NATRELLE Saline-Filled Breast Implants 468-380Recalls & reported problems
Allergan, Inc. · NATRELLE 468-380 Moderate Projection BIOCELL |textured|contour|saline · Class 3 · Implant
All models of Natrelle Breast Implants (1167) · NATRELLE Saline-Filled Breast Implants (103)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
These are Allergan NATRELLE468-380 Moderate Projection BIOCELL textured saline breast implants. The 38 reports mostly describe implants losing their saline fill or rupturing, along with hardening and tightening of the surrounding tissue (capsular contracture); all38 are injury reports and no deaths are described. Reports rose from 2 in the prior 12 months to 7 in the most recent 12 months. One recall remains open, started in July 2019 after FDA updated safety information on a rare lymphoma linked to textured breast implants.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 42
- Deaths reported
- 0
- Injuries reported
- 42
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 10888628001138), received between Jul 25, 2017 and Sep 13, 2026 — classified as 42 injuries.
The most frequently reported specific device problem is “Fluid/Blood Leak” (36 reports).
1 FDA recall record name this device's identifier, 1 still open.
4 other recalls cover devices cleared under the same FDA submission (P990074); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Jul 24, 2019Class IOpen, 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 · Recall details · FDA record ↗
Most reported problems
Device problems
- Fluid/Blood Leak36
- Device Appears to Trigger Rejection5
- Patient-Device Incompatibility2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Failure of Implant28
- Capsular Contracture8
- No Clinical Signs, Symptoms or Conditions6
- Swollen Lymph Nodes/Glands1
Recent adverse event reports
The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.
InjurySep 13, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50747524 ↗InjurySep 13, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50747520 ↗InjuryAug 28, 2026Fluid/Blood Leak
Healthcare professional reported "deflation". This record is for the right side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50506100 ↗InjuryAug 14, 2026Fluid/Blood Leak
Patient reported "deflation". Later Healthcare Professional reported "volume loss", ¿rupture¿ and ¿exchange from textured to smooth breast implant¿. This record is for the left side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50261377 ↗InjuryJul 28, 2026Fluid/Blood Leak
Healthcare professional reported "saline rupture". This record is for the right side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50060242 ↗InjuryJun 25, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "SALINE RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25626597 ↗InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED OF THE RIGHT SIDE DEVICE: "POTENTIAL BREAST IMPLANT RECALL". LATER PATIENT REPORTED "I HAVE HAD SYMPTOMS FOR OVER 5 YEARS AND MY DOCTOR SAYS IT¿S MEDICALLY NECESSARY TO REMOVE THEM". LATER PATIENT REPORTED "CYST AND LYMPH NODES SWOLLEN". THE DEVICE REMAINS IMPLANTED.
Patient problems: Swollen Lymph Nodes/Glands
MAUDE report 24754456 ↗InjuryMar 18, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED A "DEFLATION". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 24632135 ↗InjuryJan 15, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "LEAKING AND EXCHANGE FROM TEXTURED TO SMOOTH DEVICES DUE TO THE PATIENTS CONCERN WITH THE PRODUCT". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 24078306 ↗InjuryNov 14, 2025Fluid/Blood Leak; Fluid/Blood Leak
PATIENT REPORTED "DEFLATION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED. IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23555206 ↗InjuryNov 7, 2025Fluid/Blood Leak; Fluid/Blood Leak
InjuryOct 27, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED RIGHT SIDE "JOINT PAIN IN HANDS, WEIGHT GAIN, SWOLLEN BODY, NOT SLEEPING WELL" (NOT DEVICE RELATED) AND "PATIENTS CONCERN WITH THE PRODUCT". HEALTHCARE PROFESSIONAL LATER REPORTED "RASHES, CAPSULAR CONTRACTURE BAKER GRADE III AND PTOSIS". THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 23388292 ↗InjuryOct 15, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION" AND "EXCHANGE FROM TEXTURED TO SMOOTH DUE TO THE PATIENT¿S CONCERN OF THE PRODUCT". THIS RELATES TO THE RIGHT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 23278943 ↗InjuryAug 9, 2024Fluid/Blood Leak; Device Appears to Trigger Rejection; Fluid/Blood Leak; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "TEXTURED IMPLANTS, BAKER GRADE III CAPSULAR CONTRACTURES, BREAST ASYMMETRY, POSSIBLE LEAKING OF MAMMARY IMPLANT". DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 19947719 ↗InjuryOct 17, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED, RIGHT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 17954071 ↗InjuryOct 12, 2023Fluid/Blood Leak; Fluid/Blood Leak
InjuryOct 3, 2023Fluid/Blood Leak; Fluid/Blood Leak
PATIENT REPORTED A RIGHT SIDE "BELIEVE I'M HAVING A LEAK". HEALTHCARE PROFESSIONAL LATER REPORTED A RIGHT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 17865299 ↗InjuryAug 8, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III AND EXCHANGE DUE TO CONCERNS WITH THE PRODUCT. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17483506 ↗InjuryAug 8, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED, LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. AND TEXTURED TO SMOOTH, DUE TO THE CONCERNS OF THE PRODUCT. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17478220 ↗InjuryMay 14, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION AND EXCHANGE DUE TO PATIENT'S CONCERN WITH THE PRODUCT. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 16928264 ↗InjuryFeb 28, 2023Fluid/Blood Leak; Fluid/Blood Leak
InjuryJan 18, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE BREAST DEFORMITY, PAIN IN THE BREASTS, AND A BAKER GRADE II CAPSULAR CONTRACTURE IN ADDITION TO POSSIBLE LEAKING OF THE MAMMARY IMPLANTS SUSPECTED DUE TO THE CHANGE IN SIZE OF THE IMPLANTS. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 16194286 ↗InjuryNov 4, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 15723770 ↗InjuryAug 18, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 15256153 ↗InjuryJan 5, 2022Fluid/Blood Leak; Fluid/Blood Leak
PATIENT REPORTED RIGHT SIDE DEFLATION AND EXCHANGE FROM TEXTURED TO SMOOTH. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 13170046 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P990074. One submission often covers many models, so check the product and lot details in each record.
- Z-0699-2020 · Nov 6, 2019 · TerminatedNatrelle Saline-Filled Breast Implant, for the following Styles and sizes, Style LP, Style 68 HP, Style 68 MP, Style LP/UDI: NATRELLE Style 68LP-125 Saline Round Low 108886280
- Z-0337-06 · Dec 14, 2005 · TerminatedMcGhan Style 163-360cc Saline-Filled BIOCELL textured Breast Implants, Catalogue Number :163-360
- Z-0336-06 · Dec 14, 2005 · TerminatedMcGhan Style 468-380cc Saline-Filled BIOCELL textured Breast Implants, Catalog Number:468-380
- Z-0851-05 · May 5, 2005 · TerminatedStyle 363 Saline-Filled BIOCELL textured Breast Implants
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- MENTOR Smooth Round Moderate Profile 3501640Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline1,294 reports
- MENTOR Smooth Round Moderate Profile 3501680Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline1,095 reports
- MENTOR Smooth Round Moderate Profile 3501635Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline864 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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