NATRELLE Saline-Filled Breast ImplantsRecalls & reported problems across all models
Allergan, Inc. · 103 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 Saline-Filled Breast Implants model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 7,892
- Deaths reported
- 0
- Injuries reported
- 7,813
- Recalls
- 1
We found 103 models of NATRELLE Saline-Filled Breast Implants by Allergan, Inc. in the FDA's device registry (GUDID). Together they are named in 7,892 adverse event reports in the FDA's MAUDE database, received between Sep 30, 2011 and Sep 30, 2026 — classified as 7,813 injuries, 79 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (6,554 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 Saline-Filled 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-2451-2019 · Root cause: Unknown/Undetermined by firm · names 48 of these models · Recall details · FDA record ↗
Most reported NATRELLE Saline-Filled Breast Implants problems
Device problems
- Fluid/Blood Leak6,554
- Device Appears to Trigger Rejection909
- Patient-Device Incompatibility361
- Adverse Event Without Identified Device or Use Problem125
- Material Rupture111
- Deflation Problem87
- No Apparent Adverse Event67
- Break49
Patient problems
- Failure of Implant5,927
- Capsular Contracture1,239
- No Clinical Signs, Symptoms or Conditions645
- Unspecified Infection84
- Seroma42
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available26
- No Known Impact Or Consequence To Patient21
- Complaint, Ill-Defined16
NATRELLE Saline-Filled Breast Implants models
103 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- NATRELLE Saline-Filled Breast Implants 68-360Prosthesis, Breast, Inflatable, Internal, Saline580 reports
- NATRELLE Saline-Filled Breast Implants 68-330Prosthesis, Breast, Inflatable, Internal, Saline528 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 Saline-Filled Breast Implants 68-300Prosthesis, Breast, Inflatable, Internal, Saline379 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 Saline-Filled Breast Implants 68HP-350Prosthesis, Breast, Inflatable, Internal, Saline288 reports
- NATRELLE Saline-Filled Breast Implants 68HP-500Prosthesis, Breast, Inflatable, Internal, Saline270 reports
- NATRELLE Saline-Filled Breast Implants 68HP-400Prosthesis, Breast, Inflatable, Internal, Saline265 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 Saline-Filled Breast Implants 68HP-425Prosthesis, Breast, Inflatable, Internal, Saline237 reports
- NATRELLE Saline-Filled Breast Implants 68-550Prosthesis, Breast, Inflatable, Internal, Saline235 reports
- NATRELLE Saline-Filled Breast Implants 68HP-550Prosthesis, Breast, Inflatable, Internal, Saline218 reports
- NATRELLE Saline-Filled Breast Implants 68HP-600Prosthesis, Breast, Inflatable, Internal, Saline173 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 Saline-Filled Breast Implants 68HP-800Prosthesis, Breast, Inflatable, Internal, Saline133 reports
- NATRELLE Saline-Filled Breast Implants 68-600Prosthesis, Breast, Inflatable, Internal, Saline122 reports
- NATRELLE Saline-Filled Breast Implants 68HP-650Prosthesis, Breast, Inflatable, Internal, Saline105 reports
- NATRELLE Saline-Filled Breast Implants 68HP-280Prosthesis, Breast, Inflatable, Internal, Saline97 reports
- NATRELLE Saline-Filled Breast Implants 168-390Prosthesis, Breast, Inflatable, Internal, Saline1 recall42 reports
- NATRELLE Saline-Filled Breast Implants 468-380Prosthesis, Breast, Inflatable, Internal, Saline1 recall42 reports
- NATRELLE Saline-Filled Breast Implants 168-300Prosthesis, Breast, Inflatable, Internal, Saline1 recall40 reports
