Natrelle Breast ImplantsRecalls & reported problems across all models
Allergan, Inc. · 1,167 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
7 open recalls name at least one Natrelle Breast Implants model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 38,972
- Deaths reported
- 4
- Injuries reported
- 38,610
- Recalls
- 7
We found 1,167 models of Natrelle Breast Implants by Allergan, Inc. in the FDA's device registry (GUDID). Together they are named in 38,972 adverse event reports in the FDA's MAUDE database, received between Sep 30, 2011 and Sep 30, 2026 — classified as 4 deaths, 38,610 injuries, 358 malfunctions.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (17,076 reports).
7 FDA recall records name at least one of these models by its device identifier, 7 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 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-2457-2019 · Root cause: Unknown/Undetermined by firm · names 42 of these models · Recall details · FDA record ↗
- 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-2456-2019 · Root cause: Unknown/Undetermined by firm · names 84 of these models · Recall details · FDA record ↗
- 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-2455-2019 · Root cause: Unknown/Undetermined by firm · names 42 of these models · Recall details · FDA record ↗
- 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-2454-2019 · Root cause: Unknown/Undetermined by firm · names 46 of these models · Recall details · FDA record ↗
- 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 299 of these models · Recall details · FDA record ↗
- 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-2452-2019 · Root cause: Unknown/Undetermined by firm · names 118 of these models · Recall details · FDA record ↗
- 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-2451-2019 · Root cause: Unknown/Undetermined by firm · names 48 of these models · Recall details · FDA record ↗
Most reported Natrelle Breast Implants problems
Device problems
- Device Appears to Trigger Rejection17,076
- Material Rupture7,719
- Fluid/Blood Leak6,897
- Patient-Device Incompatibility6,296
- Adverse Event Without Identified Device or Use Problem1,971
- No Apparent Adverse Event318
- Migration274
- Malposition of Device238
Patient problems
- Capsular Contracture23,050
- Failure of Implant12,018
- No Clinical Signs, Symptoms or Conditions1,969
- Unspecified Infection1,071
- Seroma805
- Wound Dehiscence212
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available170
- Foreign Body Reaction132
Natrelle Breast Implants models
1,167 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 Saline-Filled Breast Implants 68-360Prosthesis, Breast, Inflatable, Internal, Saline580 reports
- Natrelle INSPIRA Breast Implants SRM-405Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled546 reports
- NATRELLE Saline-Filled Breast Implants 68-330Prosthesis, Breast, Inflatable, Internal, Saline528 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 Saline-Filled Breast Implants 68-390Prosthesis, Breast, Inflatable, Internal, Saline446 reports
- NATRELLE Saline-Filled Breast Implants 68-420Prosthesis, Breast, Inflatable, Internal, Saline443 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 Saline-Filled Breast Implants 68-300Prosthesis, Breast, Inflatable, Internal, Saline379 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 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 Breast Implants SRM-330Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled324 reports
- NATRELLE Saline-Filled Breast Implants 68-450Prosthesis, Breast, Inflatable, Internal, Saline323 reports
- NATRELLE Saline-Filled Breast Implants 68-480Prosthesis, Breast, Inflatable, Internal, Saline322 reports
- NATRELLE Saline-Filled Breast Implants 68-510Prosthesis, Breast, Inflatable, Internal, Saline297 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 SoftTouch Breast Implants SSF-385Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled289 reports
- NATRELLE Saline-Filled Breast Implants 68HP-350Prosthesis, Breast, Inflatable, Internal, Saline288 reports
- Natrelle INSPIRA Breast Implants SRF-295Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled278 reports
- NATRELLE Saline-Filled Breast Implants 68HP-500Prosthesis, Breast, Inflatable, Internal, Saline270 reports
- Natrelle INSPIRA Breast Implants SRF-325Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled269 reports
- Natrelle Inspira SoftTouch Breast Implants SSM-405Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled266 reports
- NATRELLE Saline-Filled Breast Implants 68HP-400Prosthesis, Breast, Inflatable, Internal, Saline265 reports
- Natrelle INSPIRA Breast Implants SRM-485Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled259 reports
- NATRELLE Saline-Filled Breast Implants 68-270Prosthesis, Breast, Inflatable, Internal, Saline243 reports
- NATRELLE Saline-Filled Breast Implants 68HP-465Prosthesis, Breast, Inflatable, Internal, Saline243 reports
- Natrelle INSPIRA Breast Implants SRM-295Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled243 reports
- NATRELLE Saline-Filled Breast Implants 68HP-425Prosthesis, Breast, Inflatable, Internal, Saline237 reports
- NATRELLE Saline-Filled Breast Implants 68-550Prosthesis, Breast, Inflatable, Internal, Saline235 reports
- Natrelle Inspira SoftTouch Breast Implants SSF-485Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled235 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 Saline-Filled Breast Implants 68HP-550Prosthesis, Breast, Inflatable, Internal, Saline218 reports
- Natrelle INSPIRA Breast Implants SRM-255Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled214 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 Breast Implants SRX-400Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled206 reports
