NATRELLE Saline-Filled Breast Implants 68HP-280Recalls & reported problems

Allergan, Inc. · NATRELLE Sty 68HP-280 High 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 NATRELLE saline-filled breast implant from Allergan has 95 reports, all describing injuries, and no deaths. The reports mostly describe the implant losing its saline and deflating, rupturing, or the scar tissue around it tightening (capsular contracture), and several say the device was removed. 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: 97
Deaths reported: 0
Injuries reported: 97
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 97 adverse event reports that list this exact device (DI 10888628000384), received between Sep 28, 2017 and Sep 21, 2026 — classified as 97 injuries.

The most frequently reported specific device problem is “Fluid/Blood Leak” (74 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 Leak74
Device Appears to Trigger Rejection19
Material Rupture4
Patient-Device Incompatibility3

Patient problems

Failure of Implant71
Capsular Contracture22
No Clinical Signs, Symptoms or Conditions4
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Unspecified Infection1

Recent adverse event reports

The 25 most recent of 97 reports, in the reporter's own words as published by the FDA.

InjurySep 21, 2026Fluid/Blood Leak
Healthcare Professional reported "deflation". Healthcare Professional later reported "any creases". This record is for the right side. Device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50840662 ↗
InjurySep 8, 2026Fluid/Blood Leak
Healthcare professional reported "deflation". Later healthcare professional reported "no complaint against the device". Later healthcare professional reported "rupture/deflation". Later healthcare professional over phone reported "deflated during surgery". This record is for left side. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50668674 ↗
InjuryAug 26, 2026Fluid/Blood Leak
Healthcare professional reported "deflation". This record is for the right side. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50443415 ↗
InjuryJul 14, 2026Fluid/Blood Leak
PATIENT REPORTED "DEFLATION", "COLLAPSED", "A BIT SWOLLEN", "10 DAYS AFTER SURGERY COULDN'T TELL THERE WAS AN IMPLANT", "LOOSE". HEALTHCARE PROFESSIONAL REPORTED "RUPTURE FOR A SALINE DEVICE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25821812 ↗
InjuryJul 2, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE II". HEALTHCARE PROFESSIONAL LATER REPORTED "PARTIAL DEFLATION OF BREAST IMPLANT". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25691350 ↗
InjuryFeb 9, 2026Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE/DEFLATION" AND "RUPTURED". THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24299231 ↗
InjuryFeb 3, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24254013 ↗
InjuryFeb 2, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "NO COMPLAINT AGAINST THE DEVICE". LATER HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 24240516 ↗
InjuryFeb 2, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 24235306 ↗
InjuryOct 21, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 23353519 ↗
InjuryOct 1, 2025Fluid/Blood Leak; Device Appears to Trigger Rejection; Fluid/Blood Leak; Device Appears to Trigger Rejection
PATIENT REPORTED "FIRM AND LOOKS ABNORMAL DUE TO CAPSULAR CONTRACTURE". LATER HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 23190836 ↗
InjurySep 24, 2025Fluid/Blood Leak; Fluid/Blood Leak
DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 23137759 ↗
InjurySep 11, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE RIGHT-SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 23030952 ↗
InjuryJul 28, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED " IMPLANTED THE BREAST IMPLANT AND FILLED THE DEVICE, THE FILL TUBE WAS REMOVED BUT PART OF IT REMAINED INSIDE THE IMPLANT CAUSING IT TO LEAK. PATIENT CONTACT WITH THE DEVICE OCCURRED". THIS RECORD IS FOR AN UNKNOWN SIDE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 22639472 ↗
InjuryJul 8, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 22435076 ↗
InjuryJun 6, 2025Fluid/Blood Leak; Fluid/Blood Leak
PATIENT REPORTED "HURTING, LEAKING, AND COMPLETELY FLAT". LATER HEALTHCARE PROFESSIONAL REPORTED "SALINE RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22158781 ↗
InjuryApr 28, 2025Fluid/Blood Leak; Device Appears to Trigger Rejection; Fluid/Blood Leak; Device Appears to Trigger Rejection
PATIENT LATER REPORTED CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN AND PAIN.
Patient problems: Capsular Contracture; Failure of Implant
MAUDE report 21923416 ↗
InjuryApr 21, 2025Fluid/Blood Leak; Fluid/Blood Leak
PATIENT REPORTED A RIGHT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 21878650 ↗
InjuryApr 17, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS REPORT IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 21855162 ↗
InjuryNov 28, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED DEFLATION. THE DEVICE HAS BEEN EXPLANTED. THIS RELATES TO THE LEFT SIDE.
Patient problems: Failure of Implant
MAUDE report 18218018 ↗
InjuryNov 13, 2023Fluid/Blood Leak; Fluid/Blood Leak
PATIENT REPORTED DEFLATION AND BREAST CANCER NOT DEVICE RELATED. DEVICE REMAINS IMPLANTED. THIS RELATES TO THE RIGHT SIDE.
Patient problems: Failure of Implant
MAUDE report 18124556 ↗
InjuryOct 16, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURED". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 17945763 ↗
InjurySep 26, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DEFLATION. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 17815339 ↗
InjurySep 22, 2023Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED, LEFT SIDE DEFLATION. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 17804746 ↗
InjurySep 15, 2023Fluid/Blood Leak; Fluid/Blood Leak
PATIENT REPORTED RIGHT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 17754321 ↗

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	`10888628000384`
Brand	NATRELLE Saline-Filled Breast Implants
Model	68HP-280
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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