- NATRELLE Saline-Filled Breast Implants 168-330Prosthesis, Breast, Inflatable, Internal, Saline1 recall40 reports
- NATRELLE Saline-Filled Breast Implants 168-360Prosthesis, Breast, Inflatable, Internal, Saline1 recall39 reports
- NATRELLE Saline-Filled Breast Implants 468-350Prosthesis, Breast, Inflatable, Internal, Saline1 recall39 reports
- NATRELLE Saline-Filled Breast Implants 468-300Prosthesis, Breast, Inflatable, Internal, Saline1 recall35 reports
- NATRELLE Saline-Filled Breast Implants 68-210Prosthesis, Breast, Inflatable, Internal, Saline84 reports
- NATRELLE Saline-Filled Breast Implants 68HP-700Prosthesis, Breast, Inflatable, Internal, Saline82 reports
- NATRELLE Saline-Filled Breast Implants 68-650Prosthesis, Breast, Inflatable, Internal, Saline78 reports
- NATRELLE Saline-Filled Breast Implants 168-420Prosthesis, Breast, Inflatable, Internal, Saline1 recall26 reports
- NATRELLE Saline-Filled Breast Implants 168-270Prosthesis, Breast, Inflatable, Internal, Saline1 recall25 reports
- NATRELLE Saline-Filled Breast Implants 168-450Prosthesis, Breast, Inflatable, Internal, Saline1 recall23 reports
- NATRELLE Saline-Filled Breast Implants 468-450Prosthesis, Breast, Inflatable, Internal, Saline1 recall23 reports
- NATRELLE Saline-Filled Breast Implants 68LP-325Prosthesis, Breast, Inflatable, Internal, Saline72 reports
- NATRELLE Saline-Filled Breast Implants 68-800Prosthesis, Breast, Inflatable, Internal, Saline71 reports
- NATRELLE Saline-Filled Breast Implants 468-270Prosthesis, Breast, Inflatable, Internal, Saline1 recall20 reports
- NATRELLE Saline-Filled Breast Implants 168-240Prosthesis, Breast, Inflatable, Internal, Saline1 recall16 reports
- NATRELLE Saline-Filled Breast Implants 168-510Prosthesis, Breast, Inflatable, Internal, Saline1 recall16 reports
- NATRELLE Saline-Filled Breast Implants 68LP-300Prosthesis, Breast, Inflatable, Internal, Saline65 reports
- NATRELLE Saline-Filled Breast Implants 168-480Prosthesis, Breast, Inflatable, Internal, Saline1 recall15 reports
- NATRELLE Saline-Filled Breast Implants 68-700Prosthesis, Breast, Inflatable, Internal, Saline63 reports
- NATRELLE Saline-Filled Breast Implants 168-550Prosthesis, Breast, Inflatable, Internal, Saline1 recall12 reports
- NATRELLE Saline-Filled Breast Implants 468-230Prosthesis, Breast, Inflatable, Internal, Saline1 recall12 reports
- NATRELLE Saline-Filled Breast Implants 68LP-350Prosthesis, Breast, Inflatable, Internal, Saline59 reports
- NATRELLE Saline-Filled Breast Implants 168-600Prosthesis, Breast, Inflatable, Internal, Saline1 recall8 reports
- NATRELLE Saline-Filled Breast Implants 168-210Prosthesis, Breast, Inflatable, Internal, Saline1 recall6 reports
- NATRELLE Saline-Filled Breast Implants 168-650Prosthesis, Breast, Inflatable, Internal, Saline1 recall6 reports
- NATRELLE Saline-Filled Breast Implants 363LF-690Prosthesis, Breast, Inflatable, Internal, Saline1 recall5 reports
- NATRELLE Saline-Filled Breast Implants 468-495Prosthesis, Breast, Inflatable, Internal, Saline1 recall5 reports
- NATRELLE Saline-Filled Breast Implants 468-560Prosthesis, Breast, Inflatable, Internal, Saline1 recall5 reports
- NATRELLE Saline-Filled Breast Implants 68HP-750Prosthesis, Breast, Inflatable, Internal, Saline54 reports
- NATRELLE Saline-Filled Breast Implants 168-800Prosthesis, Breast, Inflatable, Internal, Saline1 recall4 reports
- NATRELLE Saline-Filled Breast Implants 363LF-370Prosthesis, Breast, Inflatable, Internal, Saline1 recall4 reports
- NATRELLE Saline-Filled Breast Implants 363LF-410Prosthesis, Breast, Inflatable, Internal, Saline1 recall4 reports
