Natrelle Inspira Cohesive Breast Implants SCX-470Recalls & reported problems
Allergan, Inc. · Natrelle Inspira SCX 470cc 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 cohesive breast implant (SCX-470, extra full profile) is a silicone gel-filled implant used for breast reconstruction or augmentation. Most of the 28 reports describe the scar tissue around the implant tightening and hardening, which the records grade as severe capsular contracture, sometimes with the implant shifting out of position or the shell breaking; a few mention infection or wound reopening. All 28 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 10888628030329), received between Jul 17, 2019 and Sep 24, 2026 — classified as 28 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (14 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 Rejection14
- Patient-Device Incompatibility7
- Adverse Event Without Identified Device or Use Problem5
- Material Rupture2
- Migration1
Patient problems
- Capsular Contracture21
- Failure of Implant2
- Unspecified Infection2
- Wound Dehiscence2
- Cellulitis1
- Seroma1
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
Healthcare Professional reported "Dehiscence". This record is for the left side. Device has been explanted.
Patient problems: Wound Dehiscence
MAUDE report 50889721 ↗InjuryDec 22, 2025Migration; Migration
HEALTHCARE PROFESSIONAL REPORTED THROUGH THE NATIONAL BREAST IMPLANT REGISTRY (NBIR) "DEVICE MIGRATION/IMPLANT MALPOSITION". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED. IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23864968 ↗InjuryDec 17, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED THROUGH THE NATIONAL BREAST IMPLANT REGISTRY (NBIR) "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED. IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED.
Patient problems: Capsular Contracture
MAUDE report 23832062 ↗InjuryJan 15, 2025Device 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 21158913 ↗InjuryJun 1, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17038001 ↗InjuryMay 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE INFECTION (UNKNOWN ONSET). DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Unspecified Infection
MAUDE report 16909542 ↗InjuryMar 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "PERIPROSTHETIC INFECTION". DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Unspecified Infection
MAUDE report 16550134 ↗InjuryDec 28, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED AND DISCARDED.
Patient problems: Capsular Contracture
MAUDE report 16064017 ↗InjuryDec 5, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "CAPSULAR CONTRACTURE", BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15915064 ↗InjuryNov 29, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15882377 ↗InjuryNov 29, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. MANUFACTURER OF THE DEVICE IS UNKNOWN." DEVICE HAS BEEN EXPLANTED
Patient problems: Capsular Contracture
MAUDE report 15880540 ↗InjuryJul 19, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED VIA NBIR LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15060116 ↗InjuryMar 20, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 13830982 ↗InjuryJan 31, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED VIA NBIR RIGHT SIDE "CAPSULAR CONTRACTURE BAKER GRADE-IV, MIGRATION". THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 13397222 ↗InjuryJan 14, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED VIA NBIR LEFT SIDE "CAPSULAR CONTRACTURE BAKER GRADE IV, MIGRATION". THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 13258492 ↗InjuryDec 14, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED VIA NBIR RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 13001752 ↗InjuryOct 26, 2021Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "TEAR, CAPSULAR CONTRACTURE, BAKER GRADE IV". DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 12698223 ↗InjuryJul 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DEVICE LAB ANALYSIS RECEIVED A DEVICE THAT WAS EXPLANTED AND RETURNED. HEALTHCARE PROFESSIONAL LATER REPORTED LEFT SIDE SEROMA. DEVICE HAS BEEN EXPLANTED.
Patient problems: Seroma
MAUDE report 12160188 ↗InjuryMar 26, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 11573995 ↗InjuryMar 26, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 11573873 ↗InjuryDec 15, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
InjurySep 29, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 10603799 ↗InjuryJun 26, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
InjuryDec 4, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
InjuryDec 4, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKE GRADE UNKNOWN OF AN UNKNOWN SIDE. DEVICE STATUS IS UNKNOWN.
Patient problems: Capsular Contracture
MAUDE report 9412081 ↗
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-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-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-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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