Natrelle Inspira Cohesive Breast Implants SCF-520Recalls & reported problems
Allergan, Inc. · Natrelle Inspira SCF 520cc 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 SCF-520 breast implant has 103 adverse event reports mentioning 102 injuries, no deaths, and 1 malfunction. Reports mostly describe capsular contracture, implant rupture or failure, and apparent rejection or incompatibility; many implants are explanted. No recalls name this device. Reports fell to 7 in the last 12 months from 15 the prior year.
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
- 105
- Deaths reported
- 0
- Injuries reported
- 104
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 105 adverse event reports that list this exact device (DI 10888628030152), received between Jun 14, 2019 and Sep 25, 2026 — classified as 104 injuries, 1 malfunction.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (58 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 Rejection58
- Material Rupture15
- Patient-Device Incompatibility14
- Adverse Event Without Identified Device or Use Problem10
- Malposition of Device5
- Device Handling Problem3
- No Apparent Adverse Event2
- Difficult to Open or Remove Packaging Material1
Patient problems
- Capsular Contracture71
- Failure of Implant22
- No Clinical Signs, Symptoms or Conditions4
- Seroma3
- Unspecified Infection3
- Necrosis2
- Abscess1
- Cellulitis1
Recent adverse event reports
The 25 most recent of 105 reports, in the reporter's own words as published by the FDA.
InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Seroma
MAUDE report 50905344 ↗InjurySep 24, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Grade IV capsular contracture" against the left side. The device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50889287 ↗InjurySep 24, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Grade IV capsular contracture" against the right side. The device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50889168 ↗InjurySep 21, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture
MAUDE report 50849317 ↗InjuryAug 19, 2026Device Appears to Trigger Rejection; No Apparent Adverse Event
Healthcare professional reported "Capsular contracture". This record is for the left side. Device was explanted.
Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions
MAUDE report 50323733 ↗InjuryJul 7, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED; OPEN CAPSULOTOMY PERFORMED.
Patient problems: Capsular Contracture
MAUDE report 25733658 ↗InjuryJun 8, 2026Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED "SEROMA". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Seroma
MAUDE report 25428758 ↗InjuryMay 13, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR) MANUFACTURER REGISTRY SPECIFIC DATA REPORT (MRSDR) "SUSPECTED/ACTUAL RUPTURE/DEFLATION". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25157075 ↗InjuryApr 20, 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 24930420 ↗InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED VIA NBIR "INFECTION". THIS RECORD IS FOR RIGHT SIDE. THE DEVICE STATUS IS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 23376192 ↗InjuryOct 15, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED ¿LEAKING.¿ THIS RECORD IS FOR THE UNKNOWN SIDE. THE DEVICE STATUS IS UNKNOWN.
Patient problems: Failure of Implant
MAUDE report 23287677 ↗InjuryOct 2, 2025Material Rupture; No Apparent Adverse Event; Material Rupture; No Apparent Adverse Event
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" VIA ULTRASOUND. THIS RECORD IS FOR THE LEFT-SIDE. DEVICE REMAINS IMPLANTED AND WILL BE RETURNED.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 23199153 ↗InjurySep 25, 2025Malposition of Device; Malposition of Device
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "FLIPPING". THE DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 23147793 ↗InjurySep 12, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
TREATMENT HAS BEEN REPORTED AS SINGULAIR. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 23041470 ↗InjuryAug 4, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE III" AND "PATIENT WAS IMPLANTED PRIOR TO AGE 22". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22709572 ↗InjuryJul 15, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22508412 ↗InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED VIA THE NATIONAL BREAST IMPLANT REGISTRY (NBIR) LEFT SIDE INFECTION AND SKIN NECROSIS. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Necrosis; Unspecified Infection
MAUDE report 22208871 ↗MalfunctionJun 4, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material
COMPANY REPRESENTATIVE REPORTED VIA HEALTHCARE PROVIDER TYVEK OR THERMOFORM PACKAGING IS "NOT RIPPING CLEANLY". THIS RECORD IS FOR THE LEFT SIDE. NO PATIENT HARM WAS REPORTED. PACKAGING WAS DISCARDED. THE DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22146379 ↗InjuryMay 20, 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 REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22057782 ↗InjuryMay 15, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 22028937 ↗InjuryMay 13, 2025Malposition of Device; Malposition of Device
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "FLIPPING". HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED PATIENT DESIRED LARGER SIZE TO AVOID FLIPPING. CAPSULECTOMY WAS PERFORMED. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 22013021 ↗InjuryMay 13, 2025Malposition of Device; Malposition of Device
HEALTHCARE PROFESSIONAL REPORTED "LATERAL DISPLACEMENT OF IMPLANT." THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 22012243 ↗InjuryMay 13, 2025Malposition of Device; Malposition of Device
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "LATERAL DISPLACEMENT OF IMPLANT." THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 22009794 ↗InjuryMay 8, 2025Malposition of Device; Malposition of Device
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "IMPLANT FLIP". HEALTHCARE PROFESSIONAL LATER REPORTED PATIENT DESIRED LARGER SIZE TO AVOID FLIPPING. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 21990024 ↗InjurySep 16, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED VIA NBIR LEFT-SIDE "CAPSULAR CONTRACTURE BAKER GRADE III". DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 20226363 ↗
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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