NATRELLE Saline-Filled Breast Implants 68-800Recalls & reported problems
Allergan, Inc. · NATRELLE Style 68MP-800 Moderate 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 saline-filled breast implant is a smooth, round, moderate-projection implant made by Allergan. The 68 reports mostly describe the implant losing fluid or deflating, sometimes requiring removal and replacement, along with scarring that tightens the breast. Sixty-six reports involved injuries and no deaths were reported. 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
- 71
- Deaths reported
- 0
- Injuries reported
- 69
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 10888628000346), received between Sep 29, 2017 and Sep 28, 2026 — classified as 69 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (56 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 Leak56
- Device Appears to Trigger Rejection8
- Patient-Device Incompatibility4
- Device Damaged Prior to Use2
- Device Handling Problem2
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Deflation Problem1
Patient problems
- Failure of Implant55
- Capsular Contracture9
- No Clinical Signs, Symptoms or Conditions5
- Foreign Body Reaction2
- Unspecified Infection2
- Discharge1
- Hematoma1
- Impaired Healing1
Recent adverse event reports
The 25 most recent of 71 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Fluid/Blood Leak; Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926026 ↗InjurySep 28, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924886 ↗InjurySep 24, 2026Fluid/Blood Leak
Healthcare professional reported "Rupture". This record is for the left side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884397 ↗InjuryJun 3, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE/DEFLATION" AND "IMPLANTED EXPLANTED". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25374509 ↗InjurySep 11, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "SIDE EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE". LATER HEALTHCARE PROFESSIONAL REPORTED "DEFLATION" THIS RECORD RELATES TO THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 23027559 ↗InjuryAug 15, 2025Device Handling Problem; Device Handling Problem
HEALTHCARE PROFESSIONAL REPORTED USE ERROR, THIS REPORT IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22818610 ↗InjuryJul 19, 2025Fluid/Blood Leak; Fluid/Blood Leak
PATIENT REPORTED LEFT SIDE DEFLATION AND CAN FEEL THE VALVE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22550516 ↗InjuryApr 15, 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 21845785 ↗InjuryApr 10, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CHANGE IN SHAPE AND FEEL, AND DEFLATION. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 21819368 ↗InjuryNov 8, 2023Fluid/Blood Leak; Fluid/Blood Leak
InjurySep 29, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED A "LEFT SIDE DEFLATION." DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 17842951 ↗InjuryAug 18, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED DEFLATION. THE DEVICE REMAINS IMPLANTED. THIS RELATES TO THE RIGHT SIDE.
Patient problems: Failure of Implant
MAUDE report 17571622 ↗InjuryJul 28, 2023Fluid/Blood Leak; Fluid/Blood Leak
PATIENT REPORTED RIGHT SIDE "RUPTURE". ADDITIONALLY, HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 17418516 ↗InjuryJul 27, 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 17408451 ↗InjuryJun 7, 2023Fluid/Blood Leak; Fluid/Blood Leak
InjuryJun 5, 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 17056750 ↗InjuryMay 12, 2023Fluid/Blood Leak; Fluid/Blood Leak
PATIENT REPORTED LEFT SIDE DEFLATION. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 16920132 ↗InjuryMay 11, 2023Fluid/Blood Leak; Fluid/Blood Leak
PATIENT REPORTED RIGHT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 16911927 ↗InjuryMar 27, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A "LEFT SIDE HEMATOMA, INFECTION, CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN". DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture; Hematoma; Unspecified Infection
MAUDE report 16619978 ↗InjuryMar 8, 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 16501728 ↗InjuryMar 7, 2023Fluid/Blood Leak; Device Appears to Trigger Rejection; Fluid/Blood Leak; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE BAKER IV AND LEAKING SALINE IMPLANT. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 16500268 ↗InjuryMar 6, 2023Fluid/Blood Leak; Device Appears to Trigger Rejection; Fluid/Blood Leak; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE BAKER IV AND LEAKING SALINE IMPLANT. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 16492085 ↗MalfunctionJan 10, 2023Break; Break
COMPANY REPRESENTATIVE REPORTED, ON BEHALF OF PHYSICIAN, ''LEAKING SALINE IMPLANT WHEN FILLED DURING SURGERY" AGAINST AN UNKNOWN SIDE. THE DEVICE WAS NOT IMPLANTED. IT IS UNKNOWN IF A BACKUP DEVICE WAS USED.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 16132389 ↗InjuryJan 9, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION AND HOLE IN RADIUS (EDGE). DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 16124599 ↗InjuryDec 1, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "PARTIAL" DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 15894118 ↗
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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