Allergan

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Top device categories

• Implant, Intragastric For Morbid ObesityLTI5,065
• Implant, Dermal, For Aesthetic UseLMH1,524
• Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-FilledFTR1,403
• Prosthesis, Breast, Inflatable, Internal, SalineFWM492
• Mesh, Surgical, Absorbable, Plastic And Reconstructive SurgeryOXF200
• Unit, PhacofragmentationHQC86
• Intraocular LensHQL78
• Tissue Expander And AccessoriesLCJ70
• Lens, Multifocal IntraocularMFK40
• Mesh, Surgical, PolymericFTL31

Recent recalls

• 2024-04-29Open, ClassifiedProcess design

  Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only,

  Their is a potential that breast implants lack the lubricious coating that allows them to slide through the funnels during the implantation procedure.

• 2019-09-11Open, ClassifiedUnknown/Undetermined by firm

  Natrelle, Saline-Filled Breast Implant Biocell Full Height with Fill Tube, Sterile, for the following style numbers: Style 163:163-360CC, 163-440CC, 163-530CC, 163-655CC, 163-780CC; Style 168:168-120,168-150,168-180,168-210,168-240,168-270,168-300,168-330,168-360,168-390,168-420,168-450,168-480,168-510,168-550,168-600, 168-650,168-700,168-750, 168-800; Style 363: 363LF-170, 363LF-200, 363LF-230, 363LF-260, 363LF-300, 363LF-330, 363LF-370, 363LF-410, 363LF-450, 363LF-510, 363LF-560, 363LF-620, 363LF-690; Syle 468: 468-195, 468-230, 468-270, 468-300, 468-350, 468-380, 468-450, 468-495, 468-560, 468-620 These products may have been sold under the McGhan, Inamed or NATRELLE brands. Product Usage: Breast augmentation and Breast reconstruction

  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.

• 2019-09-11Open, ClassifiedUnknown/Undetermined by firm

  Natrelle 410, Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implant Biocell Low Height Low Projection, Sterile, for the following style numbers: Syle LL: LL-410135,LL-410180,LL-410210,LL-410240,LL-410300; Style LM: LM-410140, LM-410190, LM-410220, LM-410250, LM-410320; Style LF: LF-410125, LF-410150,LF-410175,LF-410205,LF-410240,LF-410270,LF-410310,LF-410390,LF-410440,LF-410490,LF-410540,LF-410595,LL-410135,LL-410180,LL-410210,LL-410240,LL-410300; style LX: LX-410145,LX-410175,LX-410195,LX-410225,LX-410255,LX-410290,LX-410330,LX-410365,LX-410405,LX-410455,LX-410515,LX-410570,LX-410625; Style ML: ML-410125,ML-410170,ML-410195,ML-410220,ML-410285; Style MM: MM-410160,MM-410185,MM-410215,MM-410245,MM-410280,MM-410320,MM-410360,MM-410400,MM-410450; Style MF: MF-410140MF-410165,MF-410195,MF-410225,MF-410255,MF-410295,MF-410335,MF-410375,MF-410420,MF-410470,MF-410525,MF-410580,MF-410640; Style MX: MX-410165,MX-410195,MX-410225,MX-410255,MX-410290,MX-410325,MX-410370,MX-410410,MX-410445,MX-410520,MX-410550,MX-410620,MX-410685; Style FL: FL-410140,FL-410190,FL-410220,FL-410250,FL-410320; Style FM:FM-410155,FM-410180,FM-410205,FM-410235,FM-410270,FM-410310,FM-410350,FM-410395,FM-410440,FM-410500,FM-410550,FM-410605,FM-410670; Style FF: FF-410160,FF-410185,FF-410220,FF-410255,FX-410290,FF-410335,FF-410375,FF-410425,FF-410475,FF-410535,FF-410595,FF-410655,FF-410740; Style FX: FX-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 Usage: Breast augmentation and Breast reconstruction

  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.

