NATRELLE Saline-Filled Breast Implants 168-300Recalls & reported problems
Allergan, Inc. · NATRELLE 168-300 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 NATRELLE saline-filled breast implant is a textured, round implant placed in the chest. The 38 reports, all describing injuries and no deaths, mostly mention the implant going flat or leaking, plus hardening of scar tissue around it, often leading to removal or exchange. One open recall began in July 2019 over concerns about textured implants and a type of lymphoma. Reports rose from 2 to 13 in the last 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
- 40
- Deaths reported
- 0
- Injuries reported
- 40
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 10888628000810), received between Feb 6, 2018 and Aug 9, 2026 — classified as 40 injuries.
The most frequently reported specific device problem is “Fluid/Blood Leak” (30 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 Leak30
- Device Appears to Trigger Rejection7
- Adverse Event Without Identified Device or Use Problem1
- Material Rupture1
- No Apparent Adverse Event1
- Patient-Device Incompatibility1
Patient problems
- Failure of Implant28
- Capsular Contracture8
- No Clinical Signs, Symptoms or Conditions4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.
InjuryAug 9, 2026Device Appears to Trigger Rejection
Healthcare professional reported "exchange from textured to smooth breast implants". Healthcare professional later reported "Fear ALCL and capsular contracture Baker grade Unknown". This record is for the left side. The device has been explanted.
Patient problems: Capsular Contracture
MAUDE report 50188923 ↗InjuryJul 8, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25753509 ↗InjuryJun 15, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL LATER REPORTED "HOLE IN RADIUS (EDGE)." DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25506560 ↗InjuryJun 11, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25473986 ↗InjuryApr 3, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DEFLATION AND TEXTURED DEVICE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24776180 ↗InjuryFeb 20, 2026Fluid/Blood Leak; No Apparent Adverse Event
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION" AND EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 24407653 ↗InjuryJan 28, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED OF THE LEFT SIDE DEVICE: "DEFLATION" AND "IMPLANT REMOVAL FROM TEXTURED TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT". LATER HEALTHCARE PROFESSIONAL REPORTED "CALCIFICATIONS". THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 24202091 ↗InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED "EXCHANGE OF TEXTURED DEVICES DUE TO PRODUCT CONCERN" AND "PTOSIS AND ATROPHY". THIS RECORD IS FOR RIGHT SIDE. DEVICE REMAINS IMPLANTED AND WILL BE RETURNED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23857919 ↗InjuryDec 4, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED " EXCHANGE DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT". PATIENT LATER REPORTED THROUGH REGULATORY AGENCY "A LOT OF PAIN", "CHRONIC INFLAMMATION IN THE CAPSULE" AND "CAPSULAR CONTRACTURE STAGE IV". THIS RECORD IS FOR THE "LEFT" SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 23717236 ↗InjuryDec 1, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED " EXCHANGE DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT". PATIENT LATER REPORTED THROUGH REGULATORY AGENCY "A LOT OF PAIN", "CHRONIC INFLAMMATION IN THE CAPSULE" AND "CAPSULAR CONTRACTURE STAGE IV". THIS RECORD IS FOR THE "RIGHT" SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 23688424 ↗InjuryNov 25, 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" CONFIRMED BY MAMMOGRAM. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 23649782 ↗InjuryNov 19, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION" AND "TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED, REPLACED AND WILL BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23595874 ↗InjuryNov 19, 2025Fluid/Blood Leak; Fluid/Blood Leak
InjuryNov 7, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED ¿DEFLATION¿ AND "REMOVAL FROM TEXTURED TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT". THIS RECORD IS FOR THE RIGHT-SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 23501048 ↗InjuryNov 4, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION" AND "EXCHANGE FROM TEXTURED TO SMOOTH DUE TO THE PATIENTS CONCERNS WITH THE PRODUCT". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED, REPLACED AND WILL BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23466117 ↗InjuryOct 28, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED RIGHT SIDE "CAPSULAR CONTRACTURE BAKER GRADE II", "EXPERIENCING DISCOMFORT AND THE SHAPE OF THE IMPLANTS ARE DIFFERENT". LATER HEALTHCARE PROFESSIONAL REPORT "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN". DEVICE WAS EXPLANTED, REPLACED, AND DISCARDED.
Patient problems: Capsular Contracture
MAUDE report 23407832 ↗InjuryOct 27, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III, "EXPERIENCING DISCOMFORT AND THE SHAPE OF THE IMPLANTS ARE DIFFERENT". LATER HEALTHCARE PROFESSIONAL REPORT "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN". DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 23391880 ↗InjuryOct 3, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED " IMPLANT EXCHANGE SECONDARY TO CAPSULAR CONTRACTURE, EXPLANTS WERE NOTED TO BE MCGHAN TEXTURED SALINE IMPLANTS". THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 20363700 ↗InjuryJun 20, 2024Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "PAIN, POSSIBLE LEAKING OF MAMMARY IMPLANTS AND TEXTURED MAMMARY IMPLANTS". THIS RECORD IS FOR THE RIGHT-SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 19573170 ↗InjuryJun 11, 2024Fluid/Blood Leak; Fluid/Blood Leak
"PARTICLES IN VALVE" WAS OBSERVED DURING SURGERY. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 19512688 ↗InjurySep 19, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "DEFLATED IMPLANT" DEVICE EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 17773012 ↗InjuryAug 2, 2023Fluid/Blood Leak; Fluid/Blood Leak
PATIENT CALLED TO REPORT A RIGHT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 17445922 ↗InjuryJun 2, 2023Fluid/Blood Leak; Fluid/Blood Leak
InjuryApr 20, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED A RIGHT-SIDE DEFLATION AND EXCHANGE OF TEXTURED DEVICE DUE TO PATIENT'S CONCERN WITH PRODUCT. HEALTHCARE PROFESSIONAL LATER ALSO REPORTED "HOLE ON PATCH SIDE" WHICH IS CAPTURED UNDER DEFLATION. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 16781858 ↗InjuryFeb 28, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 16456159 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page