Recall of textured Allergan Natrelle BIOCELL and McGhan implants and tissue expanders (2018)
| BfArM, FDA: “Based on currently available information, including newly submitted data, our analysis shows that the risk of BIA-ALCL with textured Allergan Biocell implants is approximately six times higher than the risk of BIA-ALCL with textured implants from other manufacturers, and continued distribution of Allergan Biocell textured breast implants would likely cause serious adverse health consequences and possibly death from BIA-ALCL.” The U.S. FDA does not currently recommend that women have their Allergan Natrelle saline or silicone implants removed unless they have symptoms. |
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| Es sind die Biocell-Implantate, einschließlich Brustimplantate mit gefüllter Textur und Gewebeexpander, die im folgenden aufgelistet sind: Natrelle-Brustimplantate mit Kochsalzlösung 168, 363, 468 McGhan and Natrelle 410 breats implants LL, LM, LF, LX, ML, MM, MF, MX, FL, FM, FF, FX Natrelle and McGhan 410 Soft Touch Brustimplantattypen LL, LM, LF, LX, ML, MM, MF, MX, FL, FM, FF, FX Natrelle 510 Dual-Gel-types LX, MX, FX Natrelle Inspira breast implants TRL, TRLP, TRM, TRF, TRX, TSL, TSLP, TSM, TSF, TSX, TCL, TCLP, TCM, TCF, TCX Natrelle and McGhan Round Gel implant types 110, 110 Soft Touch, 120, 120 Soft Touch Natrelle Komuro breast implants KML, KMM, KLL und KLM Natrelle Ritz Princess breast implants RML, RMM, RFL, RFM Natrelle 150 double-lumen implants Natrelle 133 tissue expander: Typen 133FV, 133MV, 133LV, 133MX, 133SX, 133SV, T-133FV, T-133MV, T-133LV, T-133MX, T-133SX, T-133SV, 133FV-T, 133MV-T, 133LV-T, 133MX-T, 133SX-T, 133SV-T Natrelle 133 Plus tissue expander 133P-FV, 133P-MV, 133P-LV, 133P-MX, 133P-SX, 133P-SV, T-133P-FV, T-133P-MV, T-133P-LV, T-133P-MX, T-133P-SX, T-133P-SV, 133P-FV-T, 133P-MV-T, 133P-LV-T, 133P-MX-T, 133P-SX-T, 133P-SV-T The recall does not affect Allergan’s Natrelle Smooth or Microcell breast implants and tissue expanders. We recommend to seek information directly from the implanting surgoen, the relevant health authorities or the manufacturers |
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| Author(s) | Source |
| attorneys advice, without source citation | https://patientenanwalt.de/ |
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