NATRELLE Saline-Filled Breast Implants 168-420Recalls & reported problems
Allergan, Inc. · NATRELLE 168-420 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.
Quick summary
This Allergan Natrelle saline breast implant is a textured round implant filled with saline. Reports mostly describe deflation with asymmetry and hardening with pain, often with removal or swap to a smooth implant. There are 25 reports, including 25 mentioning injury and no deaths. There is 1 open recall from July 2019 about a higher occurrence of a type of lymphoma with textured implants, with 8 reports in the last 12 months compared with 1 in the prior 12 months.
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
- 26
- Deaths reported
- 0
- Injuries reported
- 26
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10888628000858), received between Sep 26, 2017 and Jul 16, 2026 — classified as 26 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 Rejection7
- Material Rupture1
Patient problems
- Failure of Implant18
- Capsular Contracture7
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
InjuryJul 16, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "LEAKING". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25841906 ↗InjuryMay 22, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS.". HEALTHCARE PROFESSIONAL THEN REPORTED "PARTIALLY DEFLATED AND SIGNIFICANT ASYMMETRY". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 25256270 ↗InjuryMar 19, 2026Device Appears to Trigger Rejection
PATIENT REPORTED "EXCHANGE FROM TEXTURED TO SMOOTH DUE TO CONCERNS WITH THE PRODUCT". LATER HEALTHCARE PROFESSIONAL REPORTED "FIRMNESS", "ENGORGEMENT" AND "EXCHANGE FROM A TEXTURED TO SMOOTH BREAST IMPLANT DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT". LATER HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE". LATER HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24639037 ↗InjuryJan 2, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "CAPSULAR CONTRACTURE BAKER GRADE IV", "PAIN", AND "IMPLANT REMOVAL FROM TEXTURE TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT". THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 23951715 ↗InjuryJan 2, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "CAPSULAR CONTRACTURE BAKER GRADE II/III", "PAIN", AND "IMPLANT REMOVAL FROM TEXTURE TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT". THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 23951534 ↗InjuryDec 23, 2025Fluid/Blood Leak; Fluid/Blood Leak
PATIENT REPORTED "POPPED". HEALTHCARE PROFESSIONAL CONFIRMED VIA PHYSICAL EXAM ON (B)(6) 2025. THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED. DEVICE WILL NOT BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23876013 ↗InjuryDec 3, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPRESENTATIVE REPORTED ¿EXCHANGE FROM TEXTURED TO SMOOTH DUE TO THE PATIENT¿S CONCERN OF THE PRODUCT¿, "CAPSULAR CONTRACTURE", "INFLAMMATION/IRRITATION" AND "CANCER". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 23708127 ↗InjuryDec 3, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED AND IT UNKNOWN IF THE DEVICE WILL BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23706045 ↗InjuryNov 29, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPRESENTATIVE REPORTED ¿EXCHANGE FROM TEXTURED TO SMOOTH DUE TO THE PATIENT¿S CONCERN OF THE PRODUCT¿, "CAPSULAR CONTRACTURE", "INFLAMMATION/IRRITATION" AND "CANCER". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 23676158 ↗InjuryOct 29, 2025Fluid/Blood Leak; Fluid/Blood Leak
InjurySep 26, 2024Fluid/Blood Leak; Fluid/Blood Leak
InjurySep 26, 2024Material Rupture; Material Rupture
InjurySep 20, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A RIGHT CAPSULAR CONTRACTURES, BAKER GRADES III, AND EXCHANGE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17781433 ↗InjuryJul 19, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 15060071 ↗InjuryJan 5, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION AND EXCHANGE FROM TEXTURED TO SMOOTH. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 13172647 ↗InjuryOct 15, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE EXCHANGE FROM ¿TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT, CAPSULAR CONTRACTURE BAKER GRADE IV, RIGHT SIDE PAIN THAT RADIATE DOWN ARM TO FINGERS;¿ PATIENT HAS BEEN ATTENDING PHYSICAL THERAPY DUE TO THE RIGHT ARM PAIN. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 12639153 ↗InjuryJun 10, 2021Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 11976104 ↗InjuryDec 21, 2020Fluid/Blood Leak; Fluid/Blood Leak
PATIENT REPORTED RIGHT SIDE "PATIENT¿S CONCERN WITH THE PRODUCT" AND DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 11045324 ↗InjuryJun 26, 2020Fluid/Blood Leak; Fluid/Blood Leak
InjuryJun 6, 2019Fluid/Blood Leak; Fluid/Blood Leak
InjuryJun 6, 2019Fluid/Blood Leak; Fluid/Blood Leak
InjuryApr 25, 2019Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 8548752 ↗InjuryMar 21, 2019Fluid/Blood Leak; Fluid/Blood Leak
InjuryMar 14, 2019Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 8423134 ↗InjuryOct 11, 2017Fluid/Blood Leak; Fluid/Blood Leak
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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