NATRELLE Saline-Filled Breast Implants 68-390Recalls & reported problems
Allergan, Inc. · NATRELLE Style 68MP-390 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 has 430 adverse event reports, with 427 injuries and no deaths. The reports mostly describe the implant leaking fluid, losing volume or deflating, and some mention capsular contracture, scar tissue tightening around the implant. There were 56 reports in the last 12 months, up from 37 in the 12 months before. 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
- 446
- Deaths reported
- 0
- Injuries reported
- 443
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 446 adverse event reports that list this exact device (DI 10888628000247), received between Sep 30, 2011 and Sep 28, 2026 — classified as 443 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (386 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 Leak386
- Device Appears to Trigger Rejection40
- Patient-Device Incompatibility26
- Adverse Event Without Identified Device or Use Problem6
- Deflation Problem5
- Material Rupture3
- Improper or Incorrect Procedure or Method2
- No Apparent Adverse Event2
Patient problems
- Failure of Implant348
- Capsular Contracture64
- No Clinical Signs, Symptoms or Conditions36
- Seroma4
- Unspecified Infection4
- Adhesion(s)1
- Anaplastic Large Cell Lymphoma1
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 446 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923401 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
Patient reported "pain". Later, patient reported "physically sick" and "discomfort". Later, patient reported "breast cancer" which is not device related. This record is for the left side. Device remains implanted.
Patient problems: Breast Discomfort/Pain
MAUDE report 50894850 ↗InjurySep 24, 2026Fluid/Blood Leak
Healthcare professional reported "folding, possible deflation". This record is for the left side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889536 ↗InjurySep 24, 2026Fluid/Blood Leak
Patient reported "deflation". Later, healthcare professional reported "deflation". Later, patient reported "pain", "stiffness in arm, chest, shoulder", "physically sick, "discomfort" and "breast significantly smaller". Later patient reported "cancer" which is not device related. This record is for the right side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50880041 ↗InjurySep 21, 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 50839250 ↗InjurySep 16, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796854 ↗InjurySep 16, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796775 ↗InjurySep 15, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50782162 ↗InjurySep 14, 2026Fluid/Blood Leak
Healthcare professional reported "deflation". This record is for left side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50757356 ↗InjurySep 7, 2026Fluid/Blood Leak
The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50649732 ↗InjurySep 1, 2026Fluid/Blood Leak
Healthcare professional reported "Rupture". This record is for the right side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50547994 ↗InjuryAug 28, 2026Fluid/Blood Leak
Healthcare professional reported "deflation". This record is for the left side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50507794 ↗InjuryAug 27, 2026Fluid/Blood Leak
Patient reported "looks like it is losing volume". Later healthcare professional reported "possible deflation". This record is for the right side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50475545 ↗InjuryAug 24, 2026Fluid/Blood Leak
Healthcare Professional reported "rupture". This records is for the left side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50408854 ↗InjuryAug 20, 2026Adverse Event Without Identified Device or Use Problem
Healthcare Professional reported "seroma". This record is for the left side. Device remains implanted.
Patient problems: Seroma
MAUDE report 50359507 ↗InjuryAug 14, 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 50254407 ↗InjuryAug 12, 2026Fluid/Blood Leak
Later, healthcare professional reported ¿Any Creases¿. The device has been explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50229443 ↗InjuryJul 27, 2026Fluid/Blood Leak
Healthcare professional reported "deflation". This record is for left side. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50048121 ↗InjuryJul 27, 2026Fluid/Blood Leak
Healthcare professional reported "deflation/leak". This record is for the right side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50031502 ↗InjuryJul 27, 2026Fluid/Blood Leak
Healthcare professional reported through National Breast Implant Registry "Suspected/Actual Rupture/Deflation, Change shape/size/style". This record is for the right side. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50025339 ↗InjuryJul 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 25856874 ↗InjuryJul 8, 2026Fluid/Blood Leak
Device has been explanted and replaced.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25753543 ↗InjuryJul 7, 2026Fluid/Blood Leak
Healthcare Professional reported "rupture". Healthcare Professional later reported "hole non-specific". This record is for the left side. Device was explanted.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25735251 ↗InjuryJun 26, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATED", "IMPLANT WAS SLOWLY LEAKING IN THE POCKET AND GETTING SMALLER". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25642160 ↗InjuryJun 22, 2026Fluid/Blood Leak
The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25578151 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page