Natrelle Inspira Cohesive Breast Implants SCX-445Recalls & reported problems
Allergan, Inc. · Natrelle Inspira SCX 445cc 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 silicone gel breast implant (SCX-445, extra full profile) is a soft-shell implant filled with silicone gel for breast reconstruction or enlargement. The 36 reports mostly describe the scar tissue around the implant tightening and shrinking (capsular contracture), the implant shifting position or changing shape, and the shell breaking or rupturing, along with infection and wound healing problems. All36 reports describe injuries, and no deaths were reported. Several reports note the implant was removed or replaced. 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
- 38
- Deaths reported
- 0
- Injuries reported
- 38
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10888628030312), received between May 31, 2019 and Sep 17, 2026 — classified as 38 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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
Most reported problems
Device problems
- Device Appears to Trigger Rejection15
- Patient-Device Incompatibility12
- Material Rupture6
- Adverse Event Without Identified Device or Use Problem5
- Malposition of Device3
- Migration2
Patient problems
- Capsular Contracture26
- Failure of Implant5
- Unspecified Infection4
- Wound Dehiscence3
- Foreign Body Reaction1
- No Clinical Signs, Symptoms or Conditions1
- Seroma1
Recent adverse event reports
The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.
InjurySep 17, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Contour deformity" and "Capsular Contracture Baker grade III/IV". This record is for the right side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50804181 ↗InjuryJun 3, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR) MANUFACTURER REGISTRY SPECIFIC DATA REPORT (MRSDR) "CAPSULAR CONTRACTURE BAKER GRADE II" AND "DEVICE MIGRATION/IMPLANT MALPOSITION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25384161 ↗InjuryMay 28, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE IV". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25318124 ↗InjuryApr 27, 2026Material Rupture; Malposition of Device
PATIENT REPORTED "RUPTURE". LATER HEALTHCARE PROFESSIONAL REPORTED "FLIPPED IMPLANT". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25010354 ↗InjuryFeb 12, 2026Malposition of Device; Migration
HEALTHCARE PROFESSIONAL REPORTED "DEVICE MIGRATION/IMPLANT MALPOSITION, CHANGE SHAPE/SIZE/STYLE" VIA THE NATIONAL BREAST IMPLANT REGISTRY (NBIR). THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24327672 ↗InjuryFeb 12, 2026Malposition of Device; Migration
HEALTHCARE PROFESSIONAL REPORTED "DEVICE MIGRATION/IMPLANT MALPOSITION, CHANGE SHAPE/SIZE/STYLE" VIA THE NATIONAL BREAST IMPLANT REGISTRY (NBIR). THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24326043 ↗InjuryJul 23, 2025Material Rupture; Material Rupture
PATIENT REPORTED IMPLANT "BURST". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22574030 ↗InjuryJun 3, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED " CAPSULAR CONTRACTURE BAKER GRADE III. " THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 22130754 ↗InjuryMay 19, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED " CAPSULAR CONTRACTURE BAKER GRADE III/IV". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 22048293 ↗InjuryMay 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED "INFECTION" VIA NBIR. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 22002934 ↗InjuryOct 6, 2023Device 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 17884297 ↗InjuryJul 20, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
SALES REP REPORTED ON BEHALF OF HEALTHCARE PROFESSIONAL "CAPSULAR CONTRACTURE" BAKER GRADE IV. THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17368028 ↗InjuryJun 28, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 17222021 ↗InjuryJan 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE INFECTION. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 16083016 ↗InjuryNov 15, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTH CARE PROFESSIONAL REPORTED "RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III/IV." DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15802218 ↗InjuryJul 22, 2022Material Rupture; Patient-Device Incompatibility; Material Rupture; Patient-Device Incompatibility
HEALTHCARE PROVIDER REPORTED A RIGHT SIDE RUPTURE, WOUND DEHISCENCE AND EXPOSURE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Foreign Body Reaction; Wound Dehiscence
MAUDE report 15085705 ↗InjuryApr 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED VIA NBIR, RIGHT SIDE "INFECTION." DEVICE EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 14196508 ↗InjuryMar 10, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED A LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 13726472 ↗InjuryFeb 18, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 13562439 ↗InjuryNov 7, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULE CONTRACTURE/IMPLANT MIGRATION.¿ BAKER GRADE NOT SPECIFIED . DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 12758751 ↗InjuryNov 7, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 12756338 ↗InjuryJul 15, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III/IV. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 12175075 ↗InjuryJul 7, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 12130293 ↗InjuryApr 8, 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 11633945 ↗InjuryOct 28, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 10750398 ↗
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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