NATRELLE Saline-Filled Breast Implants 68HP-800Recalls & reported problems
Allergan, Inc. · NATRELLE Sty 68HP-800 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 130 adverse event reports on record, with no deaths and 127 injuries. The reports mostly describe the implant deflating or leaking, and some mention hard scar tissue forming around it (capsular contracture) or the body reacting as if rejecting the implant. There are no recalls naming this device. The last 12 months show 7 reports, compared with 14 in the 12 months before.
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
- 133
- Deaths reported
- 0
- Injuries reported
- 130
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 133 adverse event reports that list this exact device (DI 10888628000506), received between Sep 1, 2017 and Sep 18, 2026 — classified as 130 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (108 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 Leak108
- Device Appears to Trigger Rejection17
- Adverse Event Without Identified Device or Use Problem5
- Break2
- Improper or Incorrect Procedure or Method2
- No Apparent Adverse Event2
- Patient-Device Incompatibility2
- Deflation Problem1
Patient problems
- Failure of Implant99
- Capsular Contracture19
- No Clinical Signs, Symptoms or Conditions10
- Seroma4
- Unspecified Infection4
- Swollen Lymph Nodes/Glands2
- Erosion1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 133 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50831618 ↗InjuryAug 30, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture; Ptosis
MAUDE report 50514143 ↗InjuryAug 30, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture
MAUDE report 50514142 ↗InjuryAug 28, 2026Fluid/Blood Leak
Healthcare professional reported: "deflation". This record is for the left-side device. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50503408 ↗InjuryAug 10, 2026Device Appears to Trigger Rejection
Healthcare professional reported of the right side device: "late onset hematoma". Later healthcare professional reported "capsular contracture, Baker grade IV, arrhythmia (not device related), swelling, fatigue and joint issues (not device related)", "severe pain", and "patient claims to possibly have breast implant illness (not device related)". The patient received a drain as treatment. The device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50193489 ↗InjuryJul 15, 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 25827155 ↗InjuryMay 29, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25327380 ↗InjuryMay 28, 2026Fluid/Blood Leak; No Apparent Adverse Event
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 25314452 ↗InjuryMay 20, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED A "DEFLATION". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25230873 ↗InjuryMar 3, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE/DEFLATION". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24503016 ↗InjurySep 19, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III"; SINGULAIR¿ PRESCRIBED AS TREATMENT. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 23096462 ↗InjurySep 18, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 23085647 ↗InjurySep 5, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE LEFT-SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 22982384 ↗InjuryAug 28, 2025Fluid/Blood Leak; Fluid/Blood Leak
InjuryAug 6, 2025Fluid/Blood Leak; No Apparent Adverse Event; Fluid/Blood Leak; No Apparent Adverse Event
HEALTHCARE PROFESSIONAL CONFIRMED THE RIGHT DEVICE TO BE INTACT. THIS RECORD IS NO LONGER REPORTABLE TO THE FDA AND IS BEING UN-REPORTED.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 22734040 ↗InjuryAug 5, 2025Fluid/Blood Leak; Device Appears to Trigger Rejection; Fluid/Blood Leak; Device Appears to Trigger Rejection
HEALTHCARE PROVIDER REPORTED A LEFT SIDE DEFLATION. LATER HEALTHCARE PROFESSIONAL REPORTED "THERE WAS A SIGNIFICANT CAPSULAR AND SCAR, SKIN CONTRACTURE, SOLDED IN UPON ITSELF." THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture; Failure of Implant
MAUDE report 22720143 ↗InjuryJul 30, 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 22664557 ↗InjuryJun 24, 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 22324037 ↗InjuryJun 3, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED ¿BAKER IV CAPSULAR CONTRACTURE, PAINFUL LEFT BREAST¿. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 22131973 ↗InjuryJun 2, 2025Fluid/Blood Leak; Device Appears to Trigger Rejection; Fluid/Blood Leak; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED ¿BAKER IV CAPSULAR CONTRACTURE, DEFLATED SALINE BREAST IMPLANT. RIGHT BREAST DEFORMITY, PAINFUL, HARDENING OF RIGHT BREAST.¿ THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 22125591 ↗InjuryApr 29, 2025Fluid/Blood Leak; Fluid/Blood Leak
PATIENT REPORTED RIGHT SIDE PAIN AND DEFLATION. HEALTHCARE PROVIDER REPORTED RIGHT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 21930046 ↗InjuryApr 28, 2025Fluid/Blood Leak; Fluid/Blood Leak
PATIENT REPORTED LEFT SIDE DEFLATION. HEALTHCARE PROVIDER CONFIRMED. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 21920362 ↗InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED "INFECTION". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 21859616 ↗InjuryMar 10, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DEFLATION. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 21560857 ↗InjuryNov 17, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "RUPTURE". DEVICE HAS BEEN EXPLANTED .
Patient problems: Failure of Implant
MAUDE report 18162875 ↗
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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