Natrelle INSPIRA Breast Implants SRF-485Recalls & reported problems
Allergan, Inc. · NATRELLE INSPIRA Sty SRF-485 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 Allergan Natrelle INSPIRA breast implant is a silicone gel-filled implant placed in the breast. Most of its 468 reports mention hardening of the scar tissue around the implant, with others describing the body reacting against it and the implant rupturing. The reports include 466 injuries and no deaths, and reports in the last 12 months fell to 22 from 44 before. 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
- 475
- Deaths reported
- 0
- Injuries reported
- 473
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 475 adverse event reports that list this exact device (DI 10888628007352), received between May 10, 2019 and Sep 28, 2026 — classified as 473 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (303 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 Rejection303
- Patient-Device Incompatibility114
- Material Rupture63
- Adverse Event Without Identified Device or Use Problem14
- Break2
- No Apparent Adverse Event2
- Device Handling Problem1
- Improper or Incorrect Procedure or Method1
Patient problems
- Capsular Contracture410
- Failure of Implant45
- Unspecified Infection11
- No Clinical Signs, Symptoms or Conditions7
- Seroma5
- Foreign Body Reaction3
- Foreign Body Sensation in Eye3
- Impaired Healing3
Recent adverse event reports
The 25 most recent of 475 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923226 ↗InjurySep 23, 2026Device Appears to Trigger Rejection
Healthcare professional reported "capsular contracture, Baker grade IV". This record is for the right side. The device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50872774 ↗InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Ischemia
MAUDE report 50848359 ↗InjurySep 17, 2026Device Appears to Trigger Rejection
Patient reported "Capsular Contracture Baker Grade III". This record is for the left side. Device remains implanted. Patient received Zafirlukast as treatment.
Patient problems: Capsular Contracture
MAUDE report 50800141 ↗InjurySep 16, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture
MAUDE report 50796490 ↗InjurySep 9, 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 50697716 ↗InjurySep 6, 2026Material Rupture; Malposition of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50641378 ↗InjurySep 1, 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 50546840 ↗InjurySep 1, 2026Device Appears to Trigger Rejection
Later healthcare professional reported "pain". Device has been explanted and replaced.
Patient problems: Capsular Contracture; Seroma
MAUDE report 50541772 ↗InjuryAug 26, 2026Device Appears to Trigger Rejection
Healthcare professional reported "capsular contracture, Baker IV with pain". Healthcare professional later reported "Seroma". This record is for the left side. The device was explanted.
Patient problems: Capsular Contracture; Seroma
MAUDE report 50454973 ↗InjuryAug 17, 2026Material Rupture
Healthcare professional reported "pain" and "rupture". Later Healthcare professional reported "Asymmetry", "found to be intact" and "hole, non specific". This record is for the right side. The device was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50275547 ↗InjuryJul 8, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED ¿CAPSULAR CONTRACTURE BAKER GRADE IV¿. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25748315 ↗InjuryJun 24, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". HEALTHCARE PROFESSIONAL LATER REPORTED "HOLE, NON-SPECIFIC." THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25616692 ↗InjuryJun 11, 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 25470533 ↗InjuryJun 1, 2026Material Rupture
PATIENT REPORTED "RUPTURE". LATER HEALTHCARE PROFESSIONAL REPORTED "SUSPECTED RUPTURE DUE TO PAIN, DISCOMFORT, AND A FEELING OF SLIGHT LEAKING" AND RIPPLING IN HER CHEST AFTER A PHYSICAL ALTERCATION AND A LOSS OF VOLUME IN ONE IMPLANT. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 25351952 ↗InjuryMay 14, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED VIA THE NATIONAL BREAST IMPLANT REGISTRY (NBIR) MANUFACTURER REGISTRY SPECIFIC DATA REPORT (MRSDR) "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25167054 ↗InjuryMay 14, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED VIA THE NATIONAL BREAST IMPLANT REGISTRY (NBIR) MANUFACTURER REGISTRY SPECIFIC DATA REPORT (MRSDR) "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25167037 ↗InjuryApr 22, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24958209 ↗InjuryMar 9, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24543258 ↗InjuryJan 21, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED NO COMPLAINT AGAINST THE DEVICE. LATER HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE III AND ¿PAIN AND TIGHTNESS¿. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24136150 ↗InjuryJan 12, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR LEFT SIDE. THE DEVICE WAS EXPLANTED. DEVICE WILL BE RETURNED.
Patient problems: Capsular Contracture
MAUDE report 24044721 ↗InjuryJan 12, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR RIGHT SIDE. THE DEVICE WAS EXPLANTED. DEVICE WILL BE RETURNED.
Patient problems: Capsular Contracture
MAUDE report 24044580 ↗InjuryJan 8, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED. DEVICE WILL BE RETURNED.
Patient problems: Capsular Contracture
MAUDE report 24007033 ↗InjuryDec 26, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED. PATIENT RECEIVED SINGULAIR AND ACCOLATE AS TREATMENT.
Patient problems: Capsular Contracture
MAUDE report 23899350 ↗InjuryNov 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III" VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR). THIS RECORD IS FOR LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED. IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED.
Patient problems: Capsular Contracture
MAUDE report 23588622 ↗
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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- MENTOR MemoryGel Breast Implant 3503504BCMentor Texas L.P. · Prosthesis, breast, noninflatable, internal, silicone gel-filled1,749 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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