Natrelle INSPIRA Breast Implants SRF-450Recalls & reported problems
Allergan, Inc. · NATRELLE INSPIRA Sty SRF-450 Full profile |smooth|round|silicone · Class 3 · Implant
All models of Natrelle Breast Implants (1167) · Natrelle INSPIRA Breast Implants (197)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Natrelle INSPIRA silicone gel breast implant is an internal implant used in breast augmentation or reconstruction. Its 741 reports mostly describe capsular contracture, where scar tissue tightens around the implant, and many also describe ruptures and reactions the body has to the implant. The reports include no deaths and 738 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
- 748
- Deaths reported
- 0
- Injuries reported
- 745
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 748 adverse event reports that list this exact device (DI 10888628007345), received between Feb 5, 2019 and Sep 30, 2026 — classified as 745 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (481 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 Rejection481
- Patient-Device Incompatibility172
- Material Rupture95
- Adverse Event Without Identified Device or Use Problem20
- Device Handling Problem4
- Improper or Incorrect Procedure or Method3
- Break2
- Fluid/Blood Leak2
Patient problems
- Capsular Contracture647
- Failure of Implant75
- Unspecified Infection11
- No Clinical Signs, Symptoms or Conditions8
- Pain4
- Seroma4
- Impaired Healing3
- Wound Dehiscence3
Recent adverse event reports
The 25 most recent of 748 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Device Appears to Trigger Rejection
Healthcare professional reported: unspecified Baker grade capsular contracture. This record is for the left-side device. The device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50950530 ↗InjurySep 29, 2026Device Appears to Trigger Rejection
Healthcare professional reported "capsular contracture, Baker grade IV". This record is for the right side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50936285 ↗InjurySep 28, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture
MAUDE report 50923701 ↗InjurySep 28, 2026Device Appears to Trigger Rejection
Healthcare professional reported Baker grade III capsular contracture. This record is for the right side. Device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50912162 ↗InjurySep 22, 2026Device Appears to Trigger Rejection
Healthcare professional reported "capsular contracture Baker Grade IV" and "hardening". The patient was prescribed montelukast and massage therapy. This record is for the right side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50859628 ↗InjurySep 22, 2026Material Rupture
Healthcare professional reported "Rupture". This record is for the right side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50854701 ↗InjurySep 17, 2026Device Appears to Trigger Rejection
Patient reported "pain, hurting, and capsular contracture, baker grade unknown". Later, healthcare professional and patient reported "capsular contracture Baker grade III". This record is for the right side. The device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50805028 ↗InjurySep 14, 2026Device Appears to Trigger Rejection
Healthcare professional reported "capsular contracture Baker grade lll" and "breast hardened and abnormal". This record is for right side. The device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50756261 ↗InjurySep 10, 2026Device Appears to Trigger Rejection
InjurySep 9, 2026Device Appears to Trigger Rejection
Patient reported "Capsular contracture" Baker Grade IV, "Pain" and "distorsion". Healthcare professional later reported "Capsular contracture" Baker Grade III. This record is for the right side. Device remains implanted. Patient was prescribed Singulair.
Patient problems: Capsular Contracture
MAUDE report 50692727 ↗InjurySep 7, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture
MAUDE report 50653390 ↗InjuryAug 18, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Grade 3 capsular contracture" against the left side. The device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50303547 ↗InjuryAug 14, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Grade 3 capsular contracture" against the right side. The device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50256673 ↗InjuryAug 12, 2026Device Appears to Trigger Rejection
Healthcare professional reported Capsular Contracture Baker grade IV. This record is for the right side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50224369 ↗InjuryAug 11, 2026Material Rupture
Healthcare professional reported "rupture". This record is for the left side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50209932 ↗InjuryAug 11, 2026Material Rupture
Healthcare professional reported "rupture". This record is for the left side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50202156 ↗InjuryJul 27, 2026Device Appears to Trigger Rejection
Healthcare professional reported through the National Breast Implant Registry (NBIR) ¿Capsular Contracture Baker Grade III¿. Capsulectomy/Capsulotomy was performed. This record is for the left side. Device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50024673 ↗InjuryJul 20, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE IV". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25877182 ↗InjuryJul 16, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE 4". THIS RECORD IS FOR LEFT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25850519 ↗InjuryJul 15, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE IV". THIS RECORD IS FOR RIGHT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25832386 ↗InjuryJul 9, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25769465 ↗InjuryJul 8, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25756540 ↗InjuryJun 24, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV" AND "IMPLANT LOOKED LARGER AND FIRM TO THE TOUCH". THIS RECORD IS FOR RIGHT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25611449 ↗InjuryJun 24, 2026Device Appears to Trigger Rejection; Improper or Incorrect Procedure or Method
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN", "IMPLANT BOTTOMING OUT". THIS RECORD IS FOR RIGHT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25611431 ↗InjuryJun 11, 2026Device Appears to Trigger Rejection
DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 25480126 ↗
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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- MENTOR MemoryGel Breast Implant 3503001BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,752 reports
- MENTOR MemoryGel Breast Implant 3503504BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,749 reports
- MENTOR MemoryGel Breast Implant 3504501BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,690 reports
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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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