- NATRELLE Saline-Filled Breast Implants 468-620Prosthesis, Breast, Inflatable, Internal, Saline1 recall4 reports
- NATRELLE Saline-Filled Breast Implants 363LF-560Prosthesis, Breast, Inflatable, Internal, Saline1 recall3 reports
- NATRELLE Saline-Filled Breast Implants 168-700Prosthesis, Breast, Inflatable, Internal, Saline1 recall2 reports
- NATRELLE Saline-Filled Breast Implants 363LF-300Prosthesis, Breast, Inflatable, Internal, Saline1 recall2 reports
- NATRELLE Saline-Filled Breast Implants 363LF-450Prosthesis, Breast, Inflatable, Internal, Saline1 recall2 reports
- NATRELLE Saline-Filled Breast Implants 363LF-510Prosthesis, Breast, Inflatable, Internal, Saline1 recall2 reports
- NATRELLE Saline-Filled Breast Implants 163-360Prosthesis, Breast, Inflatable, Internal, Saline1 recall1 report
- NATRELLE Saline-Filled Breast Implants 163-440Prosthesis, Breast, Inflatable, Internal, Saline1 recall1 report
- NATRELLE Saline-Filled Breast Implants 168-120Prosthesis, Breast, Inflatable, Internal, Saline1 recall1 report
- NATRELLE Saline-Filled Breast Implants 168-180Prosthesis, Breast, Inflatable, Internal, Saline1 recall1 report
- NATRELLE Saline-Filled Breast Implants 168-750Prosthesis, Breast, Inflatable, Internal, Saline1 recall1 report
- NATRELLE Saline-Filled Breast Implants 363LF-620Prosthesis, Breast, Inflatable, Internal, Saline1 recall1 report
- NATRELLE Saline-Filled Breast Implants 468-195Prosthesis, Breast, Inflatable, Internal, Saline1 recall1 report
- NATRELLE Saline-Filled Breast Implants 163-530Prosthesis, Breast, Inflatable, Internal, Saline1 recall0 reports
- NATRELLE Saline-Filled Breast Implants 163-655Prosthesis, Breast, Inflatable, Internal, Saline1 recall0 reports
- NATRELLE Saline-Filled Breast Implants 163-780Prosthesis, Breast, Inflatable, Internal, Saline1 recall0 reports
- NATRELLE Saline-Filled Breast Implants 168-150Prosthesis, Breast, Inflatable, Internal, Saline1 recall0 reports
- NATRELLE Saline-Filled Breast Implants 363LF-170Prosthesis, Breast, Inflatable, Internal, Saline1 recall0 reports
- NATRELLE Saline-Filled Breast Implants 363LF-200Prosthesis, Breast, Inflatable, Internal, Saline1 recall0 reports
- NATRELLE Saline-Filled Breast Implants 363LF-230Prosthesis, Breast, Inflatable, Internal, Saline1 recall0 reports
- NATRELLE Saline-Filled Breast Implants 363LF-260Prosthesis, Breast, Inflatable, Internal, Saline1 recall0 reports
- NATRELLE Saline-Filled Breast Implants 363LF-330Prosthesis, Breast, Inflatable, Internal, Saline1 recall0 reports
- NATRELLE Saline-Filled Breast Implants 68LP-250Prosthesis, Breast, Inflatable, Internal, Saline44 reports
- NATRELLE Saline-Filled Breast Implants 68LP-275Prosthesis, Breast, Inflatable, Internal, Saline41 reports
- NATRELLE Saline-Filled Breast Implants 68-180Prosthesis, Breast, Inflatable, Internal, Saline39 reports
- NATRELLE Saline-Filled Breast Implants 68HP-240Prosthesis, Breast, Inflatable, Internal, Saline34 reports
- NATRELLE Saline-Filled Breast Implants 68LP-200Prosthesis, Breast, Inflatable, Internal, Saline34 reports
- NATRELLE Saline-Filled Breast Implants 68LP-400Prosthesis, Breast, Inflatable, Internal, Saline32 reports
- NATRELLE Saline-Filled Breast Implants 68LP-440Prosthesis, Breast, Inflatable, Internal, Saline31 reports
- NATRELLE Saline-Filled Breast Implants 68-750Prosthesis, Breast, Inflatable, Internal, Saline29 reports
- NATRELLE Saline-Filled Breast Implants 68LP-225Prosthesis, Breast, Inflatable, Internal, Saline27 reports
