Natrelle INSPIRA Breast ImplantsRecalls & reported problems across all models
Allergan, Inc. · 197 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 Breast Implants model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 15,057
- Deaths reported
- 0
- Injuries reported
- 15,002
- Recalls
- 1
We found 197 models of Natrelle INSPIRA Breast Implants by Allergan, Inc. in the FDA's device registry (GUDID). Together they are named in 15,057 adverse event reports in the FDA's MAUDE database, received between Sep 11, 2017 and Sep 30, 2026 — classified as 15,002 injuries, 55 malfunctions.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (8,618 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 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 98 of these models · Recall details · FDA record ↗
Most reported Natrelle INSPIRA Breast Implants problems
Device problems
- Device Appears to Trigger Rejection8,618
- Patient-Device Incompatibility3,538
- Material Rupture2,958
- Adverse Event Without Identified Device or Use Problem476
- No Apparent Adverse Event102
- Migration80
- Device Handling Problem67
- Malposition of Device61
Patient problems
- Capsular Contracture12,034
- Failure of Implant2,285
- No Clinical Signs, Symptoms or Conditions347
- Unspecified Infection276
- Seroma201
- Wound Dehiscence65
- Foreign Body Reaction48
- Swollen Lymph Nodes38
Natrelle INSPIRA Breast Implants models
197 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- Natrelle INSPIRA Breast Implants SRF-450Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled748 reports
- Natrelle INSPIRA Breast Implants SRF-415Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled730 reports
- Natrelle INSPIRA Breast Implants SRM-405Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled546 reports
- Natrelle INSPIRA Breast Implants SRF-385Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled499 reports
- Natrelle INSPIRA Breast Implants SRF-520Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled479 reports
- Natrelle INSPIRA Breast Implants SRF-485Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled475 reports
- Natrelle INSPIRA Breast Implants SRM-375Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled441 reports
- Natrelle INSPIRA Breast Implants SRM-445Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled434 reports
- Natrelle INSPIRA Breast Implants SRM-345Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled410 reports
- Natrelle INSPIRA Breast Implants SRF-365Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled403 reports
- Natrelle INSPIRA Breast Implants SRF-560Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled387 reports
- Natrelle INSPIRA Breast Implants SRF-345Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled384 reports
- Natrelle INSPIRA Breast Implants SRM-310Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled370 reports
- Natrelle INSPIRA Breast Implants SRM-360Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled353 reports
- Natrelle INSPIRA Breast Implants SRM-330Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled324 reports
- Natrelle INSPIRA Breast Implants SRF-605Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled297 reports
- Natrelle INSPIRA Breast Implants SRM-275Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled289 reports
- Natrelle INSPIRA Breast Implants SRF-295Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled278 reports
- Natrelle INSPIRA Breast Implants SRF-325Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled269 reports
- Natrelle INSPIRA Breast Implants SRM-485Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled259 reports
- Natrelle INSPIRA Breast Implants SRM-295Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled243 reports
- Natrelle INSPIRA Breast Implants SRX-445Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled226 reports
- Natrelle INSPIRA Breast Implants SRM-520Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled220 reports
- Natrelle INSPIRA Breast Implants SRM-255Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled214 reports
- Natrelle INSPIRA Breast Implants SRX-400Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled206 reports
- Natrelle INSPIRA Breast Implants SRX-800Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled187 reports
- Natrelle INSPIRA Breast Implants SRX-495Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled172 reports
- Natrelle INSPIRA Breast Implants SRF-650Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled171 reports
- Natrelle INSPIRA Breast Implants SRF-265Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled170 reports
- Natrelle INSPIRA Breast Implants SRM-560Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled162 reports
- Natrelle INSPIRA Breast Implants SRX-470Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled159 reports
- Natrelle INSPIRA Breast Implants SRM-240Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled157 reports
- Natrelle INSPIRA Breast Implants SRX-650Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled157 reports
- Natrelle INSPIRA Breast Implants SRX-375Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled145 reports
- Natrelle INSPIRA Breast Implants SRX-420Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled137 reports
- Natrelle INSPIRA Breast Implants SRX-525Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled133 reports
- Natrelle INSPIRA Breast Implants SRX-340Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled128 reports
- Natrelle INSPIRA Breast Implants SRX-580Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled128 reports
- Natrelle INSPIRA Breast Implants SRM-210Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled123 reports
- Natrelle INSPIRA Breast Implants SRM-600Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled115 reports
- Natrelle INSPIRA Breast Implants TRM-405Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall61 reports
- Natrelle INSPIRA Breast Implants SRX-560Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled109 reports
- Natrelle INSPIRA Breast Implants SRX-615Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled109 reports
- Natrelle INSPIRA Breast Implants SRX-545Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled108 reports
- Natrelle INSPIRA Breast Implants SRF-240Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled104 reports
- Natrelle INSPIRA Breast Implants TRF-415Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall53 reports
- Natrelle INSPIRA Breast Implants SRX-700Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled102 reports
- Natrelle INSPIRA Breast Implants SRF-695Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled97 reports
- Natrelle INSPIRA Breast Implants SRF-335Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled96 reports
- Natrelle INSPIRA Breast Implants TRM-445Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall42 reports
- Natrelle INSPIRA Breast Implants TRM-375Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall37 reports
- Natrelle INSPIRA Breast Implants TRM-240Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall36 reports
- Natrelle INSPIRA Breast Implants SRX-750Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled85 reports
- Natrelle INSPIRA Breast Implants TRF-450Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall34 reports
- Natrelle INSPIRA Breast Implants TRF-520Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall32 reports
- Natrelle INSPIRA Breast Implants TRM-345Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall31 reports
