Natrelle Inspira SoftTouch Breast ImplantsRecalls & reported problems across all models
Allergan, Inc. · 195 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Natrelle Inspira SoftTouch Breast Implants model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 6,571
- Deaths reported
- 0
- Injuries reported
- 6,496
- Recalls
- 1
We found 195 models of Natrelle Inspira SoftTouch Breast Implants by Allergan, Inc. in the FDA's device registry (GUDID). Together they are named in 6,571 adverse event reports in the FDA's MAUDE database, received between Mar 21, 2018 and Sep 30, 2026 — classified as 6,496 injuries, 75 malfunctions.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (4,339 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 SoftTouch 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, 2019Open, 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 SoftTouch Breast Implants problems
Device problems
- Device Appears to Trigger Rejection4,339
- Patient-Device Incompatibility999
- Material Rupture772
- Adverse Event Without Identified Device or Use Problem435
- Malposition of Device72
- Migration63
- No Apparent Adverse Event41
- Difficult to Open or Remove Packaging Material39
Patient problems
- Capsular Contracture5,252
- Failure of Implant624
- Unspecified Infection306
- No Clinical Signs, Symptoms or Conditions209
- Seroma120
- Wound Dehiscence59
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available50
- Foreign Body Reaction37
Natrelle Inspira SoftTouch Breast Implants models
195 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- Natrelle Inspira SoftTouch Breast Implants SSF-450Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled348 reports
- Natrelle Inspira SoftTouch Breast Implants SSF-415Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled330 reports
- Natrelle Inspira SoftTouch Breast Implants SSF-385Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled289 reports
- Natrelle Inspira SoftTouch Breast Implants SSM-405Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled266 reports
- Natrelle Inspira SoftTouch Breast Implants SSF-485Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled235 reports
- Natrelle Inspira SoftTouch Breast Implants SSF-365Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled212 reports
- Natrelle Inspira SoftTouch Breast Implants SSM-310Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled211 reports
- Natrelle Inspira SoftTouch Breast Implants SSM-375Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled205 reports
- Natrelle Inspira SoftTouch Breast Implants SSF-520Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled200 reports
- Natrelle Inspira SoftTouch Breast Implants SSM-445Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled195 reports
- Natrelle Inspira SoftTouch Breast Implants SSM-345Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled179 reports
- Natrelle Inspira SoftTouch Breast Implants SSF-560Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled175 reports
- Natrelle Inspira SoftTouch Breast Implants SSF-345Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled159 reports
- Natrelle Inspira SoftTouch Breast Implants SSM-330Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled153 reports
- Natrelle Inspira SoftTouch Breast Implants SSF-605Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled152 reports
- Natrelle Inspira SoftTouch Breast Implants SSF-325Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled143 reports
- Natrelle Inspira SoftTouch Breast Implants SSM-360Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled135 reports
- Natrelle Inspira SoftTouch Breast Implants SSM-275Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled129 reports
- Natrelle Inspira SoftTouch Breast Implants SSM-485Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled125 reports
- Natrelle Inspira SoftTouch Breast Implants SSF-295Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled121 reports
- Natrelle Inspira SoftTouch Breast Implants SSM-255Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled111 reports
- Natrelle Inspira SoftTouch Breast Implants SSF-650Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled101 reports
- Natrelle Inspira SoftTouch Breast Implants SSM-520Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled98 reports
- Natrelle Inspira SoftTouch Breast Implants SSX-445Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled86 reports
- Natrelle Inspira SoftTouch Breast Implants SSM-240Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled85 reports
- Natrelle Inspira SoftTouch Breast Implants SSM-295Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled84 reports
- Natrelle Inspira SoftTouch Breast Implants SSX-800Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled84 reports
- Natrelle Inspira SoftTouch Breast Implants SSX-650Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled83 reports
- Natrelle Inspira SoftTouch Breast Implants SSX-400Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled66 reports
- Natrelle Inspira SoftTouch Breast Implants SSF-265Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled65 reports
- Natrelle Inspira SoftTouch Breast Implants SSX-495Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled65 reports
- Natrelle Inspira SoftTouch Breast Implants SSF-335Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled63 reports
