NATRELLE Saline-Filled Breast Implants 68HP-500Recalls & reported problems
Allergan, Inc. · NATRELLE Sty 68HP-500 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 breast implant is used for breast augmentation. Its 255 reports mostly describe the implant leaking, with some mentioning flattening, rippling, capsular contracture and implant removal. There were no deaths and 251 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
- 270
- Deaths reported
- 0
- Injuries reported
- 266
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 270 adverse event reports that list this exact device (DI 10888628000445), received between Oct 5, 2017 and Sep 25, 2026 — classified as 266 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (225 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 Leak225
- Device Appears to Trigger Rejection31
- Adverse Event Without Identified Device or Use Problem8
- Patient-Device Incompatibility8
- Deflation Problem6
- Migration3
- Break2
- Device Contamination with Chemical or Other Material1
Patient problems
- Failure of Implant197
- Capsular Contracture38
- No Clinical Signs, Symptoms or Conditions27
- Unspecified Infection4
- Cellulitis3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Abscess1
- Breast Discomfort/Pain1
Recent adverse event reports
The 25 most recent of 270 reports, in the reporter's own words as published by the FDA.
InjurySep 25, 2026Fluid/Blood Leak
Patient reported Deflation and ¿had bumps¿. This record is for the right side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50898256 ↗InjurySep 24, 2026Device Appears to Trigger Rejection
Healthcare professional reported "68HP-500 device filled to 560cc". Later, healthcare professional reported "Capsular contracture Baker grade IV", "Painful". This record is for the right side. Device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50879829 ↗InjurySep 22, 2026Migration
Healthcare professional reported "Implant moved". Healthcare professional then reported "Cephalad displacement". This record is for the right side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50852767 ↗InjurySep 17, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50812646 ↗InjurySep 15, 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 50779539 ↗InjurySep 14, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50763979 ↗InjurySep 14, 2026Fluid/Blood Leak; Device Appears to Trigger Rejection
Healthcare professional reported "Capsular contracture Baker grade IV", "Deflation". This record is for the left side. Device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50762775 ↗InjurySep 14, 2026Fluid/Blood Leak
Healthcare professional reported "deflation". Later, healthcare professional reported "Rupture/Deflation". This record is for the left side. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50752578 ↗InjurySep 10, 2026Fluid/Blood Leak
Healthcare professional reported "Deflation", "68HP-500 filled to 585". This record is for the right side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50717159 ↗InjuryAug 31, 2026Fluid/Blood Leak
Healthcare professional reported "flattened". This record is for the right side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50525655 ↗InjuryAug 28, 2026Fluid/Blood Leak
Patient reported "Leaking slowly, smaller than the other, caused a wrinkle or ripple". This record is for the left side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50506107 ↗InjuryAug 27, 2026Fluid/Blood Leak
Healthcare professional reported: "deflation". This record is for the left-side device. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50477437 ↗InjuryAug 24, 2026Migration
Healthcare professional reported through National Breast Implant Registry (NBIR) "Device Migration/Implant Malposition, Change shape/size/style". This records is for the right side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50417147 ↗InjuryAug 24, 2026Malposition of Device; Migration
Healthcare professional reported through National Breast Implant Registry (NBIR) "Device Migration/Implant Malposition, Correction of Asymmetry, Change shape/size/style". This records is for the left side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50416972 ↗InjuryAug 19, 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 50331301 ↗InjuryAug 7, 2026Fluid/Blood Leak
Device has been explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50176747 ↗InjuryAug 6, 2026Fluid/Blood Leak
Healthcare professional reported ¿saline deflation¿. This record is for the right side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50158139 ↗InjuryJul 27, 2026Fluid/Blood Leak
Healthcare professional reported of the right side device: "deflation". The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50001054 ↗InjuryJul 20, 2026Fluid/Blood Leak
Healthcare professional reported "exchange with no complaint against the device". Later Healthcare Professional reported "deflation". This record is for the right side. Device has been explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25881222 ↗InjuryJul 1, 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 25676673 ↗InjuryJun 26, 2026Fluid/Blood Leak
Healthcare professional reported "rupture". Later healthcare professional reported "ptosis", "macromastia" and "implant collapsed". This record is for right side. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25638003 ↗InjuryJun 17, 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 25535835 ↗InjuryJun 16, 2026Fluid/Blood Leak
PATIENT REPORTED "PERFORATION OF THE IMPLANT". LATER HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25527195 ↗InjuryJun 16, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "PAIN" AND "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR LEFT SIDE. THE DEVICE REMAINS IMPLANTED. PATIENT HAD SINGULAIR TREATMENT.
Patient problems: Capsular Contracture
MAUDE report 25522423 ↗InjuryJun 11, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE IV". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25480505 ↗
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