Natrelle Inspira Cohesive Breast Implants SCF-265Recalls & reported problems
Allergan, Inc. · Natrelle Inspira SCF 265cc 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 is placed inside the breast for augmentation or reconstruction. Reports mostly describe painful tightening of scar tissue around the implant, often leading to removal, with a few mentions of rupture or exposure. There are 25 reports naming its identifier, with no deaths and 25 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
- 24
- Deaths reported
- 0
- Injuries reported
- 24
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10888628030053), received between Aug 6, 2019 and Jul 28, 2026 — classified as 24 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (15 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 Rejection15
- Patient-Device Incompatibility6
- Material Rupture3
- Break1
Patient problems
- Capsular Contracture20
- Failure of Implant2
- Foreign Body Reaction1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
InjuryJul 28, 2026Device Appears to Trigger Rejection; Material Rupture
Patient reported "rupture". Later Healthcare professional reported "Capsular Contracture " against the left side record. The device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50056419 ↗InjuryMay 13, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25157868 ↗InjuryApr 3, 2026Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED OF THE LEFT SIDE DEVICE: "EXPOSED". THE DEVICE WAS EXPLANTED.
Patient problems: Foreign Body Reaction
MAUDE report 24782062 ↗InjuryJan 12, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "NO COMPLAINT TOWARDS THE DEVICE¿. LATER, HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE III". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED. EXPLANT SURGERY IS NOT YET SCHEDULED, AND THE EXPLANTED DEVICE WILL BE RETURNED.
Patient problems: Capsular Contracture
MAUDE report 24049298 ↗InjuryAug 12, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. THE DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 22786872 ↗InjuryAug 7, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22740062 ↗InjuryJun 28, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17221698 ↗InjuryJun 8, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED, A RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 17090640 ↗InjuryJan 25, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED AND WILL NOT BE RETURNED.
Patient problems: Capsular Contracture
MAUDE report 16240674 ↗InjuryNov 15, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15797622 ↗InjuryOct 27, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "A RIGHT-SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV." DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15686491 ↗InjuryJun 6, 2022Device 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 14607851 ↗InjuryMay 24, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED VIA DEVICE TRACKING "RUPTURED WHILE ATTEMPTING TO IMPLANT" AGAINST DEVICE. THE DEVICE WAS NOT IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14489185 ↗InjuryMay 18, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 14430418 ↗InjuryDec 1, 2021Device 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 12913221 ↗InjuryNov 29, 2021Device 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 12886167 ↗InjurySep 10, 2021Device 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 12455275 ↗InjuryJun 18, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 12026020 ↗InjuryDec 18, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED "LEFT-SIDE EXCHANGE, CAPSULAR CONTRACTURE, BAKER GRADE IV". DEVICE HAS BEEN EXPLANTED AND DISCARDED.
Patient problems: Capsular Contracture
MAUDE report 11037206 ↗InjuryOct 9, 2020Break; Break
HEALTHCARE PROFESSIONAL REPORTED UNKNOWN SIDE "IMPLANT BURST WHILE PLACING INTO OPERATIVE SITE. SENDING BACK TO MANUFACTURER." DEVICE WAS NOT IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 10656857 ↗InjuryJan 13, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 9581770 ↗InjurySep 24, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE "III-IV." DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 9109706 ↗InjuryAug 6, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 8867430 ↗InjuryAug 6, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 8867379 ↗
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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