Natrelle Inspira Cohesive Breast ImplantsRecalls & reported problems across all models
Allergan, Inc. · 192 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names at least one Natrelle Inspira Cohesive Breast Implants model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2,949
- Deaths reported
- 0
- Injuries reported
- 2,911
- Recalls
- 1
We found 192 models of Natrelle Inspira Cohesive Breast Implants by Allergan, Inc. in the FDA's device registry (GUDID). Together they are named in 2,949 adverse event reports in the FDA's MAUDE database, received between Nov 2, 2017 and Sep 30, 2026 — classified as 2,911 injuries, 38 malfunctions.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (1,603 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Natrelle Inspira Cohesive Breast Implants recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jul 24, 2019Class IOpen, Classified
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.
Z-2453-2019 · Root cause: Unknown/Undetermined by firm · names 100 of these models · Recall details · FDA record ↗
Most reported Natrelle Inspira Cohesive Breast Implants problems
Device problems
- Device Appears to Trigger Rejection1,603
- Patient-Device Incompatibility538
- Material Rupture402
- Adverse Event Without Identified Device or Use Problem357
- Malposition of Device57
- Migration40
- Device Handling Problem21
- Difficult to Open or Remove Packaging Material21
Patient problems
- Capsular Contracture2,078
- Failure of Implant396
- Unspecified Infection193
- No Clinical Signs, Symptoms or Conditions89
- Seroma73
- Wound Dehiscence54
- Foreign Body Reaction34
- Impaired Healing32
Natrelle Inspira Cohesive Breast Implants models
192 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- Natrelle Inspira Cohesive Breast Implants SCF-415Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled126 reports
- Natrelle Inspira Cohesive Breast Implants SCX-800Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled126 reports
- Natrelle Inspira Cohesive Breast Implants SCF-450Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled123 reports
- Natrelle Inspira Cohesive Breast Implants SCF-485Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled122 reports
- Natrelle Inspira Cohesive Breast Implants SCM-405Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled106 reports
- Natrelle Inspira Cohesive Breast Implants SCF-520Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled105 reports
- Natrelle Inspira Cohesive Breast Implants SCF-560Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled94 reports
- Natrelle Inspira Cohesive Breast Implants SCF-605Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled94 reports
- Natrelle Inspira Cohesive Breast Implants SCF-365Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled90 reports
- Natrelle Inspira Cohesive Breast Implants SCF-385Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled88 reports
- Natrelle Inspira Cohesive Breast Implants SCF-650Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled61 reports
- Natrelle Inspira Cohesive Breast Implants SCX-700Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled61 reports
- Natrelle Inspira Cohesive Breast Implants SCM-445Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled60 reports
- Natrelle Inspira Cohesive Breast Implants SCX-580Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled60 reports
- Natrelle Inspira Cohesive Breast Implants SCM-485Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled58 reports
- Natrelle Inspira Cohesive Breast Implants SCX-615Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled56 reports
- Natrelle Inspira Cohesive Breast Implants TCF-385Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall6 reports
- Natrelle Inspira Cohesive Breast Implants SCX-650Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled55 reports
- Natrelle Inspira Cohesive Breast Implants TCM-275Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall5 reports
- Natrelle Inspira Cohesive Breast Implants TCM-310Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall5 reports
- Natrelle Inspira Cohesive Breast Implants TCM-330Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall5 reports
- Natrelle Inspira Cohesive Breast Implants TCM-445Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall5 reports
- Natrelle Inspira Cohesive Breast Implants TCX-560Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall5 reports
- Natrelle Inspira Cohesive Breast Implants TCX-800Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall5 reports
- Natrelle Inspira Cohesive Breast Implants TCL-260Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall4 reports
- Natrelle Inspira Cohesive Breast Implants TCM-560Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall4 reports
- Natrelle Inspira Cohesive Breast Implants TCF-365Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall3 reports
- Natrelle Inspira Cohesive Breast Implants TCF-450Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall3 reports
- Natrelle Inspira Cohesive Breast Implants TCF-485Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall3 reports
- Natrelle Inspira Cohesive Breast Implants TCF-560Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall3 reports
- Natrelle Inspira Cohesive Breast Implants TCX-400Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall3 reports
- Natrelle Inspira Cohesive Breast Implants TCM-375Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall2 reports
- Natrelle Inspira Cohesive Breast Implants TCM-405Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall2 reports
- Natrelle Inspira Cohesive Breast Implants TCM-520Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall2 reports
- Natrelle Inspira Cohesive Breast Implants TCF-295Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall2 reports
