NATRELLE Saline-Filled Breast Implants 68-700Recalls & reported problems
Allergan, Inc. · NATRELLE Style 68MP-700 Moderate 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 is a smooth, round, moderate-projection implant made by Allergan. The 61 reports mostly describe the implant losing its saline or rupturing, with several explanted and replaced, along with a few cases of the body tightening around the implant (capsular contracture) and infection. All reports describe injuries; no deaths were reported. 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
- 63
- Deaths reported
- 0
- Injuries reported
- 63
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 10888628000322), received between Oct 7, 2017 and Sep 30, 2026 — classified as 63 injuries.
The most frequently reported specific device problem is “Fluid/Blood Leak” (57 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 Leak57
- Patient-Device Incompatibility5
- Adverse Event Without Identified Device or Use Problem2
- Deflation Problem1
- Device Appears to Trigger Rejection1
Patient problems
- Failure of Implant52
- Capsular Contracture5
- No Clinical Signs, Symptoms or Conditions3
- Unspecified Infection2
- Discharge1
- Impaired Healing1
- Pocket Erosion1
- Wound Dehiscence1
Recent adverse event reports
The 25 most recent of 63 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Fluid/Blood Leak
Healthcare professional reported "Deflation". Later patient reported "Deflation" against the right side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946475 ↗InjuryJul 27, 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 50048040 ↗InjuryJul 5, 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 25712919 ↗InjuryApr 29, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "RUPTURED". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 25038247 ↗InjuryDec 12, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED. DEVICE WILL BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23795306 ↗InjuryJul 10, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE "RIGHT" SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22466682 ↗InjuryJul 2, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "DEFLATION". DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22384759 ↗InjuryApr 18, 2025Fluid/Blood Leak; Fluid/Blood Leak
PATIENT REPORTED LEFT SIDE DEFLATION (CONFIRMED BY PHYSICIAN). THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 21869551 ↗InjuryJan 13, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DEFLATION. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 21145506 ↗InjuryJan 6, 2025Fluid/Blood Leak; Fluid/Blood Leak
InjuryJan 2, 2024Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 18432737 ↗InjuryOct 23, 2023Fluid/Blood Leak; Fluid/Blood Leak
InjuryAug 22, 2023Fluid/Blood Leak; Fluid/Blood Leak
InjuryMay 8, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "PARTIAL DEFLATIONS." THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 16887889 ↗InjuryMar 16, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED, A LEFT-SIDE DEFLATION. HEALTHCARE PROFESSIONAL, LATER REPORTED, "VALVE-LEAK/DAMAGE". DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 16557598 ↗InjuryFeb 1, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 16280351 ↗InjuryDec 13, 2022Fluid/Blood Leak; Fluid/Blood Leak
PATIENT REPORTED LEFT-SIDE "PAIN" AND "LEAKAGE.'' DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 15974068 ↗InjuryDec 12, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROVIDER REPORTED UNKNOWN SIDE OF DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 15959381 ↗InjuryNov 30, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED A LEFT-SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 15888999 ↗InjuryNov 10, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DEFLATION AGAINST THE DEVICE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 15772062 ↗InjuryAug 17, 2022Fluid/Blood Leak; Fluid/Blood Leak
PATIENT REPORTED RIGHT SIDE DEFLATION AND INFECTION. DEVICE REMAINS IMPLANTED.
Patient problems: Unspecified Infection
MAUDE report 15242498 ↗InjuryAug 12, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 15217758 ↗InjuryJul 15, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DEFLATION. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 15032672 ↗InjuryMay 31, 2022Fluid/Blood Leak; Fluid/Blood Leak
PATIENT REPORTED DEFLATION AGAINST LEFT DEVICE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 14555326 ↗InjuryApr 21, 2022Device 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 14171086 ↗
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-0337-06 · Dec 14, 2005 · TerminatedMcGhan Style 163-360cc Saline-Filled BIOCELL textured Breast Implants, Catalogue Number :163-360
- Z-0336-06 · Dec 14, 2005 · TerminatedMcGhan Style 468-380cc Saline-Filled BIOCELL textured Breast Implants, Catalog Number:468-380
- 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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