NATRELLE Saline-Filled Breast Implants 468-350Recalls & reported problems
Allergan, Inc. · NATRELLE 468-350 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
This Natrelle BIOCELL textured saline breast implant is a soft implant filled with salt water. The 36 reports mostly describe implants leaking or deflating, and the surrounding scar tissue tightening around the implant, sometimes with pain, swelling or removal and replacement surgery;36 injuries and no deaths were reported. One open recall, started in July 2019, concerns a rare type of 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
- 39
- Deaths reported
- 0
- Injuries reported
- 39
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10888628001121), received between Oct 20, 2017 and Aug 28, 2026 — classified as 39 injuries.
The most frequently reported specific device problem is “Fluid/Blood Leak” (26 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 Leak26
- Device Appears to Trigger Rejection10
- Adverse Event Without Identified Device or Use Problem2
- Patient-Device Incompatibility2
- Deflation Problem1
- Malposition of Device1
- No Apparent Adverse Event1
Patient problems
- Failure of Implant23
- Capsular Contracture12
- No Clinical Signs, Symptoms or Conditions4
- Seroma3
Recent adverse event reports
The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.
InjuryAug 28, 2026Fluid/Blood Leak
Healthcare Professional reported "deflation, pain and inverted nipple" 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 50507466 ↗InjuryAug 3, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Grade III Capsule". This record is for the right side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50122207 ↗InjuryJul 30, 2026Malposition of Device
Healthcare professional reported "shifted" and "exchange from textured to smooth". This record is for the left side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50093762 ↗InjuryJul 27, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Grade III Capsule". This record is for the left side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50013686 ↗InjuryJun 18, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED OF THE RIGHT SIDE DEVICE: "DEFLATION". THE DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25555246 ↗InjuryMar 9, 2026Device Appears to Trigger Rejection
PATIENT REPORTED "PAIN, SCAR TISSUE, STRUCTURAL PROBLEMS, LOTS OF ENCAPSULATION, PULLING IN PECK AND SCAPULA, INFLAMMATION, SOMETHING WASN'T RIGHT, IMPLANTS LOOKED CLOUDY AND A BILATERAL IMPLANT REMOVAL OF TEXTURED DEVICES DUE TO THE PATIENTS CONCERNS WITH THE PRODUCT". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24547459 ↗InjuryFeb 17, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "EXCHANGE OF TEXTURED DEVICES DUE TO PATIENT'S CONCERN WITH PRODUCT" AND LATER REPORTED "TEXTURE CLAIM" AND "DEFLATION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24364880 ↗InjuryFeb 16, 2026Fluid/Blood Leak
PATIENT REPORTED "DEFLATION". HEALTHCARE PROFESSIONAL LATER REPORTED "DEFLATION". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 24345693 ↗InjuryDec 31, 2025Fluid/Blood Leak; Device Appears to Trigger Rejection; Fluid/Blood Leak; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "POSSIBLE DEFLATION, CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN" AND "EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT". THIS RECORD IS FOR LEFT SIDE. DEVICE REMAINS IMPLANTED. DEVICE WILL BE RETURNED.
Patient problems: Capsular Contracture
MAUDE report 23935430 ↗InjuryDec 27, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATED BIOCELL IMPLANT". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED AND WILL BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23901686 ↗InjuryDec 23, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "FLUID", "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN", "PAIN", "SWELLING" AND "REPLACEMENT FROM TEXTURED TO SMOOTH DUE TO THE PATIENT CONCERN OF THE IMPLANT". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture; Seroma
MAUDE report 23885574 ↗InjuryDec 19, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED DEFLATION. LATER, HEALTHCARE PROFESSIONAL REPORTED "TEXTURED DEVICE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED. THE DEVICE WILL BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23857763 ↗InjuryDec 10, 2025Fluid/Blood Leak; Fluid/Blood Leak
PATIENT REPORTED "DEFLATION AND EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT". HEALTHCARE PROFESSIONAL LATER REPORTED "RUPTURE AND LEAKING". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED. THE DEVICE WAS RETURNED.
