Natrelle Inspira Cohesive Breast Implants SCX-340Recalls & reported problems
Allergan, Inc. · Natrelle Inspira SCX 340cc Extra Full profile |smooth|round|silicone · Class 3 · Implant
All models of Natrelle Breast Implants (1167) · Natrelle Inspira Cohesive Breast Implants (192)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Natrelle Inspira silicone breast implant (SCX-340) is a soft, round implant filled with silicone gel. The 27 reports mostly describe the scar tissue around the implant tightening and hardening, which can make the breast feel firm, painful or misshapen, and in some cases the implant is removed and replaced. Reports also mention infection, wound reopening, and a couple of cases where the implant ruptured or deflated. All 27 reports describe injuries, and no deaths were reported. 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
- 28
- Deaths reported
- 0
- Injuries reported
- 28
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10888628030275), received between May 23, 2019 and Sep 18, 2026 — classified as 28 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (17 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
Most reported problems
Device problems
- Device Appears to Trigger Rejection17
- Patient-Device Incompatibility5
- Adverse Event Without Identified Device or Use Problem3
- Biofilm coating in Device2
- Material Rupture2
Patient problems
- Capsular Contracture22
- Unspecified Infection4
- Wound Dehiscence3
- Failure of Implant1
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Healthcare professional reported "multiple wound dehiscence repairs". This record is for the left side. Device has been explanted.
Patient problems: Wound Dehiscence
MAUDE report 50820621 ↗InjuryJul 6, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III/IV". PATIENT WAS PRESCRIBED MILKTHISTLE, VITAMIN E AND SINGULAIR. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25717987 ↗InjuryApr 3, 2026Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV, SUSPECTED/ACTUAL RUPTURE/DEFLATION, WRINKLING/RIPPLING, CORRECTION OF ASYMMETRY" VIA NATIONAL BREAST IMPLANT REGISTRY. CAPSULECTOMY/CAPSULOTOMY WAS PERFORMED. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24781532 ↗InjurySep 9, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE" BAKER GRADE UNKNOWN. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 23009916 ↗InjuryAug 14, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22810053 ↗InjuryJun 9, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED, "CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN". THIS REPORT IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22166152 ↗InjuryMay 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED "INFECTION". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 21973397 ↗InjuryNov 15, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 18144370 ↗InjuryAug 15, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. HEALTHCARE PROFESSIONAL REPORTED "ANY CREASES" THAT WAS CHECKED OFF UNDER OBSERVATION MADE DURING SURGERY IN THE RGA. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17552465 ↗InjuryApr 10, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE "CAPSULAR CONTRACTURE BAKER GRADE III." DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 16709788 ↗InjuryMar 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL CALLED TO REPORT LEFT-SIDE "INFECTED". DEVICE HAS BEEN EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 16517037 ↗InjuryNov 27, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT-SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 15867382 ↗InjuryJul 26, 2022Biofilm coating in Device; Biofilm coating in Device
PATIENT REPORTED RIGHT SIDE " FEELING EXCRUCIATING PAIN AND MRI REVEALED AGGRESSIVE BIOFILM INFECTION AND MY CULTURES WERE POSITIVE". DEVICE HAS BEEN EXPLANTED.
Patient problems: Unspecified Infection; Wound Dehiscence
MAUDE report 15104148 ↗InjuryJul 26, 2022Biofilm coating in Device; Biofilm coating in Device
PATIENT REPORTED LEFT SIDE " FEELING EXCRUCIATING PAIN AND MRI REVEALED AGGRESSIVE BIOFILM INFECTION AND MY CULTURES WERE POSITIVE". DEVICE HAS BEEN EXPLANTED.
Patient problems: Unspecified Infection; Wound Dehiscence
MAUDE report 15104066 ↗InjuryJul 26, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "CAPSULAR CONTRACTURE BAKER GRADE IV". DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15102726 ↗InjuryMay 4, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "RIGHT SIDE ONLY CAPSULAR CONTRACTURE BAKER GRADE III". DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 14279506 ↗InjuryJan 31, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTH CARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 13406031 ↗InjuryJan 27, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED BROKEN DEVICE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 13367606 ↗InjuryNov 16, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
InjuryNov 7, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
InjuryNov 4, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
InjuryNov 1, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN AND "BIA/ALCL TESTING." THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 12733738 ↗InjuryFeb 2, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. THE DEVICE HAS BEEN EXPLANTED AND DISCARDED.
Patient problems: Capsular Contracture
MAUDE report 11268126 ↗InjuryJan 29, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 9645041 ↗InjuryDec 2, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 9398255 ↗
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 · TerminatedNatrelle 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 · TerminatedNatrelle 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-2453-2019 · Jul 24, 2019 · Open, ClassifiedNatrelle 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
- Z-2454-2019 · Jul 24, 2019 · Open, ClassifiedNatrelle 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-
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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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