NATRELLE Silicone-Filled Breast ImplantsRecalls & reported problems across all models
Allergan, Inc. · 128 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 Silicone-Filled Breast Implants model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 4,507
- Deaths reported
- 1
- Injuries reported
- 4,499
- Recalls
- 1
We found 128 models of NATRELLE Silicone-Filled Breast Implants by Allergan, Inc. in the FDA's device registry (GUDID). Together they are named in 4,507 adverse event reports in the FDA's MAUDE database, received between Feb 9, 2012 and Sep 30, 2026 — classified as 1 death, 4,499 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (2,956 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 Silicone-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-2454-2019 · Root cause: Unknown/Undetermined by firm · names 46 of these models · Recall details · FDA record ↗
Most reported NATRELLE Silicone-Filled Breast Implants problems
Device problems
- Material Rupture2,956
- Device Appears to Trigger Rejection1,239
- Patient-Device Incompatibility550
- Adverse Event Without Identified Device or Use Problem150
- No Apparent Adverse Event75
- Migration46
- Malposition of Device20
- Gel Leak19
Patient problems
- Failure of Implant2,030
- Capsular Contracture1,787
- No Clinical Signs, Symptoms or Conditions584
- Seroma140
- Swollen Lymph Nodes/Glands41
- Unspecified Infection31
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available28
- Lymphoma25
NATRELLE Silicone-Filled Breast Implants models
128 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- NATRELLE Silicone-Filled Breast Implants 115-290Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall151 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 Silicone-Filled Breast Implants 15-304Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 death183 reports
- NATRELLE Silicone-Filled Breast Implants 15-397Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled156 reports
- NATRELLE Silicone-Filled Breast Implants 115-354Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall96 reports
- NATRELLE Silicone-Filled Breast Implants 15-421Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled133 reports
- NATRELLE Silicone-Filled Breast Implants 115-272Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall80 reports
- NATRELLE Silicone-Filled Breast Implants 20-400Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled128 reports
- NATRELLE Silicone-Filled Breast Implants 115-253Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall76 reports
- NATRELLE Silicone-Filled Breast Implants 15-457Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled117 reports
- NATRELLE Silicone-Filled Breast Implants 115-378Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall63 reports
- NATRELLE Silicone-Filled Breast Implants 120-340Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall60 reports
- NATRELLE Silicone-Filled Breast Implants 120-400Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall58 reports
- NATRELLE Silicone-Filled Breast Implants 20-450Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled107 reports
- NATRELLE Silicone-Filled Breast Implants 20-500Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled104 reports
- NATRELLE Silicone-Filled Breast Implants 115-222Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall52 reports
- NATRELLE Silicone-Filled Breast Implants 120-440Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall50 reports
- NATRELLE Silicone-Filled Breast Implants 20-350Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled98 reports
- NATRELLE Silicone-Filled Breast Implants 115-435Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall47 reports
- NATRELLE Silicone-Filled Breast Implants 15-492Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled95 reports
- NATRELLE Silicone-Filled Breast Implants 115-401Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall44 reports
- NATRELLE Silicone-Filled Breast Implants 20-550Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled93 reports
- NATRELLE Silicone-Filled Breast Implants 20-375Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled91 reports
- NATRELLE Silicone-Filled Breast Implants 120-500Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall41 reports
- NATRELLE Silicone-Filled Breast Implants 20-425Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled90 reports
- NATRELLE Silicone-Filled Breast Implants 120-300Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall39 reports
- NATRELLE Silicone-Filled Breast Implants 110-150Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall29 reports
- NATRELLE Silicone-Filled Breast Implants 110-240Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall26 reports
- NATRELLE Silicone-Filled Breast Implants 120-550Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall24 reports
- NATRELLE Silicone-Filled Breast Implants 115-203Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall22 reports
- NATRELLE Silicone-Filled Breast Implants 120-600Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall22 reports
- NATRELLE Silicone-Filled Breast Implants 15-286Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled71 reports
- NATRELLE Silicone-Filled Breast Implants 110-210Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall20 reports
- NATRELLE Silicone-Filled Breast Implants 110-330Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall20 reports
