Natrelle Inspira Cohesive Breast Implants SCX-375Recalls & reported problems
Allergan, Inc. · Natrelle Inspira SCX 375cc 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 SCX 375cc silicone gel breast implant is a smooth, round, extra-full-profile implant made by Allergan. The 30 reports mostly describe the scar tissue around the implant tightening and hardening (capsular contracture), which can make the breast feel firm, change shape or look creased; others describe the implant shifting out of position, rupturing or being punctured, and needing removal or replacement. All 30 reports involve injuries, with no deaths and no device malfunctions 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
- 30
- Deaths reported
- 0
- Injuries reported
- 30
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10888628030282), received between Jul 29, 2019 and Apr 16, 2026 — classified as 30 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (13 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 Rejection13
- Patient-Device Incompatibility8
- Material Rupture7
- Adverse Event Without Identified Device or Use Problem3
- Break1
- Malposition of Device1
- Migration1
Patient problems
- Capsular Contracture20
- Failure of Implant7
- Unspecified Infection2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Deformity/ Disfigurement1
- Foreign Body Reaction1
- Seroma1
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
InjuryApr 16, 2026Malposition of Device; Migration
HEALTHCARE PROFESSIONAL REPORTED VIA THE NATIONAL BREAST IMPLANT REGISTRY (NBIR) MANUFACTURER REGISTRY SPECIFIC DATA REPORT (MRSDR) "MIGRATION/IMPLANT MALPOSITION, NEED FOR BIOPSY/TUMOR". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Deformity/ Disfigurement
MAUDE report 24905476 ↗InjuryApr 16, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED VIA THE NATIONAL BREAST IMPLANT REGISTRY (NBIR) MANUFACTURER REGISTRY SPECIFIC DATA REPORT (MRSDR) "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24903995 ↗InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED "WRINKLING/RIPPLING" VIA NATIONAL BREAST IMPLANT REGISTRY. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24800842 ↗InjuryFeb 19, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED THROUGH A SALES REPRESENTATIVE A "CONTRACTURE GRADE 3". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24387149 ↗InjuryAug 27, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE III". THIS RELATES TO THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22903595 ↗InjuryJun 30, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "PUNCTURED". THE DEVICE HAS BEEN EXPLANTED, REPLACED, AND DISCARDED.
Patient problems: Failure of Implant
MAUDE report 22365687 ↗InjuryApr 25, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. LATER HEALTHCARE PROFESSIONAL REPORTED "CREASED IMPLANT" AND BAKER GRADE III. THIS RECORD IS FOR RIGHT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 21913317 ↗InjurySep 25, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED VIA NBIR "CAPSULAR CONTRACTURE BAKER GRADE III, CHANGE SHAPE/SIZE/STYLE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 20299383 ↗InjurySep 13, 2023Break; Material Rupture; Break; Material Rupture
COMPANY REPRESENTATIVE REPORTED UNKNOWN SIDE "DEFECTIVE/ RUPTURED". DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 17737574 ↗InjuryApr 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED RIGHT SIDE HEMATOMA AND INFECTION. HEALTHCARE PROFESSIONAL REPORTED "HEMATOMA WAS EVACUATED IN (B)(6) 2023, AND INFECTION IN (B)(6) 2023." DEVICE HAS BEEN EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 16800754 ↗InjuryFeb 15, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16382093 ↗InjuryDec 16, 2022Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RUPTURE AND CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED. THIS RECORD IS FOR THE RIGHT SIDE.
Patient problems: Capsular Contracture; Failure of Implant
MAUDE report 15999643 ↗InjuryNov 20, 2022Device Appears to Trigger Rejection; Patient-Device Incompatibility; Device Appears to Trigger Rejection; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV AND EXPOSURE. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture; Foreign Body Reaction
MAUDE report 15831615 ↗InjuryNov 7, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "A PREVIOUS LEFT SIDE SMALL SEROMA WITH CAPSULAR TEAR WITH SIGNIFICANT SOFT TISSUE SWELLING. NO EVIDENCE OF INFECTION, SILICONE IMPLANT INTACT WITH CAPSULAR CONTRACTURE BAKER IV." DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture; Seroma
MAUDE report 15748706 ↗InjuryOct 5, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT RUPTURE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 15547540 ↗InjuryMay 27, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROVIDER REPORTED VIA COMPANY REPRESENTATIVE A LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 14525698 ↗InjuryMay 21, 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 14465073 ↗InjuryFeb 25, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED VIA NBIR RIGHT SIDE "SUSPECTED/ACTUAL RUPTURE/DEFLATION" AND "CHANGE SHAPE/SIZE/STYLE." DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 13602614 ↗InjuryFeb 18, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" AGAINST RIGHT DEVICE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 13564091 ↗InjuryNov 24, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 12870517 ↗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 12129061 ↗InjurySep 28, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
InjuryAug 25, 2020Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 10451276 ↗InjuryJul 1, 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 10219589 ↗InjuryDec 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTH PROFESSIONAL REPORTED LEFT SIDE "INFECTION." THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 9503540 ↗
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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