Natrelle Inspira Cohesive Breast Implants SCF-325Recalls & reported problems
Allergan, Inc. · Natrelle Inspira SCF 325cc 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 325cc silicone gel breast implant is a smooth, round, full-profile implant made by Allergan. The 48 reports mostly describe the scar tissue around the implant tightening and hardening, sometimes with pain, and in some cases the implant shifting position, wrinkling or needing removal. There are no deaths, and 47 reports describe injuries. 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
- 46
- Deaths reported
- 0
- Injuries reported
- 45
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 10888628030077), received between May 24, 2019 and Apr 20, 2026 — classified as 45 injuries, 1 malfunction.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (27 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 Rejection27
- Patient-Device Incompatibility14
- Adverse Event Without Identified Device or Use Problem3
- Break1
- Malposition of Device1
- Material Rupture1
Patient problems
- Capsular Contracture39
- Failure of Implant3
- Unspecified Infection3
- Foreign Body Reaction1
- Foreign Body Sensation in Eye1
- Wound Dehiscence1
Recent adverse event reports
The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.
InjuryApr 20, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV", "DEVICE MIGRATION/IMPLANT MALPOSITION", "WRINKLING/RIPPLING" AND "CORRECTION OF ASYMMETRY" VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR). PATIENT UNDERWENT CAPSULECTOMY. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24924191 ↗InjuryApr 15, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "BAKER GRADE 4 CAPSULAR CONTRACTURE", "HARDNESS" AND "PAIN". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24889412 ↗InjuryFeb 16, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED OF THE LEFT SIDE DEVICE: "BAKER GRADE IV CAPSULE". THE PATIENT WAS PRESCRIBED STEROIDS. THE DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24345162 ↗InjuryJan 5, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE" BAKER GRADE IV TREATED WITH SINGULAIR. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED. DEVICE WILL NOT BE RETURNED.
Patient problems: Capsular Contracture
MAUDE report 23963050 ↗InjurySep 22, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A RIGHT-SIDE CAPSULAR CONTRACTURE GRADE IV. A CAPSULOTOMY WAS PERFORMED IN OFFICE ON (B)(6) 2025. ADDITIONALLY, SINGULAIR WAS PRESCRIBED AS TREATMENT. THE DEVICE REMAINED IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 23118877 ↗InjurySep 17, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
InjuryAug 13, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED ¨BAKER GRADE IV CAPSULAR CONTRACTURE¨. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22800257 ↗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 RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22784317 ↗InjuryJun 16, 2025Malposition of Device; Malposition of Device
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "FLIPPING". DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 22212695 ↗InjuryApr 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED "INFECTION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Unspecified Infection
MAUDE report 21825532 ↗InjurySep 18, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED VIA NBIR LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 20246220 ↗InjurySep 29, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 17841309 ↗InjuryJun 2, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17049454 ↗InjuryMay 24, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16997033 ↗InjuryNov 21, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "CAPSULAR CONTRACTURE, BAKER GRADE IV". DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15835093 ↗InjuryNov 18, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15827075 ↗InjuryOct 13, 2022Device Appears to Trigger Rejection; Patient-Device Incompatibility; Device Appears to Trigger Rejection; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE IMPLANT RECEIVED BY THE LAB WITH NO INFORMATION AS TO WHY THE DEVICE WAS RETURNED. HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV AND IMPLANT EXPOSURE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture; Foreign Body Reaction
MAUDE report 15601530 ↗InjurySep 22, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15466880 ↗InjuryAug 19, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 15261741 ↗InjuryAug 19, 2022Device 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 15261640 ↗InjuryJun 25, 2022Device 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 14820573 ↗InjuryJun 23, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PHYSICIAN REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 14790042 ↗InjuryJun 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE REMOVAL AS OPEN WOUND. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Wound Dehiscence
MAUDE report 14697858 ↗InjuryJun 7, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 14622623 ↗InjuryJun 1, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "CAPSULAR CONTRACTURE, BAKER GRADE IV". DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 14569342 ↗
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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