NATRELLE Saline-Filled Breast Implants 468-450Recalls & reported problems
Allergan, Inc. · NATRELLE 468-450 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.
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 23
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10888628001145), received between Jun 13, 2018 and Jul 27, 2026 — classified as 23 injuries.
The most frequently reported specific device problem is “Fluid/Blood Leak” (18 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 Leak18
- Device Appears to Trigger Rejection4
- Adverse Event Without Identified Device or Use Problem1
- Detachment of Device or Device Component1
Patient problems
- Failure of Implant17
- Capsular Contracture4
- Anxiety2
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
InjuryJul 27, 2026Device Appears to Trigger Rejection
Patient reported Capsular Contracture Baker grade unknown and ¿build up and scar tissue¿. This record is for the right side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50039096 ↗InjuryJul 15, 2026Device Appears to Trigger Rejection
Healthcare professional reported "textured implants part of recall". Later healthcare professional reported "capsular contracture". This record is for the left side. Device was explanted.
Patient problems: Capsular Contracture
MAUDE report 25827120 ↗InjuryJul 14, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "TEXTURED IMPLANTS PART OF RECALL". LATER HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE". THIS RECORD IS FOR AN UNKNOWN SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25819677 ↗InjuryMay 4, 2026Detachment of Device or Device Component
HEALTHCARE PROFESSIONAL REPORTED "EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE". HEALTHCARE PROFESSIONAL LATER REPORTED "PLUG STRAP SEPARATED BY FIBROUS CAPSULE LOOP". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 25072937 ↗InjuryFeb 16, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24344645 ↗InjuryJan 6, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "SALINE IMPLANT RUPTURE" AND "RUPTURED AND FOUND TO HAVE A SMALL HOLE IN THE ANTERIOR SHELL". HEALTHCARE PROFESSIONAL LATER REPORTED "TEXTURED". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Anxiety
MAUDE report 23975229 ↗InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED "DEFLATION". LATER HEALTHCARE PROFESSIONAL REPORTED "BIOCELL RECALL CASE IS COMING UP. PATIENT WILL HAVE TO REMOVE TEXTURED SALINE IMPLANTS TO REPLACE SMOOTH SILICONE IMPLANTS". LATER HEALTHCARE PROFESSIONAL REPORTED "BIOCELL RECALL". DEVICE WAS EXPLANTED AND REPLACED. DEVICE WILL BE RETURNED.
Patient problems: Anxiety
MAUDE report 23521558 ↗InjuryNov 4, 2025Fluid/Blood Leak; Fluid/Blood Leak
PATIENT REPORTED "NO COMPLAINT AGAINST THE DEVICE". LATER HEALTHCARE PROFESSIONAL REPORTED "BIOCELL RECALL CASE IS COMING UP. PATIENT WILL HAVE TO REMOVE TEXTURED SALINE IMPLANTS TO REPLACE SMOOTH SILICONE IMPLANTS". LATER HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED AND WILL RETURN.
Patient problems: Failure of Implant
MAUDE report 23464887 ↗InjuryOct 31, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION" AND "FROM TEXTURED TO SMOOTH". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 23433394 ↗InjurySep 8, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22992743 ↗InjuryFeb 28, 2024Fluid/Blood Leak; Device Appears to Trigger Rejection; Fluid/Blood Leak; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "TEXTURED SALINE IMPLANTS, "RECENTLY NOTICED A CHANGE IN THE SIZE OF BREASTS", "SUSPECT LEAKING", AND CAPSULAR CONTRACTURE BAKER GRADE III. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 18804397 ↗InjuryMay 31, 2023Fluid/Blood Leak; Fluid/Blood Leak
InjuryApr 11, 2023Fluid/Blood Leak; Fluid/Blood Leak
PATIENT REPORTED RIGHT SIDE "DEFLATION" AND "EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENT'S CONCERNS WITH THE PRODUCT." PHYSICIAN ALSO REPORTED A RIGHT DEFLATION. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 16716113 ↗InjuryApr 5, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE DEFLATION AND EXCHANGE FROM A TEXTURED TO SMOOTH BREAST IMPLANT DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 16682835 ↗InjuryNov 30, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT DEFLATION AND "TEXTURED TO SMOOTH DUE TO PRODUCT CONCERN". DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 15889830 ↗InjuryMar 23, 2022Fluid/Blood Leak; Fluid/Blood Leak
PHYSICIAN REPORTED RIGHT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 13869045 ↗InjuryMar 23, 2022Fluid/Blood Leak; Fluid/Blood Leak
PHYSICIAN REPORTED LEFT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 13862687 ↗InjuryOct 28, 2020Fluid/Blood Leak; Fluid/Blood Leak
InjurySep 28, 2020Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED "IMPLANT ADHERED TO CAPSULE". DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 10591977 ↗InjuryAug 12, 2020Fluid/Blood Leak; Fluid/Blood Leak
InjuryDec 17, 2018Fluid/Blood Leak; Fluid/Blood Leak
InjuryNov 27, 2018Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 8105994 ↗InjuryJun 13, 2018Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE DEFLATION. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 7597965 ↗
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
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- 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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