Natrelle Inspira Cohesive Breast Implants SCX-525Recalls & reported problems
Allergan, Inc. · Natrelle Inspira SCX 525cc 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 breast implant (SCX-525) is a soft, round, extra-full-profile implant used in breast reconstruction or augmentation. The 33 reports mostly describe the scar tissue around the implant tightening and hardening (capsular contracture), so breasts can feel firm, look misshapen, and sometimes need to be removed and replaced; a few mention infection or the implant breaking. All 33 reports describe injuries, with no deaths. 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
- 34
- Deaths reported
- 0
- Injuries reported
- 34
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10888628030343), received between Jan 22, 2020 and Sep 21, 2026 — classified as 34 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (20 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 Rejection20
- Patient-Device Incompatibility8
- Material Rupture5
- Adverse Event Without Identified Device or Use Problem3
Patient problems
- Capsular Contracture26
- Failure of Implant5
- Unspecified Infection5
- Abscess1
- Foreign Body Reaction1
- Impaired Healing1
- Pocket Erosion1
Recent adverse event reports
The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.
InjurySep 21, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture
MAUDE report 50846678 ↗InjuryAug 24, 2026Device Appears to Trigger Rejection
Healthcare professional reported "capsular contracture Baker grade IV". This record is for the left side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50416915 ↗InjuryAug 17, 2026Device Appears to Trigger Rejection
Healthcare professional reported ¿Capsular Contracture Baker grade III/IV¿. This record is for the right side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50274220 ↗InjuryMay 19, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV" AND "EXPLANTED AND REPLACED BY THE EXACT SAME IMPLANT". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22043814 ↗InjurySep 21, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED, A UNILATERAL RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17795436 ↗InjuryAug 11, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
InjuryJul 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED UNKNOWN SIDE "INFECTION","CENTRAL LINE AND MONTHS OF ANTIBIOTICS", "PSEUDOMONAS A AND E-COLI". DEVICE STATUS IS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 17328896 ↗InjuryJul 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED UNKNOWN SIDE "INFECTION", "CENTRAL LINE AND MONTHS OF ANTIBIOTICS", AND "PSEUDOMONAS A AND E-COLI". DEVICE STATUS IS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 17299275 ↗InjuryJul 3, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III/IV. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 17249547 ↗InjuryMay 25, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 17005515 ↗InjuryNov 11, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15781314 ↗InjuryAug 5, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III/IV. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15180118 ↗InjuryJun 23, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III" AGAINST LEFT DEVICE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 14793999 ↗InjuryJun 2, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED LEFT SIDE "MY HEALTH DECLINED TO THE POINT I WAS GETTING 2-3 MIGRAINES A WEEK", "MAJOR GI ISSUES, BRAIN FOG" "MY HAIR WAS FALLING OUT", "EXTREME FATIGUE", "I DID HAVE CAPSULAR CONTRACTURE AROUND BOTH MY IMPLANTS". DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 14575956 ↗InjuryJun 1, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED: ¿MIGRAINES¿ ¿MAJOR GI ISSUES¿, ¿BRAIN FOG¿, ¿HAIR WAS FALLING OUT¿ (NDR) "EXTREME FATIGUE¿ (NDR) ¿CAPSULAR CONTRACTURE AROUND BOTH MY IMPLANTS¿ BAKER GRADE UNKNOWN THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 14570087 ↗InjuryMay 10, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTION BAKER GRADE III/IV " AGAINST RIGHT DEVICE. THE DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 14350598 ↗InjuryMar 17, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED VIA DEVICE TRACKING FORM "CAPSULAR CONTRACTURE" BAKER GRADE NOT SPECIFIED AGAINST LEFT DEVICE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 13791881 ↗InjuryFeb 4, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED VIA NBIR LEFT SIDE "CAPSULAR CONTRACTURE BAKER GRADE III". THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 13453218 ↗InjuryNov 2, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN AND ANXIETY ABOUT THE PRODUCT. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 12738464 ↗InjuryJul 15, 2021Device 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 12174180 ↗InjuryJun 16, 2021Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 12008532 ↗InjuryMar 31, 2021Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 11594501 ↗InjuryMar 12, 2021Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE EXPOSURE AND INFECTION. DEVICE HAS BEEN EXPLANTED.
Patient problems: Foreign Body Reaction; Unspecified Infection
MAUDE report 11476357 ↗InjuryFeb 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE REMOVAL WAS NOTED AS "NON-HEALING WOUNDS". THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Impaired Healing
MAUDE report 11262264 ↗InjuryOct 16, 2020Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "ROTATED", "VISIBLE RIPPLING", AND "GEL STUCK IN THIS ODD SHAPE BELIEVED TO BE A FRACTURE". DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 10690579 ↗
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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