Natrelle Inspira Cohesive Breast Implants SCF-745Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10888628030206), received between Jan 30, 2019 and Jul 14, 2026 — classified as 16 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (7 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryJul 14, 2026Device Appears to Trigger Rejection; Malposition of Device

  Healthcare Professional reported "Capsular Contracture Baker grade Unknown". Healthcare Professional later reported "implant malposition with lateral displacement" also "ptosis" that have been deem no device related. This record is for an unknown side. Device was explanted. Patient undergo a capsulectomy and a capsulorrhaphy.

  Patient problems: Capsular Contracture

  MAUDE report 25812569 ↗
• InjuryJul 14, 2026Device Appears to Trigger Rejection; Malposition of Device

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN". HEALTHCARE PROFESSIONAL LATER REPORTED "IMPLANT MALPOSITION WITH LATERAL DISPLACEMENT" ALSO "PTOSIS" THAT HAVE BEEN DEEM NO DEVICE RELATED. THIS RECORD IS FOR AN UNKNOWN SIDE. DEVICE WAS EXPLANTED. PATIENT UNDERGO A CAPSULECTOMY AND A CAPSULORRHAPHY.

  Patient problems: Capsular Contracture

  MAUDE report 25812480 ↗
• InjuryMay 19, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED ¿RIGHT SIDE EXPOSED IMPLANT.¿ THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Foreign Body Reaction

  MAUDE report 22046175 ↗
• MalfunctionApr 17, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  COMPANY REPRESENTATIVE REPORTED "THE OUTER SHELL OF THE IMPLANT CONTAINER IS RIPPING WHEN THEY OPEN IT" AND "WHERE THE INNER STERILE PACKAGING ON THE IMPLANT IS NEARLY IMPOSSIBLE TO REMOVE FROM THE OUTSIDE TRAY". THIS RECORD IS FOR UNKNOWN SIDE. THE DEVICE WAS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 21861363 ↗
• InjuryNov 20, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 18176155 ↗
• InjurySep 27, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RUPTURE. DEVICE HAS BEEN EXPLANTED. THIS RECORD IS FOR THE LEFT SIDE.

  Patient problems: Failure of Implant

  MAUDE report 17824720 ↗
• InjurySep 26, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RUPTURE CONFIRMED BY MRI. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 17819196 ↗
• InjuryMay 2, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 16857585 ↗
• InjuryApr 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "INFECTION." DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Unspecified Infection

  MAUDE report 16823302 ↗
• InjuryAug 23, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 15277808 ↗
• InjuryAug 23, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR BAKER GRADE III" AGAINST LEFT DEVICE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 15277608 ↗
• InjuryJul 6, 2022Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

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

  Patient problems: Capsular Contracture; Failure of Implant

  MAUDE report 14940815 ↗
• InjuryApr 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED ¿SEROMA, BIOFILM.¿ THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS UNILATERALLY REPLACED.

  Patient problems: Seroma; Unspecified Infection

  MAUDE report 14163510 ↗
• InjuryMar 24, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED VIA DEVICE TRACKING "RUPTURE" AGAINST RIGHT SIDE DEVICE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 13873692 ↗
• InjuryJan 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED REASON FOR LEFT SIDE DEVICE REMOVAL AS ¿INFECTION.¿ DEVICE HAS BEEN EXPLANTED AND DISCARDED.

  Patient problems: Unspecified Infection

  MAUDE report 11236477 ↗
• InjuryDec 12, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

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

  Patient problems: Capsular Contracture

  MAUDE report 10995712 ↗
• InjuryJun 13, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

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

  Patient problems: Capsular Contracture

  MAUDE report 8698102 ↗
• MalfunctionJan 30, 2019Adverse Event Without Identified Device or Use Problem

  A PATIENT'S LEFT BREAST IMPLANT REQUIRED REMOVAL DUE TO INFECTION. BOTH BREASTS WERE IMPLANTED 3 MONTHS PRIOR AT ANOTHER FACILITY. THE REMOVAL PROCEDURE OCCURRED WITHOUT COMPLICATIONS AND THE IMPLANT IS BEING STORED BY CLINICAL ENGINEERING.

  Patient problems: Unspecified Infection

  MAUDE report 8288295 ↗

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