- Natrelle Inspira SoftTouch Breast Implants SSM-560Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled61 reports
- Natrelle Inspira SoftTouch Breast Implants TSF-295Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall10 reports
- Natrelle Inspira SoftTouch Breast Implants TSX-310Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall9 reports
- Natrelle Inspira SoftTouch Breast Implants SSX-525Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled58 reports
- Natrelle Inspira SoftTouch Breast Implants SSX-545Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled58 reports
- Natrelle Inspira SoftTouch Breast Implants TSM-275Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall8 reports
- Natrelle Inspira SoftTouch Breast Implants TSF-415Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall8 reports
- Natrelle Inspira SoftTouch Breast Implants TSX-340Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall8 reports
- Natrelle Inspira SoftTouch Breast Implants TSM-360Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall7 reports
- Natrelle Inspira SoftTouch Breast Implants TSM-485Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall7 reports
- Natrelle Inspira SoftTouch Breast Implants TSF-450Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall7 reports
- Natrelle Inspira SoftTouch Breast Implants SSX-700Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled56 reports
- Natrelle Inspira SoftTouch Breast Implants TSM-330Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall5 reports
- Natrelle Inspira SoftTouch Breast Implants TSM-405Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall5 reports
- Natrelle Inspira SoftTouch Breast Implants TSF-240Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall5 reports
- Natrelle Inspira SoftTouch Breast Implants TSF-265Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall5 reports
- Natrelle Inspira SoftTouch Breast Implants TSF-365Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall5 reports
- Natrelle Inspira SoftTouch Breast Implants TSF-345Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall4 reports
- Natrelle Inspira SoftTouch Breast Implants TSF-385Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall4 reports
- Natrelle Inspira SoftTouch Breast Implants TSX-470Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall4 reports
- Natrelle Inspira SoftTouch Breast Implants SSX-580Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled53 reports
- Natrelle Inspira SoftTouch Breast Implants SSX-615Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled53 reports
- Natrelle Inspira SoftTouch Breast Implants TSM-240Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall3 reports
- Natrelle Inspira SoftTouch Breast Implants TSM-310Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall3 reports
- Natrelle Inspira SoftTouch Breast Implants TSM-375Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall3 reports
- Natrelle Inspira SoftTouch Breast Implants TSM-445Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall3 reports
- Natrelle Inspira SoftTouch Breast Implants TSF-335Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall3 reports
- Natrelle Inspira SoftTouch Breast Implants TSF-485Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall3 reports
- Natrelle Inspira SoftTouch Breast Implants TSX-375Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall3 reports
- Natrelle Inspira SoftTouch Breast Implants SSM-210Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled52 reports
- Natrelle Inspira SoftTouch Breast Implants SSX-470Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled52 reports
- Natrelle Inspira SoftTouch Breast Implants TSL-260Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall2 reports
- Natrelle Inspira SoftTouch Breast Implants TSLP-205Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall2 reports
- Natrelle Inspira SoftTouch Breast Implants TSM-255Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall2 reports
- Natrelle Inspira SoftTouch Breast Implants TSM-345Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall2 reports
- Natrelle Inspira SoftTouch Breast Implants TSF-220Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall2 reports
- Natrelle Inspira SoftTouch Breast Implants TSF-520Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall2 reports
- Natrelle Inspira SoftTouch Breast Implants TSX-255Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall2 reports
- Natrelle Inspira SoftTouch Breast Implants TSX-420Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall2 reports
- Natrelle Inspira SoftTouch Breast Implants TSX-525Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall2 reports
- Natrelle Inspira SoftTouch Breast Implants SSX-750Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled51 reports
- Natrelle Inspira SoftTouch Breast Implants TSL-125Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall1 report
- Natrelle Inspira SoftTouch Breast Implants TSLP-165Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall1 report
- Natrelle Inspira SoftTouch Breast Implants TSLP-190Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall1 report
- Natrelle Inspira SoftTouch Breast Implants TSLP-250Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall1 report