- Natrelle Inspira SoftTouch Breast Implants SSM-375Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled205 reports
- NATRELLE Silicone-Filled Breast Implants 115-290Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall151 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 Silicone-Filled Breast Implants 15-371Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled191 reports
- NATRELLE Silicone-Filled Breast Implants 15-339Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled188 reports
- NATRELLE Silicone-Filled Breast Implants 115-322Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall137 reports
- Natrelle INSPIRA Breast Implants SRX-800Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled187 reports
- NATRELLE Silicone-Filled Breast Implants 15-304Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 death183 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 Saline-Filled Breast Implants 68HP-600Prosthesis, Breast, Inflatable, Internal, Saline173 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 Saline-Filled Breast Implants 68HP-320Prosthesis, Breast, Inflatable, Internal, Saline168 reports
- NATRELLE Saline-Filled Breast Implants 68-240Prosthesis, Breast, Inflatable, Internal, Saline162 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 SoftTouch Breast Implants SSF-345Prosthesis, 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 Silicone-Filled Breast Implants 15-397Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled156 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 Silicone-Filled Breast Implants 115-354Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall96 reports
- Natrelle INSPIRA Breast Implants SRX-375Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled145 reports
- Natrelle Inspira SoftTouch Breast Implants SSF-325Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled143 reports
- Natrelle INSPIRA Breast Implants SRX-420Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled137 reports
- Natrelle Inspira SoftTouch Breast Implants SSM-360Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled135 reports
- NATRELLE Saline-Filled Breast Implants 68HP-800Prosthesis, Breast, Inflatable, Internal, Saline133 reports
- NATRELLE Silicone-Filled Breast Implants 15-421Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled133 reports
- Natrelle INSPIRA Breast Implants SRX-525Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled133 reports
- NATRELLE Silicone-Filled Breast Implants 115-272Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall80 reports
- Natrelle Inspira SoftTouch Breast Implants SSM-275Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled129 reports
- NATRELLE Silicone-Filled Breast Implants 20-400Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled128 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 Silicone-Filled Breast Implants 115-253Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall76 reports
- 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 SoftTouch Breast Implants SSM-485Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled125 reports
- Natrelle INSPIRA Breast Implants SRM-210Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled123 reports
- Natrelle Inspira Cohesive Breast Implants SCF-450Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled123 reports
- NATRELLE Saline-Filled Breast Implants 68-600Prosthesis, Breast, Inflatable, Internal, Saline122 reports
- Natrelle Inspira Cohesive Breast Implants SCF-485Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled122 reports
- Natrelle Inspira SoftTouch Breast Implants SSF-295Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled121 reports
- NATRELLE Silicone-Filled Breast Implants 15-457Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled117 reports
- Natrelle INSPIRA Breast Implants SRM-600Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled115 reports
- NATRELLE Silicone-Filled Breast Implants 115-378Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall63 reports
- NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants FX-410495Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall62 reports
- Natrelle INSPIRA Breast Implants TRM-405Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall61 reports
Recent Natrelle 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, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952942 ↗InjurySep 30, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952872 ↗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 50952789 ↗InjurySep 30, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952555 ↗InjurySep 30, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture
MAUDE report 50952540 ↗InjurySep 30, 2026Material Rupture
Healthcare professional, through company representative, reported "rupture". The inner silicone gel touch the patient. This record is for the right side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951661 ↗InjurySep 30, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture
MAUDE report 50951318 ↗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, 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, 2026Fluid/Blood Leak
Healthcare professional reported ¿deflation¿. This record is for the right side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950160 ↗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 ↗
Other Allergan, Inc. products
- 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
- 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, combining the brand names used for this product line.
- 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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