Natrelle Inspira Cohesive Breast Implants SCM-520Recalls & reported problems
Allergan, Inc. · Natrelle Inspira SCM 520cc Moderate 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 gel breast implant is a smooth, round implant used in breast reconstruction or augmentation. Most of the 45 reports describe the scar tissue tightening around the implant (capsular contracture), leaving the breast hard and sore, along with implant rupture, the implant shifting position, infection, and fluid buildup. All 45 reports involve 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
- 45
- Deaths reported
- 0
- Injuries reported
- 45
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 10888628029958), received between Apr 27, 2018 and Aug 6, 2026 — classified as 45 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (24 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 Rejection24
- Adverse Event Without Identified Device or Use Problem7
- Material Rupture7
- Patient-Device Incompatibility4
- Malposition of Device3
- Migration3
- Difficult to Open or Remove Packaging Material1
- Fluid/Blood Leak1
Patient problems
- Capsular Contracture28
- Failure of Implant8
- Unspecified Infection5
- Seroma4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Fluid Discharge1
- Foreign Body Reaction1
- Impaired Healing1
Recent adverse event reports
The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.
InjuryAug 6, 2026Improper or Incorrect Procedure or Method; Difficult to Open or Remove Packaging Material
Healthcare professional reported "Tyvek paper ripping". This record is for an unknown side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50164322 ↗InjuryFeb 26, 2026Malposition of Device; Migration
HEALTHCARE PROFESSIONAL REPORTED THROUGH NATIONAL BREAST IMPLANT REGISTRY "DEVICE MIGRATION/IMPLANT MALPOSITION, CHANGE SHAPE/SIZE/STYLE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24457938 ↗InjuryFeb 25, 2026Malposition of Device; Migration
HEALTHCARE PROFESSIONAL REPORTED THROUGH NATIONAL BREAST IMPLANT REGISTRY "DEVICE MIGRATION/IMPLANT MALPOSITION, CHANGE SHAPE/SIZE/STYLE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 24440490 ↗InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR) "SEROMA". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED. IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED.
Patient problems: Seroma
MAUDE report 23812845 ↗InjurySep 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "INFECTION". THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 22946276 ↗InjuryAug 28, 2025Material Rupture; Material Rupture
PATIENT REPORTED RIGHT SIDE "RUPTURE". DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22919378 ↗InjuryMay 27, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED WARRANTY CLAIM FOR CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. PATIENT LATER REPORTED RIGHT SIDE IMPLANT THAT NEVER DROPPED AND IS HARD AND A POSSIBLE CAPSULAR CONTRACTURE WITH BAKER GRADE UNKNOWN. HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED RIGHT SIDE THAT NEVER DROPPED, IS HARD AND CAPSULAR CONTRACTURE BAKER GRADE IV. HEALTHCARE PROFESSIONAL LATER REPORTED CAPSULAR CONTRACTURE BAKER GRADE III. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22090282 ↗InjuryMay 25, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV WITH SORENESS. PATIENT TREATED WITH SINGULAIR AND MASSAGE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22082670 ↗InjuryMay 22, 2025Gel Leak; Device Appears to Trigger Rejection; Material Rupture; Gel Leak; Device Appears to Trigger Rejection; Material Rupture
PATIENT REPORTED RUPTURE AND LEAKING CONFIRMED VIA SONOGRAM. LATER, HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. THIS RECORD IS FOR RIGHT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture; Seroma
MAUDE report 22073551 ↗InjuryNov 6, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED VIA NBIR LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III, CORRECTION OF ASYMMETRY, CHANGE SHAPE/SIZE/STYLE, STAGED RECONSTRUCTION. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 20619280 ↗InjuryJun 24, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED VIA NBIR A RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 19602395 ↗InjuryJun 13, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PHYSICIAN REPORTED, VIA NBIR. RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 19534332 ↗InjuryJan 2, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED VIA NBIR RIGHT SIDE "CAPSULAR CONTRACTURE BAKER GRADE III". THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 18425990 ↗InjuryOct 27, 2023Material Rupture; Material Rupture
PATIENT REPORTED RIGHT SIDE "RUPTURE, LEAKING" . DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 18021221 ↗InjuryOct 11, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROVIDER REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. THE HEALTHCARE PROVIDER NOTED "OBSERVATIONS MADE DURING EXPLANT SURGERY" "ANY CREASES". THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17916080 ↗InjuryOct 4, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 17867438 ↗InjuryJul 26, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE. HEALTHCARE PROFESSIONAL LATER REPORTED "GRADE IV" AND "ANY CREASES." DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 17401809 ↗InjuryMar 7, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 16499896 ↗InjuryMar 3, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE REMAINS IMPLANTED. THIS RELATES TO THE RIGHT SIDE.
Patient problems: Capsular Contracture
MAUDE report 16479225 ↗InjuryJan 12, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED VIA NBIR LEFT CAPSULAR CONTRACTURE BAKER GRADE III. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 16153081 ↗InjuryDec 9, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE HAS BEEN EXPLANTED. THIS RELATES TO THE LEFT SIDE.
Patient problems: Capsular Contracture
MAUDE report 15950605 ↗InjuryAug 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE INFECTION. DEVICE HAS BEEN EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 15330049 ↗InjuryAug 24, 2022Malposition of Device; Migration; Malposition of Device; Migration
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "BOTTOMING OUT AND MALPOSITION, WORSE ON THE LEFT" AND "LARGE AIR POCKET/CREASE IN IMPLANT." DEVICE HAS BEEN EXPLANTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 15284483 ↗InjuryJul 29, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III". DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15128738 ↗InjuryJun 17, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 14738848 ↗
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-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-
- 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
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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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