Reported Sep 18, 2019 · Ongoing
Natrelle Inspira, Silicone-Filled Breast Implants, Sterile, for the following style numbers: Style TRL:…
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 Inspira, Silicone-Filled Breast Implants, Sterile
- for the following style numbersStyle
- TRL
TRL-110TRL-125TRL-140TRL-170TRL-200TRL-230TRL-260TRL-290TRL-320TRL-350TRL-380TRL-410TRL-460TRL-510TRL-560TRL-610
- Style TRLP
TRLP-125TRLP-145TRLP-165TRLP-190TRLP-205TRLP-220TRLP-235TRLP-250TRLP-265TRLP-280TRLP-300TRLP-320TRLP-340TRLP-360TRLP-400TRLP-440TRLP-490TRLP-540TRLP-590TRLP-640
- Style TRM
TRM-140TRM-175TRM-195TRM-210TRM-240TRM-255TRM-275TRM-295TRM-310TRM-330TRM-345TRM-360TRM-375TRM-405TRM-445TRM-485TRM-520TRM-560TRM-600TRM-640TRM-685
- TRM-755 Style TRF
TRF-180TRF-200TRF-220TRF-240TRF-265TRF-295TRF-325TRF-335TRF-345TRF-365TRF-385TRF-415TRF-450TRF-485TRF-520TRF-560TRF-605TRF-650TRF-695TRF-745TRF-770
- Style TRX
TRX-205TRX-225TRX-255TRX-285TRX-310TRX-340TRX-375TRX-400TRX-420TRX-445TRX-470TRX-495TRX-525TRX-545TRX-560TRX-580TRX-615TRX-650TRX-700TRX-750TRX-800
- Style TSL
TSL-110TSL-125TSL-140TSL-170TSL-200TSL-230TSL-260TSL-290TSL-320TSL-350TSL-380TSL-410TSL-460TSL-510TSL-560TSL-610
- Style TSLP
TSLP-125TSLP-145TSLP-165TSLP-190TSLP-205TSLP-220TSLP-235TSLP-250TSLP-265TSLP-280TSLP-300TSLP-320TSLP-340TSLP-360TSLP-400TSLP-440TSLP-490TSLP-540TSLP-590TSLP-640
- Style TSM
TSM-140TSM-175TSM-195TSM-210TSM-240TSM-255TSM-275TSM-295TSM-310TSM-330TSM-345TSM-360TSM-375TSM-405TSM-445TSM-485TSM-520TSM-560TSM-600TSM-640TSM-685TSM-755
- Style TSF
TSF-180TSF-200TSF-220TSF-240TSF-265TSF-295TSF-325TSF-335TSF-345TSF-365TSF-385TSF-415TSF-450TSF-485TSF-520TSF-560TSF-605TSF-650
- TSF-695 TSF-745 TSF-770 Style TSX
TSX-205TSX-225TSX-255TSX-285TSX-310TSX-340TSX-375TSX-400TSX-420TSX-445TSX-470TSX-495TSX-525TSX-545TSX-560TSX-580TSX-615TSX-650TSX-700TSX-750TSX-800
- Style TCL
TCL-110TCL-125TCL-140TCL-170TCL-200TCL-230TCL-260TCL-290TCL-320TCL-350TCL-380TCL-410TCL-460TCL-510TCL-560TCL-610
- Style TCLP
TCLP-125TCLP-145TCLP-165TCLP-190TCLP-205TCLP-220TCLP-235TCLP-250TCLP-265TCLP-280TCLP-300TCLP-320TCLP-340TCLP-360TCLP-400TCLP-440TCLP-490TCLP-540TCLP-590TCLP-640
- Style TCM
TCM-140TCM-175TCM-195TCM-210TCM-240TCM-255TCM-275 TCM-295 TCM-310TCM-330TCM-345TCM-360TCM-375TCM-405TCM-445TCM-485TCM-520TCM-560TCM-600TCM-640TCM-685TCM-755
- Style TCF
TCF-180TCF-200TCF-220TCF-240TCF-265TCF-295TCF-325TCF-335TCF-345TCF-365TCF-385TCF-415TCF-450TCF-485TCF-520TCF-560TCF-605TCF-650
- TCF-695 TCF-745 TCF-770 Style TCXTCX-205, TCX-225, TCX-255, TCX-285, TCX-310, TCX-340, TCX-375, TCX-400 TCX-420, TCX-445, TCX-470, TCX-495, TCX-525, TCX-545, TCX-560, TCX-580, TCX-615, TCX-650, TCX-700, TCX-750, TCX-800; These products may have been sold under the McGhan, Inamed or NATRELLE brands
- Product UsageBreast augmentation and Breast reconstruction
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Barcodes Product as published TSLP-36010888628033764TSLP-400 10888628033771, TSLP-440 10888628033788, TSLP-490 10888628033795, TSLP-540 10888628033801, TSLP-590 10888628033818, TSLP-640 10888628033825; Style TSM: TSM-140 10888628033832, TSM-175 10888628033849, TSM-195 10888628033856, TSM-210 10888628033863, TSM-240 10888628033870, TSM-255 10888628033887, TSM-275 10888628033894, TSM-295 10888628033900, TSM-310 10888628033917, TSM-330 10888628033924, TSM-345 10888628033931, TSM-360 10888628033948, TSM-375 10888628033955, TSM-405 10888628033962, TSM-445 10888628033979, TSM-485 10888628033986, TSM-520 10888628033993, TSM-560 10888628034006, TSM-600 10888628034013, TSM-640 10888628034020, TSM-685 10888628034037, TSM-755 10888628034044; Style