NATRELLE Saline-Filled Breast Implants 68HP-320Recalls & reported problems
Allergan, Inc. · NATRELLE Sty 68HP-320 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 Natrelle saline breast implant is used for breast augmentation and reconstruction. Most reports describe leaks and deflation, and some describe hardening of the scar capsule around the implant. The 158 reports include no deaths and 155 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
- 168
- Deaths reported
- 0
- Injuries reported
- 165
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 168 adverse event reports that list this exact device (DI 10888628000391), received between Jul 25, 2017 and Sep 30, 2026 — classified as 165 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (128 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 Leak128
- Device Appears to Trigger Rejection28
- Patient-Device Incompatibility10
- Break2
- Material Rupture2
- Adverse Event Without Identified Device or Use Problem1
- Delivered as Unsterile Product1
- Peeled/Delaminated1
Patient problems
- Failure of Implant116
- Capsular Contracture37
- No Clinical Signs, Symptoms or Conditions15
- Erosion1
- Fluid Discharge1
- Hematoma1
- Unspecified Infection1
Recent adverse event reports
The 25 most recent of 168 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952555 ↗InjurySep 29, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture
MAUDE report 50937946 ↗InjurySep 22, 2026Device Appears to Trigger Rejection
Patient reported "capsular contracture, Baker grade unknown". Later patient reported "exchange with no complaint against the device". This record is for the left side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50855027 ↗InjurySep 7, 2026Fluid/Blood Leak
Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50650754 ↗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 50464073 ↗InjuryAug 25, 2026Fluid/Blood Leak
Healthcare professional reported: "leak". This record is for the left-side device. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50441764 ↗InjuryAug 18, 2026Fluid/Blood Leak
Device has been explanted and replaced.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50303905 ↗InjuryAug 13, 2026Fluid/Blood Leak
Healthcare professional reported "deflation". This record is for the right side. Device has been explanted and replaced.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50236528 ↗InjuryAug 6, 2026Fluid/Blood Leak
Patient reported "exchange with no complaint against the device". Later 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 50156152 ↗InjuryJul 27, 2026Fluid/Blood Leak
Patient reported "Deflation/leak". Healthcare professional then confirmed "Deflation". This record is for the right side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50031646 ↗InjuryJul 27, 2026Fluid/Blood Leak
Healthcare professional reported " deflation" and "breast mass". This record is for the right side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50015084 ↗InjuryJul 16, 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 25837061 ↗InjuryJun 25, 2026Fluid/Blood Leak; Device Appears to Trigger Rejection
PATIENT REPORTED "LEAK, DEFLATING, LOSS OF VOLUME" WITH "IT'S LOOSE FEELING". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions
MAUDE report 25631057 ↗InjuryMay 14, 2026Fluid/Blood Leak
PATIENT REPORTED "DEFLATION". LATER HEALTHCARE PROFESSIONAL REPORTED "COMPLETE DEFLATION" AND "HOLE LOCATED IN THE LATERAL CREASE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 25175098 ↗InjuryApr 27, 2026Device Appears to Trigger Rejection
DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 25003717 ↗InjuryApr 13, 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 24859743 ↗InjuryMar 17, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "RIGHT SIDE DEFLATION". HEALTHCARE PROFESSIONAL LATER REPORTED "ANY CREASES" OBSERVED DURING SURGERY. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED
Patient problems: Failure of Implant
MAUDE report 24622221 ↗InjuryMar 10, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION CONFIRMED VIA UNKNOWN IMAGING". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24562868 ↗InjuryMar 5, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". LATER HEALTHCARE PROFESSIONAL REPORTED "HOLE IN VALVE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24520641 ↗InjuryMar 5, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN" AND "BREAST CANCER" WHICH IS NOT DEVICE RELATED. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24520052 ↗InjuryFeb 17, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 24373024 ↗InjuryFeb 12, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 24321885 ↗InjuryFeb 6, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24276647 ↗InjuryJan 23, 2026Material Rupture
PATIENT REPORTED "RUPTURE/SLOW LEAK, SKIN SAGGING/STRETCHING/WRINKLING". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 24160508 ↗InjuryJan 12, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL LATER REPORTED "INTACT BUT LEAKING AT VALVE." THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 24048667 ↗
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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