Natrelle INSPIRA Breast Implants SRX-470Recalls & reported problems

Summary

The FDA's MAUDE database contains 159 adverse event reports that list this exact device (DI 10888628007536), received between May 21, 2019 and Sep 30, 2026 — classified as 154 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (92 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 159 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Device Appears to Trigger Rejection

  Patient reported "Pain" and "sort of burning sensation". Later patient reported Capsular Contracture Baker Grade III/IV against the left side record. The device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50949615 ↗
• InjurySep 8, 2026Device Appears to Trigger Rejection; Material Rupture; Migration

  Patient reported "implant capsulated", "caving in". This record is for the left side. Device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50669989 ↗
• InjuryAug 4, 2026Device Appears to Trigger Rejection

  Healthcare professional reported of the right side device: Baker grade IV capsular contracture. The device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50135969 ↗
• InjuryJul 27, 2026Device Appears to Trigger Rejection; Material Rupture

  Healthcare Professional reported "rupture". This record is for the right side. Device remains implanted.

  Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50025384 ↗
• InjuryJun 15, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "capsular contracture, Baker grade IV". This record is for the left side. Device has been explanted.

  Patient problems: Capsular Contracture

  MAUDE report 25509272 ↗
• InjuryMar 31, 2026Device Appears to Trigger Rejection

  PATIENT REPORTED "ENCAPSULATED A LOT". LATER HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24742928 ↗
• InjuryMar 9, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". ACCOLATE WAS PROVIDED AS TREATMENT. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24553864 ↗
• MalfunctionMar 2, 2026Contamination

  HEALTHCARE PROFESSIONAL REPORTED "WHEN OPENING THE PACKAGING FOR THE NATRELLE IMPLANT THAT THE PAPER RIPPED AND CAUSE SOME PARTICLES TO FALL INTO THE STERILE ENVIRONMENT". DEVICE WAS NOT IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24484588 ↗
• InjuryDec 16, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "IMPLANT RUPTURED AS IT WAS BEING INSERTED". THIS RECORD IS FOR UNKNOWN SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 23815216 ↗
• InjurySep 12, 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 WAS EXPLANTED. DEVICE WAS RETURNED.

  Patient problems: Capsular Contracture

  MAUDE report 23037872 ↗
• InjurySep 11, 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. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23033619 ↗
• InjurySep 9, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE III. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23000065 ↗
• InjuryJul 30, 2025Fluid/Blood Leak; Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED DEFLATION ON LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 22666465 ↗
• InjuryJul 16, 2025Device Appears to Trigger Rejection; Device 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 22523986 ↗
• InjuryJul 10, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22471901 ↗
• InjuryJun 17, 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. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22235043 ↗
• InjuryJun 5, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "GEL FRACTURE". HOLE OBSERVED DURING SURGERY. DEVICE WAS EXPLANTED. CAPSULECTOMY PERFORMED.

  Patient problems: Failure of Implant

  MAUDE report 22155333 ↗
• InjuryJun 2, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED "CONTRACTURE BAKER III". LATER, HEALTHCARE PROFESSIONAL CONFIRMED "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE LEFT SIDE. TREATMENT REPORTED AS SINGULAIR. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22128390 ↗
• InjuryMay 13, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RUPTURE. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 22015179 ↗
• InjuryApr 21, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "CAPSULAR CONTRACTURE BAKER GRADE IV". DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 21877828 ↗
• InjuryJan 18, 2025Material Rupture; Migration; Material Rupture; Migration

  PATIENT REPORTED "FLAT, CHUNKY, LEAKING, HURTING, UNABLE TO GRIP, MOVED". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 21186793 ↗
• InjuryNov 27, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV AND PAIN. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 18210700 ↗
• InjuryOct 17, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED, LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 17954261 ↗
• InjuryOct 16, 2023Material Rupture; Material Rupture

  PATIENT REPORTED LEFT SIDE "POSSIBLE RUPTURE" AND "RASHES ON HANDS ALMOST LIKE A FUNGUS, BRAIN FOG, SWEAT PROFUSELY, ARTHRITIS IN HANDS, FEET AND ELBOWS, WEIGHT LOSS AND HAIR LOSS, FEELS LIKE THEY ARE INFECTED, HOWEVER THE PATIENT SAID THERE IS NO SIGN OF INFECTION DESPITE THE ODOR COMING FROM ARMS AND BETWEEN THE BREAST." THE EVENT OF ARTHRITIS IN HANDS, FEET AND ELBOWS IS NOT DEVICE RELATED. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 17939690 ↗
• InjuryOct 13, 2023Material Rupture; Material Rupture

  PATIENT REPORTED A LEFT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 17936203 ↗

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 · Terminated
  Natrelle 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 · Terminated
  Natrelle 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, Classified
  Natrelle 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, Classified
  Natrelle 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