Natrelle INSPIRA Breast Implants SRF-345Recalls & reported problems
Allergan, Inc. · NATRELLE INSPIRA Sty SRF-345 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 is a silicone gel-filled breast implant. Its 378 reports mostly describe the body reacting against the implant, most often with hardening of the scar tissue around it, and some describe ruptures. The reports include 376 injuries and 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
- 384
- Deaths reported
- 0
- Injuries reported
- 382
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 384 adverse event reports that list this exact device (DI 10888628007307), received between May 14, 2019 and Sep 30, 2026 — classified as 382 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (239 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 Rejection239
- Patient-Device Incompatibility91
- Material Rupture51
- Adverse Event Without Identified Device or Use Problem8
- Deformation Due to Compressive Stress2
- No Apparent Adverse Event2
- Break1
- Device Handling Problem1
Patient problems
- Capsular Contracture325
- Failure of Implant37
- No Clinical Signs, Symptoms or Conditions10
- Unspecified Infection8
- Foreign Body Reaction3
- Wound Dehiscence3
- Fluid Discharge2
- Foreign Body Sensation in Eye2
Recent adverse event reports
The 25 most recent of 384 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture
MAUDE report 50950022 ↗InjurySep 30, 2026Material Rupture
Healthcare professional reported "possible rupture". This record is for the left side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947443 ↗InjurySep 28, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Capsular Contracture, Baker grade III". This record is for the right side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50918220 ↗InjurySep 25, 2026Device Appears to Trigger Rejection
Patient reported "Capsular Contracture Baker Grade unknown" and "pain". This record is for unknown side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50896299 ↗InjurySep 24, 2026Device Appears to Trigger Rejection
Patient reported "Capsular Contracture Baker Grade unknown" and "pain". This record is for unknown side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50883675 ↗InjurySep 18, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50831612 ↗InjurySep 18, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Capsular contracture Baker grade III". This record is for the right side. The device was explanted. Patient received capsulectomy as treatment.
Patient problems: Capsular Contracture
MAUDE report 50820423 ↗InjurySep 8, 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 50671216 ↗InjuryAug 24, 2026Device Appears to Trigger Rejection
Patient reported "capsular contracture Baker grade III and burning". Later healthcare professional reported "capsular contracture, Baker grade III, burning and exchange". This record is for the left side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50422021 ↗InjuryJul 27, 2026Material Rupture
Healthcare professional reported "Rupture" and "looked different". Healthcare professional later reported "Large defect on posterior implant capsule". This record is for the right side. Device was explanted.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50047754 ↗InjuryJul 27, 2026Device Appears to Trigger Rejection
Patient reported Capsular Contracture Baker Grade III. This record is for the right side. The device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50016949 ↗InjuryJul 27, 2026Device Appears to Trigger Rejection
Patient reported Capsular Contracture Baker Grade III. This record is for the left side. The device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50016925 ↗InjuryJul 17, 2026Device Appears to Trigger Rejection
Healthcare professional reported no complaint against the device. Healthcare professional later reported "capsular contracture Baker grade III". Capsulotomy was performed. This record is for the left side. The device was explanted.
Patient problems: Capsular Contracture
MAUDE report 25860905 ↗InjuryJul 17, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". CAPSULOTOMY WAS PERFORMED. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25856772 ↗InjuryJul 13, 2026Material Rupture
Healthcare professional reported "Rupture", "Capsular Contracture Baker grade Unknown" and "Seroma". Healthcare professional then reported there was no Capsular Contracture. Later healthcare professional reported "audible pop discomfort" and "subsequent swelling". Patient received Aspiration to treat the Seroma. This record is for the right side. Device was explanted.
Patient problems: Seroma
MAUDE report 25803881 ↗InjuryJul 6, 2026Device Appears to Trigger Rejection; No Apparent Adverse Event
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE IV. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions
MAUDE report 25726073 ↗InjuryJul 6, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" AGAINST THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25725279 ↗InjuryJun 22, 2026Device Appears to Trigger Rejection
PATIENT REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN WAS VERY HARD". LATER PATIENT REPORTED "BAKER II". MONTELUKAST HAS BEEN PRESCRIBED. LATER HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25581179 ↗InjuryJun 20, 2026Material Rupture
PATIENT REPORTED "LEAK" AND "HAVE A LUMP". LATER HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25570254 ↗InjuryJun 5, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "EXCHANGE WITH NO COMPLAINTS TOWARDS THE DEVICE". HEALTHCARE PROFESSIONAL LATER REPORTED "CAPSULAR CONTRACTURE". BAKER GRADE WAS NOT PROVIDED. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25409417 ↗InjuryJun 1, 2026Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE/DEFLATION¿. THIS RECORD IS FOR AN UNKNOWN SIDE. DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25356385 ↗InjuryApr 28, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE¿ BAKER GRADE III. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25019599 ↗InjuryApr 20, 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". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24927573 ↗InjuryApr 8, 2026Device Appears to Trigger Rejection
PATIENT REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN" AND "STARTING GETTING HIGHER AND HARDER". HEALTHCARE PROFESSIONAL ALTER REPORTED CAPSULAR CONTRACTURE, BAKER GRADE IV. THIS RECORD IS FOR RIGHT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24821907 ↗InjuryMar 30, 2026Migration
HEALTHCARE PROFESSIONAL REPORTED "CAPSULORRHAPHY". LATER THE HEALTHCARE PROFESSIONAL REPORTED "PREVIOUS SURGEON ERROR, MISPLACING IMPLANT ON CHEST ALLOWING TO BOTTOM OUT". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24715837 ↗
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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