Natrelle Inspira Cohesive Breast Implants SCF-605Recalls & reported problems
Allergan, Inc. · Natrelle Inspira SCF 605cc 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 Allergan Natrelle Inspira cohesive silicone breast implant has 94 reports, 93 of them injuries, and no deaths. Common reports describe scar tissue tightening around the implant (capsular contracture), breast deformity, implants moving out of place, and infections, and many say the implant was removed. Reports fell from 10 in the prior 12 months to 6 in the latest 12 months. 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
- 94
- Deaths reported
- 0
- Injuries reported
- 93
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 94 adverse event reports that list this exact device (DI 10888628030176), received between May 30, 2019 and Sep 10, 2026 — classified as 93 injuries, 1 malfunction.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (45 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 Rejection45
- Patient-Device Incompatibility19
- Adverse Event Without Identified Device or Use Problem18
- Material Rupture7
- Migration3
- Device Contamination with Chemical or Other Material1
- Device Handling Problem1
- Malposition of Device1
Patient problems
- Capsular Contracture62
- Unspecified Infection12
- Failure of Implant11
- Wound Dehiscence7
- Seroma2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Foreign Body Reaction1
- Foreign Body Sensation in Eye1
Recent adverse event reports
The 25 most recent of 94 reports, in the reporter's own words as published by the FDA.
InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem
Healthcare professional reported removal due to "Open Wound". This record is for the right side. Device was explanted.
Patient problems: Wound Dehiscence
MAUDE report 50713758 ↗InjuryAug 7, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Capsular contracture Baker grade lll". This record is for the the right side. Device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50176389 ↗InjuryJul 10, 2026Device Appears to Trigger Rejection; No Apparent Adverse Event
Healthcare professional reported Capsular Contracture Baker Grade III. Later healthcare professional reported "Capsular Contracture Baker Grade I". This record is for the right side. Device has been explanted. Patient was treated with singulair.
Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions
MAUDE report 25781526 ↗InjuryApr 17, 2026Malposition of Device; Migration
HEALTHCARE PROFESSIONAL REPORTED VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR) MANUFACTURER REGISTRY SPECIFIC DATA REPORT (MRSDR) "DEVICE MIGRATION/IMPLANT MALPOSITION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24913777 ↗InjuryApr 17, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED VIA 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 24910499 ↗InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED "DEFORMITY OF BREAST". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24775823 ↗InjuryOct 15, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
InjurySep 3, 2025Migration; Migration
HEALTHCARE PROFESSIONAL REPORTED ¿LATERAL DISPLACEMENT¿. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 22952528 ↗InjurySep 2, 2025Migration; Migration
HEALTHCARE PROFESSIONAL REPORTED ¿LATERAL DISPLACEMENT¿. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 22941674 ↗InjuryAug 12, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE LLL". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22786060 ↗InjuryJun 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED "INFECTION" THIS RECORD IS FOR THE LEFT. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Unspecified Infection
MAUDE report 22347477 ↗InjuryJun 10, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 22179705 ↗InjuryJun 10, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 22179703 ↗InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED INFECTION-UNKNOWN ONSET. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 22029839 ↗InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED "INFECTION". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Unspecified Infection
MAUDE report 21912867 ↗InjuryNov 26, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
RECEIVED, DEVICE TRACKING INFORMATION. THE REASON FOR LEFT SIDE REMOVAL WAS NOTED, AS CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 20788909 ↗InjuryOct 29, 2024Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED, LEFT SIDE EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE. HEALTHCARE PROFESSIONAL, LATER REPORTED, RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 20559518 ↗InjuryOct 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
COMPANY REPRESENTATIVE REPORTED "COULD NOT GET INNER STERILE PLASTIC OUT" AGAINST DEVICE. HEALTHCARE PROFESSIONAL REPORTER LATER REPORTED INFECTION AND SEROMA. DEVICE EXPLANTED AND DISCARDED.
Patient problems: Seroma; Unspecified Infection
MAUDE report 20500462 ↗InjurySep 30, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED VIA NBIR RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 20339249 ↗InjurySep 17, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
ALLERGAN AESTHETICS RECEIVED A REPORT VIA NBIR OF A LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 20243094 ↗InjuryFeb 6, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED VIA NBIR RIGHT SIDE "CAPSULAR CONTRACTURE BAKER GRADE III". DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 18650983 ↗InjuryNov 8, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
LATER, HEALTHCARE PROFESSIONAL CONFIRMED, RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 18094012 ↗InjuryOct 23, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A RIGHT CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17990932 ↗InjurySep 11, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17726296 ↗InjurySep 11, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17726295 ↗
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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