NATRELLE Saline-Filled Breast Implants 68-450Recalls & reported problems
Allergan, Inc. · NATRELLE Style 68MP-450 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 prosthesis filled with saline solution. Most of the 314 reports describe the implant deflating or leaking fluid, and some describe capsular contracture, meaning the scar tissue around the implant tightens. There were 310 injury reports and no deaths, and 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
- 323
- Deaths reported
- 0
- Injuries reported
- 319
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 323 adverse event reports that list this exact device (DI 10888628000261), received between Jul 20, 2017 and Sep 25, 2026 — classified as 319 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (278 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 Leak278
- Device Appears to Trigger Rejection29
- Patient-Device Incompatibility16
- Material Rupture4
- Adverse Event Without Identified Device or Use Problem3
- Deflation Problem3
- No Apparent Adverse Event3
- Break2
Patient problems
- Failure of Implant258
- Capsular Contracture43
- No Clinical Signs, Symptoms or Conditions24
- Unspecified Infection2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Erosion1
- Impaired Healing1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 323 reports, in the reporter's own words as published by the FDA.
InjurySep 25, 2026Device Appears to Trigger Rejection
Healthcare professional reported "capsular contracture baker grade IV." This record is for the right side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50900933 ↗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 50839923 ↗InjurySep 17, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50812239 ↗InjurySep 9, 2026Fluid/Blood Leak
Device has been explanted and replaced.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50694870 ↗InjurySep 7, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50651642 ↗InjuryAug 31, 2026Fluid/Blood Leak
Healthcare professional reported "deflation". This record is for the left side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50532059 ↗InjuryAug 26, 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 50455356 ↗InjuryAug 10, 2026Fluid/Blood Leak
Patient reported "lump", "rupture for saline device". This record is for the left side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50195244 ↗InjuryAug 4, 2026Fluid/Blood Leak
Patient reported "flattened". Later healthcare professional reported "rupture". This record is for the right side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50132332 ↗InjuryJul 27, 2026Fluid/Blood Leak
Healthcare Professional reported "rupture". This record is for the right side. Device has been explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50046762 ↗InjuryJul 3, 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 25707264 ↗InjuryJul 3, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "SALINE DEFLATION". HEALTHCARE PROFESSIONAL LATER REPORTED "HOLE, NON-SPECIFIC". THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25707014 ↗InjuryJun 26, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25644204 ↗InjuryJun 24, 2026Fluid/Blood Leak
Healthcare professional reported "Deflation". "Hole in radius (edge)" were observed during surgery. This record is for the right side. The device has been explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25610265 ↗InjuryJun 22, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "SALINE RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25588233 ↗InjuryJun 4, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED ¿SALINE IMPLANT LEAK¿. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25391146 ↗InjuryMay 15, 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 25183630 ↗InjuryMay 12, 2026Fluid/Blood Leak
PATIENT REPORTED "APPEARED FLAT, SLOW LEAK". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25152678 ↗InjuryApr 16, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "SALINE IMPLANT RUPTURE LESS THAN 2 MONTHS AFTER IT WAS PLACED" AND "DID NOT SEE ANY OBVIOUS TEAR". THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24900553 ↗InjuryApr 7, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL, THROUGH COMPANY REPRESENTATIVE, REPORTED OF THE RIGHT SIDE DEVICE: "DEFLATION". THE DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24811402 ↗InjuryApr 3, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED A "DEFLATION". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24776601 ↗InjuryFeb 24, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". HEALTHCARE PROFESSIONAL LATER REPORTED "ANY CREASES ASSOCIATED WITH HOLE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24437496 ↗InjuryFeb 20, 2026Fluid/Blood Leak
PATIENT REPORTED "IMPLANT SAT HIGHER" AND "ABOUT 1 WEEK AGO" IT DEFLATED". THIS RECORD IS FOR RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24408219 ↗InjuryFeb 10, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "SALINE RUPTURE" AND "CHANGE IN BREAST SHAPE AND SIZE IN BREAST". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED. PATIENT WAS PRESCRIBED CEPHALEXIN AND NORCO.
Patient problems: Failure of Implant
MAUDE report 24304847 ↗InjuryFeb 5, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24272267 ↗
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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