NATRELLE Saline-Filled Breast Implants 68HP-650Recalls & reported problems
Allergan, Inc. · NATRELLE Sty 68HP-650 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 an implant filled with saline. Its 102 FDA reports include 101 injuries and no deaths, and mostly describe leaks that cause the implant to deflate, with some reports of hard scar tissue forming around it and infection. 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
- 105
- Deaths reported
- 0
- Injuries reported
- 103
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 105 adverse event reports that list this exact device (DI 10888628000476), received between Jul 19, 2017 and Sep 28, 2026 — classified as 103 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (82 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 Leak82
- Device Appears to Trigger Rejection14
- Patient-Device Incompatibility6
- Adverse Event Without Identified Device or Use Problem3
- Deflation Problem3
- Migration2
- Peeled/Delaminated2
- Break1
Patient problems
- Failure of Implant75
- Capsular Contracture17
- No Clinical Signs, Symptoms or Conditions8
- Pocket Erosion2
- Unspecified Infection2
- Bacterial Infection1
- Impaired Healing1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 105 reports, in the reporter's own words as published by the FDA.
InjurySep 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 50912400 ↗MalfunctionSep 23, 2026Device Contaminated During Manufacture or Shipping
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873426 ↗InjuryAug 30, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50514192 ↗InjuryAug 11, 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 50204486 ↗InjuryJun 25, 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 25623006 ↗InjuryJun 3, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "BREAST ASYMMETRY", "CAPSULAR CONTRACTURE" BAKER GRADE UNKNOWN AND "IMPLANT FLIPPING". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25376412 ↗InjuryMar 31, 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 24742448 ↗InjuryMar 23, 2026Fluid/Blood Leak
PATIENT REPORTED DEFLATION. THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24669135 ↗InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED ¿INCISION AND DRAINAGE TO OBTAIN CULTURE, PSEUDOMONAS AERUGINOSA¿. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Bacterial Infection
MAUDE report 24411608 ↗InjuryFeb 6, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 24283533 ↗InjuryNov 24, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "NO COMPLAINT AGAINST THE DEVICE". LATER HEALTHCARE PROFESSIONAL REPORTED "IT WAS LEAKING FROM SALINE INSERTION SITE", "DEFLATION" AND "SALINE IMPLANT HAD THE RUPTURE". THIS RECORD IS FOR LEFT SIDE. DEVICE WAS EXPLANTED. DEVICE WILL BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23639697 ↗InjuryNov 6, 2025Fluid/Blood Leak; No Apparent Adverse Event; Fluid/Blood Leak; No Apparent Adverse Event
THE EVENT OF DEFLATION WAS CONFIRMED NOT TO HAVE OCCURRED. THIS RECORD IS NO LONGER REPORTABLE TO THE FDA AND WILL BE UN-REPORTED.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 23490544 ↗InjurySep 29, 2025Fluid/Blood Leak; Device Appears to Trigger Rejection; Fluid/Blood Leak; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION, CAPSULAR CONTRACTURE, BAKER GRADE IV. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 23168321 ↗InjurySep 28, 2025Fluid/Blood Leak; Device Appears to Trigger Rejection; Fluid/Blood Leak; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION, CAPSULAR CONTRACTURE, BAKER GRADE IV. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 23164045 ↗InjuryJul 25, 2025Fluid/Blood Leak; Fluid/Blood Leak
PATIENT'S SPOUSE REPORTED LEFT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22610568 ↗InjuryJul 7, 2025Migration; Migration
PATIENT REPORTED RIGHT SIDE "HAS DROPPED DOWN". DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22426368 ↗InjuryJul 7, 2025Peeled/Delaminated; Peeled/Delaminated
PATIENT REPORTED "CAPSULAR CONTRACTURE, "POSSIBLY BAKER GRADE II", ¿DEFORMED BOOB¿, ¿IMPLANT REPOSITIONED¿, ¿VALVE PROTRUDING INTO THE BREAST¿, AND ¿DISFORMED". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22424614 ↗InjuryJun 27, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22347731 ↗InjuryJun 26, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22337925 ↗InjuryJun 4, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22142795 ↗InjuryMay 21, 2025Migration; Migration
HEALTHCARE PROFESSIONAL REPORTED ¿IMF FAILED CAUSING THE IMPLANT TO BOTTOM OUT/ THE INFRAMAMMARY FOLD BORDER FAILED CAUSING THE IMPLANT TO BOTTOM OUT.¿ THIS REPORT IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 22067137 ↗InjuryJan 8, 2024Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 18466094 ↗InjuryNov 21, 2023Fluid/Blood Leak; Fluid/Blood Leak
InjuryOct 10, 2023Fluid/Blood Leak; Fluid/Blood Leak
PATIENT REPORTED "I BELIEVE THE RIGHT HAND SIDE HAS RUPTURED AS IT'S VOLUME IS DOWN AND NOTICEABLE SIZE DIFFERENCE WITH A PROTRUSION." THIS IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 17906996 ↗InjuryAug 29, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 17646123 ↗
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 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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