Natrelle Inspira Cohesive Breast Implants SCX-750Recalls & reported problems
Allergan, Inc. · Natrelle Inspira SCX 750cc 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 has 51 adverse event reports, with no deaths and 51 injuries. Reports mostly describe hard scar tissue tightening around the implant, wounds or skin thinning that expose the implant, and implants rupturing or shifting, often leading to removal. No recalls name this device. Reports rose from 1 in the previous 12 months to 12 in the past 12 months.
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
- 50
- Deaths reported
- 0
- Injuries reported
- 50
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 10888628030411), received between Jul 18, 2019 and Aug 17, 2026 — classified as 50 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (18 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 Rejection18
- Adverse Event Without Identified Device or Use Problem12
- Patient-Device Incompatibility11
- Material Rupture7
- Migration2
- Break1
Patient problems
- Capsular Contracture25
- Failure of Implant9
- Wound Dehiscence6
- Unspecified Infection4
- Foreign Body Reaction3
- Abscess1
- Foreign Body Sensation in Eye1
- Impaired Healing1
Recent adverse event reports
The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.
InjuryAug 17, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Capsular contracture". This record is for the right side. Device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50279361 ↗InjuryAug 13, 2026Adverse Event Without Identified Device or Use Problem
Healthcare professional reported: "INCISION AND DRAINAGE HEMATOMA, SEROMA, FLUID COLLECTION "[1075917210]",INSERTION OR REPLACEMENT OF BR". This record if for the right-side device. The device was explanted.
Patient problems: Seroma
MAUDE report 50235415 ↗InjuryAug 12, 2026Device Appears to Trigger Rejection
Healthcare professional reported ¿Capsular Contracture Baker Grade IV severe scar tissue painful, hardening of breast, bottoming out. Breast deformity" and "Thickening with severe hardening of breast painful breast deformity¿. This record is for the right side. Device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50222987 ↗InjuryJul 27, 2026Device Appears to Trigger Rejection; Patient-Device Incompatibility
Healthcare professional reported "capsular contracture, Baker grade III", "skin thinning out" and "implant exposure" against the left side record. The device was explanted.
Patient problems: Capsular Contracture; Foreign Body Reaction
MAUDE report 50024483 ↗InjuryJun 2, 2026Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED ¿WOUND WITH IMPLANT EXPOSURE¿. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Foreign Body Reaction; Wound Dehiscence
MAUDE report 25362102 ↗InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED VIA NATIONAL BREAST IMPLANT REGISTRY (B)(6) MANUFACTURER REGISTRY SPECIFIC DATA REPORT (MRSDR) "WOUND PROBLEMS". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Impaired Healing
MAUDE report 24933335 ↗InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED "INFECTION". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 24830816 ↗InjuryApr 3, 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 III". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24780499 ↗InjuryMar 16, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV", "DEVICE MIGRATION/IMPLANT MALPOSITION", "CORRECTION OF ASYMMETRY" THROUGH THE NATIONAL BREAST IMPLANT REGISTRY (NBIR). PATIENT UNDERGONE CAPSULECTOMY. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24613707 ↗InjuryJan 13, 2026Migration
HEALTHCARE PROFESSIONAL REPORTED VIA NATIONAL BREAST IMPLANT REGISTRY "DEVICE MIGRATION/IMPLANT MALPOSITION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 24063099 ↗InjuryJan 13, 2026Migration
HEALTHCARE PROFESSIONAL REPORTED VIA NATIONAL BREAST IMPLANT REGISTRY "DEVICE MIGRATION/IMPLANT MALPOSITION, CORRECTION OF ASYMMETRY". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 24062900 ↗InjuryOct 31, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR) "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 23441211 ↗InjuryOct 26, 2023Device 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 18015246 ↗InjuryOct 2, 2023Material Rupture; Material Rupture
PATIENT REPORTED LEFT SIDE INTRACAPSULAR RUPTURE CONFIRMED VIA MRI. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 17857597 ↗InjuryApr 13, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16737108 ↗InjuryMar 10, 2023Adverse 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 AND REPLACED.
Patient problems: Unspecified Infection
MAUDE report 16526657 ↗InjuryJan 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "WOUND DEHISCENCE AND NECROSIS". THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Necrosis; Wound Dehiscence
MAUDE report 16189556 ↗InjuryJan 5, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE "CAPSULAR CONTRACTURE - CHEST TIGHTNESS" BAKER GRADE NOT PROVIDED. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16109355 ↗InjuryJan 5, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE "CAPSULAR CONTRACTURE - CHEST TIGHTNESS" BAKER GRADE NOT PROVIDED. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16109118 ↗InjuryDec 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "INFECTION." DEVICE HAS BEEN EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 16039933 ↗InjuryDec 1, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE AND MALPOSITION. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 15896906 ↗InjuryOct 3, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15532939 ↗InjuryOct 3, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15532884 ↗InjurySep 7, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 15371730 ↗InjuryAug 1, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE RUPTURE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 15139596 ↗
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-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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