NATRELLE Saline-Filled Breast Implants 68HP-550Recalls & reported problems
Allergan, Inc. · NATRELLE Sty 68HP-550 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-filled breast implant has 211 adverse event reports, with no deaths and 208 injuries. Most describe the implant leaking or deflating, and some mention capsular contracture, a hardening of scar tissue around the implant. 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
- 218
- Deaths reported
- 0
- Injuries reported
- 215
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 218 adverse event reports that list this exact device (DI 10888628000452), received between Jul 21, 2017 and Sep 28, 2026 — classified as 215 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (189 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 Leak189
- Device Appears to Trigger Rejection21
- Patient-Device Incompatibility6
- Adverse Event Without Identified Device or Use Problem5
- Deflation Problem4
- Break2
- Device Handling Problem1
- Improper or Incorrect Procedure or Method1
Patient problems
- Failure of Implant176
- Capsular Contracture26
- No Clinical Signs, Symptoms or Conditions13
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Swollen Lymph Nodes2
- Cellulitis1
- Granuloma1
- Impaired Healing1
Recent adverse event reports
The 25 most recent of 218 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 50925991 ↗InjuryAug 31, 2026Fluid/Blood Leak
Device has been explanted and replaced.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 50531286 ↗InjuryAug 21, 2026Fluid/Blood Leak
Healthcare professional reported "Deflation". This record is for the right side. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50382823 ↗InjuryAug 7, 2026Fluid/Blood Leak
Patient reported "implant popped" against the lefts side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50176746 ↗InjuryAug 3, 2026Fluid/Blood Leak; Device Appears to Trigger Rejection
Healthcare professional reported "possible deflation". This record is for left side. The device was explanted.
Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions
MAUDE report 50116694 ↗InjuryJul 27, 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 50041406 ↗InjuryJul 16, 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 25845753 ↗InjuryJun 30, 2026Fluid/Blood Leak
PATIENT REPORTED "DEFLATION¿. THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25673525 ↗InjuryMay 28, 2026Fluid/Blood Leak
Patient reported "Deflation". Healthcare professional later reported "Deflation". This record is for the right side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25317602 ↗InjuryApr 17, 2026Fluid/Blood Leak
PATIENT REPRESENTATIVE REPORTED OF THE RIGHT-SIDE DEVICE: "(SALINE) RUPTURE". THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 24916764 ↗InjuryApr 8, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 24818670 ↗InjuryMar 31, 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 24742342 ↗InjuryMar 13, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24592113 ↗InjuryMar 2, 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 24483213 ↗InjuryFeb 19, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 24389911 ↗InjuryJan 29, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24215023 ↗InjuryJan 5, 2026Fluid/Blood Leak
PATIENT REPORTED "DEFLATION". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED AND IT IS UNKNOWN IF IT WILL BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23967212 ↗InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED "LATERAL DISPLACEMENT OF IMPLANTS WITH ANIMATION DEFORMITY". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23869153 ↗InjuryDec 4, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 23716752 ↗InjuryDec 1, 2025Fluid/Blood Leak; Fluid/Blood Leak
InjuryOct 30, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant
MAUDE report 23423084 ↗InjuryOct 27, 2025Fluid/Blood Leak; Fluid/Blood Leak
InjurySep 9, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATED SALINE IMPLANT". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 23009288 ↗InjuryAug 27, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE LEFT -SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 22906629 ↗InjuryAug 27, 2025Fluid/Blood Leak; Fluid/Blood Leak
PATIENT REPORTED ¿POSSIBLE LEAKING¿, "BIG DEFORMATION", "PAIN" AND "LOST SOME SIZE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22906593 ↗
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