TSF: TSF-180 10888628034051, TSF-200 10888628034068, TSF-220 10888628034075, TSF-240 10888628034082, TSF-265 10888628034099, TSF-295 10888628034105, TSF-325 10888628034112, TSF-335 10888628034129, TSF-345 10888628034136, TSF-365 10888628034143, TSF-385 10888628034150, TSF-415 10888628034167, TSF-450 10888628034174, TSF-485 10888628034181, TSF-520 10888628034198, TSF-560 10888628034204, TSF-605 10888628034211, TSF-650 10888628034228, TSF-695 10888628034235, TSF-745 10888628034242, TSF-770 10888628034259; Style TSX: TSX-205 10888628034266, TSX-225 10888628034273, TSX-255 10888628034280, TSX-285 10888628034297, TSX-310 10888628034303, TSX-340 10888628034310, TSX-375 10888628034327, TSX-400 10888628034334, TSX-420 10888628034341, TSX-445 10888628034358, TSX-470 10888628034365, TSX-495 10888628034372, TSX-525 10888628034389, TSX-545 10888628034396, TSX-560 10888628034402, TSX-580 10888628034419, TSX-615 10888628034426, TSX-650 10888628034433, TSX-700 10888628034440, TSX-750 10888628034457, TSX-800 10888628034464; Style TCL: TCL-110 10888628030435, TCL-125 10888628030442, TCL-140 10888628030459, TCL-170 10888628030466, TCL-200 10888628030473, TCL-230 10888628030480, TCL-260 10888628030497, TCL-290 10888628030503, TCL-320 10888628030510, TCL-350 10888628030527, TCL-380 10888628030534, TCL-410 10888628030541, TCL-460 10888628030558, TCL-510 10888628030565, TCL-560 10888628030572, TCL-610 10888628030589; Style TCLP: TCLP-125 10888628030596, TCLP-145 10888628030602, TCLP-165 10888628030619, TCLP-190 10888628030626, TCLP-205 10888628030633, TCLP-220 10888628030640, TCLP-235 10888628030657, TCLP-250 10888628030664, TCLP-265 10888628030671, TCLP-280 10888628030688, TCLP-300 10888628030695, TCLP-320 10888628030701, TCLP-340 10888628030718, TCLP-360 10888628030725, TCLP-400 10888628030732, TCLP-440 10888628030749, TCLP-490 10888628030756, TCLP-540 10888628030763, TCLP-590 10888628030770, TCLP-640 10888628030787; Style TCM: TCM-140 10888628030794, TCM-175 10888628030800, TCM-195 10888628030817, TCM-210 10888628030824, TCM-240 10888628030831, TCM-255 10888628030848, TCM-275 10888628030855, TCM-295 10888628030862, TCM-310 10888628030879, TCM-330 10888628030886, TCM-345 10888628030893 TCM-36010888628030909TCM-375 10888628030916, TCM-405 10888628030923, TCM-445 10888628030930, TCM-485 10888628030947, TCM-520 10888628030954, TCM-560 10888628030961, TCM-600 10888628030978, TCM-640 10888628030985, TCM-685 10888628030992, TCM-755 10888628031005; Style TCF: TCF-180 10888628031012, TCF-200 10888628031029, TCF-220 10888628031036, TCF-240 10888628031043, TCF-265 10888628031050, TCF-295 10888628031067, TCF-325 10888628031074, TCF-335 10888628031081, TCF-345 10888628031098, TCF-365 10888628031104, TCF-385 10888628031111, TCF-415 10888628031128, TCF-450 10888628031135, TCF-485 10888628031142, TCF-520 10888628031159, TCF-560 10888628031166, TCF-605 10888628031173, TCF-650 10888628031180, TCF-695 10888628031197, TCF-745 10888628031203, TCF-770 10888628031210; Style TCX: TCX-205 10888628031227, TCX-225 10888628031234, TCX-255 10888628031241, TCX-285 10888628031258, TCX-310 10888628031265, TCX-340 10888628031272, TCX-375 10888628031289, TCX-400 10888628031296, TCX-420 10888628031302, TCX-445 10888628031319, TCX-470 10888628031326, TCX-495 10888628031333, TCX-525 10888628031340, TCX-545 10888628031357, TCX-560 10888628031364, TCX-580 10888628031371, TCX-615 10888628031388, TCX-650 10888628031395, TCX-700 10888628031401, TCX-750 10888628031418 TCX-80010888628031425— - 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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