NATRELLE Saline-Filled Breast Implants 68HP-425Recalls & reported problems
Allergan, Inc. · NATRELLE Sty 68HP-425 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 high-projection saline breast implant is a breast prosthesis. The 227 reports mostly describe fluid leaks and deflation, with some describing hardened scar tissue forming around the implant. The reports include 222 injuries and no deaths. 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
- 237
- Deaths reported
- 0
- Injuries reported
- 232
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 237 adverse event reports that list this exact device (DI 10888628000421), received between Jul 18, 2017 and Sep 25, 2026 — classified as 232 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (191 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 Leak191
- Device Appears to Trigger Rejection28
- Patient-Device Incompatibility11
- Break5
- Material Rupture4
- Adverse Event Without Identified Device or Use Problem3
- Device Handling Problem3
- Deflation Problem2
Patient problems
- Failure of Implant173
- Capsular Contracture38
- No Clinical Signs, Symptoms or Conditions18
- Unspecified Infection4
- No Known Impact Or Consequence To Patient3
- Wound Dehiscence3
- Abscess2
- Fluid Discharge2
Recent adverse event reports
The 25 most recent of 237 reports, in the reporter's own words as published by the FDA.
InjurySep 25, 2026Device Appears to Trigger Rejection
Healthcare professional reported: Baker grade IV capsular contracture. This record is for the right-side device. The device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50898208 ↗InjurySep 25, 2026Fluid/Blood Leak; Device Appears to Trigger Rejection
Healthcare professional reported: Baker grade IV capsular contracture, and "deflation". This record is for the left-side device. The device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50898006 ↗InjurySep 21, 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 50839743 ↗InjurySep 1, 2026Fluid/Blood Leak
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 50534729 ↗InjuryAug 30, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50514539 ↗InjuryAug 28, 2026Fluid/Blood Leak
Patient problems: Breast Mass
MAUDE report 50509777 ↗InjuryAug 21, 2026Device Appears to Trigger Rejection
Patient reported ¿exchange with no complaint against the device¿. Healthcare professional later reported "capsular contracture Baker grade III". Device was implanted after expiration date. This record is for the left side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50380115 ↗InjuryAug 5, 2026Fluid/Blood Leak
Healthcare professional reported "Suspected/Actual Rupture/Deflation, Change shape/size/style" via the National Breast Implant Registry (NBIR). This record is for the left side. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50141906 ↗InjuryAug 3, 2026Fluid/Blood Leak
Healthcare professional reported through National Breast Implant Registry (NBIR) "Suspected/Actual Rupture/Deflation, Change shape/size/style". This record is for the left side. Device has been explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50122600 ↗InjuryJul 27, 2026Material Rupture
Healthcare Professional reported via the National Breast Implant Registry (NBIR) "Suspected/Actual Rupture/Deflation, Change shape/size/style, Ptosis". This record is for the left side. Device has been explanted.
Patient problems: Ptosis
MAUDE report 50047871 ↗InjuryJul 14, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25815863 ↗InjuryJul 9, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE LEFT SIDE. DEVICE EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25769213 ↗InjuryJul 1, 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 25686060 ↗InjuryJun 22, 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 25578876 ↗InjuryJun 12, 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 25490059 ↗InjuryJun 2, 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 25360586 ↗InjuryMay 13, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE¿ OF A SALINE DEVICE. THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25160083 ↗InjuryApr 13, 2026Fluid/Blood Leak
Patient reported "Rupture". And later Healthcare Professional reported "rupture". This record is for the right side. Device has been explanted and replaced.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24860555 ↗InjuryMar 11, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION" AND LATER REPORTED "HOLE ON PATCH SIDE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24567272 ↗InjuryFeb 20, 2026Fluid/Blood Leak
InjuryFeb 18, 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 24378351 ↗InjuryFeb 6, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "SALINE RUPTURE". LATER PHYSICIAN REPORTED "WHOLE AT THE BOTTOM". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24276673 ↗InjuryJan 22, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED ¿DEFLATION¿. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 24153191 ↗InjuryJan 14, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED EXCHANGE WITH NO COMPLAINT. HEALTHCARE PROFESSIONAL LATER REPORTED "RUPTURE BREAST IMPLANT, BAKER IV CAPSULAR CONTRACTURE PAINFUL, HARDENING OF BREAST AND BREAST DEFORMITY". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 24067870 ↗InjuryDec 9, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 23757400 ↗
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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