NATRELLE Saline-Filled Breast Implants 168-550Recalls & reported problems
Allergan, Inc. · NATRELLE 168-550 Moderate Projection BIOCELL |textured|round|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
- 12
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10888628000896), received between Aug 15, 2018 and Aug 21, 2026 — classified as 12 injuries.
The most frequently reported specific device problem is “Fluid/Blood Leak” (10 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 Leak10
- Patient-Device Incompatibility2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Failure of Implant9
- Capsular Contracture2
- No Clinical Signs, Symptoms or Conditions1
- Swollen Lymph Nodes/Glands1
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
InjuryAug 21, 2026Adverse Event Without Identified Device or Use Problem
Healthcare professional reported "exchange from textured to smooth implant". Later healthcare professional reported "had enlarged lymph nodes that required biopsy". This record is for the right side. Device remains implanted.
Patient problems: Swollen Lymph Nodes/Glands
MAUDE report 50380688 ↗InjuryAug 13, 2026Fluid/Blood Leak
Healthcare professional reported a "Deflation". This record is for the right side. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50239403 ↗InjuryApr 6, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT DEFLATION AND TEXTURED EXCHANGE DUE TO CONCERNS OF THE PRODUCT. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 16688946 ↗InjuryJan 26, 2021Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "DEFLATION". DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 11228410 ↗InjuryDec 8, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III AND EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 10971928 ↗InjuryFeb 2, 2020Fluid/Blood Leak; Fluid/Blood Leak
InjuryOct 18, 2019Fluid/Blood Leak; Patient-Device Incompatibility; Fluid/Blood Leak; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III.
Patient problems: Capsular Contracture; Failure of Implant
MAUDE report 9209154 ↗InjuryMar 27, 2019Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 8458295 ↗InjuryFeb 14, 2019Fluid/Blood Leak; Fluid/Blood Leak
PATIENT ADDITIONALLY REPORTED "EXHAUSTION" AND "FATIGUE", "AUTOIMMUNE ISSUES", "HASHIMOTO'S THYROID" AND "BRAIN FOG"; THESE EVENTS ARE NOT RELATED TO THE DEVICE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 8338897 ↗InjuryDec 4, 2018Fluid/Blood Leak; Fluid/Blood Leak
InjuryOct 26, 2018Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 8009390 ↗InjuryAug 15, 2018Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "RUPTURE". DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 7785770 ↗
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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