Natrelle Inspira Cohesive Breast Implants SCX-580Recalls & reported problems
Allergan, Inc. · Natrelle Inspira SCX 580cc 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 Natrelle Inspira silicone gel breast implant is a smooth, round, extra-full-profile implant. The 53 reports mostly describe the scar tissue around the implant tightening hard enough to distort or flatten the breast, sometimes with the implant shifting out of position or rupturing, and fluid collecting around it. All 53 reports describe injuries, with no deaths. No recalls name this device, and the number of reports is steady at 9 in each of the last two 12-month periods.
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
- 60
- Deaths reported
- 0
- Injuries reported
- 60
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 10888628030374), received between May 15, 2019 and Sep 24, 2026 — classified as 60 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (33 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 Rejection33
- Material Rupture10
- Patient-Device Incompatibility9
- Adverse Event Without Identified Device or Use Problem5
- Malposition of Device5
- Migration2
Patient problems
- Capsular Contracture39
- Failure of Implant13
- Seroma7
- Erosion2
- Wound Dehiscence2
- Abscess1
- Foreign Body Sensation in Eye1
- Pain1
Recent adverse event reports
The 25 most recent of 60 reports, in the reporter's own words as published by the FDA.
InjurySep 24, 2026Device Appears to Trigger Rejection
Healthcare professional reported "seroma" and "capsular contracture baker grade III" against the left side record. The device remains implanted.
Patient problems: Capsular Contracture; Seroma
MAUDE report 50884972 ↗InjurySep 24, 2026Device Appears to Trigger Rejection
healthcare professional reported "capsular contracture baker grade III" against the right side record. The device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50884657 ↗InjurySep 15, 2026Device Appears to Trigger Rejection
Healthcare professional reported "capsular contracture" Baker grade III. This record is for the left side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50774798 ↗InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem
Healthcare professional reported "INCISION AND DRAINAGE HEMATOMA" and "SEROMA, FLUID COLLECTION" against the right side. The device was explanted.
Patient problems: Seroma
MAUDE report 50168703 ↗InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem
Healthcare professional reported "INCISION AND DRAINAGE HEMATOMA" and "SEROMA, FLUID COLLECTION" against the left side. The device was explanted.
Patient problems: Seroma
MAUDE report 50168595 ↗InjuryJul 17, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE 3". THIS RECORD IS FOR LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25855628 ↗InjuryJul 5, 2026Device 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 25712294 ↗InjuryJun 24, 2026Device Appears to Trigger Rejection; Material Rupture
PATIENT REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN", "HARDNESS" AND "HIGHER UP THAN THE OTHER". PATIENT LATER REPORTED "BAKER III" FOR THE CAPSULAR CONTRACTURE. HEALTHCARE PROFESSIONAL REPORTED "BAKER GRADE III CAPSULAR CONTRACTURE" AND "TIGHTER, HIGHER, AND AT TIMES PAINFUL". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25616793 ↗InjuryJun 2, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE¿ BAKER GRADE IV. PATIENT HAS UNDERGONE CAPSULECTOMY. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25364716 ↗InjuryApr 22, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR) MANUFACTURER REGISTRY SPECIFIC DATA REPORT (MRSDR) "CAPSULAR CONTRACTURE BAKER GRADE IV" AND "DEVICE MIGRATION/IMPLANT MALPOSITION". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24956528 ↗InjuryApr 9, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE", LATER HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORDS IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24830720 ↗InjuryApr 9, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE", LATER HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORDS IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24830469 ↗InjuryJan 6, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "WOUND DEHISCENCE, IMPLANT EXTRUSION". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Erosion; Seroma; Wound Dehiscence
MAUDE report 23978332 ↗InjuryJan 6, 2026Device Appears to Trigger Rejection
Healthcare professional reported "seroma".
Patient problems: Erosion; Seroma; Wound Dehiscence
MAUDE report 23977484 ↗InjuryDec 22, 2025Malposition of Device; Migration; Malposition of Device; Migration
HEALTHCARE PROFESSIONAL REPORTED "DEVICE MIGRATION/IMPLANT MALPOSITION, CHANGE SHAPE/SIZE/STYLE". THIS RECORD IS FOR A LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 23864320 ↗InjuryDec 19, 2025Malposition of Device; Migration; Malposition of Device; Migration
HEALTHCARE PROFESSIONAL REPORTED "DEVICE MIGRATION/IMPLANT MALPOSITION, CHANGE SHAPE/SIZE/STYLE". THIS RECORD IS FOR A RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED. RETURN STATUS IS UNKNOWN.
Patient problems: Failure of Implant
MAUDE report 23853594 ↗InjurySep 9, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED ¨RUPTURED¨. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 23000137 ↗InjuryAug 25, 2025Malposition of Device; Malposition of Device
HEALTHCARE PROFESSIONAL REPORTED "SIZE EXCHANGE", "IMPLANT FLIPPING" AND "PAIN". THIS IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 22891368 ↗InjuryAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED "SIZE EXCHANGE", "IMPLANT FLIPPING", "PAIN" AND "ABSCESS". THIS IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Abscess
MAUDE report 22891224 ↗InjuryAug 14, 2025Malposition of Device; Malposition of Device
HEALTHCARE PROFESSIONAL REPORTED "IMPLANT MALPOSITION". THIS RELATES TO THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED. DEVICE DISCARDED. CAPSULOTOMIES PERFORMED.
Patient problems: Failure of Implant
MAUDE report 22812096 ↗InjuryJul 25, 2025Malposition of Device; Malposition of Device
HEALTHCARE PROFESSIONAL REPORTED "SIZE EXCHANGE" AND "IMPLANT FLIPPED, EXCHANGE FOR LARGER SALINE IMPLANT". THIS RECORDS IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 22609322 ↗InjuryJun 26, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 22334072 ↗InjuryJun 26, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE DIAGNOSED. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 22334040 ↗InjuryMay 14, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 22020961 ↗InjuryApr 29, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROVIDER REPORTED A LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. HEALTHCARE PROVIDER NOTED "DAMAGE CAUSED BY EXPLANT" OF "YES-SIDE RUPTURED WHEN REMOVED"(NOT DEVICE RELATED). THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 21930447 ↗
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-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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