Natrelle Inspira Cohesive Breast Implants SCF-385Recalls & reported problems
Allergan, Inc. · Natrelle Inspira SCF 385cc 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 silicone breast implant has 86 adverse event reports: 85 injuries, 1 malfunction and no deaths. The reports mostly describe capsular contracture, a hardening of the scar tissue around the implant, with many implants removed, and some describe the implant rupturing. 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
- 88
- Deaths reported
- 0
- Injuries reported
- 87
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 88 adverse event reports that list this exact device (DI 10888628030114), received between Nov 1, 2019 and Aug 13, 2026 — classified as 87 injuries, 1 malfunction.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (60 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 Rejection60
- Patient-Device Incompatibility15
- Material Rupture9
- Migration3
- Adverse Event Without Identified Device or Use Problem2
- Device Contaminated During Manufacture or Shipping1
- Device Handling Problem1
- Fluid/Blood Leak1
Patient problems
- Capsular Contracture74
- Failure of Implant10
- No Clinical Signs, Symptoms or Conditions2
- Cellulitis1
- Foreign Body Reaction1
- Hematoma1
- Pocket Erosion1
- Unspecified Infection1
Recent adverse event reports
The 25 most recent of 88 reports, in the reporter's own words as published by the FDA.
InjuryAug 13, 2026Device Appears to Trigger Rejection
Healthcare professional reported "capsular contracture Baker grade IV". Patient was prescribed with pain medication. This record is for left side. The device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50240780 ↗InjuryAug 10, 2026Device Appears to Trigger Rejection
Healthcare professional reported of the right side device: capsular contracture of unspecified Baker grade. Later healthcare professional reported Baker grade III. The device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50193275 ↗InjuryJul 15, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III" AGAINST THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25828955 ↗InjuryJul 15, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III" AGAINST THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25828706 ↗InjuryMay 26, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED THROUGH THE NATION BREAST IMPLANT REGISTRY "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25284775 ↗InjuryMay 26, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED THROUGH THE NATION BREAST IMPLANT REGISTRY "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE LEFT SIDE. DEVICE EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25284728 ↗InjuryMay 15, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25187421 ↗InjuryMay 1, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Capsular contracture¿ Baker grade III. This record is for the right side. Device was explanted. Patient was prescribed Singulair and Celebrex.
Patient problems: Capsular Contracture
MAUDE report 25058305 ↗InjuryDec 10, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE IV". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED. IT'S UNKNOWN IF THE DEVICE WILL BE RETURNED.
Patient problems: Capsular Contracture
MAUDE report 23769933 ↗InjuryAug 22, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22873772 ↗InjuryAug 21, 2025Material Rupture; Material Rupture
PATIENT REPORTED "POSSIBLE RUPTURE, "SITS LOWER, "DOUBLE BUBBLE," "RASH UNDER RIBCAGE" AND, BRAIN FOG, BREAST IMPLANT ILLNESS, FATIGUE, HAIR LOSS, WEIGHT LOSS , "NOT SLEEPING", VISION LOSS AND METALLIC TASTE IN MOUTH" (NOT DEVICE RELATED). THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22863746 ↗InjuryAug 13, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III/IV. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22795608 ↗InjuryAug 8, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE AND CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22755407 ↗InjuryJul 23, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "¿CAPSULAR CONTRACTURE¿ BAKER GRADE UNKNOWN¿. BAKE IV". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 22574729 ↗InjuryJul 18, 2025Migration; Migration
HEALTHCARE PROFESSIONAL REPORTED ¿INFERIN AND LATERAL DUPLACEMENT¿. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 22540307 ↗InjuryMay 16, 2025Material Rupture; Material Rupture
PATIENT REPORTED " RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 22037866 ↗InjuryMay 15, 2025Fluid/Blood Leak; Device Appears to Trigger Rejection; Material Rupture; Fluid/Blood Leak; Device Appears to Trigger Rejection; Material Rupture
PREVIOUS MEDWATCH SUBMISSION NOTED RUPTURE. UPON FURTHER INFORMATION, ALLERGAN HAS DETERMINED THAT THE EVENT OF RUPTURE DID NOT OCCUR. HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN.
Patient problems: Capsular Contracture; Failure of Implant
MAUDE report 22024957 ↗InjuryApr 28, 2025Migration; Migration
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "BOTTOMING OUT." THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 21922793 ↗InjuryApr 28, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURES, BAKER GRADE III/IV". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 21919344 ↗InjuryApr 24, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURES, BAKER GRADE III/IV". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 21905548 ↗InjuryApr 22, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
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 21883495 ↗InjuryApr 17, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 21853942 ↗InjuryApr 22, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED VIA NBIR LEFT SIDE "CAPSULAR CONTRACTURE BAKER GRADE IV". DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 19152950 ↗InjuryApr 22, 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 AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 19152888 ↗InjuryDec 5, 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 18268974 ↗
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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