- NATRELLE Saline-Filled Breast Implants 68LP-480Prosthesis, Breast, Inflatable, Internal, Saline25 reports
- NATRELLE Saline-Filled Breast Implants 68LP-420Prosthesis, Breast, Inflatable, Internal, Saline23 reports
- NATRELLE Saline-Filled Breast Implants 68-150Prosthesis, Breast, Inflatable, Internal, Saline20 reports
- NATRELLE Saline-Filled Breast Implants 68HP-200Prosthesis, Breast, Inflatable, Internal, Saline15 reports
- NATRELLE Saline-Filled Breast Implants 68LP-175Prosthesis, Breast, Inflatable, Internal, Saline12 reports
- NATRELLE Saline-Filled Breast Implants 68LP-150Prosthesis, Breast, Inflatable, Internal, Saline11 reports
- NATRELLE Saline-Filled Breast Implants 68HP-160Prosthesis, Breast, Inflatable, Internal, Saline9 reports
- NATRELLE Saline-Filled Breast Implants 68LP-525Prosthesis, Breast, Inflatable, Internal, Saline8 reports
- NATRELLE Saline-Filled Breast Implants 68LP-550Prosthesis, Breast, Inflatable, Internal, Saline6 reports
- NATRELLE Saline-Filled Breast Implants 68LP-600Prosthesis, Breast, Inflatable, Internal, Saline5 reports
- NATRELLE Saline-Filled Breast Implants 68-120Prosthesis, Breast, Inflatable, Internal, Saline4 reports
Recent NATRELLE Saline-Filled 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, 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, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952555 ↗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, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949912 ↗InjurySep 30, 2026Device Appears to Trigger Rejection
Healthcare professional reported no complaint against the device. Healthcare professional reported "capsular contracture Baker grade IV and micromastia". This record is for the left side. The device has been explanted.
Patient problems: Capsular Contracture
MAUDE report 50949196 ↗InjurySep 30, 2026Fluid/Blood Leak
Healthcare professional reported "deflation". This record is for the left side. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949101 ↗InjurySep 30, 2026Fluid/Blood Leak
Healthcare professional reported "deflation". Later, healthcare professional reported "clamp used" and "no particles seen". This record is for the right side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948742 ↗InjurySep 30, 2026Fluid/Blood Leak
Patient reported "Deflation". This record is for the right side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946939 ↗InjurySep 30, 2026Fluid/Blood Leak
Healthcare professional reported "deflation". This record is for the left side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946580 ↗InjurySep 30, 2026Fluid/Blood Leak
Healthcare professional reported "Deflation". Later patient reported "Deflation" against the right side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946475 ↗InjurySep 30, 2026Fluid/Blood Leak
Healthcare Professional reported "deflation". This record is for the left side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943518 ↗InjurySep 30, 2026Fluid/Blood Leak
Healthcare professional reported "deflation and exchange from textured to smooth." This record is for the left side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943415 ↗InjurySep 30, 2026Fluid/Blood Leak
Healthcare professional reported "deflation". This record is for the left side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943195 ↗InjurySep 29, 2026Malposition of Device; Migration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941277 ↗
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 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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