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Lampert FM, Schwarz M, Grabin S, et al. The "PIP scandal" - Complications in Breast Implants of Inferior Quality: State of Knowledge, Official Recommendations and Case Report. Geburtshilfe Frauenheilkd. 2012;72(3):243-246doi: 10.1055/s-0031-1298323.
Lampert, F. M., Schwarz, M., Grabin, S., & Stark, G. B. (2012). The "PIP scandal" - Complications in Breast Implants of Inferior Quality: State of Knowledge, Official Recommendations and Case Report. Geburtshilfe und Frauenheilkunde, 72(3), 243-246. https://doi.org/10.1055/s-0031-1298323
Lampert, F M, et al. "The "PIP scandal" - Complications in Breast Implants of Inferior Quality: State of Knowledge, Official Recommendations and Case Report." Geburtshilfe und Frauenheilkunde vol. 72,3 (2012): 243-246. doi: https://doi.org/10.1055/s-0031-1298323
Lampert FM, Schwarz M, Grabin S, Stark GB. The "PIP scandal" - Complications in Breast Implants of Inferior Quality: State of Knowledge, Official Recommendations and Case Report. Geburtshilfe Frauenheilkd. 2012 Mar;72(3):243-246. doi: 10.1055/s-0031-1298323. PMID: 25308983; PMCID: PMC4168359.
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Geburtshilfe Frauenheilkd. 2012 Mar;72(3):243-246. doi: 10.1055/s-0031-1298323.

The "PIP scandal" - Complications in Breast Implants of Inferior Quality: State of Knowledge, Official Recommendations and Case Report.

Geburtshilfe und Frauenheilkunde

F M Lampert, M Schwarz, S Grabin, G B Stark

Affiliations

  1. Abteilung Plastische und Handchirurgie, Universitätsklinikum Freiburg, Freiburg i. Br.
  2. Zentrum für ambulante Diagnostik und Chirurgie, Freiburg i. Br.

PMID: 25308983 PMCID: PMC4168359 DOI: 10.1055/s-0031-1298323

Abstract

Following the clinical observation of high rate of ruptures of breast implants of the French manufacturer Poly Implant Prothèse (PIP), the French Health Products Safety Agency (Afssaps) removed these products from the market in March 2010. Physical and toxicological tests confirmed the use of silicone of improper quality both for the shell and the gel filling. Until now (12/2011), no acute toxicity or mutagenicity could be observed, but 20 cases of malignancies occured in carriers of PIP-prostheses. By means of a clinical example, we summarize the official recommendations of the Afssaps and its German equivalent, the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) for diagnosis and treatment in women with PIP breast implants. Furthermore, we intend to raise awareness for the fact that the German GfE Medizintechnik and the Dutch manufacturer Rofil distributed the identical product with a different label. Supplementary, the medical and medico-legal aspects of the "PIP scandal" are discussed.

Keywords: BRCA (breast cancer antigen); benign mammary gland tumor; breast; mammary gland tumor; mammary malformation

References

  1. J Plast Reconstr Aesthet Surg. 2006;59(8):885-6 - PubMed
  2. J Plast Reconstr Aesthet Surg. 2007;60(8):967-8 - PubMed
  3. J Plast Reconstr Aesthet Surg. 2011 Aug;64(8):e208-9 - PubMed

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