Natrelle INSPIRA Breast Implants SRX-525Recalls & reported problems

Summary

The FDA's MAUDE database contains 133 adverse event reports that list this exact device (DI 10888628007550), received between May 9, 2019 and Sep 29, 2026 — classified as 132 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (68 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 133 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Material Rupture

  Healthcare professional reported ¿rupture¿. This record is for the left side. Device remains implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50930064 ↗
• InjurySep 16, 2026Device Appears to Trigger Rejection; Material Rupture

  Healthcare Professional reported "exchange with no complaint against the device". Later healthcare professional reported "ruptured" and "caps con". This record is for the left side. Device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50792158 ↗
• InjuryJul 6, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 25718141 ↗
• InjuryJun 5, 2026Device Appears to Trigger Rejection

  Healthcare professional reported a Capsular Contracture, Baker Grade III. This record is for the right side. The device was explanted. Singular was prescribed.

  Patient problems: Capsular Contracture

  MAUDE report 25415370 ↗
• InjuryMar 2, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III/IV". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24484458 ↗
• InjuryDec 11, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND IT IS UNKNOWN IF IT WAS REPLACED. DEVICE WILL BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 23778670 ↗
• InjurySep 23, 2025Material Rupture; Material Rupture

  PATIENT REPORTED RIGHT SIDE RUPTURE. HEALTHCARE PROFESSIONAL CONFIRMED RIGHT SIDE RUPTURE VIA MAMMOGRAM AND MRI. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 23129532 ↗
• InjurySep 11, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23027070 ↗
• InjurySep 8, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22994398 ↗
• InjuryJul 2, 2025Device 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 22381920 ↗
• InjuryJun 12, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE II/III. HEALTHCARE PROFESSIONAL LATER REPORTED POSSIBLE RUPTURE AND A CAPSULAR CONTRACTURE BAKER GRADE III. AND LATER "CAPSULAR CONTRACTURE BAKER GRADE II/III" AND "THERE IS NO CONFIRMED RUPTURE". LATER HEALTHCARE PROFESSIONAL REPORTED "HOLE, NON-SPECIFIC" AND "RUPTURED". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22195912 ↗
• InjuryJun 11, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN." THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22181719 ↗
• InjuryJun 5, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 22149383 ↗
• InjuryJun 4, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURES BAKER GRADE IV". THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22145189 ↗
• InjuryMay 28, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22102232 ↗
• InjuryMay 8, 2025Material Rupture; Material Rupture

  PATIENT REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 21989296 ↗
• InjuryMay 7, 2025Material Rupture; Material Rupture

  PATIENT REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 21979509 ↗
• InjuryMay 2, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 21950348 ↗
• InjuryApr 9, 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 21810359 ↗
• InjuryDec 19, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE IMPLANT EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE. HEALTHCARE PROFESSIONAL LATER REPORTED CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 20978503 ↗
• InjuryNov 26, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE VIA NBIR CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 20780410 ↗
• InjuryNov 21, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE VIA NBIR CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 20751072 ↗
• InjuryNov 29, 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 18230477 ↗
• InjuryNov 29, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE II. HEALTHCARE PROFESSIONAL LATER REPORTED BAKER GRADE III. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 18228326 ↗
• InjuryOct 20, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "ALLERGAN/SILICONE TACT". HEALTHCARE PROFESSIONAL LATER REPORTED "GRADE 3 CAPSULAR CONTRACTURE WITH FULL CAPSULECTOMY". THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 17980582 ↗

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-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
• 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-