Natrelle Inspira Cohesive Breast Implants SCF-650Recalls & reported problems
Allergan, Inc. · Natrelle Inspira SCF 650cc 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 is an Allergan Natrelle Inspira silicone gel breast implant in the full profile 650cc size. The 61 reports mostly describe the scar tissue around the implant tightening and hardening the breast, sometimes so severely that the implant had to be removed and replaced, along with a few reports of the implant shifting position or rupturing. There were60 injuries and no deaths. 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
- 61
- Deaths reported
- 0
- Injuries reported
- 60
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 10888628030183), received between Jul 17, 2019 and Sep 30, 2026 — classified as 60 injuries, 1 malfunction.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (28 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 Rejection28
- Material Rupture13
- Patient-Device Incompatibility13
- Adverse Event Without Identified Device or Use Problem8
- Malposition of Device2
- Migration2
- Difficult to Open or Remove Packaging Material1
Patient problems
- Capsular Contracture39
- Failure of Implant10
- Unspecified Infection4
- Necrosis3
- No Clinical Signs, Symptoms or Conditions3
- Seroma3
- Foreign Body Reaction2
- Cellulitis1
Recent adverse event reports
The 25 most recent of 61 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Healthcare professional reported ¿Wound dehiscence" and "scabbing¿. This record is for the right side. Device was explanted.
Patient problems: Wound Dehiscence
MAUDE report 50943604 ↗InjuryJan 12, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL, THROUGH NATIONAL BREAST IMPLANT REGISTRY, REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV, CHANGE SHAPE/SIZE/STYLE". CAPSULECTOMY WAS PERFORMED. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED. IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED.
Patient problems: Capsular Contracture
MAUDE report 24047076 ↗InjuryJan 12, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL, THROUGH NATIONAL BREAST IMPLANT REGISTRY, REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III, CHANGE SHAPE/SIZE/STYLE". CAPSULECTOMY WAS PERFORMED. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED. IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED.
Patient problems: Capsular Contracture
MAUDE report 24039334 ↗InjuryDec 9, 2025Malposition of Device; Migration; Malposition of Device; Migration
HEALTHCARE PROFESSIONAL VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR) REPORTED "DEVICE MIGRATION" AND "IMPLANT MALPOSITION". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED. RETURN STATUS IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23757954 ↗InjuryDec 9, 2025Malposition of Device; Migration; Malposition of Device; Migration
HEALTHCARE PROFESSIONAL VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR) REPORTED "DEVICE MIGRATION" AND "IMPLANT MALPOSITION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED. RETURN STATUS IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23757902 ↗InjurySep 23, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED LEFT SIDE ¿TIGHTNESS, LUMP, IMPLANT SITS HIGH, FEELS ABNORMAL, CAPSULECTOMY, CAN FEEL OTHER THINGS¿ DIAGNOSED VIA MAMMOGRAM AND "EXCHANGE". HEALTHCARE PROFESSIONAL LATER REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III, HARDNESS AND PAIN" DIAGNOSED VIA SONOGRAM. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 23127223 ↗InjurySep 17, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "RUPTURE¿. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 23078886 ↗InjuryAug 12, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE III. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22783818 ↗MalfunctionJul 14, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material
HEALTHCARE PROFESSIONAL REPORTED "UNABLE TO REMOVE STERILY FROM PACKAGE¿. DEVICE WAS NOT IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22494265 ↗InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE NECROSIS. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Necrosis
MAUDE report 22374546 ↗InjuryJun 9, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE ¿CAPSULAR CONTRACTURE BAKER GRADE III¿. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22168965 ↗InjuryJun 5, 2025Device 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 22154427 ↗InjuryMay 8, 2024Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED VIA NBIR RIGHT SIDE "SUSPECTED/ACTUAL RUPTURE/DEFLATION." DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 19268268 ↗InjuryApr 18, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED, VIA NBIR RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 19140488 ↗InjuryMay 18, 2023Material Rupture; Material Rupture
PATIENT'S SPOUSE REPORTED RIGHT SIDE RUPTURE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 16958738 ↗InjuryApr 20, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 16781542 ↗InjuryApr 17, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED AND DISCARDED.
Patient problems: Failure of Implant
MAUDE report 16755780 ↗InjuryMar 21, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE AND "IMPLANT WAS LEAKING". DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 16581836 ↗InjuryMar 8, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE REMAINS IMPLANTED. THIS RELATES TO THE LEFT SIDE.
Patient problems: Capsular Contracture
MAUDE report 16501894 ↗InjuryFeb 21, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED VIA NATIONAL BREAST IMPLANT REGISTRY A RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 16414497 ↗InjuryFeb 20, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED VIA NATIONAL BREAST IMPLANT REGISTRY A LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 16405323 ↗InjuryJan 23, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE ¿CAPSULAR CONTRACTURE¿ BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16224325 ↗InjuryJan 23, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE ¿CAPSULAR CONTRACTURE¿ BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16224130 ↗InjuryJan 17, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16188255 ↗InjuryJan 13, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED VIA NBIR LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE-3. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16159662 ↗
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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