- Natrelle Inspira Cohesive Breast Implants TCF-335Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall2 reports
- Natrelle Inspira Cohesive Breast Implants TCF-520Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall2 reports
- Natrelle Inspira Cohesive Breast Implants TCF-605Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall2 reports
- Natrelle Inspira Cohesive Breast Implants TCF-695Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall2 reports
- Natrelle Inspira Cohesive Breast Implants SCM-375Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled51 reports
- Natrelle Inspira Cohesive Breast Implants TCL-290Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall1 report
- Natrelle Inspira Cohesive Breast Implants TCLP-280Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall1 report
- Natrelle Inspira Cohesive Breast Implants TCLP-300Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall1 report
- Natrelle Inspira Cohesive Breast Implants TCLP-400Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall1 report
- Natrelle Inspira Cohesive Breast Implants TCLP-490Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall1 report
- Natrelle Inspira Cohesive Breast Implants TCM-295Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall1 report
- Natrelle Inspira Cohesive Breast Implants TCM-345Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall1 report
- Natrelle Inspira Cohesive Breast Implants TCM-485Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall1 report
- Natrelle Inspira Cohesive Breast Implants TCM-600Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall1 report
- Natrelle Inspira Cohesive Breast Implants TCF-650Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall1 report
- Natrelle Inspira Cohesive Breast Implants TCF-745Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall1 report
- Natrelle Inspira Cohesive Breast Implants TCX-525Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall1 report
- Natrelle Inspira Cohesive Breast Implants TCX-650Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall1 report
- Natrelle Inspira Cohesive Breast Implants TCX-750Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall1 report
- Natrelle Inspira Cohesive Breast Implants SCM-345Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled50 reports
- Natrelle Inspira Cohesive Breast Implants SCX-750Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled50 reports
- Natrelle Inspira Cohesive Breast Implants TCL-110Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall0 reports
- Natrelle Inspira Cohesive Breast Implants TCL-125Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall0 reports
- Natrelle Inspira Cohesive Breast Implants TCL-140Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall0 reports
- Natrelle Inspira Cohesive Breast Implants TCL-170Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall0 reports
- Natrelle Inspira Cohesive Breast Implants TCL-200Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall0 reports
- Natrelle Inspira Cohesive Breast Implants TCL-230Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall0 reports
- Natrelle Inspira Cohesive Breast Implants TCL-320Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall0 reports
- Natrelle Inspira Cohesive Breast Implants TCL-350Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall0 reports
- Natrelle Inspira Cohesive Breast Implants TCL-380Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall0 reports
- Natrelle Inspira Cohesive Breast Implants TCL-410Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall0 reports
- Natrelle Inspira Cohesive Breast Implants TCL-460Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall0 reports
- Natrelle Inspira Cohesive Breast Implants TCL-510Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall0 reports
- Natrelle Inspira Cohesive Breast Implants TCL-560Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall0 reports
- Natrelle Inspira Cohesive Breast Implants TCL-610Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall0 reports
- Natrelle Inspira Cohesive Breast Implants TCLP-125Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall0 reports
- Natrelle Inspira Cohesive Breast Implants TCLP-145Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall0 reports
- Natrelle Inspira Cohesive Breast Implants TCLP-165Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall0 reports
- Natrelle Inspira Cohesive Breast Implants TCLP-190Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall0 reports
- Natrelle Inspira Cohesive Breast Implants TCLP-205Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall0 reports
- Natrelle Inspira Cohesive Breast Implants TCLP-220Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall0 reports
- Natrelle Inspira Cohesive Breast Implants TCLP-235Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall0 reports
- Natrelle Inspira Cohesive Breast Implants TCLP-250Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall0 reports
- Natrelle Inspira Cohesive Breast Implants TCLP-265Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall0 reports
- Natrelle Inspira Cohesive Breast Implants TCLP-320Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall0 reports
- Natrelle Inspira Cohesive Breast Implants TCLP-340Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall0 reports
- Natrelle Inspira Cohesive Breast Implants TCLP-360Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall0 reports
- Natrelle Inspira Cohesive Breast Implants TCLP-440Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall0 reports
- Natrelle Inspira Cohesive Breast Implants TCLP-540Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall0 reports
