Natrelle INSPIRA Breast Implants SRF-770Recalls & reported problems
Allergan, Inc. · NATRELLE INSPIRA Sty SRF-770 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 smooth, round, full-profile implant made by Allergan. Most of the 70 reports describe the scar tissue around the implant tightening and hardening (capsular contracture), or the implant shell breaking and gel leaking out, with a few mentioning the implant shifting position. All 70 reports describe injuries, and no deaths were reported. There are no recalls naming 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
- 72
- Deaths reported
- 0
- Injuries reported
- 72
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 10888628007420), received between Jun 6, 2019 and Sep 17, 2026 — classified as 72 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (38 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 Rejection38
- Material Rupture21
- Patient-Device Incompatibility10
- Adverse Event Without Identified Device or Use Problem5
- Migration3
- Malposition of Device2
Patient problems
- Capsular Contracture47
- Failure of Implant19
- Fluid Discharge2
- Unspecified Infection2
- Impaired Healing1
- No Clinical Signs, Symptoms or Conditions1
- Seroma1
- Swollen Lymph Nodes1
Recent adverse event reports
The 25 most recent of 72 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 left side. The device remains implanted. Patient received massages as treatment.
Patient problems: Capsular Contracture
MAUDE report 50805350 ↗InjurySep 11, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50740311 ↗InjuryJul 1, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25684575 ↗InjuryMar 2, 2026Malposition of Device; Migration
HEALTHCARE PROFESSIONAL REPORTED OF THE LEFT SIDE DEVICE: "DEVICE MIGRATION/IMPLANT MALPOSITION, CHANGE SHAPE/SIZE/STYLE". THE DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24490161 ↗InjuryMar 2, 2026Malposition of Device; Migration
HEALTHCARE PROFESSIONAL REPORTED OF THE RIGHT SIDE DEVICE: "DEVICE MIGRATION/IMPLANT MALPOSITION, CHANGE SHAPE/SIZE/STYLE". THE DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 24490087 ↗InjurySep 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 23091257 ↗InjuryMay 29, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "NO COMPLAINT AGAINST THE DEVICE". PATIENT LATER REPORTED "RUPTURED" DIAGNOSED VIA MRI. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22110964 ↗InjuryApr 23, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER IV". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 21890833 ↗InjuryApr 22, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 21885248 ↗InjuryNov 27, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL CALLED TO REPORT A LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 18210032 ↗InjuryNov 17, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED VIA DEVICE TRACKING INFORMATION THAT THE REASON FOR THE RIGHT SIDE REMOVAL NOTED AS ¿RUPTURE¿. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 18163686 ↗InjuryOct 20, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 17980168 ↗InjuryOct 12, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17925932 ↗InjuryOct 3, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17865300 ↗InjurySep 1, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17670828 ↗InjuryAug 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "POOR HEALING". DEVICE HAS BEEN EXPLANTED AND DISCARDED.
Patient problems: Impaired Healing
MAUDE report 17646516 ↗InjuryAug 1, 2023Material Rupture; Material Rupture
PATIENT REPORTED LEFT SIDE LUMP, INDENTATION, BILATERAL RUPTURES, HARDNESS AND POSSIBLE EXCHANGE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 17436525 ↗InjuryAug 1, 2023Material Rupture; Material Rupture
PATIENT REPORTED RIGHT SIDE INDENTATION, RUPTURE, HARDNESS AND POSSIBLE EXCHANGE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 17435004 ↗InjuryJul 5, 2023Material Rupture; Migration; Material Rupture; Migration
HEALTHCARE PROFESSIONAL REPORTED POSSIBLE RUPTURE. DEVICE HAS BEEN EXPLANTED AND REPLACED. THIS RECORD RELATES TO THE LEFT SIDE.
Patient problems: Failure of Implant
MAUDE report 17259747 ↗InjuryJul 5, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. THE DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 17257027 ↗InjuryJun 13, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 17121303 ↗InjuryFeb 17, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 16400652 ↗InjuryFeb 15, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 16382962 ↗InjuryDec 9, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED RIGHT SIDE "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN" AND "RIGHT SIDE IS DISFIGURED THE MOST, AND GET SUPER COLD TO THE TOUCH." PATIENT LATER REPORTED BAKER GRADE IV. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15954965 ↗InjuryDec 9, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED A CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE REMAINS IMPLANTED. THIS RELATES TO THE LEFT SIDE.
Patient problems: Capsular Contracture
MAUDE report 15950342 ↗
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-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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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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