Natrelle INSPIRA Breast Implants SRL-140Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10888628006669), received between Jun 20, 2019 and Aug 14, 2026 — classified as 14 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (9 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2026Device Appears to Trigger Rejection

  Patient reported "encapsulated" and "fluid". This record is for the right side. Device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50262425 ↗
• InjuryJul 9, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV" DIAGNOSED VIA MRI. LATER, HEALTHCARE PROFESSIONAL REPORTED "IMPLANT WAS FOLDED FROM TIGHTENING OF CAPSULE" AND "DISFIGURED". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED WITH A NON-ABBVIE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 22462292 ↗
• InjuryJul 8, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "CAPSULAR CONTRACTURE BAKER GRADE IV" DIAGNOSED VIA MRI. HEALTHCARE PROFESSIONAL LATER REPORTED "IMPLANT WAS FOLDED FROM TIGHTENING OF CAPSULE" AND "DISFIGURED". DEVICE HAS BEEN EXPLANTED AND REPLACED WITH A NON-ABBVIE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 22445440 ↗
• InjuryMay 22, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  PATIENT REPORTED RIGHT SIDE "IMPLANT PROTRUDED THE LOWER SIDE OF THE BREAST", "LUMP IN THE UPPER RIGHT BREAST", "IMPLANT WAS STILL PROTRUDING FROM THE BOTTOM OF THE BREAST" AND "MAY HAVE RUPTURED". PATIENT STATED IMAGING AT THE TIME "DID NOT SHOW A RUPTURE" AND THE PATIENT "CHOSE NOT TO REMOVE THE CONTRACTED IMPLANTS". PATIENT LATER REPORTED RIGHT SIDE "RUPTURE" VIA CALCIUM SCAN AND "HISTORY OF CONTRACTURE" BAKER GRADE UNKNOWN. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22075167 ↗
• InjuryMay 22, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  PATIENT REPORTED LEFT SIDE NO COMPLAINT. PATIENT LATER REPORTED LEFT SIDE "RUPTURE" VIA CALCIUM SCAN AND "HISTORY OF CONTRACTURE" BAKER GRADE UNKNOWN. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22075166 ↗
• InjuryApr 17, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  DEVICE EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 16756288 ↗
• InjuryDec 7, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 15936918 ↗
• InjuryDec 7, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT-SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 15936913 ↗
• InjuryNov 30, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT RUPTURE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 15890643 ↗
• InjuryJun 2, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED ¿REVISION, CAPSULAR CONTRACTURE¿. BAKER GRADE NOT SPECIFIED. DEVICE HAS BEEN EXPLANTED. LEFT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 14573424 ↗
• InjuryJun 17, 2021Material Rupture; Material Rupture

  PATIENT REPORTED RIGHT SIDE "IMPLANT PROTRUDED THE LOWER RT SIDE OF THE RT BREAST", "LUMP IN THE UPPER RIGHT BREAST" AND "MAY HAVE RUPTURED. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 12020958 ↗
• InjuryNov 27, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

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

  Patient problems: Capsular Contracture

  MAUDE report 9385477 ↗
• InjuryAug 9, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

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

  Patient problems: Capsular Contracture

  MAUDE report 8879504 ↗
• InjuryJun 20, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

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

  Patient problems: Capsular Contracture

  MAUDE report 8719156 ↗

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-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-