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.
In December 2018, sales of Allergan textured breast implants were discontinued in Germany and the European Union, as well as in Israel, Brazil and Australia. Canada followed suit in May 2019 and the U.S. in June 2019.

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

Author(s)Source
attorneys advice, without source citationhttps://patientenanwalt.de/
This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register.
Comments: n/a
let us know