• 2019-09-11Open, ClassifiedUnknown/Undetermined by firm

  Natrelle Inspira, Silicone-Filled Breast Implants, Sterile, for the following style numbers: Style TRL: TRL-110TRL-125,TRL-140,TRL-170,TRL-200,TRL-230,TRL-260,TRL-290,TRL-320,TRL-350,TRL-380,TRL-410,TRL-460,TRL-510,TRL-560,TRL-610; Style TRLP: TRLP-125TRLP-145,TRLP-165,TRLP-190,TRLP-205,TRLP-220,TRLP-235,TRLP-250, TRLP-265,TRLP-280,TRLP-300,TRLP-320,TRLP-340,TRLP-360,TRLP-400,TRLP-440,TRLP-490,TRLP-540,TRLP-590,TRLP-640; Style TRM: TRM-140,TRM-175,TRM-195,TRM-210,TRM-240,TRM-255,TRM-275,TRM-295,TRM-310,TRM-330,TRM-345,TRM-360,TRM-375TRM-405,TRM-445,TRM-485,TRM-520,TRM-560,TRM-600,TRM-640,TRM-685,TRM-755 Style TRF: TRF-180TRF-200,TRF-220,TRF-240,TRF-265,TRF-295,TRF-325,TRF-335,TRF-345,TRF-365,TRF-385,TRF-415,TRF-450,TRF-485,TRF-520,TRF-560,TRF-605,TRF-650,TRF-695,TRF-745,TRF-770; Style TRX: TRX-205,TRX-225,TRX-255,TRX-285,TRX-310,TRX-340,TRX-375,TRX-400,TRX-420,TRX-445,TRX-470,TRX-495,TRX-525,TRX-545,TRX-560,TRX-580,TRX-615,TRX-650,TRX-700,TRX-750,TRX-800; Style TSL: TSL-110, TSL-125, TSL-140, TSL-170, TSL-200, TSL-230, TSL-260, TSL-290, TSL-320, TSL-350, TSL-380, TSL-410, TSL-460, TSL-510, TSL-560, TSL-610; Style TSLP: TSLP-125, TSLP-145, TSLP-165, TSLP-190, TSLP-205, TSLP-220, TSLP-235, TSLP-250, TSLP-265, TSLP-280, TSLP-300, TSLP-320, TSLP-340, TSLP-360, TSLP-400, TSLP-440, TSLP-490, TSLP-540, TSLP-590, TSLP-640; Style TSM: TSM-140, TSM-175, TSM-195, TSM-210, TSM-240, TSM-255, TSM-275, TSM-295, TSM-310, TSM-330, TSM-345, TSM-360, TSM-375, TSM-405, TSM-445, TSM-485, TSM-520, TSM-560, TSM-600, TSM-640, TSM-685, TSM-755; Style TSF: TSF-180 TSF-200 TSF-220 TSF-240 TSF-265 TSF-295 TSF-325 TSF-335 TSF-345 TSF-365 TSF-385 TSF-415 TSF-450 TSF-485 TSF-520 TSF-560 TSF-605 TSF-650 TSF-695 TSF-745 TSF-770 Style TSX: TSX-205, TSX-225, TSX-255, TSX-285, TSX-310, TSX-340, TSX-375, TSX-400, TSX-420, TSX-445, TSX-470, TSX-495, TSX-525, TSX-545, TSX-560, TSX-580, TSX-615, TSX-650, TSX-700, TSX-750, TSX-800; Style TCL: TCL-110, TCL-125, TCL-140, TCL-170, TCL-200, TCL-230, TCL-260, TCL-290, TCL-320, TCL-350, TCL-380, TCL-410, TCL-460, TCL-510, TCL-560, TCL-610; Style TCLP: TCLP-125, TCLP-145, TCLP-165, TCLP-190, TCLP-205, TCLP-220, TCLP-235, TCLP-250, TCLP-265, TCLP-280, TCLP-300, TCLP-320, TCLP-340, TCLP-360, TCLP-400, TCLP-440, TCLP-490, TCLP-540, TCLP-590, TCLP-640; Style TCM: TCM-140, TCM-175, TCM-195, TCM-210, TCM-240, TCM-255, TCM-275 TCM-295 TCM-310, TCM-330, TCM-345, TCM-360, TCM-375, TCM-405, TCM-445, TCM-485, TCM-520, TCM-560, TCM-600, TCM-640, TCM-685, TCM-755; Style TCF: TCF-180 TCF-200 TCF-220 TCF-240 TCF-265 TCF-295 TCF-325 TCF-335 TCF-345 TCF-365 TCF-385 TCF-415 TCF-450 TCF-485 TCF-520 TCF-560 TCF-605 TCF-650 TCF-695 TCF-745 TCF-770 Style TCX: TCX-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 Usage: Breast augmentation and Breast reconstruction

