Natrelle INSPIRA Breast Implants SRF-745Recalls & reported problems
Allergan, Inc. · NATRELLE INSPIRA Sty SRF-745 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 Natrelle INSPIRA silicone gel breast implant is a round, smooth, full-profile implant made by Allergan. Most of the 60 reports describe the scar tissue around the implant tightening and hardening (capsular contracture), which can make the breast feel firm and painful, and others describe the implant shell breaking (rupture), the body rejecting the implant, or the implant shifting out of position. All 60 reports involve injuries, and no deaths were reported. 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
- 62
- Deaths reported
- 0
- Injuries reported
- 62
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 10888628007413), received between May 15, 2019 and Sep 17, 2026 — classified as 62 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
- Patient-Device Incompatibility16
- Material Rupture15
- Malposition of Device1
- Migration1
Patient problems
- Capsular Contracture46
- Failure of Implant12
- No Clinical Signs, Symptoms or Conditions3
- Foreign Body Reaction1
- Pocket Erosion1
- Unspecified Infection1
Recent adverse event reports
The 25 most recent of 62 reports, in the reporter's own words as published by the FDA.
InjurySep 17, 2026Device Appears to Trigger Rejection
Patient reported "capsular contracture Baker grade unknown". This record is for the right side. The device remains implanted. Patient received massages as treatment.
Patient problems: Capsular Contracture
MAUDE report 50805263 ↗InjurySep 11, 2026Device Appears to Trigger Rejection; Material Rupture
Patient problems: Capsular Contracture
MAUDE report 50744628 ↗InjuryAug 20, 2026Material Rupture
Patient reported: "rupture". This record is for the right-side device. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50347376 ↗InjuryJun 22, 2026Material Rupture
This record is currently for the right side.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25575372 ↗InjuryJun 9, 2026Malposition of Device; Migration
HEALTHCARE PROFESSIONAL REPORTED VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR) MANUFACTURER REGISTRY SPECIFIC DATA REPORT (MRSDR) "DEVICE MIGRATION/IMPLANT MALPOSITION". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25448379 ↗InjuryAug 22, 2025Material Rupture; Material Rupture
THE DEVICE WAS EXPLANTED AND REPLACED WITH NON-ABBVIE DEVICE.
Patient problems: Failure of Implant
MAUDE report 22871735 ↗InjuryJul 16, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE". LATER HEALTHCARE PROFESSIONAL REPORTED "NOT CONFIRMED CAPSULAR CONTRACTURE". LATER HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22520975 ↗InjuryJul 16, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL INITIALLY REPORTED "CAPSULAR CONTRACTURE". LATER, HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE II" AND THEN REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE 3". AFFECTED SIDE IS LEFT. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22519945 ↗InjuryOct 19, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED. THIS RELATES TO THE RIGHT SIDE.
Patient problems: Capsular Contracture
MAUDE report 17969761 ↗InjurySep 13, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "RUPTURE, AND MIGRATION" VIA NBIR. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 17741391 ↗InjuryJun 1, 2023Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL AND PATIENT REPORTED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN AND RUPTURE. DEVICE REMAINS IMPLANTED. THIS RELATES TO THE RIGHT SIDE.
Patient problems: Capsular Contracture
MAUDE report 17040716 ↗InjuryMay 19, 2023Material Rupture; Material Rupture
PATIENT REPORTED RIGHT SIDE "FLAT AREA/GAP, OPEN SPOT". HEALTHCARE PROFESSIONAL REPORTED RIGHT RUPTURE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 16968245 ↗InjuryApr 13, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
InjuryMar 27, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE REMAINS IMPLANTED. THIS RELATES TO THE RIGHT SIDE.
Patient problems: Capsular Contracture
MAUDE report 16620018 ↗InjuryMar 27, 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 16619907 ↗InjuryMar 10, 2023Device 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 16526599 ↗InjuryJan 10, 2023Material Rupture; Material Rupture
PATIENT REPORTED "A POSSIBLE RIGHT SIDE RUPTURE". DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 16132897 ↗InjuryDec 26, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE PAIN. HEALTHCARE PROFESSIONAL LATER REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 16048682 ↗InjuryDec 26, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE PAIN. HEALTHCARE PROFESSIONAL LATER REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 16048666 ↗InjuryNov 9, 2022Device 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 15764932 ↗InjuryOct 27, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15680440 ↗InjuryAug 8, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE ¿CAPSULAR CONTRACTURE¿, BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15189187 ↗InjuryMay 20, 2022Device Appears to Trigger Rejection; Patient-Device Incompatibility; Device Appears to Trigger Rejection; Patient-Device Incompatibility
COMPANY REPRESENTATIVE REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture; Foreign Body Reaction
MAUDE report 14459749 ↗InjuryMay 20, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV AND PAIN." DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 14459119 ↗InjuryMar 1, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN" AND "HARDNESS/DENTED" AGAINST LEFT DEVICE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 13637878 ↗
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
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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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