NATRELLE Saline-Filled Breast Implants 68HP-400Recalls & reported problems
Allergan, Inc. · NATRELLE Sty 68HP-400 High 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 a breast prosthesis filled with saline. Most reports describe the implant leaking fluid or deflating, others describe hardening of the scar tissue around the implant, and some say the implant was removed. There are 260 reports, with no deaths and 255 injuries. Reports rose to 36 in the last 12 months from 18 in the year 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
- 265
- Deaths reported
- 0
- Injuries reported
- 260
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 265 adverse event reports that list this exact device (DI 10888628000414), received between Aug 24, 2017 and Sep 21, 2026 — classified as 260 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (193 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 Leak193
- Device Appears to Trigger Rejection50
- Patient-Device Incompatibility13
- Adverse Event Without Identified Device or Use Problem6
- Break3
- Improper or Incorrect Procedure or Method3
- No Apparent Adverse Event3
- Deflation Problem2
Patient problems
- Failure of Implant176
- Capsular Contracture62
- No Clinical Signs, Symptoms or Conditions16
- Complaint, Ill-Defined3
- No Known Impact Or Consequence To Patient3
- Unspecified Infection3
- Breast Mass2
- Seroma2
Recent adverse event reports
The 25 most recent of 265 reports, in the reporter's own words as published by the FDA.
InjurySep 21, 2026Fluid/Blood Leak; Device Appears to Trigger Rejection
Patient problems: Capsular Contracture
MAUDE report 50849011 ↗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 50846286 ↗InjurySep 21, 2026Device Appears to Trigger Rejection
Healthcare professional reported capsular contracture "Baker Grade IV". This record is for the left side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50838695 ↗InjurySep 14, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50763628 ↗InjuryAug 30, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50512686 ↗InjuryAug 28, 2026Fluid/Blood Leak
Healthcare professional reported "deflated". Later reported "Hole in valve". This record is for the left side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50509104 ↗InjuryAug 27, 2026Fluid/Blood Leak
Healthcare professional reported: "deflation". This record is for the left-side device. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50470318 ↗InjuryAug 25, 2026Fluid/Blood Leak
Device has been explanted and replaced.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50439026 ↗InjuryAug 25, 2026Adverse Event Without Identified Device or Use Problem
Healthcare professional reported: "Seroma, Change shape/size/style". This record is for the left-side device. The device was explanted.
Patient problems: Seroma
MAUDE report 50435428 ↗InjuryAug 24, 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 50406092 ↗InjuryAug 14, 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 50251346 ↗InjuryAug 5, 2026Device Appears to Trigger Rejection
Patient reported of the left side device: "scar tissue" and exchange. Later, healthcare professional reported no complaint against the device. Later healthcare professional reported unspecified Baker grade capsular contracture and "breast ptosis" not device related. The device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50145360 ↗InjuryAug 5, 2026Device Appears to Trigger Rejection
Healthcare professional reported via National Breast Implant Registry (NBIR) "Capsular Contracture Baker Grade IV, Change shape/size/style". This record is for the right side. The device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50144569 ↗InjuryJul 31, 2026Device Appears to Trigger Rejection
Healthcare professional reported through National Breast Implant Registry "Capsular Contracture Baker Grade III" against the left side record. The device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50102491 ↗InjuryJul 27, 2026Fluid/Blood Leak
Healthcare professional reported "rupture". This record is for the left side. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50038706 ↗InjuryJul 7, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". LATER HEALTHCARE PROFESSIONAL REPORTED "SALINE RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25734174 ↗InjuryJun 16, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN". HEALTHCARE PROFESSIONAL LATER REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25519041 ↗InjuryJun 10, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "THE IMPLANT WAS LEAKING AT THE FILL VALVE". HEALTHCARE PROFESSIONAL THEN REPORTED "DEFECT IN VALVE PLUG GRAP ATTACHMENT THAT WAS LEAKING". THIS RECORD IS FOR THE LEFT SIDE. DEVICE STATUS IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25459702 ↗InjuryJun 2, 2026Fluid/Blood Leak; No Apparent Adverse Event
PATIENT REPORTED "DEFLATION". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25366940 ↗InjuryJun 2, 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 25364269 ↗InjuryJun 2, 2026Fluid/Blood Leak
PATIENT REPORTED "DEFLATION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 25363791 ↗InjuryMay 13, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURES, BAKER GRADE III". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25157030 ↗InjuryMay 13, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURES, BAKER GRADE III". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25157021 ↗InjuryMay 7, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 25115775 ↗InjuryApr 29, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25035841 ↗
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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