  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.

• 2019-09-11Open, ClassifiedUnknown/Undetermined by firm

  Natrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate Profile, Sterile, for the following style numbers: Style 110:110-090, 110-120, 110-150, 110-180, 110-210, 110-240, 110-270, 110-300, 110-330, 110-360, 110-390, 110-420, 110-450, 110-480, 110-510; Style 115 :115-150, 115-167, 115-185, 115-203, 115-222, 115-253, 115-272, 115-290, 115-322, 115-354, 115-378, 115-401, 115-435, 115-469, 115-507, 115-547, 115-586, 115-627, 115-666, 115-716; Style 120: 120-180, 120-220, 120-260, 120-300, 120-340, 120-400, 120-440, 120-500, 120-550, 120-600, 120-650; These products may have been sold under the McGhan, Inamed or NATRELLE brands. Product Usage: Breast augmentation and Breast reconstruction

  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.

• 2019-09-11Open, ClassifiedUnknown/Undetermined by firm

  Natrelle 133 Tissue Expanders (also named style 133 BIOSPAN Tissue Expander and Mcghan Magna-Site Tissue Expander) BioCell Full Height Variable Projection with Magna-Fider Xact & 21G Needle Infusion Set, Sterile, for the following style numbers: STYLE 133FV: 133FV-11, 133FV-12, 133FV-13, 133FV-14, 133FV-15, 133FV-16; STYLE 133MV: 133MV-11, 133MV-12, 133MV-13, 133MV-14, 133MV-15, 133MV-16; STYLE 133LV: 133LV-11, 133LV-12, 133LV-13, 133LV-14, 133LV-15, 133LV-16; STYLE 133FX: 133FX-11 133FX-12 133FX-13 133FX-14 133FX-15 133FX-16 STYLE 133MX: 133MX-11, 133MX-12, 133MX-13, 133MX-14, 133MX-15, 133MX-16; STYLE 133SX: 133SX-11, 133SX-12, 133SX-13, 133SX-14, 133SX-15, 133SX-16; STYLE 133SV: 133SV-11, 133SV-12, 133SV-13, 133SV-14, 133SV-15, 133SV-16; These products may have been sold under the McGhan, Inamed or NATRELLE brands. Product Usage: intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection until the desired amount of tissue is developed.

  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.