- NATRELLE Silicone-Filled Breast Implants 110-120Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall19 reports
- NATRELLE Silicone-Filled Breast Implants 110-270Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall19 reports
- NATRELLE Silicone-Filled Breast Implants 110-300Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall18 reports
- NATRELLE Silicone-Filled Breast Implants 115-469Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall16 reports
- NATRELLE Silicone-Filled Breast Implants 110-360Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall15 reports
- NATRELLE Silicone-Filled Breast Implants 115-507Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall14 reports
- NATRELLE Silicone-Filled Breast Implants 20-600Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled63 reports
- NATRELLE Silicone-Filled Breast Implants 115-185Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall13 reports
- NATRELLE Silicone-Filled Breast Implants 115-547Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall13 reports
- NATRELLE Silicone-Filled Breast Implants 110-390Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall11 reports
- NATRELLE Silicone-Filled Breast Implants 120-650Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall11 reports
- NATRELLE Silicone-Filled Breast Implants 110-420Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall10 reports
- NATRELLE Silicone-Filled Breast Implants 15-265Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled59 reports
- NATRELLE Silicone-Filled Breast Implants 110-090Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall9 reports
- NATRELLE Silicone-Filled Breast Implants 115-150Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall9 reports
- NATRELLE Silicone-Filled Breast Implants 120-260Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall9 reports
- NATRELLE Silicone-Filled Breast Implants 15-533Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled58 reports
- NATRELLE Silicone-Filled Breast Implants 20-475Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled56 reports
- NATRELLE Silicone-Filled Breast Implants 110-480Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall5 reports
- NATRELLE Silicone-Filled Breast Implants 110-180Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall4 reports
- NATRELLE Silicone-Filled Breast Implants 110-450Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall4 reports
- NATRELLE Silicone-Filled Breast Implants 115-586Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall4 reports
- NATRELLE Silicone-Filled Breast Implants 10-270Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled53 reports
- NATRELLE Silicone-Filled Breast Implants 115-627Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall2 reports
- NATRELLE Silicone-Filled Breast Implants 120-220Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall2 reports
- NATRELLE Silicone-Filled Breast Implants 115-167Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall1 report
- NATRELLE Silicone-Filled Breast Implants 115-716Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall1 report
- NATRELLE Silicone-Filled Breast Implants 20-325Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled50 reports
- NATRELLE Silicone-Filled Breast Implants 110-510Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall0 reports
- NATRELLE Silicone-Filled Breast Implants 115-666Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall0 reports
- NATRELLE Silicone-Filled Breast Implants 120-180Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled1 recall0 reports
- NATRELLE Silicone-Filled Breast Implants 10-300Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled47 reports
- NATRELLE Silicone-Filled Breast Implants 20-650Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled45 reports
- NATRELLE Silicone-Filled Breast Implants 10-330Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled40 reports
- NATRELLE Silicone-Filled Breast Implants 15-234Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled39 reports
- NATRELLE Silicone-Filled Breast Implants 20-300Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled39 reports
- NATRELLE Silicone-Filled Breast Implants 10-240Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled38 reports
- NATRELLE Silicone-Filled Breast Implants 15-575Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled38 reports
- NATRELLE Silicone-Filled Breast Implants 20-700Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled36 reports
- NATRELLE Silicone-Filled Breast Implants 45-800Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled36 reports
- NATRELLE Silicone-Filled Breast Implants 20-800Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled35 reports
- NATRELLE Silicone-Filled Breast Implants 10-360Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled34 reports
- NATRELLE Silicone-Filled Breast Implants 45-550Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled33 reports
- NATRELLE Silicone-Filled Breast Implants 20-750Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled30 reports
- NATRELLE Silicone-Filled Breast Implants 45-600Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled27 reports
- NATRELLE Silicone-Filled Breast Implants 10-420Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled26 reports
- NATRELLE Silicone-Filled Breast Implants 45-650Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled26 reports
- NATRELLE Silicone-Filled Breast Implants 10-210Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled24 reports
