NATRELLE Saline-Filled Breast Implants 68-240Recalls & reported problems

Allergan, Inc. · NATRELLE Style 68MP-240 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 Allergan Natrelle saline-filled breast implant is a smooth, round implant filled with saline. Of the 160 reports, most describe the implant deflating or leaking saline, and some describe capsular contracture (hardening of the scar tissue around the implant). The reports include no deaths and 160 injuries, and reports rose to 27 in the last 12 months from 16 before. 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: 162
Deaths reported: 0
Injuries reported: 162
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 162 adverse event reports that list this exact device (DI 10888628000193), received between Aug 28, 2017 and Sep 29, 2026 — classified as 162 injuries.

The most frequently reported specific device problem is “Fluid/Blood Leak” (137 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 Leak137
Device Appears to Trigger Rejection21
Patient-Device Incompatibility5
Device Handling Problem2
Material Rupture2
Peeled/Delaminated2
Adverse Event Without Identified Device or Use Problem1
Deflation Problem1

Patient problems

Failure of Implant126
Capsular Contracture25
No Clinical Signs, Symptoms or Conditions13
Abscess1
Erosion1
Unspecified Infection1
Wound Dehiscence1

Recent adverse event reports

The 25 most recent of 162 reports, in the reporter's own words as published by the FDA.

InjurySep 29, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941145 ↗
InjurySep 28, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922244 ↗
InjurySep 22, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50849434 ↗
InjuryAug 28, 2026Fluid/Blood Leak
Healthcare professional reported "deflation". Later, healthcare professional reported "ruptured implant" and "saline leakage." This record is for the left side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50504866 ↗
InjuryAug 19, 2026Fluid/Blood Leak
Healthcare professional reported "deflation". This record is for the left side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50329800 ↗
InjuryAug 9, 2026Fluid/Blood Leak
Healthcare professional reported "deflation". This record is for left side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50188966 ↗
InjuryAug 6, 2026Fluid/Blood Leak
Healthcare professional reported ¿deflation¿. This record is for the right side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50159383 ↗
InjuryJul 27, 2026Fluid/Blood Leak
Healthcare professional reported "deflation". This record is for the right side. Device has been explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50017073 ↗
InjuryJul 7, 2026Fluid/Blood Leak
Healthcare professional reported "deflation". This record is for the right side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25741971 ↗
InjuryJun 17, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE "CAPSULAR CONTRACTURE BAKER GRADE IV". THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25535491 ↗
InjuryMay 15, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION CAUSED BY A VALVE MALFUNCTION". LATER HEALTHCARE PROFESSIONAL REPORTED "PARTICLES IN VALVE" AND "TISSUE IN VALVE". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25185284 ↗
InjuryMar 31, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD RELATES TO THE LEFT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24745222 ↗
InjuryMar 31, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED A "DEFLATION". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24742544 ↗
InjuryFeb 20, 2026Fluid/Blood Leak
PATIENT REPORTED "DEFLATION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 24404799 ↗
InjuryFeb 19, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "LEAK". THIS RECORD IS FOR RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 24389937 ↗
InjuryFeb 11, 2026Fluid/Blood Leak; Peeled/Delaminated
HEALTHCARE PROFESSIONAL REPORTED A "DEFLATION". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 24316534 ↗
InjuryJan 28, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24199390 ↗
InjuryJan 24, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 24173388 ↗
InjuryJan 5, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATED". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED. DEVICE WILL BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23958195 ↗
InjuryDec 21, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED. THE DEVICE WILL BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23861269 ↗
InjuryDec 17, 2025Fluid/Blood Leak; Fluid/Blood Leak
DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 23832612 ↗
InjuryDec 11, 2025Fluid/Blood Leak; Fluid/Blood Leak
PATIENT REPORTED "DEFLATION". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 23776607 ↗
InjuryNov 28, 2025Fluid/Blood Leak; Device Appears to Trigger Rejection; Fluid/Blood Leak; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION WITH "LEAK FOUND AT THE FILL SITE". HEALTHCARE PROFESSIONAL LATER REPORTED "RUPTURED AT SURGERY". HEALTHCARE PROFESSIONAL LATER REPORTED "MILD TO MODERATE CAPSULAR CONTRACTURE". HEALTHCARE PROFESSIONAL LATER REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture; Failure of Implant
MAUDE report 23672112 ↗
InjuryNov 19, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED. DEVICE RETURN UNKNOWN.
Patient problems: Failure of Implant
MAUDE report 23598328 ↗
InjuryNov 19, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED AND IT WILL BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23598316 ↗

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	`10888628000193`
Brand	NATRELLE Saline-Filled Breast Implants
Model	68-240
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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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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