NATRELLE Saline-Filled Breast Implants 68LP-350Recalls & reported problems
Allergan, Inc. · NATRELLE Style 68LP-350 Low Projection |smooth|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
Quick summary
This Natrelle Style 68LP-350 low-profile smooth round saline breast implant by Allergan is placed under the skin to add breast volume. Most of the 58 reports describe the implant leaking or deflating, sometimes with pain, and several implants had to be taken out and replaced; others mention lumps, hardening of the surrounding tissue, or a size exchange. The reports describe 57 injuries and no deaths. No recalls name this device.
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
- 59
- Deaths reported
- 0
- Injuries reported
- 58
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 10888628000605), received between Feb 1, 2018 and Sep 9, 2026 — classified as 58 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (51 reports).
5 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
Most reported problems
Device problems
- Fluid/Blood Leak51
- Device Appears to Trigger Rejection3
- Adverse Event Without Identified Device or Use Problem2
- Patient-Device Incompatibility2
- Deflation Problem1
- Device Contamination with Chemical or Other Material1
- Device Handling Problem1
- Material Invagination1
Patient problems
- Failure of Implant48
- Capsular Contracture5
- No Clinical Signs, Symptoms or Conditions3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Breast Mass2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 59 reports, in the reporter's own words as published by the FDA.
InjurySep 9, 2026Fluid/Blood Leak
Healthcare professional reported: "leaking". This record is for the left-side device. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50694399 ↗InjuryAug 11, 2026Fluid/Blood Leak
Healthcare professional reported "deflation". This record is for the right side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50202475 ↗InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem
THE PATIENT REPORTED LUMP/NODULE AND ¿NOT ENOUGH MILK PRODUCTION¿. LATER HEALTHCARE PROFESSIONAL REPORTED "SIZE EXCHANGE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Breast Mass
MAUDE report 24070344 ↗InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem
THE PATIENT REPORTED LUMP/NODULE AND ¿NOT ENOUGH MILK PRODUCTION¿. LATER HEALTHCARE PROFESSIONAL REPORTED "SIZE EXCHANGE". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Breast Mass
MAUDE report 24070343 ↗InjuryDec 9, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 23757861 ↗InjuryDec 3, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED. THE DEVICE WILL NOT BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23708352 ↗InjuryOct 29, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "LEAKING SALINE". THIS RECORD IS FOR RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED. THE DEVICES WILL BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23420280 ↗InjurySep 4, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 22967580 ↗InjuryAug 27, 2025Device Handling Problem; Device Handling Problem
HEALTHCARE PROFESSIONAL REPORTED "FILLED TO 460CC". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22903524 ↗InjuryMay 8, 2025Fluid/Blood Leak; Fluid/Blood Leak
PATIENT REPORTED A RIGHT SIDE DEFLATION. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 21987324 ↗InjuryOct 25, 2023Fluid/Blood Leak; Material Invagination; Fluid/Blood Leak; Material Invagination
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DEFLATION. HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED RIGHT SIDE "FOLD FAILURE.¿ THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 18008161 ↗InjuryOct 18, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED, LEFT SIDE DEFLATION.
Patient problems: Failure of Implant
MAUDE report 17961230 ↗InjuryAug 8, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DEFLATION AND ¿HOLE IN RADIUS,¿ AND ¿IMPLANTS EMPTIED WITH FILL TUBING." THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 17480909 ↗InjuryAug 7, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 17469488 ↗InjuryAug 7, 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 17469318 ↗InjuryJul 10, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE DEFLATION. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 17295401 ↗InjuryMay 3, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 16859918 ↗InjuryMar 26, 2023Fluid/Blood Leak; Fluid/Blood Leak
PHYSICIAN REPORTED RIGHT SIDE DEFLATION. PATIENT REPORTED A RIGHT SIDE DEFLATION AND EXCHANGE. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 16616781 ↗InjuryMar 24, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 16615841 ↗InjuryFeb 28, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED A "LEFT SIDE DEFLATION." DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 16455734 ↗InjuryFeb 24, 2023Fluid/Blood Leak; Fluid/Blood Leak
THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 16440360 ↗InjuryJan 8, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED THE EVENT OF LEFT SIDE DEFLATION. DEVICES REMAIN IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 16119253 ↗InjuryDec 16, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED A RIGHT DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 16000333 ↗InjuryDec 8, 2022Fluid/Blood Leak; Device Appears to Trigger Rejection; Fluid/Blood Leak; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT-SIDE DEFLATION AND CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15945817 ↗InjuryDec 8, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT-SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15944461 ↗
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-2451-2019 · Jul 24, 2019 · Open, ClassifiedNatrelle, Saline-Filled Breast Implant Biocell Full Height with Fill Tube, Sterile, for the following style numbers: Style 163:163-360CC, 163-440CC, 163-530CC, 163-655CC, 163-7
- Z-0336-06 · Dec 14, 2005 · TerminatedMcGhan Style 468-380cc Saline-Filled BIOCELL textured Breast Implants, Catalog Number:468-380
- Z-0337-06 · Dec 14, 2005 · TerminatedMcGhan Style 163-360cc Saline-Filled BIOCELL textured Breast Implants, Catalogue Number :163-360
- 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
- 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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