Reported Sep 18, 2019 · Ongoing
Natrelle 410, Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implant Biocell Low Height Low Projection,…
Allergan PLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Allergan PLC · 2525 Dupont Dr · Irvine, CA · 92612-1531
Is this the product you have?
- Natrelle 410, Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implant Biocell Low Height Low Projection, Sterile
- for the following style numbersSyle
- LL
LL-410135LL-410180LL-410210LL-410240LL-410300
- Style LM
LM-410140LM-410190LM-410220LM-410250LM-410320
- Style LF
LF-410125LF-410150LF-410175LF-410205LF-410240LF-410270LF-410310LF-410390LF-410440LF-410490LF-410540LF-410595LL-410135LL-410180LL-410210LL-410240LL-410300
- style LX
LX-410145LX-410175LX-410195LX-410225LX-410255LX-410290LX-410330LX-410365LX-410405LX-410455LX-410515LX-410570LX-410625
- Style ML
ML-410125ML-410170ML-410195ML-410220ML-410285
- Style MM
MM-410160MM-410185MM-410215MM-410245MM-410280MM-410320MM-410360MM-410400MM-410450
- Style MF
MF-410140MF-410165MF-410195MF-410225MF-410255MF-410295MF-410335MF-410375MF-410420MF-410470MF-410525MF-410580MF-410640
- Style MX
MX-410165MX-410195MX-410225MX-410255MX-410290MX-410325MX-410370MX-410410MX-410445MX-410520MX-410550MX-410620MX-410685
- Style FL
FL-410140FL-410190FL-410220FL-410250FL-410320
- Style FM
FM-410155FM-410180FM-410205FM-410235FM-410270FM-410310FM-410350FM-410395FM-410440FM-410500FM-410550FM-410605FM-410670
- Style FF
FF-410160FF-410185FF-410220FF-410255FX-410290FF-410335FF-410375FF-410425FF-410475FF-410535FF-410595FF-410655FF-410740
- Style FXFX-410185FX-410215,FX-410245,FX-410280,FX-410315,FX-410360,FX-410410,FX-410450,FX-410495,FX-410560,FX-410615,FX-410690,FX-410775 These products may have been sold under the McGhan, Inamed or NATRELLE brands
- Product UsageBreast augmentation and Breast reconstruction
- Lot codes and dates
12 of 12 products
Products covered by this recall # Barcodes Product as published 1 1088862800317010888628003187108886280031941088862800320010888628003217LL-410135/10888628003170,LL-410180/10888628003187,LL-410210/10888628003194,LL-410240/10888628003200,LL-410300/10888628003217 2 1088862800322410888628003231108886280032481088862800325510888628003262Style LM: LM-410140/10888628003224,LM-410190/10888628003231,LM-410220/10888628003248,LM-410250/10888628003255,LM-410320/10888628003262 3 108886280030571088862800306410888628003071108886280030881088862800309510888628003101108886280031181088862800312510888628003132108886280031491088862800315610888628003163Style LF: LF-410125/10888628003057,LF-410150/10888628003064,LF-410175/10888628003071,LF-410205/10888628003088,LF-410240/10888628003095,LF-410270/10888628003101,LF-410310/10888628003118,LF-410390/10888628003125,LF-410440/10888628003132,LF-410490/10888628003149,LF-410540/10888628003156,LF-410595/10888628003163 4 10888628003279108886280032861088862800329310888628003309108886280033161088862800332310888628003330108886280033471088862800335410888628003361108886280033781088862800338510888628003392Style LX: LX-410145/10888628003279,LX-410175/10888628003286,LX-410195/10888628003293,LX-410225/10888628003309,LX-410255/10888628003316,LX-410290/10888628003323,LX-410330/10888628003330,LX-410365/10888628003347,LX-410405/10888628003354,LX-410455/10888628003361,LX-410515/10888628003378,LX-410570/10888628003385,LX-410625/10888628003392 5 1088862800353810888628003545108886280035521088862800356910888628003576Style ML: ML-410125/10888628003538,ML-410170/10888628003545,ML-410195/10888628003552,ML-410220/10888628003569,ML-410285/10888628003576 6 