NATRELLE Saline-Filled Breast Implants 68LP-275Recalls & reported problems
Allergan, Inc. · NATRELLE Style 68LP-275 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 Allergan Natrelle saline-filled breast implant is a smooth, round breast implant. The 40 reports mostly describe the implant losing saline and deflating, often leading to removal or replacement; some mention capsular contracture or infection. They include 40 injuries and no deaths. No recalls name this device, and reports fell from 5 in the previous 12 months to 1 in the latest 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
- 41
- Deaths reported
- 0
- Injuries reported
- 41
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 10888628000575), received between Aug 2, 2017 and May 19, 2026 — classified as 41 injuries.
The most frequently reported specific device problem is “Fluid/Blood Leak” (37 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 Leak37
- Device Appears to Trigger Rejection3
- Adverse Event Without Identified Device or Use Problem2
- Patient-Device Incompatibility2
- Device Handling Problem1
- Material Rupture1
Patient problems
- Failure of Implant37
- Capsular Contracture4
- No Clinical Signs, Symptoms or Conditions2
- Unspecified Infection2
Recent adverse event reports
The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.
InjuryMay 19, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "SALINE RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25220159 ↗InjuryApr 16, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION AND CAPSULAR CONTRACTURE BAKER GRADE 1". HEALTHCARE PROFESSIONAL LATER REPORTED "PRESENCE OF FOLDS." THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 24905289 ↗InjuryOct 31, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATED". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED, REPLACED AND WILL BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23444232 ↗InjurySep 12, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "DEFLATION". DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 23037647 ↗InjuryAug 26, 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 22898289 ↗InjuryJul 18, 2025Fluid/Blood Leak; Fluid/Blood Leak
THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 22541988 ↗InjuryJun 3, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION." THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 22135656 ↗InjuryMar 6, 2024Fluid/Blood Leak; Fluid/Blood Leak
InjuryNov 10, 2023Device Handling Problem; Device Handling Problem
HEALTHCARE PROVIDER REPORTED A RIGHT SIDE EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE. THE DEVICE WAS IMPLANTED AFTER THE EXPIRATION DATE OF THE DEVICE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 18112096 ↗InjuryNov 6, 2023Fluid/Blood Leak; Fluid/Blood Leak
InjurySep 18, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 17765794 ↗InjuryAug 8, 2023Fluid/Blood Leak; Fluid/Blood Leak
InjuryJul 31, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 17429564 ↗InjuryJun 27, 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 17213001 ↗InjuryApr 13, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 16733167 ↗InjuryJan 18, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT-SIDE "RUPTURE.'' DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 16199517 ↗InjuryNov 1, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 15712617 ↗InjuryOct 14, 2022Fluid/Blood Leak; Fluid/Blood Leak
DEVICE ANALYSIS LAB RECEIVED A DEVICE WITH LOT NUMBER 3272342 AND CATALOG NUMBER 68LP-275. HEALTHCARE PROFESSIONAL REPORTED VIA RGA LEFT SIDE "ANY CREASES" AND "IMPLANT TOTALLY DEFLATED WITH SOME FOLDING ON ITSELF". DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 15605184 ↗InjurySep 30, 2022Fluid/Blood Leak; Fluid/Blood Leak
PATIENT REPORTED BILATERAL DEFLATION. THIS RECORD IS FOR UNKNOWN SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 15519952 ↗InjurySep 30, 2022Fluid/Blood Leak; Fluid/Blood Leak
PATIENT REPORTED BILATERAL DEFLATION. THIS RECORD IS FOR UNKNOWN SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 15519896 ↗InjuryAug 18, 2022Fluid/Blood Leak; Fluid/Blood Leak
PATIENT REPORTED LEFT SIDE DEFLATION. HEALTHCARE PROFESSIONAL CONFIRMED LEFT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 15254111 ↗InjuryMay 27, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 14525787 ↗InjuryApr 19, 2022Fluid/Blood Leak; Device Appears to Trigger Rejection; Fluid/Blood Leak; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION AND CAPSULAR CONTRACTURE BAKER GRADE III" AGAINST RIGHT DEVICE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 14146231 ↗InjuryMar 11, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 13731905 ↗InjuryFeb 15, 2022Fluid/Blood Leak; Fluid/Blood Leak
PATIENT REPORTED LEFT SIDE DEFLATION AND RIPPLING. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 13538545 ↗
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-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
- 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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