- Natrelle INSPIRA Breast Implants TRM-275Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall29 reports
- Natrelle INSPIRA Breast Implants TRM-310Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall29 reports
- Natrelle INSPIRA Breast Implants TRF-365Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall27 reports
- Natrelle INSPIRA Breast Implants TRF-385Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall26 reports
- Natrelle INSPIRA Breast Implants TRM-360Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall24 reports
- Natrelle INSPIRA Breast Implants TRM-485Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall24 reports
- Natrelle INSPIRA Breast Implants TRM-295Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall23 reports
- Natrelle INSPIRA Breast Implants SRF-770Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled72 reports
- Natrelle INSPIRA Breast Implants TRM-330Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall22 reports
- Natrelle INSPIRA Breast Implants TRF-485Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall22 reports
- Natrelle INSPIRA Breast Implants TRF-345Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall21 reports
- Natrelle INSPIRA Breast Implants TRX-800Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall20 reports
- Natrelle INSPIRA Breast Implants TRM-255Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall19 reports
- Natrelle INSPIRA Breast Implants TRF-295Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall19 reports
- Natrelle INSPIRA Breast Implants TRF-605Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall19 reports
- Natrelle INSPIRA Breast Implants SRM-640Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled66 reports
- Natrelle INSPIRA Breast Implants TRM-520Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall15 reports
- Natrelle INSPIRA Breast Implants TRF-325Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall13 reports
- Natrelle INSPIRA Breast Implants TRF-560Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall13 reports
- Natrelle INSPIRA Breast Implants TRF-695Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall13 reports
- Natrelle INSPIRA Breast Implants TRX-495Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall13 reports
- Natrelle INSPIRA Breast Implants SRF-745Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled62 reports
- Natrelle INSPIRA Breast Implants TRX-615Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall12 reports
- Natrelle INSPIRA Breast Implants SRX-310Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled61 reports
- Natrelle INSPIRA Breast Implants TRM-560Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall11 reports
- Natrelle INSPIRA Breast Implants TRX-340Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall11 reports
- Natrelle INSPIRA Breast Implants TRX-400Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall11 reports
- Natrelle INSPIRA Breast Implants TRX-445Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall11 reports
- Natrelle INSPIRA Breast Implants SRF-220Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled59 reports
- Natrelle INSPIRA Breast Implants TRX-470Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall9 reports
- Natrelle INSPIRA Breast Implants SRF-200Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled58 reports
- Natrelle INSPIRA Breast Implants TRM-600Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall8 reports
- Natrelle INSPIRA Breast Implants TRF-650Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall8 reports
- Natrelle INSPIRA Breast Implants TRX-420Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall8 reports
- Natrelle INSPIRA Breast Implants TRX-750Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall8 reports
- Natrelle INSPIRA Breast Implants TRLP-190Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall7 reports
- Natrelle INSPIRA Breast Implants TRM-210Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall7 reports
- Natrelle INSPIRA Breast Implants TRX-375Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall7 reports
- Natrelle INSPIRA Breast Implants TRX-650Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall7 reports
- Natrelle INSPIRA Breast Implants TRL-260Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall6 reports
- Natrelle INSPIRA Breast Implants TRL-350Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall6 reports
- Natrelle INSPIRA Breast Implants TRLP-320Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall6 reports
- Natrelle INSPIRA Breast Implants TRLP-360Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall6 reports
- Natrelle INSPIRA Breast Implants TRX-310Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall6 reports
Recent Natrelle INSPIRA 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
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954843 ↗InjurySep 30, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture
MAUDE report 50954699 ↗InjurySep 30, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture
MAUDE report 50954612 ↗InjurySep 30, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture
MAUDE report 50952789 ↗InjurySep 30, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture
MAUDE report 50951318 ↗InjurySep 30, 2026Device Appears to Trigger Rejection
Healthcare professional reported: unspecified Baker grade capsular contracture. This record is for the left-side device. The device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50950530 ↗InjurySep 30, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture
MAUDE report 50950066 ↗InjurySep 30, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture
MAUDE report 50950022 ↗InjurySep 30, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture
MAUDE report 50949643 ↗InjurySep 30, 2026Device Appears to Trigger Rejection
Patient reported "Pain" and "sort of burning sensation". Later patient reported Capsular Contracture Baker Grade III/IV against the left side record. The device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50949615 ↗InjurySep 30, 2026Device Appears to Trigger Rejection
Healthcare professional reported "capsular contracture, Baker grade unknown, and exchange". Later, healthcare professional reported "capsular contracture Baker grade III". This record is for the left side. The device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50948921 ↗InjurySep 30, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Capsular Contracture Baker grade III" and "Impressioned the area of palpable concern related to the implants. Folds are seen suggesting capsular contracture". This record is for the right side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50947649 ↗InjurySep 30, 2026Material Rupture
Healthcare professional reported "possible rupture". This record is for the right side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947563 ↗InjurySep 30, 2026Material Rupture
Healthcare professional reported "possible rupture". This record is for the left side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947443 ↗InjurySep 30, 2026Material Rupture
Patient reported "rupture" and "felt something weird on breast". This record is for the left side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946807 ↗
Other Allergan, Inc. products
- Natrelle Breast Implants1,167 models · 38,972 reports · 7 recalls
- 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
- 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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