- NATRELLE Silicone-Filled Breast Implants 10-390Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled22 reports
- NATRELLE Silicone-Filled Breast Implants 10-450Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled21 reports
- NATRELLE Silicone-Filled Breast Implants 20-280Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled21 reports
- NATRELLE Silicone-Filled Breast Implants 45-700Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled21 reports
- NATRELLE Silicone-Filled Breast Implants 15-213Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled20 reports
- NATRELLE Silicone-Filled Breast Implants 10-510Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled17 reports
- NATRELLE Silicone-Filled Breast Implants 45-460Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled17 reports
- NATRELLE Silicone-Filled Breast Implants 45-500Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled17 reports
- NATRELLE Silicone-Filled Breast Implants 15-616Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled16 reports
- NATRELLE Silicone-Filled Breast Implants 45-400Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled16 reports
- NATRELLE Silicone-Filled Breast Implants 20-260Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled13 reports
- NATRELLE Silicone-Filled Breast Implants 15-659Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled11 reports
- NATRELLE Silicone-Filled Breast Implants 15-700Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled11 reports
- NATRELLE Silicone-Filled Breast Implants 45-320Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled11 reports
- NATRELLE Silicone-Filled Breast Implants 15-752Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled9 reports
- NATRELLE Silicone-Filled Breast Implants 40-360Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled9 reports
Recent NATRELLE Silicone-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, 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, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950089 ↗InjurySep 30, 2026Material Rupture
Healthcare professional reported "rupture". This record is for the left side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949740 ↗InjurySep 30, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949652 ↗InjurySep 30, 2026Material Rupture
Healthcare professional reported ¿asymmetry¿, ¿deflation¿, ¿rupture¿, ¿bottomed out¿, ¿too large¿ and ¿ptosis¿, which is not device related. This record is for the right side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949016 ↗InjurySep 30, 2026Material Rupture
Healthcare professional reported "rupture". This record is for the right side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947856 ↗InjurySep 30, 2026Device Appears to Trigger Rejection
Healthcare professional reported "capsular contracture" Baker grade III. This record is for the left side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50947212 ↗InjurySep 30, 2026Material Rupture
Healthcare professional reported "Rupture" against the left side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946601 ↗InjurySep 30, 2026Device Appears to Trigger Rejection
Healthcare professional reported "capsular contracture Baker grade unknown" and "implants are too large". This record is for left side. The remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50946349 ↗InjurySep 30, 2026Device Appears to Trigger Rejection; Material Rupture
Healthcare professional reported "Rupture", "fibroadenoma", "Capsular contracture" Baker Grade III, " breast tissue hangs off inferiorly", " implants sit high on the chest" and "past medical history of Depression/Anxiety". This record is for the right side. Device remains implanted. Healthcare professional also reported "Ptosis" and "past medical history of cold sores" which are not device related. Patient is taking the following medications: GLP1, Ambien, Estrogen 0.5 mg, Ezetimibe 5 mg, Progesterone micronized 200 mg capsule, Prozac, Rosuvastatin, Testosterone, Tizanidine 4 mg capsule. Patient was prescribed Hibiciens soap and scopolamine patch.
Patient problems: Capsular Contracture
MAUDE report 50943780 ↗InjurySep 30, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Capsular contracture" Baker Grade III, " breast tissue hangs off inferiorly", " implants sit high on the chest" and "past medical history of Depression/Anxiety". This record is for the left side. Device remains implanted. Healthcare professional also reported "Ptosis" and "past medical history of cold sores" which are not device related. Patient is taking the following medications: GLP1, Ambien, Estrogen 0.5 mg, Ezetimibe 5 mg, Progesterone micronized 200 mg capsule, Prozac, Rosuvastatin, Testosterone, Tizanidine 4 mg capsule. Patient was prescribed Hibiciens soap and scopolamine patch.
Patient problems: Capsular Contracture
MAUDE report 50943665 ↗InjurySep 29, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940906 ↗InjurySep 29, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940013 ↗InjurySep 29, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939791 ↗InjurySep 29, 2026Material Rupture
Healthcare professional reported "Rupture". This record is for the left side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937924 ↗
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 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.
How reports and recalls are matched · Editorial policy · Report an error on this page