NATRELLE Saline-Filled Breast Implants 168-390Recalls & reported problems

Allergan, Inc. · NATRELLE 168-390 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.

Quick summary

This Allergan Natrelle saline breast implant is a textured, fluid-filled implant placed in the breast. Reports mostly describe implants leaking and deflating and tissue hardening around the implant, often with removal. There are 42 reports naming its identifier, with no deaths and 42 mentioning injury. There is 1 open recall from July 2019 about textured implants and higher incidence of anaplastic large cell lymphoma, and reports rose to 12 in the last 12 months from 3 the year 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: 42
Deaths reported: 0
Injuries reported: 42
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 10888628000841), received between Sep 13, 2017 and Jul 31, 2026 — classified as 42 injuries.

The most frequently reported specific device problem is “Fluid/Blood Leak” (29 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 Leak29
Device Appears to Trigger Rejection10
Adverse Event Without Identified Device or Use Problem3
Detachment of Device or Device Component3
Patient-Device Incompatibility3

Patient problems

Failure of Implant25
Capsular Contracture13
Chest Pain2
No Clinical Signs, Symptoms or Conditions2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Purulent Discharge1

Recent adverse event reports

The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

InjuryJul 31, 2026Device Appears to Trigger Rejection
Healthcare professional reported "capsular contracture". Later healthcare professional reported "grade 4 capsular contracture, palpable calcification and a palpable mass consistent with fluid filled cyst". This record is for the right side. Device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50106118 ↗
InjuryJul 17, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION" AGAINST THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25860912 ↗
InjuryJun 25, 2026Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED "TEXTURED TO SMOOTH". LATER HEALTHCARE PROFESSIONAL REPORTED "FEAR ALCL" AND "RIPPLING". THIS RECORD IS FOR LEFT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25630447 ↗
InjuryJun 11, 2026Fluid/Blood Leak
Healthcare professional reported "textured and deflated¿. This record is for the right side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25469946 ↗
InjuryFeb 6, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE III" AND "TEXTURED TO SMOOTH DUE TO THE CONCERNS". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24282276 ↗
InjuryFeb 6, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE III" AND "TEXTURED TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24277210 ↗
InjuryFeb 4, 2026Fluid/Blood Leak
PATIENT REPORTED "BELIEVE IMPLANT WAS RECALLED" AND "IMPLANT HAS RUPTURED". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 24258733 ↗
InjuryJan 9, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "POSSIBLE PARTIAL DEFLATION". THIS RECORD IS FOR LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24028350 ↗
InjuryJan 6, 2026Fluid/Blood Leak
PATIENT REPORTED "DEFLATION" AND "EXCHANGE FROM TEXTURED TO SMOOTH DUE TO THE PATIENT¿S CONCERN OF THE PRODUCT". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 23984240 ↗
InjuryDec 22, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION" AND "REMOVAL FROM TEXTURED TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 23865921 ↗
InjuryDec 1, 2025Device Appears to Trigger Rejection; Detachment of Device or Device Component; Device Appears to Trigger Rejection; Detachment of Device or Device Component
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV AND EXCHANGE FROM TEXTURE TO SMOOTH". HEALTHCARE PROFESSIONAL LATER REPORTED "PTOSIS". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 23688711 ↗
InjuryNov 7, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED "EXCHANGE FROM TEXTURED TO SMOOTH DUE TO CONCERN WITH THE PRODUCT". LATER, HEALTHCARE PROFESSIONAL REPORTED "BECOME CAPSULIZED, VERY HARD AND TENDER, SEVERELY DISTORTED, MODERATE PAIN," CAPSULAR CONTRACTURE, BAKER GRADE IV AND EXCHANGE OF TEXTURED DEVICE DUE TO PATIENT'S CONCERN WITH PRODUCT". THIS RELATES TO THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 23500676 ↗
InjuryOct 27, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV" AND "IMPLANT REMOVAL FROM TEXTURED TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT". THIS RECORD IS FOR LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED AND WILL BE RETURNED.
Patient problems: Capsular Contracture
MAUDE report 23392085 ↗
InjurySep 19, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 23099297 ↗
InjuryMar 26, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 21701198 ↗
InjurySep 12, 2024Fluid/Blood Leak; Device Appears to Trigger Rejection; Detachment of Device or Device Component; Fluid/Blood Leak; Device Appears to Trigger Rejection; Detachment of Device or Device Component
HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED PARTICLES IN VALVE, PLUG STRAP SEPARATED, AND CREASES.
Patient problems: Capsular Contracture
MAUDE report 20206234 ↗
InjurySep 12, 2024Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROVIDER REPORTED PATIENT HAS TEXTURED MAMMARY IMPLANTS AND A LEFT SIDE DEFLATION. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 20200321 ↗
InjuryNov 29, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE DEFLATION. HEALTHCARE PROFESSIONAL LATER REPORTED "HOLE, NON-SPECIFIC." DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 18226460 ↗
InjuryAug 1, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. HEALTHCARE PROFESSIONAL LATER REPORTED CAPSULAR CONTRACTURE, BAKER GRADE IV. PATIENT TREATED WITH CEPHALEXIN 500 MG TID, METHOCARBAMOL 750 MG TID, PERCOCET 7.5/325 MG Q6H PRN, AND SCOPOLAMINE PATCH Q3D. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture; Purulent Discharge
MAUDE report 17433645 ↗
InjuryJul 5, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 17258766 ↗
InjuryMay 25, 2023Fluid/Blood Leak; Fluid/Blood Leak
PATIENT REPORTED, A RIGHT SIDE NO COMPLAINT AGAINST THE DEVICE. HEALTHCARE PROFESSIONAL CONFIRMED, RIGHT SIDE NO COMPLAINT AGAINST THE DEVICE. PATIENT LATER REPORTED, A RIGHT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 17007985 ↗
InjuryMar 6, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION AND EXCHANGE OF A TEXTURED DEVICE DUE TO PATIENT'S CONCERN WITH PRODUCT. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 16491915 ↗
InjuryDec 21, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DEFLATION AND EXCHANGE OF TEXTURED DEVICE DUE TO PATIENT'S CONCERN WITH PRODUCT. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 16029115 ↗
InjuryOct 3, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 15532518 ↗
InjuryApr 7, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE DEFLATION AND DEVICE EXCHANGE DUE TO CONCERN WITH THE IMPLANT. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 14045737 ↗

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	`10888628000841`
Brand	NATRELLE Saline-Filled Breast Implants
Model	168-390
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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