Natrelle INSPIRA Breast Implants SRF-695Recalls & reported problems
Allergan, Inc. · NATRELLE INSPIRA Sty SRF-695 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 full-profile silicone gel breast implant. The FDA records hold 97 reports, with no deaths and 94 injuries; many describe capsular contracture, where scar tissue tightens around the implant, and some describe ruptures, swelling or pain. 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
- 97
- Deaths reported
- 0
- Injuries reported
- 94
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 97 adverse event reports that list this exact device (DI 10888628007406), received between Dec 21, 2017 and Sep 25, 2026 — classified as 94 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (54 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 Rejection54
- Material Rupture23
- Patient-Device Incompatibility15
- Adverse Event Without Identified Device or Use Problem4
- Device Handling Problem2
- Fluid/Blood Leak2
- No Apparent Adverse Event2
- Break1
Patient problems
- Capsular Contracture67
- Failure of Implant20
- No Clinical Signs, Symptoms or Conditions4
- Unspecified Infection4
- Impaired Healing3
- Hematoma2
- Breast Mass1
- Fluid Discharge1
Recent adverse event reports
The 25 most recent of 97 reports, in the reporter's own words as published by the FDA.
InjurySep 25, 2026Material Rupture
Healthcare professional reported "Rupture". This record is for the right side. The device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896621 ↗InjurySep 11, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Capsular contracture Baker grade III/IV". Patient was prescribed Singulair, Prednisone and Minocycline. This record is for the right side. Device was explanted.
Patient problems: Capsular Contracture
MAUDE report 50736294 ↗InjurySep 11, 2026Material Rupture
Healthcare professional reported "rupture". This record is for the right side. Device remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50734096 ↗InjuryJul 28, 2026Device Appears to Trigger Rejection
Patient reported "capsular contracture, Baker grade III/IV". This record is for the left side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50053638 ↗InjuryMay 1, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Capsular Contracture Baker grade IV". This record is for the right side. The device has been explanted.
Patient problems: Capsular Contracture
MAUDE report 25057933 ↗InjuryFeb 5, 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 24271149 ↗InjuryJan 30, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE IV". PATIENT WAS PRESCRIBED SINGULAIR. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 24226000 ↗InjuryOct 15, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE". LATER HEALTHCARE PROFESSIONAL REPORTED THERE WAS NO CAPSULAR CONTRACTURE FOR THIS SIDE. LATER, PATIENT REPORTED "THEY ARE A BREAST CANCER PATIENT". LATER, PATIENT'S LEGAL REPRESENTATIVE REPORTED "CAPSULAR CONTRACTURE", "HARDENING" (NDR), "UNCOMFORTABLE FEELING" (NDR), "TIREDNESS, IRRITABILITY, FATIGUE" (NDR), "INADEQUACY AS A WOMAN" (NDR), "HEADACHES" (NDR), "DEPRESSION" (NDR) AND "JOINT PAIN" (NDR). THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 23305155 ↗InjurySep 9, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
InjurySep 2, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CONTRACTURE BAKER GRADE IV". LATER HEALTHCARE PROFESSIONAL REPORTED "R BREAST FLUID". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED. DEVICE WAS RETURNED.
Patient problems: Capsular Contracture
MAUDE report 22935359 ↗InjuryAug 21, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 22865156 ↗InjuryAug 19, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
PATIENT REPORTED "RUPTURE". LATER HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE LLL". THIS IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture; Failure of Implant
MAUDE report 22842291 ↗InjuryJun 13, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE, "DEVICE LOOKED CLOUDY," AND CAPSULAR CONTRACTURE, BAKER GRADE IV. PATIENT ADDITIONALLY REPORTED BREAST CANCER NOT RELATED TO THE DEVICE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22207400 ↗InjuryJun 4, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22147130 ↗InjuryMay 9, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE IV. RECORD IS FOR RIGHT SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED. CAPSULECTOMY PERFORMED. PHYSICIAN REPORTED RIGHT CONTRACTURE HAS NOT IMPROVED WITH CONSERVATIVE THERAPY.
Patient problems: Capsular Contracture
MAUDE report 21996828 ↗InjuryMay 7, 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. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 21979888 ↗InjuryMay 6, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 21966248 ↗InjuryApr 20, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 21870322 ↗InjuryApr 17, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
InjuryDec 2, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED, A LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. CORRECTION OF ASYMMETRY. DEVICE STATUS UNKNOWN.
Patient problems: Capsular Contracture
MAUDE report 20819553 ↗InjuryNov 6, 2023Material Rupture; Material Rupture
PATIENT REPORTED, LEFT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 18080663 ↗InjuryNov 6, 2023Material Rupture; Material Rupture
PATIENT REPORTED, RIGHT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 18080623 ↗InjuryNov 5, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED, LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 18070774 ↗InjuryOct 31, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 18041105 ↗InjuryOct 25, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. HEALTHCARE PROFESSIONAL LATER REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV." DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 18003065 ↗
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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