NATRELLE Saline-Filled Breast Implants 68LP-150Recalls & reported problems

Allergan, Inc. · NATRELLE Style 68LP-150 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: 11
Deaths reported: 0
Injuries reported: 11
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10888628000520), received between Aug 15, 2018 and Oct 12, 2023 — classified as 11 injuries.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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 Leak6
Device Appears to Trigger Rejection3
Patient-Device Incompatibility2

Patient problems

Failure of Implant6
Capsular Contracture5

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

InjuryOct 12, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 17921807 ↗
InjuryOct 3, 2023Fluid/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 17865585 ↗
InjuryJun 2, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE. LATER, HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. "ANY CREASES" OBSERVED DURING SURGERY VIA RGA. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 17053269 ↗
InjuryApr 21, 2023Fluid/Blood Leak; Fluid/Blood Leak
THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 16789213 ↗
InjuryApr 4, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "CAPSULAR CONTRACTURE BAKER GRADE IV." DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16674488 ↗
InjuryMar 14, 2023Fluid/Blood Leak; Fluid/Blood Leak
DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 16542474 ↗
InjuryOct 31, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 15700435 ↗
InjuryApr 28, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DEFLATION. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 14243829 ↗
InjuryDec 13, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 9468319 ↗
InjuryMay 1, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 8568555 ↗
InjuryAug 15, 2018Fluid/Blood Leak; Fluid/Blood Leak
PATIENT REPORTED LEFT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 7785469 ↗

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	`10888628000520`
Brand	NATRELLE Saline-Filled Breast Implants
Model	68LP-150
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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