NATRELLE Saline-Filled Breast Implants 68LP-420Recalls & reported problems

Allergan, Inc. · NATRELLE Style 68LP-420 Low 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

Adverse event reports: 23
Deaths reported: 0
Injuries reported: 23
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10888628000629), received between Jun 27, 2019 and Feb 19, 2026 — classified as 23 injuries.

The most frequently reported specific device problem is “Fluid/Blood Leak” (23 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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Fluid/Blood Leak23
Device Appears to Trigger Rejection2
Deflation Problem1

Patient problems

Failure of Implant21
Capsular Contracture2

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

InjuryFeb 19, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24389141 ↗
InjuryNov 12, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED AND WILL BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23529479 ↗
InjuryJun 2, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE FOR A SALINE DEVICE". THIS RECORD IS FOR FOR THE "RIGHT" SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22125310 ↗
InjuryApr 9, 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 21803893 ↗
InjuryOct 15, 2024Fluid/Blood Leak; Device Appears to Trigger Rejection; Fluid/Blood Leak; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "PATIENT HAS NOTICED A CHANGE IN THE SIZE OF IMPLANTS, SUSPECTING LEAK OR DEFLATION AND CAPSULAR CONTRACTURE, BAKER GRADE III". DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 20455953 ↗
InjuryOct 15, 2024Fluid/Blood Leak; Device Appears to Trigger Rejection; Fluid/Blood Leak; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "PATIENT HAS NOTICED A CHANGE IN THE SIZE OF IMPLANTS, SUSPECTING LEAK OR DEFLATION AND CAPSULAR CONTRACTURE, BAKER GRADE III". DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 20455105 ↗
InjuryJun 21, 2024Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 19581604 ↗
InjuryJun 21, 2024Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 19581139 ↗
InjuryOct 2, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED DEFLATION. THE DEVICE REMAINS IMPLANTED. THIS RELATES TO THE RIGHT SIDE.
Patient problems: Failure of Implant
MAUDE report 17855382 ↗
InjurySep 21, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 17786693 ↗
InjurySep 11, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE "RUPTURE". DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 17720237 ↗
InjurySep 8, 2023Fluid/Blood Leak; Fluid/Blood Leak
PATIENT REPORTED A LEFT SIDE "RUPTURE". DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 17715682 ↗
InjuryJul 11, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 17300941 ↗
InjuryJul 18, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROVIDER REPORTED A RIGHT SIDE DEFLATION. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 15044121 ↗
InjuryApr 21, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 14167095 ↗
InjuryNov 16, 2021Fluid/Blood Leak; Fluid/Blood Leak
DEVICE EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 12821266 ↗
InjuryMar 2, 2021Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 11402539 ↗
InjuryMar 1, 2021Deflation Problem; Fluid/Blood Leak; Deflation Problem; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 11393214 ↗
InjuryNov 18, 2020Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 10862692 ↗
InjuryNov 16, 2020Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "RIGHT SIDE DEFLATION¿. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 10849109 ↗
InjuryNov 20, 2019Fluid/Blood Leak; Fluid/Blood Leak
DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 9347983 ↗
InjuryAug 1, 2019Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 8849703 ↗
InjuryJun 27, 2019Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 8741692 ↗

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 · Terminated
Natrelle 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, Classified
Natrelle, 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 · Terminated
McGhan Style 163-360cc Saline-Filled BIOCELL textured Breast Implants, Catalogue Number :163-360
Z-0336-06 · Dec 14, 2005 · Terminated
McGhan Style 468-380cc Saline-Filled BIOCELL textured Breast Implants, Catalog Number:468-380
Z-0851-05 · May 5, 2005 · Terminated
Style 363 Saline-Filled BIOCELL textured Breast Implants

Device details

UDI-DI	`10888628000629`
Brand	NATRELLE Saline-Filled Breast Implants
Model	68LP-420
Company	Allergan, Inc.
Product code	FWM · Prosthesis, Breast, Inflatable, Internal, Saline
Class	Class 3
FDA submission	P990074
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Safe
Status	In Commercial Distribution
Record updated	Apr 30, 2021

Device type (GMDN): Saline-filled breast implant, unstructured, smooth-surface

An implantable device designed to reconstruct or augment the breast that is composed of a silicone rubber outer shell, made of polysiloxane(s), with a single lumen inflated with sterile isotonic saline to the desired size; the shell surface is smooth. The implant may be of fixed or adjustable volume and may be prefilled, partially filled, or empty and filled during the implantation procedure; the volume of saline solution in adjustable volume implants may be adjusted after implantation. The device may vary in shape, profile, volume and shell thickness.

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All Prosthesis, Breast, Inflatable, Internal, Saline devices →

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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