NATRELLE Saline-Filled Breast Implants 68-420Recalls & reported problems
Allergan, Inc. · NATRELLE Style 68MP-420 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 Allergan Natrelle saline breast implant has 423 reports, including 420 injuries and no deaths. Most reports describe the implant leaking or deflating, and some mention scar tissue tightening around the implant (capsular contracture). 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
- 443
- Deaths reported
- 0
- Injuries reported
- 440
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 443 adverse event reports that list this exact device (DI 10888628000254), received between Aug 3, 2017 and Sep 28, 2026 — classified as 440 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (398 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 Leak398
- Device Appears to Trigger Rejection26
- Patient-Device Incompatibility15
- Adverse Event Without Identified Device or Use Problem9
- Deflation Problem8
- No Apparent Adverse Event8
- Material Rupture6
- Malposition of Device2
Patient problems
- Failure of Implant360
- No Clinical Signs, Symptoms or Conditions46
- Capsular Contracture41
- Unspecified Infection7
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Complaint, Ill-Defined1
- Fluid Discharge1
- Seroma1
Recent adverse event reports
The 25 most recent of 443 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 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 50918351 ↗InjurySep 24, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892468 ↗InjurySep 23, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876125 ↗InjurySep 22, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50862636 ↗InjurySep 17, 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 50805431 ↗InjurySep 13, 2026Fluid/Blood Leak; Malposition of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50747272 ↗InjuryAug 29, 2026Fluid/Blood Leak
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50509827 ↗InjuryAug 24, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50413536 ↗InjuryAug 24, 2026Fluid/Blood Leak
Patient reported "deflation". Later healthcare professional confirmed. This record is for the left side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50413158 ↗InjuryAug 24, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50412343 ↗InjuryAug 21, 2026Fluid/Blood Leak
Healthcare professional reported "Deflation". This record is for the right side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50379558 ↗InjuryAug 14, 2026Fluid/Blood Leak; Device Appears to Trigger Rejection
Healthcare professional reported Capsular Contracture Baker IV, "Painful breast deformity" and "Deflated saline implant". This record is for the right side. Device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50262060 ↗InjuryAug 7, 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 50180926 ↗InjuryAug 7, 2026Fluid/Blood Leak
Healthcare professional reported "gradual deflation". This record is for left side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50175185 ↗InjuryAug 6, 2026Fluid/Blood Leak
Healthcare professional reported "Deflation". Later healthcare professional reported "Particles in valve". This record is for the right side. Device has been explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50157831 ↗InjuryAug 5, 2026Fluid/Blood Leak
Device was explanted and replaced.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50136766 ↗InjuryAug 4, 2026Fluid/Blood Leak
Healthcare professional reported patient "awoke from sleep with a deflated breast implant. She denied any history of trauma to the breast or chest". This record is for the right side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50136394 ↗InjuryAug 4, 2026Fluid/Blood Leak; Device Appears to Trigger Rejection
Healthcare professional reported "deflation" and Capsular Contracture Baker grade unknown. This record is for the right side. Device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50132756 ↗InjuryAug 3, 2026Fluid/Blood Leak
Device has been explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50122486 ↗InjuryJul 31, 2026Device Appears to Trigger Rejection; Malposition of Device
Healthcare professional reported "Capsular contracture" Baker Grade unknown and "rippling ". This record is for the left side. Device remains implanted.
Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions
MAUDE report 50107859 ↗InjuryJul 31, 2026Fluid/Blood Leak
Healthcare professional reported "deflation" and implant date is after the expiry date. This record is for the left side. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50100140 ↗InjuryJul 30, 2026Fluid/Blood Leak
Healthcare professional reported "deflation" and "defect at the valve". This record is for the right side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50093832 ↗InjuryJul 29, 2026Fluid/Blood Leak
Healthcare professional reported "deflation". This record is for right side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50074746 ↗InjuryJul 22, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25909477 ↗InjuryJul 20, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION" AND "DISCOMFORT". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25884256 ↗
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
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- 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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