- Natrelle Inspira SoftTouch Breast Implants TSLP-440Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall1 report
- Natrelle Inspira SoftTouch Breast Implants TSM-295Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall1 report
- Natrelle Inspira SoftTouch Breast Implants TSM-560Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall1 report
- Natrelle Inspira SoftTouch Breast Implants TSM-600Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall1 report
- Natrelle Inspira SoftTouch Breast Implants TSF-180Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall1 report
- Natrelle Inspira SoftTouch Breast Implants TSF-605Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall1 report
- Natrelle Inspira SoftTouch Breast Implants TSF-650Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall1 report
- Natrelle Inspira SoftTouch Breast Implants TSX-285Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall1 report
- Natrelle Inspira SoftTouch Breast Implants TSX-400Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall1 report
- Natrelle Inspira SoftTouch Breast Implants TSX-495Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall1 report
- Natrelle Inspira SoftTouch Breast Implants TSX-580Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall1 report
- Natrelle Inspira SoftTouch Breast Implants TSX-615Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall1 report
- Natrelle Inspira SoftTouch Breast Implants TSX-650Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall1 report
- Natrelle Inspira SoftTouch Breast Implants TSL-110Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall0 reports
- Natrelle Inspira SoftTouch Breast Implants TSL-140Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall0 reports
- Natrelle Inspira SoftTouch Breast Implants TSL-170Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall0 reports
- Natrelle Inspira SoftTouch Breast Implants TSL-200Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall0 reports
- Natrelle Inspira SoftTouch Breast Implants TSL-230Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall0 reports
- Natrelle Inspira SoftTouch Breast Implants TSL-290Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall0 reports
- Natrelle Inspira SoftTouch Breast Implants TSL-320Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall0 reports
- Natrelle Inspira SoftTouch Breast Implants TSL-350Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall0 reports
- Natrelle Inspira SoftTouch Breast Implants TSL-380Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall0 reports
- Natrelle Inspira SoftTouch Breast Implants TSL-410Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall0 reports
Recent Natrelle Inspira SoftTouch 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, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture
MAUDE report 50952822 ↗InjurySep 30, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture
MAUDE report 50952540 ↗InjurySep 30, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Capsular contracture". Healthcare professional then reported "Baker Grade 2" and then reported "Baker Grade 3". This record is for the left side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50951043 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50950102 ↗InjurySep 30, 2026Device Appears to Trigger Rejection
Healthcare professional reported "cloudy". Later, healthcare professional reported "capsular contracture Baker grade 4". This record is for the left side. The device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50948882 ↗InjurySep 30, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Capsular Contracture Baker grade IV" and Pain. Patient received Singulair and Quercetin as treatment. This report is for the right side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50947823 ↗InjurySep 30, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Capsular Contracture". Later Healthcare professional reported "Capsular Contracture Baker Grade III". This record is for the left side. Device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50947821 ↗InjurySep 30, 2026Material Rupture
Patient reported ¿rupture¿ and ¿device was setting higher and didn't drop". This record is for the right side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946720 ↗InjurySep 30, 2026Device Appears to Trigger Rejection
Healthcare professional reported "capsular contracture baker grade IV". This record is for the left side. Device remains implanted. Patient was prescribed Singulair and Massages.
Patient problems: Capsular Contracture
MAUDE report 50946034 ↗InjurySep 30, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture
MAUDE report 50941515 ↗InjurySep 30, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture
MAUDE report 50941462 ↗InjurySep 29, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture
MAUDE report 50939767 ↗InjurySep 29, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture
MAUDE report 50938586 ↗InjurySep 29, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937954 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50937935 ↗
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 Silicone-Filled Breast Implants128 models · 4,507 reports · 1 recall
- Natrelle Inspira Cohesive Breast Implants192 models · 2,949 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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