Natrelle INSPIRA Breast Implants SRL-230Recalls & reported problems

Allergan, Inc. · NATRELLE INSPIRA Sty SRL-230 Low profile |smooth|round|silicone · Class 3 · Implant

All models of Natrelle Breast Implants (1167) · Natrelle INSPIRA Breast Implants (197)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This Natrelle INSPIRA silicone gel breast implant is a soft, smooth, round implant. The 31 reports mostly describe implants rupturing or leaking gel, and the surrounding scar tissue tightening around the implant so the breast becomes hard and painful; some implants had to be removed and replaced. No deaths were reported, and all 31 reports involved injuries. There are no recalls naming 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: 33
Deaths reported: 0
Injuries reported: 33
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10888628006690), received between May 4, 2019 and Sep 17, 2026 — classified as 33 injuries.

The most frequently reported specific device problem is “Material Rupture” (15 reports).

4 other recalls cover devices cleared under the same FDA submission (P020056); 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

Material Rupture15
Device Appears to Trigger Rejection13
Patient-Device Incompatibility8
Gel Leak1

Patient problems

Capsular Contracture19
Failure of Implant12
No Clinical Signs, Symptoms or Conditions2
Pocket Erosion1

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

InjurySep 17, 2026Material Rupture
Patient reported "rupture". This record is for the left side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50801892 ↗
InjuryJul 16, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED ¿RUPTURE¿. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25846926 ↗
InjuryMar 9, 2026Device Appears to Trigger Rejection; Material Rupture
PATIENT CALLED TO REPORT "RUPTURE" AND "ENCAPSULATION, THE BAKER GRADE IS UNKNOWN". LATER THE HEALTHCARE PROFESSIONAL REPORTED THE PATIENT IS "ASYMPTOMATIC" AND "POSSIBLE RUPTURE" PER CT SCAN OF ABDOMEN. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24553106 ↗
InjuryMar 9, 2026Device Appears to Trigger Rejection; Material Rupture
PATIENT CALLED TO REPORT "RUPTURE" AND "ENCAPSULATION, THE BAKER GRADE IS UNKNOWN". LATER THE HEALTHCARE PROFESSIONAL REPORTED THE PATIENT IS "ASYMPTOMATIC" AND "POSSIBLE RUPTURE" PER CT SCAN OF ABDOMEN. THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24553102 ↗
InjuryOct 6, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" CONFIRMED VIA MAMMOGRAM. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 23229797 ↗
InjurySep 5, 2025Material Rupture; Material Rupture
PATIENT REPORTED "RUPTURE". DIAGNOSED VIA US. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22983390 ↗
InjuryAug 21, 2025Material Rupture; Material Rupture
DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 22861200 ↗
InjuryJul 1, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RUPTURE. THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22373174 ↗
InjuryMay 16, 2025Gel Leak; Gel Leak
PATIENT REPORTED "LEAK" VIA CT SCAN, CAPTURED AS GEL BLEED. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22034071 ↗
InjuryMay 9, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE III/IV". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED AND DISCARDED.
Patient problems: Capsular Contracture
MAUDE report 21998544 ↗
InjuryApr 24, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RUPTURE AND "FEELING SICK." RECORD IS FOR RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 21901915 ↗
InjuryApr 23, 2025Material Rupture; Material Rupture
PATIENT REPORTED LEFT SIDE RUPTURE AND "FEELING SICK". THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 21896421 ↗
InjuryJul 15, 2024Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE "SUSPECTED/ACTUAL RUPTURE/DEFLATION" VIA NBIR. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 19742894 ↗
InjuryOct 25, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE BAKER IV.
Patient problems: Capsular Contracture
MAUDE report 18005444 ↗
InjuryMay 19, 2023Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture; Failure of Implant
MAUDE report 16963373 ↗
InjuryFeb 20, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III/IV. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16406193 ↗
InjuryNov 25, 2022Material Rupture; Material Rupture
HEALTH CARE PROFESSIONAL REPORTED RIDE SIDE RUPTURE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 15866211 ↗
InjuryJul 20, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III" AGAINST LEFT DEVICE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15066052 ↗
InjuryMay 11, 2022Material Rupture; Material Rupture
PATIENT REPORTED LEFT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 14358425 ↗
InjuryMar 29, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL RIGHT SIDE ¿CAPSULAR CONTRACTURE,¿ BAKER GRADE IV. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 13934843 ↗
InjuryNov 9, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 12779433 ↗
InjuryJan 8, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 11141402 ↗
InjuryJan 7, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 11135957 ↗
InjuryNov 17, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 10852488 ↗
InjurySep 17, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III/IV. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 10545988 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P020056. One submission often covers many models, so check the product and lot details in each record.

Z-0701-2020 · Nov 6, 2019 · Terminated
Natrelle Inspira Sillicone-Filled Breast Implants for the following Styles and Sizes: 7607 SSM, 7608 SSF, 7609 SSX, 7513 SRL, 7514 SRLP, 7515 SRM, 7516 SRF, 7517 SRX, 7626 SCL, 762
Z-0700-2020 · Nov 6, 2019 · Terminated
Natrelle Silicone Filled Breast Implants for the following Styles and Sizes: Style 10, Style 15, Style 20, Style 40, Style 45 Style 10/UDI: NATRELLE Style 10-180 Gel Round Mod
Z-2454-2019 · Jul 24, 2019 · Open, Classified
Natrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate Profile, Sterile, for the following style numbers: Style 110:110-090, 110-120, 110-150, 110-180, 110-
Z-2453-2019 · Jul 24, 2019 · Open, Classified
Natrelle Inspira, Silicone-Filled Breast Implants, Sterile, for the following style numbers: Style TRL: TRL-110TRL-125,TRL-140,TRL-170,TRL-200,TRL-230,TRL-260,TRL-290,TRL-320,TR

Device details

UDI-DI	`10888628006690`
Brand	Natrelle INSPIRA Breast Implants
Model	SRL-230
Company	Allergan, Inc.
Product code	FTR · Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
Class	Class 3
FDA submission	P020056
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Safe
Status	In Commercial Distribution
Record updated	Apr 20, 2022

Device type (GMDN): Silicone gel-filled breast implant, smooth-surface

An implantable device designed to reconstruct or augment the breast that is composed of a silicone rubber shell, made of polysiloxane(s), with a single lumen filled with a fixed amount of silicone gel; the shell surface is smooth. The implant may vary in shape, profile, volume and shell thickness.

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All Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled devices →

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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