Natrelle Inspira Cohesive Breast Implants SCF-560Recalls & reported problems
Allergan, Inc. · Natrelle Inspira SCF 560cc 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 93 adverse event reports mentioning 89 injuries and no deaths. The reports mostly describe painful tightening of scar tissue around the implant, plus implants shifting out of place, rupturing and infections, sometimes with the implant removed. No recalls name this device, and reports rose to 10 from 3 the year before.
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
- 89
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 94 adverse event reports that list this exact device (DI 10888628030169), received between Jun 17, 2019 and Sep 23, 2026 — classified as 89 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (41 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 Rejection41
- Patient-Device Incompatibility20
- Material Rupture12
- Adverse Event Without Identified Device or Use Problem10
- Malposition of Device5
- Device Handling Problem3
- Difficult to Open or Remove Packaging Material2
- Migration2
Patient problems
- Capsular Contracture60
- Failure of Implant16
- No Clinical Signs, Symptoms or Conditions8
- Unspecified Infection7
- Hematoma2
- Foreign Body Reaction1
- Impaired Healing1
- Necrosis1
Recent adverse event reports
The 25 most recent of 94 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Difficult to Open or Remove Packaging Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50875945 ↗InjurySep 21, 2026Material Rupture
Patient professional reported "rupture". This record is for the right side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50838934 ↗InjurySep 8, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Contraction" against the right side record. The device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50670871 ↗InjurySep 6, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture
MAUDE report 50640985 ↗InjuryJul 27, 2026Malposition of Device
Healthcare professional reported ¿Implant Malposition¿. This record is for the right side. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50000308 ↗InjuryJul 7, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED; OPEN CAPSULOTOMY PERFORMED.
Patient problems: Capsular Contracture
MAUDE report 25733851 ↗InjuryMay 12, 2026Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" CONFIRMED VIA MAMMOGRAM AND CAT SCAN. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions
MAUDE report 25151645 ↗InjuryApr 8, 2026Malposition of Device
HEALTHCARE PROFESSIONAL REPORTED "PATIENT STATES IMPLANT MOVES". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24824378 ↗InjuryFeb 10, 2026Material Rupture; Improper or Incorrect Procedure or Method
HEALTHCARE PROFESSIONAL REPORTED THROUGH DEVICE TRACKING "RUPTURE/DEFLATION AND DEVICE WAS ACCIDENTALLY PUNCTURED". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS NOT IMPLANTED AND WAS DISCARDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24308711 ↗InjuryNov 7, 2025Malposition of Device; Migration; Malposition of Device; Migration
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE I" AND "DEVICE MIGRATION/IMPLANT MALPOSITION". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 23498615 ↗InjuryNov 6, 2025Malposition of Device; Migration; Malposition of Device; Migration
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE II" AND "DEVICE MIGRATION/IMPLANT MALPOSITION". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 23487546 ↗InjurySep 10, 2025Malposition of Device; Malposition of Device
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "MALPOSITION; FLIPPED¿. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 23016275 ↗MalfunctionAug 8, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
HEALTHCARE PROFESSIONAL REPORTED "CONTAMINATED". THE DEVICE WAS NOT IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22754422 ↗MalfunctionJun 4, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material
HEALTHCARE PROFESSIONAL REPORTED "COMPLAINT ON PACKAGING, DID NOT TEAR CORRECTLY". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22141426 ↗InjuryJun 19, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED VIA NBIR RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III, DEVICE MIGRATION/IMPLANT MALPOSITION, CHANGE SHAPE/SIZE/STYLE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 19566639 ↗InjuryMay 14, 2024Material Rupture; Material Rupture
ALLERGAN AESTHETICS RECEIVED A REPORT VIA NBIR OF A RIGHT SIDE "SUSPECTED/ACTUAL RUPTURE". THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 19313199 ↗InjuryNov 13, 2023Device Damaged Prior to Use; Device Handling Problem; Device Damaged Prior to Use; Device Handling Problem
HEALTHCARE PROFESSIONAL REPORTED, UNKNOWN SIDE "IMPLANT WAS PUNCTURED, DURING PLACEMENT". DEVICE NOT IMPLANTED. AND WAS DISCARDED.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 18127735 ↗InjuryOct 11, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 17916190 ↗InjurySep 15, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 17756802 ↗InjuryAug 22, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 17597764 ↗InjuryAug 18, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17579300 ↗InjuryAug 17, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE IV. THE DEVICE HAS BEEN EXPLANTED. THIS RELATES TO THE RIGHT SIDE.
Patient problems: Capsular Contracture
MAUDE report 17568147 ↗InjuryJul 27, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 17405600 ↗InjuryJun 9, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE WITH NO COMPLAINT AGAINST THE DEVICE. COMPANY REPRESENTATIVE REPORTED ON BEHALF OF EXPLANTING PHYSICIAN CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 17099436 ↗InjuryJun 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "CHRONIC DEFORMITY, PAIN, AND SEROMA". THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Seroma
MAUDE report 17040661 ↗
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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