var/ansm_site/storage/original/application/39acdab927235584ccfa340e4a9d3896.pdf. Accessed 2 June 2015
- 3.Bundesinstitut für Arzneimittel und Medizinprodukte (2010) Silikongel-gefüllte Brustimplantate des Herstellers Poly Implant Prothese (PIP) Pressemitteilung 04/10. http://www.bfarm.de/SharedDocs/Risikoinformationen/Medizinprodukte/DE/Silikon_Brustimplantate_PIP.html. Accessed 9 June 2016
- 4.afssaps PIP implants mammaires. http://ansm.sante.fr/Dossiers/Implants-mammaires-PIP-pre-remplis-de-gel-de-silicone/Synthese-des-donnees-d-incidents-declares-chez-les-femmes-porteuses-d-implants-PIP/(offset)/3. Accessed 9 June 2016
- 5.BfArM (2014) Brustimplantate “PIP” und “Rofil”: Risiken, Informationen, Empfehlungen. http://www.bfarm.de/DE/Medizinprodukte/risikoerfassung/empfehlungen/PIP/_node.html. Accessed 2 June 2015
- 6.MHRA composition and toxicity of PIP silicone. https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/377370/Chemical_Analysis_Summary.pdf. Accessed 9 June 2016
- 7.afssaps Silicone based filling gel breast implants from Poly Implant Prothèse Company tests results. http://ansm.sante.fr/var/ansm_site/storage/original/application/38fbe37bdd1897eb09de4f892a317c14.pdf. Accessed 9 June 2016
- 8.(2015) PIP breast implants: update on TGA testing of PIP breast implants. https://www.tga.gov.au/alert/pip-breast-implants-update-tga-testing-pip-breast-implants. Accessed 9 June 2015
- 19.Department of Health and NHS Poly Implant Prothèse (PIP) breast implants: final report of the expert group. https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/214975/dh_134657.pdf. Accessed 1 June 2015
- 20.NHS PIP breast implants-Implant rupture-NHS choices. http://www.nhs.uk/Conditions/Breast-implants/Pages/Warning-signs.aspx. Accessed 8 June 2015
- 24.Poly Implant Prosthèse (PIP) implants: toxicology testing—GOV.UK. https://www.gov.uk/government/publications/poly-implant-prosthese-pip-implants-toxicology-testing/poly-implant-prosthese-pip-implants-toxicology-testing. Accessed 8 June 2015
- 26.Barnsley GP, Sigurdson LJ, Barnsley SE (2006) Textured surface breast implants in the prevention of capsular contracture among breast augmentation patients: a meta-analysis of randomized controlled trials. Plast Reconstr Surg 117(7):2182–2190. doi:10.1097/01.prs.0000218184.47372.d5 CrossRefPubMedGoogle Scholar