• 2019-09-11Open, ClassifiedUnknown/Undetermined by firm

  Natrelle133 Plus Tissue Expander With/Without Suture Tabs, BioCell Full Height Variable Projection with Magna-Fider Xact & 21G Needle Infusion Set, Sterile, for the following style numbers: STYLE 133P-FV: 133P-FV-11, 133P-FV-12, 133P-FV-13, 133P-FV-14, 133P-FV-15, 133P-FV-16; STYLE 133P-MV: 133P-MV-11, 133P-MV-12, 133P-MV-13, 133P-MV-14, 133P-MV-15, 133P-MV-16; STYLE 133P-LV: 133P-LV-11, 133P-LV-12, 133P-LV-13, 133P-LV-14, 133P-LV-15, 133P-LV-16; STYLE 133P-FX: 133P-FX-11, 133P-FX-12, 133P-FX-13, 133P-FX-14, 133P-FX-15, 133P-FX-16; STYLE 133P-MX:133P-MX-11,133P-MX-12, 133P-MX-13, 133P-MX-14, 133P-MX-15, 133P-MX-16; STYLE 133P-SX: 133P-SX-11, 133P-SX-12, 133P-SX-13, 133P-SX-14, 133P-SX-15, 133P-SX-16; STYLE 133P-SV: 133P-SV-11,133P-SV-12, 133P-SV-13, 133P-SV-14, 133P-SV-15, 133P-SV-16; STYLE 133P-FV-T:133P-FV-11-T, 133P-FV-12-T, 133P-FV-13-T, 133P-FV-14-T, 133P-FV-15-T, 133P-FV-16-T; STYLE 133P-MV-T: 133P-MV-11-T, 133P-MV-12-T, 133P-MV-13-T, 133P-MV-14-T, 133P-MV-15-T, 133P-MV-16-T; STYLE 133P-LV-T: 133P-LV-11-T, 133P-LV-12-T, 133P-LV-13-T, 133P-LV-14-T, 133P-LV-15-T, 133P-LV-16-T; STYLE 133P-FX-T: 133P-FX-11-T, 133P-FX-12-T, 133P-FX-13-T, 133P-FX-14-T, 133P-FX-15-T, 133P-FX-16-T; STYLE 133P-MX-T: 133P-MX-11-T, 133P-MX-12-T, 133P-MX-13-T, 133P-MX-14-T, 133P-MX-15-T, 133P-MX-16-T; STYLE 133P-SX-T: 133P-SX-11-T, 133P-SX-12-T, 133P-SX-13-T, 133P-SX-14-T, 133P-SX-15-T, 133P-SX-16-T; STYLE 133P-SV-T: 133P-SV-11-T, 133P-SV-12-T, 133P-SV-13-T, 133P-SV-14-T, 133P-SV-15-T, 133P-SV-16-T These products may have been sold under the McGhan, Inamed or NATRELLE brands. Product Usage: intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection until the desired amount of tissue is developed

  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.

• 2019-09-11Open, ClassifiedUnknown/Undetermined by firm

  Natrelle 133 Tissue Expanders w/Suture Tabs BIOCELL Full Height Variable Projection with MAGNA-FINDEr Xact & 21G Needle Infusion Set STYLE 133FV-T: 133FV-11-T, 133FV-12-T, 133FV-13-T, 133FV-14-T, 133FV-15-T, 133FV-16-T; STYLE 133MV-T: 133MV-11-T, 133MV-12-T, 133MV-13-T, 133MV-14-T, 133MV-15-T, 133MV-16-T; STYLE 133LV-T: 133LV-11-T, 133LV-12-T, 133LV-13-T, 133LV-14-T, 133LV-15-T, 133LV-16-T; STYLE 133SV-T: 133SV-11-T, 133SV-12-T, 133SV-13-T, 133SV-14-T, 133SV-15-T, 133SV-16-T STYLE 133FX-T: 133FX-11-T, 133FX-12-T, 133FX-13-T, 133FX-14-T, 133FX-15-T, 133FX-16-T; STYLE 133MX-T: 133MX-11-T, 133MX-12-T, 133MX-13-T, 133MX-14-T, 133MX-15-T, 133MX-16-T; STYLE 133SX-T: 133SX-11-T, 133SX-12-T, 133SX-13-T, 133SX-14-T, 133SX-15-T, 133SX-16-T; Product Usage: intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection until the desired amount of tissue is developed.

  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.

• 2019-09-11Open, ClassifiedUnknown/Undetermined by firm

  McGhan Croissant-Shaped Tissue Expanders, Style 134 Product Usage: intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection until the desired amount of tissue is developed.

  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.

• 2019-09-11Open, ClassifiedUnknown/Undetermined by firm

  McGhan BioDIMENSIONAL silicone-Filled Breast Implants, style 153 Product Usage: Breast augmentation and Breast reconstruction

  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.