- Natrelle Inspira Cohesive Breast Implants TCLP-590Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall0 reports
- Natrelle Inspira Cohesive Breast Implants TCLP-640Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall0 reports
- Natrelle Inspira Cohesive Breast Implants TCM-140Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall0 reports
- Natrelle Inspira Cohesive Breast Implants TCM-175Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall0 reports
- Natrelle Inspira Cohesive Breast Implants TCM-195Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall0 reports
- Natrelle Inspira Cohesive Breast Implants TCM-210Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall0 reports
- Natrelle Inspira Cohesive Breast Implants TCM-240Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall0 reports
- Natrelle Inspira Cohesive Breast Implants TCM-255Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall0 reports
- Natrelle Inspira Cohesive Breast Implants TCM-360Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall0 reports
- Natrelle Inspira Cohesive Breast Implants TCM-640Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall0 reports
- Natrelle Inspira Cohesive Breast Implants TCM-685Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall0 reports
- Natrelle Inspira Cohesive Breast Implants TCM-755Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall0 reports
- Natrelle Inspira Cohesive Breast Implants TCF-180Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall0 reports
- Natrelle Inspira Cohesive Breast Implants TCF-200Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall0 reports
- Natrelle Inspira Cohesive Breast Implants TCF-220Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall0 reports
- Natrelle Inspira Cohesive Breast Implants TCF-240Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall0 reports
Recent Natrelle Inspira Cohesive Breast Implants adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Material Rupture
Healthcare professional reported "rupture". This record is for the left side. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949061 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Healthcare professional reported ¿Wound dehiscence" and "scabbing¿. This record is for the right side. Device was explanted.
Patient problems: Wound Dehiscence
MAUDE report 50943604 ↗InjurySep 29, 2026Malposition of Device
Healthcare professional reported "Flipping¿. This record is for the left side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933550 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Healthcare professional reported "Back Pain - Downsize Implant". This record is for the left side. Device was explanted.
Patient problems: Back pain
MAUDE report 50921100 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Healthcare professional reported "Back Pain - Downsize Implant." This record is for the right side. Device was explanted.
Patient problems: Back pain
MAUDE report 50920577 ↗InjurySep 28, 2026Material Rupture
Healthcare professional reported Ruptured implants, "One is capsular and the other one is intracapsular", "Textured, cohesive" and "I lost significant amount of weight". This record is for the right side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918261 ↗InjurySep 28, 2026Material Rupture
Healthcare professional reported Ruptured implants, "One is capsular and the other one is intracapsular", "Textured, cohesive" and "I lost significant amount of weight". This record is for the left side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918213 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Seroma
MAUDE report 50905344 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
Healthcare Professional reported "Dehiscence". This record is for the left side. Device has been explanted.
Patient problems: Wound Dehiscence
MAUDE report 50889721 ↗InjurySep 24, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Grade IV capsular contracture" against the left side. The device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50889287 ↗InjurySep 24, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Grade IV capsular contracture" against the right side. The device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50889168 ↗InjurySep 24, 2026Device Appears to Trigger Rejection
Healthcare professional reported Capsular contracture Baker Grade IV. This record is for the right side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50885258 ↗InjurySep 24, 2026Device Appears to Trigger Rejection
Healthcare professional reported Capsular contracture Baker Grade IV. This record is for the left side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50885198 ↗InjurySep 24, 2026Device Appears to Trigger Rejection
Healthcare professional reported "seroma" and "capsular contracture baker grade III" against the left side record. The device remains implanted.
Patient problems: Capsular Contracture; Seroma
MAUDE report 50884972 ↗InjurySep 24, 2026Device Appears to Trigger Rejection
healthcare professional reported "capsular contracture baker grade III" against the right side record. The device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50884657 ↗
Other Allergan, Inc. products
- Natrelle Breast Implants1,167 models · 38,972 reports · 7 recalls
- Natrelle INSPIRA Breast Implants197 models · 15,057 reports · 1 recall
- NATRELLE Saline-Filled Breast Implants103 models · 7,892 reports · 1 recall
- Natrelle Inspira SoftTouch Breast Implants195 models · 6,571 reports · 1 recall
- NATRELLE Silicone-Filled Breast Implants128 models · 4,507 reports · 1 recall
- JUVEDERM ULTRA XC3 models · 550 reports
- JUVEDERM ULTRA PLUS XC2 models · 324 reports
- Natrelle 133S Tissue Expanders25 models · 319 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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