Natrelle INSPIRA Breast Implants SRM-520Recalls & reported problems

Summary

The FDA's MAUDE database contains 220 adverse event reports that list this exact device (DI 10888628007161), received between May 17, 2019 and Sep 22, 2026 — classified as 220 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (133 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 220 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "Capsular Contracture, Baker grade unknown". Patient underwent Capsulectomy/Capsulotomy. This record is for the right side. Device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50852762 ↗
• InjurySep 17, 2026Device Appears to Trigger Rejection; Material Rupture

  Healthcare professional reported "Capsular contracture, Baker grade III" and "Rupture". This record is for the right side. Device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50805540 ↗
• InjurySep 8, 2026Material Rupture

  Healthcare professional reported "rupture" and "pain". Later reported the inner silicone gel touched the patient. Then reported "pericapsular fluid", "extracapsular extravasation" and "complicated cyst" which is not device related. This record is for the left side. Device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50677944 ↗
• InjurySep 8, 2026Material Rupture

  Healthcare professional reported "rupture" and "pain". Later, reported "hole, non-specific" This record is for the right side. Device has been explanted and replaced.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50674125 ↗
• InjurySep 8, 2026Material Rupture

  Healthcare professional reported ¿Findings are possible intracapsular implant rupture¿, ¿snowstorm-type appearance¿ and ¿material/fluid-like appearance noted between the implant shell and fibrous capsule¿. Later healthcare professional reported ¿no complaint against the device¿. This record is for the left side. Device remains implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50673780 ↗
• InjurySep 8, 2026Material Rupture

  Healthcare professional reported ¿breast implant intact¿. Later healthcare professional reported ¿Rupture¿. This record is for the right side. Device remains implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50670091 ↗
• InjurySep 8, 2026Device Appears to Trigger Rejection

  Healthcare professional reported a "capsular contracture, Baker grade III/IV". This record is for the left side. The device remains implanted. Singulair was prescribed.

  Patient problems: Capsular Contracture

  MAUDE report 50669430 ↗
• InjurySep 4, 2026Device Appears to Trigger Rejection; Material Rupture

  Patient problems: Capsular Contracture

  MAUDE report 50622935 ↗
• InjurySep 4, 2026Material Rupture; No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50620359 ↗
• InjuryAug 28, 2026Material Rupture

  Company representative, on behalf of healthcare professional, reported: "rupture". This record is for the right-side device. Device has been explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50505377 ↗
• InjuryAug 14, 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 50260044 ↗
• InjuryAug 3, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "Capsular Contracture", 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 50122938 ↗
• InjuryMar 25, 2026Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 24691729 ↗
• InjuryJan 23, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "SUSPECTED/ACTUAL RUPTURE/DEFLATION" VIA NATIONAL BREAST IMPLANT REGISTRY. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 24166253 ↗
• InjuryJan 23, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "SUSPECTED/ACTUAL RUPTURE/DEFLATION" VIA NATIONAL BREAST IMPLANT REGISTRY. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 24165560 ↗
• InjuryJan 13, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED THROUGH NATIONAL BREAST IMPLANT REGISTRY (NBIR) "CAPSULAR CONTRACTURE BAKER GRADE III AND DEVICE MIGRATION/IMPLANT MALPOSITION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 24059288 ↗
• InjuryDec 22, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

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

  Patient problems: Capsular Contracture

  MAUDE report 23865100 ↗
• InjuryNov 4, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture; Inflammation

  MAUDE report 23469462 ↗
• InjurySep 23, 2025Material Rupture; Material Rupture

  PATIENT REPORTED LEFT SIDE RUPTURE WITH MRI. LATER HEALTHCARE PROFESSIONAL CONFIRMED RUPTURE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 23125272 ↗
• InjurySep 23, 2025Gel Leak; Material Rupture; Gel Leak; Material Rupture

  THE DEVICE HAS BEEN EXPLANTED AND REPLACED. HEALTHCARE PROFESSIONAL REPORTED UPON EXPLANT "ANY CREASES", "OILY, SLIMY FILM OUTER SHELL", "SILICONE BLEED", "THE IMPLANT HAD A FILM OF SILICONE ON THE OUTSIDE BUT THERE WAS NO FRANK RUPTURE OF THE PROSTHESIS". UNREPORTING THE PREVIOUSLY REPORTED RUPTURED SINCE DEVICE WAS NOT FOUND RUPTURED UPON EXPLANT.

  Patient problems: Failure of Implant

  MAUDE report 23125271 ↗
• InjurySep 16, 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 REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23064693 ↗
• InjuryAug 26, 2025Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 22896571 ↗
• InjuryAug 4, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED CAPSULAR CONTRACTURE, BAKER GRADE IV, AND CREASES. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22710397 ↗
• InjuryJul 31, 2025Device Appears to Trigger Rejection; No Apparent Adverse Event; Device Appears to Trigger Rejection; No Apparent Adverse Event

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

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

  MAUDE report 22680148 ↗
• InjuryJul 28, 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. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22639931 ↗

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