NATRELLE Saline-Filled Breast Implants 68HP-600Recalls & reported problems
Allergan, Inc. · NATRELLE Sty 68HP-600 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 has 166 reports, with no deaths and 165 injuries. Most reports describe the implant leaking saline and deflating, and some describe scar tissue tightening around it, migration, or a skin infection called cellulitis. 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
- 173
- Deaths reported
- 0
- Injuries reported
- 172
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 173 adverse event reports that list this exact device (DI 10888628000469), received between Aug 24, 2017 and Sep 30, 2026 — classified as 172 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (140 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 Leak140
- Device Appears to Trigger Rejection23
- Patient-Device Incompatibility7
- Adverse Event Without Identified Device or Use Problem4
- Deflation Problem3
- No Apparent Adverse Event3
- Migration or Expulsion of Device2
- Insufficient Device Problem Information1
Patient problems
- Failure of Implant127
- Capsular Contracture29
- No Clinical Signs, Symptoms or Conditions14
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Unspecified Infection2
- Cellulitis1
- Complaint, Ill-Defined1
- Foreign Body Reaction1
Recent adverse event reports
The 25 most recent of 173 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Fluid/Blood Leak
Healthcare professional reported "deflation". Later, healthcare professional reported "clamp used" and "no particles seen". This record is for the right side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948742 ↗InjurySep 24, 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 50889041 ↗InjurySep 22, 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 50859600 ↗InjurySep 17, 2026Fluid/Blood Leak
Patient reported "leak and pain" and "burning sensation". This record is for the left side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50805573 ↗InjurySep 14, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Baker IV capsular contracture". This record is for the left side. The device has been explanted.
Patient problems: Capsular Contracture
MAUDE report 50756386 ↗InjurySep 4, 2026Device Appears to Trigger Rejection
Healthcare professional reported "capsular contracture, Baker grade unknown and exchange". This record is for the left side. The device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50620103 ↗InjurySep 4, 2026Fluid/Blood Leak
Healthcare professional reported "deflation and exchange". This record is for the right side. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50619865 ↗InjuryAug 27, 2026Adverse Event Without Identified Device or Use Problem
Healthcare professional reported a "Cellulitis". This record is for the left side. The device was explanted.
Patient problems: Cellulitis
MAUDE report 50484982 ↗InjuryAug 7, 2026Fluid/Blood Leak
Healthcare professional reported "deflation". This record is for the left side. The device has been explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50181211 ↗InjuryJul 28, 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 50056860 ↗InjuryJun 30, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED OF THE LEFT SIDE DEVICE: "DEFLATION". THE DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25668211 ↗InjuryJun 13, 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 25495815 ↗InjuryJun 3, 2026Malposition of Device; Migration
HEALTHCARE PROFESSIONAL REPORTED VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR) MANUFACTURER REGISTRY SPECIFIC DATA REPORT (MRSDR) "DEVICE MIGRATION/IMPLANT MALPOSITION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25384360 ↗InjuryApr 22, 2026Fluid/Blood Leak; No Apparent Adverse Event
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24958110 ↗InjuryApr 4, 2026Fluid/Blood Leak; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "CAPSULAR CONTRACTURE, BAKER GRADE IV". UPON FURTHER FOLLOW UP, IT WAS NOTED THAT THE RIGHT SIDE DEVICE WAS NOT DEFLATED. HENCE UNREPORTING THE PREVIOUSLY REPORTED DEFLATION.
Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions
MAUDE report 24786556 ↗InjuryMar 3, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24503644 ↗InjuryJan 29, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 24208992 ↗InjuryJan 21, 2026Fluid/Blood Leak; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "BILATERAL BREAST DYSPHORIA", "GRADE III PTOSIS" AND "POSSIBLE SLOW LEAKAGE OF SALINE IMPLANTS". LATER HEALTHCARE REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE IV". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 24131259 ↗InjuryJan 12, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 24031520 ↗InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED "RIPPLING". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23996340 ↗InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED "RIPPLING". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23996215 ↗InjuryDec 23, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". LATER, HEALTHCARE PROFESSIONAL REPORTED "HOLE, NON-SPECIFIC". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 23885110 ↗InjuryDec 22, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 23873881 ↗InjuryNov 26, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "SLOW DEFLATION". HEALTHCARE PROFESSIONAL REPORTED LATER "SHINGLES" WHICH IS NOT DEVICE RELATED. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 23656360 ↗InjuryOct 15, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED ¿CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN¿ AND ¿CATEGORY 2 BENIGN CALCIFICATIONS¿ DIAGNOSED VIA MAMMOGRAM. LATER HEALTHCARE PROFESSIONAL REPORTED ¿ANY CREASES¿. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 23303992 ↗
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
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- 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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