NATRELLE Saline-Filled Breast Implants 68LP-175Recalls & reported problems

Allergan, Inc. · NATRELLE Style 68LP-175 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: 12
Deaths reported: 0
Injuries reported: 12
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10888628000537), received between Apr 13, 2018 and Apr 22, 2026 — classified as 12 injuries.

The most frequently reported specific device problem is “Fluid/Blood Leak” (7 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 Leak7
Device Appears to Trigger Rejection2
Adverse Event Without Identified Device or Use Problem1
Deflation Problem1
No Apparent Adverse Event1

Patient problems

Failure of Implant8
Capsular Contracture2
Pain1
Unspecified Infection1

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

InjuryApr 22, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24952549 ↗
InjuryNov 22, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 18194483 ↗
InjuryJul 26, 2023Fluid/Blood Leak; Fluid/Blood Leak
THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 17401281 ↗
InjuryMar 23, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE DEFLATION. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 16603154 ↗
InjuryMar 21, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE OF A SALINE DEVICE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 16581738 ↗
InjuryJan 20, 2023Deflation Problem; Deflation Problem
PATIENT REPORTED DEFLATION. DEVICE REMAINS IMPLANTED. THIS RELATES TO THE RIGHT SIDE.
Patient problems: Failure of Implant
MAUDE report 16218036 ↗
InjuryJan 3, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "I THINK THE PATIENT MAY HAVE ANOTHER DEFLATION" AGAINST UNKNOWN SIDE. THIS REPRESENTS THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 16086109 ↗
InjuryFeb 23, 2022Fluid/Blood Leak; Fluid/Blood Leak
PATIENT REPORTED A RIGHT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 13587351 ↗
InjuryNov 7, 2021Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 12759668 ↗
InjuryJun 12, 2020Fluid/Blood Leak; Fluid/Blood Leak
DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 10150787 ↗
InjuryAug 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "BREAST IMPLANT ILLNESS SYMPTOMS, BILATERAL SHARP SHOOTING PAINS AROUND NIPPLES, JOINT PAIN IN HANDS AND WRIST, DRY EYES, VISION CHANGES, ABDOMINAL BLOATING, FATIGUE, AND ANXIETY." THE DEVICE WAS EXPLANTED.
Patient problems: Pain
MAUDE report 8946707 ↗
InjuryApr 13, 2018No Apparent Adverse Event; No Apparent Adverse Event
PATIENT REPORTED LEFT SIDE INFECTION AND EXCESSIVE SWELLING AND DISCHARGE. THE PATIENT ALSO REPORTED "FLUID BUILT UP AROUND THE IMPLANT," NOT FEELING WELL, AND DESCRIBED HAVING "FREEZING AND CHILLS," "A HORRIBLE FEVER." THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 7428303 ↗

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-0336-06 · Dec 14, 2005 · Terminated
McGhan Style 468-380cc Saline-Filled BIOCELL textured Breast Implants, Catalog Number:468-380
Z-0337-06 · Dec 14, 2005 · Terminated
McGhan Style 163-360cc Saline-Filled BIOCELL textured Breast Implants, Catalogue Number :163-360
Z-0851-05 · May 5, 2005 · Terminated
Style 363 Saline-Filled BIOCELL textured Breast Implants

Device details

UDI-DI	`10888628000537`
Brand	NATRELLE Saline-Filled Breast Implants
Model	68LP-175
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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