NATRELLE Saline-Filled Breast Implants 168-510Recalls & reported problems

Allergan, Inc. · NATRELLE 168-510 Moderate Projection BIOCELL |textured|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

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 16
Deaths reported: 0
Injuries reported: 16
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10888628000889), received between Oct 27, 2017 and Jul 16, 2026 — classified as 16 injuries.

The most frequently reported specific device problem is “Fluid/Blood Leak” (14 reports).

1 FDA recall record name this device's identifier, 1 still open.

4 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.

Recalls naming this device

Jul 24, 2019Class IOpen, Classified
The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.
Z-2451-2019 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

Most reported problems

Device problems

Fluid/Blood Leak14
Device Appears to Trigger Rejection3
Material Rupture1
Patient-Device Incompatibility1

Patient problems

Failure of Implant13
Capsular Contracture4
Calcium Deposits/Calcification1

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

InjuryJul 16, 2026Fluid/Blood Leak; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE III¿ AND ¿BENIGN CALCIFICATIONS¿. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Calcium Deposits/Calcification; Capsular Contracture
MAUDE report 25840699 ↗
InjuryJul 5, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 17260114 ↗
InjuryApr 12, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III AND PAIN. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16724003 ↗
InjuryOct 13, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED DEFLATION AND PATIENT'S CONCERN WITH THE PRODUCT.. AFFECTED SIDE IS RIGHT. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 15595625 ↗
InjuryApr 4, 2022Fluid/Blood Leak; Material Rupture; Fluid/Blood Leak; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 13998824 ↗
InjuryJul 22, 2021Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 12214102 ↗
InjuryDec 30, 2020Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "LEFT SIDE DEFLATION AND EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT". DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 11096964 ↗
InjuryMay 26, 2020Fluid/Blood Leak; Fluid/Blood Leak
DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 10089962 ↗
InjuryFeb 12, 2020Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 9701520 ↗
InjuryJan 9, 2020Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE DEFLATION AND "EXCHANGE OF TEXTURED BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT." DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 9571675 ↗
InjuryJan 28, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV, PATIENT HAD A "RED SPOT ON THEIR CHEST" AND SWELLING. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 8281253 ↗
InjuryNov 20, 2018Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 8090989 ↗
InjuryJul 24, 2018Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE DEFLATION. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 7713183 ↗
InjuryJul 19, 2018Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE DEFLATION. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 7705066 ↗
InjuryApr 12, 2018Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DEFLATION. PATIENT'S SPOUSE REPORTED PATIENT EXPERIENCED PAIN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 7426816 ↗
InjuryOct 27, 2017Fluid/Blood Leak; Device Appears to Trigger Rejection; Fluid/Blood Leak; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED BILATERAL EXCHANGE DUE TO PATIENT¿S CONCERNS WITH THE PRODUCT AND RIGHT SIDE CAPSULAR CONTRACTION BAKER GRADE IV.
Patient problems: Capsular Contracture; Failure of Implant
MAUDE report 6983294 ↗

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-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	`10888628000889`
Brand	NATRELLE Saline-Filled Breast Implants
Model	168-510
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	Not in Commercial Distribution
Record updated	Oct 13, 2021

Device type (GMDN): Saline-filled breast implant, unstructured, textured-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 textured. 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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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 · each recall links to the FDA recall notice
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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