NATRELLE Saline-Filled Breast Implants 68-360Recalls & reported problems
Allergan, Inc. · NATRELLE Style 68MP-360 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-filled breast implant is used in breast augmentation. Its 559 reports mostly describe implants leaking or deflating, and most list the implant failing; some describe tightened scar tissue around the implant. The reports include no deaths and 555 injuries. 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
- 580
- Deaths reported
- 0
- Injuries reported
- 576
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 580 adverse event reports that list this exact device (DI 10888628000230), received between Jul 26, 2017 and Sep 30, 2026 — classified as 576 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (497 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 Leak497
- Device Appears to Trigger Rejection46
- Patient-Device Incompatibility35
- Material Rupture11
- Adverse Event Without Identified Device or Use Problem8
- Deflation Problem7
- No Apparent Adverse Event6
- Peeled/Delaminated4
Patient problems
- Failure of Implant454
- Capsular Contracture80
- No Clinical Signs, Symptoms or Conditions47
- Complaint, Ill-Defined5
- Unspecified Infection3
- Headache2
- No Known Impact Or Consequence To Patient2
- Pain2
Recent adverse event reports
The 25 most recent of 580 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Fluid/Blood Leak
Healthcare professional reported "deflation". This record is for the left side. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949101 ↗InjurySep 23, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50875808 ↗InjurySep 22, 2026Fluid/Blood Leak
Healthcare professional reported "rupture (deflation)". This record is for the right side. Device has been explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50854693 ↗InjurySep 21, 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 50840420 ↗InjurySep 15, 2026Fluid/Blood Leak
Healthcare professional reported "implant exchange with no complaint against the device". Later healthcare professional reported "deflation". This record is for the left side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50778277 ↗InjurySep 13, 2026Malposition of Device; Migration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50747538 ↗InjurySep 10, 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 50717479 ↗InjurySep 9, 2026Fluid/Blood Leak
Healthcare professional reported "deflation" and "change in appearance". This record is for the right side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50690489 ↗InjurySep 8, 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 50671913 ↗InjurySep 3, 2026Fluid/Blood Leak
Patient reported "deflation". Later healthcare professional reported rupture against the left side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50589845 ↗InjuryAug 28, 2026Fluid/Blood Leak
Healthcare professional reported "rupture". This record is for the left side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50508108 ↗InjuryAug 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 50506287 ↗InjuryAug 28, 2026Fluid/Blood Leak
Patient reported "deflation". This record is for the right side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50505228 ↗InjuryAug 20, 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 50356837 ↗InjuryAug 20, 2026Fluid/Blood Leak
Patient reported "deflation", "lumps", "implants are effecting the patient health badly" and "breast a corner piece of the implant pokes out under the skin". This record is for left side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50354869 ↗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 50213150 ↗InjuryAug 7, 2026Fluid/Blood Leak; Device Appears to Trigger Rejection
Healthcare professional reported "deflation". Later healthcare professional reported Capsular Contracture Baker Grade IV and "hole in radius (edge)". This record is for the right side. The device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50181910 ↗InjuryAug 6, 2026Fluid/Blood Leak
Healthcare Professional reported "deflated". This record is for the left side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50162544 ↗InjuryAug 5, 2026Fluid/Blood Leak
Healthcare professional reported "Implant Partially Deflated". This record is for the right side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50149891 ↗InjuryAug 5, 2026Fluid/Blood Leak
Patient reported "loss of volume", "rippling on the side", and "when I lay on my back there is nothing there". This record is for the left side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50145117 ↗InjuryAug 3, 2026Fluid/Blood Leak
Patient reported "saline implant deflation." Later, healthcare professional reported "Deflation". This record is for the right side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50123881 ↗InjuryJul 29, 2026Fluid/Blood Leak
Healthcare Professional reported "deflation". Healthcare Professional later reported "any creases, any creases associated with hole and hole in radius (edge)". This record is for the left side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50069650 ↗InjuryJul 27, 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 50031608 ↗InjuryJul 27, 2026Device Appears to Trigger Rejection
Patient reported "capsular contracture baker grade unknown" with "the implant stayed at the time and the skin dropped" and "pain on the breast and around the shoulder". This record is for the left side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50022208 ↗InjuryJul 27, 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 50016876 ↗
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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