Patient problems: Failure of Implant
MAUDE report 23767246 ↗InjuryDec 9, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "SEVERE CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN AND EXCHANGE FROM TEXTURED TO SMOOTH DEVICES DUE TO THE PATIENTS CONCERN WITH THE PRODUCT". THIS RECORD IS FOR LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 23758208 ↗InjuryDec 5, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION" AND "EXCHANGE FROM TEXTURED TO SMOOTH DUE TO CONCERN WITH THE PRODUCT". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED AND IT WILL BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23727715 ↗InjuryNov 29, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION AND EXCHANGE FROM TEXTURED TO SMOOTH DEVICES DUE TO THE PATIENTS CONCERN WITH THE PRODUCT". THIS RECORD IS FOR RIGHT SIDE. DEVICE WAS EXPLANTED, REPLACED AND WILL BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23675955 ↗InjuryOct 29, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED "CONSTANT COUGHING", "ALLERGIES", ", GASTRO PROBLEMS", "FOGGINESS" (NOT DEVICE RELATED). ALSO REPORTED "PAIN" AND "REMOVAL OF TEXTURED DEVICES DUE TO PRODUCT CONCERN". LATER HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED AND WILL BE RETURNED.
Patient problems: Capsular Contracture
MAUDE report 23417951 ↗InjuryOct 29, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DEFLATION. THE DEVICE HAS BEEN EXPLANTED AND REPLACED. IT WAS RETURNED.
Patient problems: Failure of Implant
MAUDE report 23417869 ↗InjuryOct 28, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED "CONSTANT COUGHING", "ALLERGIES", "GASTRO PROBLEMS", "FOGGINESS" AS NO DEVICE RELATED. ALSO REPORTED "REMOVAL OF TEXTURED DEVICES DUE TO PRODUCT CONCERN" AND "PAIN". LATER HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 23405993 ↗InjuryOct 20, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION AND EXCHANGE FROM TEXTURED TO SMOOTH DEVICES DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED. DEVICE WILL BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23338946 ↗InjuryOct 20, 2025Fluid/Blood Leak; No Apparent Adverse Event; Fluid/Blood Leak; No Apparent Adverse Event
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "MANUAL DEFLATION" AND EXCHANGE FROM TEXTURED TO SMOOTH DEVICES DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT. HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED RIGHT SIDE "NEEDLE DEFLATION". UPON REVIEW OF THE INFORMATION BY ABBVIE MEDICAL SAFETY, IT HAS BEEN DETERMINED THAT THE INTENTIONAL DEFLATION OF THE RIGHT SIDE IMPLANT IS NOT A COMPLAINT AGAINST THE DEVICE.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 23335526 ↗InjuryOct 15, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED "EXCHANGE FROM TEXTURED TO SMOOTH DEVICE DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT, PAIN, HARDNESS, AND CAPSULAR CONTRACTURE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 23306598 ↗InjuryOct 15, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED "EXCHANGE FROM TEXTURED TO SMOOTH DEVICE DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT, PAIN, HARDNESS, CAPSULAR CONTRACTURE" BAKER GRADE UNKNOWN AND "SWOLLEN LYMPH NODES". LATER HEALTHCARE PROFESSIONAL REPORTED "IMPLANT EXCHANGE FROM TEXTURED TO SMOOTH DUE TO THE PATIENTS CONCERNS WITH THE PRODUCT". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 23292230 ↗InjuryMay 23, 2024Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED DEFLATION. DEVICE HAS BEEN EXPLANTED. THIS RELATES TO THE LEFT SIDE.
Patient problems: Failure of Implant
MAUDE report 19386269 ↗InjuryMay 18, 2023Fluid/Blood Leak; Fluid/Blood Leak
PATIENT REPORTED A RIGHT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 16956918 ↗
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
Other Prosthesis, Breast, Inflatable, Internal, Saline devices
- MENTOR Smooth Round Moderate Profile 3501650Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline2,187 reports
- MENTOR Smooth Round Moderate Profile 3501660Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline1,972 reports
- MENTOR Smooth Round Moderate Profile 3501670Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline1,899 reports
- MENTOR Smooth Round Moderate Profile 3501645Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline1,655 reports
- MENTOR Smooth Round Moderate Profile 3501655Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline1,534 reports
- 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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