Natrelle Inspira Cohesive Breast Implants SCX-545Recalls & reported problems
Allergan, Inc. · Natrelle Inspira SCX 545cc Extra 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 cohesive silicone breast implant has 41 adverse event reports mentioning it, with no deaths and 41 injuries. Reports mostly describe capsular contracture and implant failure, along with rupture, rejection or compatibility problems that often led to removal. There are no recalls naming 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
- 39
- Deaths reported
- 0
- Injuries reported
- 39
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10888628030350), received between May 15, 2019 and Apr 15, 2026 — classified as 39 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (19 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 Rejection19
- Adverse Event Without Identified Device or Use Problem11
- Material Rupture4
- Patient-Device Incompatibility4
- Break1
- Device Handling Problem1
- Migration1
Patient problems
- Capsular Contracture22
- Failure of Implant6
- Unspecified Infection4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Ischemia2
- Erosion1
- Foreign Body Sensation in Eye1
- Seroma1
Recent adverse event reports
The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.
InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED "LARGER IMPLANT USED, RIPPLING, SLIGHT LATERAL LOWER IMF". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24888562 ↗InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED "LARGER IMPLANT USED, RIPPLING, SLIGHT LATERAL LOWER IMF". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24888382 ↗InjuryDec 4, 2025Migration; Migration
HEALTHCARE PROFESSIONAL REPORTED "DEVICE MIGRATION/IMPLANT MALPOSITION" AND "CORRECTION OF ASYMMETRY" VIA NATIONAL BREAST IMPLANT REGISTRY. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 23720366 ↗InjuryJul 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED VIA NBIR "WOUND PROBLEMS". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22469745 ↗InjuryJun 11, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "CAPSULAR CONTRACTURE BAKER GRADE III." DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 22187756 ↗InjuryMay 27, 2025Break; Device Handling Problem; Break; Device Handling Problem
HEALTHCARE PROFESSIONAL REPORTED "IMPLANT PUNCTURED DURING A PROCEDURE. THE DEVICE DID NOT COME INTO CONTACT WITH THE PATIENT". LATER HEALTHCARE PROFESSIONAL REPORTED IMPLANT SHELL HAD THE PROBLEM AND THE DEVICE HAD CONTACT WITH PATIENT. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 22093310 ↗InjuryMay 20, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RUPTURE. HEALTHCARE PROFESSIONAL LATER REPORTED "GRADE 4 CAPSULAR CONTRACTURE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture; Failure of Implant
MAUDE report 22049847 ↗InjurySep 12, 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.
Patient problems: Capsular Contracture
MAUDE report 20208197 ↗InjuryAug 23, 2024Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED SUSPECTED/ACTUAL RUPTURE/DEFLATION BY NBIR. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 20050884 ↗InjuryOct 31, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE REMAINS IMPLANTED. THIS RELATES TO THE LEFT SIDE.
Patient problems: Capsular Contracture
MAUDE report 18041122 ↗InjuryOct 31, 2023Device 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 18041049 ↗InjuryJul 5, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17259015 ↗InjuryJun 30, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE IV. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 17236381 ↗InjuryMar 8, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16504554 ↗InjuryJan 26, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
InjuryJan 26, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE " CAPSULAR CONTRACTION BAKER GRADE IV." DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 16250565 ↗InjuryNov 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE INFECTION. DEVICE EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 15870651 ↗InjuryNov 25, 2022Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 15866215 ↗InjuryOct 1, 2022Device 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 15523086 ↗InjuryJul 28, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III AND FLIPPING. THE DEVICE HAS BEEN EXPLANTED AND REPLACED AND WILL NOT BE RETURNED.
Patient problems: Capsular Contracture
MAUDE report 15124619 ↗InjuryJul 27, 2022Material Rupture; Material Rupture
PATIENT REPORTED LEFT SIDE RUPTURE. HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 15113940 ↗InjuryMay 31, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III AGAINST LEFT DEVICE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 14552386 ↗InjuryMay 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED REASON FOR LEFT SIDE REMOVAL IS EXTRUSION AND DELAYED IMPLANT INFECTION. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Erosion; Unspecified Infection
MAUDE report 14489830 ↗InjuryMay 21, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE IV." DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 14466147 ↗InjuryJan 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED VIA NBIR RIGHT SIDE "INFECTION". THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Unspecified Infection
MAUDE report 13342952 ↗
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
Other Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled devices
- MENTOR MemoryGel Breast Implant 3503501BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled2,167 reports
- MENTOR MemoryGel Breast Implant 3504001BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled2,130 reports
- MENTOR MemoryGel Breast Implant 3504004BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled2,012 reports
- MENTOR MemoryGel Breast Implant 3504504BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,754 reports
- 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
- MENTOR MemoryGel Breast Implant 3503251BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,684 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page