Natrelle INSPIRA Breast Implants SRX-615Recalls & reported problems

Summary

The FDA's MAUDE database contains 109 adverse event reports that list this exact device (DI 10888628007598), received between May 8, 2019 and Sep 28, 2026 — classified as 109 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (61 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 109 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Device Appears to Trigger Rejection

  Patient problems: Capsular Contracture

  MAUDE report 50926342 ↗
• InjurySep 17, 2026Device Appears to Trigger Rejection

  Patient problems: Capsular Contracture

  MAUDE report 50812662 ↗
• InjurySep 17, 2026Device Appears to Trigger Rejection

  Patient reported "capsular contracture Baker grade III/IV". Later 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 50799879 ↗
• InjuryFeb 6, 2026Device Appears to Trigger Rejection; Malposition of Device

  Healthcare professional originally reported "sitting a little higher" and "Capsular Contracture Baker grade unknown" and later confirmed that these events did not occur. The device has been explanted. This record is no longer reportable to FDA and will be un-reported.

  Patient problems: Capsular Contracture; Failure of Implant

  MAUDE report 24280330 ↗
• InjuryFeb 4, 2026Device Appears to Trigger Rejection

  Patient reported "Capsular Contracture Baker grade Unknown". Healthcare Professional later reported "Capsular Contracture baker grade III". Patient was prescribed a 3 month treatment of Singulair. This record is for the right side. Device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 24264396 ↗
• InjuryDec 1, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "SUSPECTED/ACTUAL RUPTURE/DEFLATION" VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR). THIS RECORD IS FOR RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED AND IS UNKNOWN IF THE DEVICE WILL BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 23688877 ↗
• InjuryNov 25, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED THROUGH NATIONAL BREAST IMPLANT REGISTRY (NBIR) "CAPSULAR CONTRACTURE BAKER GRADE III, RUPTURE AND ASYMMETRY" THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACE. DEVICE WILL NOT BE RETURNED.

  Patient problems: Capsular Contracture

  MAUDE report 23649848 ↗
• InjuryNov 19, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED THROUGH NATIONAL BREAST IMPLANT REGISTRY (NBIR) "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACE. DEVICE WILL NOT BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 23596551 ↗
• InjurySep 4, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "ANY CREASES". THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22965095 ↗
• InjuryJul 23, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 22579702 ↗
• InjuryJul 22, 2025Noise, Audible; Noise, Audible

  PATIENT REPORTED THAT THEY HEAR "SLOSHING" WHEN THEY RAISE THEIR ARM THAT MAY BE COMING "FROM THE POCKET" ON THE LEFT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 22569970 ↗
• InjuryJun 30, 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 WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22357661 ↗
• InjuryJun 20, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED ¿EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE¿ HEALTHCARE PROFESSIONAL LATER REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22301740 ↗
• InjuryMay 27, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  PATIENT REPORTED ¿RUPTURE¿. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture; Failure of Implant

  MAUDE report 22086713 ↗
• InjuryMay 22, 2025Material Rupture; Material Rupture

  PATIENT REPORTED A RIGHT SIDE RUPTURE, "BURNING", "MORE UNCOMFORTABLE", AND "MORE SYMPTOMATIC". DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 22070510 ↗
• InjuryApr 30, 2025Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 21937234 ↗
• InjuryNov 16, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED A LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 18156425 ↗
• InjuryNov 10, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV". DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 18115909 ↗
• InjuryNov 7, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 18088799 ↗
• InjuryOct 4, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 17867637 ↗
• InjurySep 15, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED, CAPSULAR CONTRACTURE, BAKER GRADE IV. THE DEVICE HAS BEEN EXPLANTED. THIS RELATES TO THE LEFT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 17760596 ↗
• InjuryAug 8, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 17478873 ↗
• InjuryJul 18, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III/IV. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 17346258 ↗
• InjuryJul 5, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 17259543 ↗
• InjuryJul 5, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 17257260 ↗

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 · 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-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-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