108886280035831088862800359010888628003606108886280036131088862800362010888628003637108886280036441088862800365110888628003668Style MM: MM-410160 10888628003583,MM-410185/10888628003590,MM-410215/10888628003606,MM-410245/10888628003613,MM-410280/10888628003620,MM-410320/10888628003637,MM-410360/10888628003644,MM-410400/10888628003651,MM-410450/10888628003668 7 10888628003408108886280034151088862800342210888628003439108886280034461088862800345310888628003460108886280034771088862800348410888628003491108886280035071088862800351410888628003521Style MF:MF-410140/10888628003408,MF-410165/10888628003415,MF-410195/10888628003422,MF-410225/10888628003439,MF-410255/10888628003446,MF-410295/10888628003453,MF-410335/10888628003460,MF-410375/10888628003477,MF-410420/10888628003484,MF-410470/10888628003491,MF-410525/10888628003507,MF-410580/10888628003514,MF-410640/10888628003521 8 10888628003675108886280036821088862800369910888628003705108886280037121088862800372910888628003736108886280037431088862800375010888628003767108886280037741088862800378110888628003798Style MX:MX-410165/10888628003675,MX-410195/10888628003682,MX-410225/10888628003699,MX-410255/10888628003705,MX-410290/10888628003712,MX-410325/10888628003729,MX-410370/10888628003736,MX-410410/10888628003743,MX-410445/10888628003750,MX-410520/10888628003767,MX-410550/10888628003774,MX-410620/10888628003781,MX-410685/10888628003798 9 1088862800274610888628002753108886280027601088862800277710888628002784Style FL: FL-410140/10888628002746,FL-410190/10888628002753,FL-410220/10888628002760,FL-410250/10888628002777,FL-410320/10888628002784 10 10888628002791108886280028071088862800281410888628002821108886280028381088862800284510888628002852108886280028691088862800287610888628002883108886280028901088862800290610888628002913Style FM:FM-410155/10888628002791,FM-410180/10888628002807,FM-410205/10888628002814,FM-410235/10888628002821,FM-410270/10888628002838,FM-410310/10888628002845,FM-410350/10888628002852,FM-410395/10888628002869,FM-410440/10888628002876,FM-410500/10888628002883,FM-410550/10888628002890,FM-410605/10888628002906,FM-410670/10888628002913 11 10888628002616108886280026231088862800263010888628002647108886280026541088862800266110888628002678108886280026851088862800269210888628002708108886280027151088862800272210888628002739Style FF: FF-410160/10888628002616,FF-410185/10888628002623,FF-410220/10888628002630,FF-410255/10888628002647,FF-410290/10888628002654,FF-410335/10888628002661,FF-410375/10888628002678,FF-410425/10888628002685,FF-410475/10888628002692,FF-410535/10888628002708,FF-410595/10888628002715,FF-410655/10888628002722,FF-410740/10888628002739 12 10888628002920108886280029371088862800294410888628002951108886280029681088862800297510888628002982108886280029991088862800300210888628003019108886280030261088862800303310888628003040Style FX: FX-410185/10888628002920,FX-410215/10888628002937,FX-410245/10888628002944,FX-410280/10888628002951,FX-410315/10888628002968,FX-410360/10888628002975,FX-410410/10888628002982,FX-410450/10888628002999,FX-410495/10888628003002,FX-410560/10888628003019,FX-410615/10888628003026,FX-410690/10888628003033,FX-410775/10888628003040 - Amount recalled
- 4,026,287 Breast Implants and Tissue Expanders Combined in total
This recall covers 15 products
The agency filed one notice per product. You are reading one of them; the other 14 are below.
2 more are in the archive.
Where it was sold
Why it was recalled
Stop using this product now
The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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