Natrelle Inspira Cohesive Breast Implants SCF-485Recalls & reported problems

Summary

The FDA's MAUDE database contains 122 adverse event reports that list this exact device (DI 10888628030145), received between May 6, 2019 and Sep 28, 2026 — classified as 120 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (70 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 122 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Healthcare professional reported "Back Pain - Downsize Implant". This record is for the left side. Device was explanted.

  Patient problems: Back pain

  MAUDE report 50921100 ↗
• InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem

  Healthcare professional reported "Infection". This record is for the right side. Device was explanted.

  Patient problems: Seroma; Unspecified Infection

  MAUDE report 50100968 ↗
• InjuryJul 27, 2026Malposition of Device

  Healthcare professional reported "Implant keeps flipping, size exchange". This record is for the left side. Device has been explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50003652 ↗
• InjuryJun 2, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED A "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25365077 ↗
• InjuryMay 11, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR) MANUFACTURER REGISTRY SPECIFIC DATA REPORT (MRSDR) "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25145531 ↗
• InjuryMay 11, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR) MANUFACTURER REGISTRY SPECIFIC DATA REPORT (MRSDR) "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25145504 ↗
• InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR) MANUFACTURER REGISTRY SPECIFIC DATA REPORT (MRSDR) "INFECTION AND WOUND PROBLEMS". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Impaired Healing; Unspecified Infection

  MAUDE report 24956307 ↗
• InjuryApr 7, 2026Malposition of Device; Migration

  HEALTHCARE PROFESSIONAL REPORTED "DEVICE MIGRATION/IMPLANT MALPOSITION, CHANGE SHAPE/SIZE/STYLE" VIA THE NATIONAL BREAST IMPLANT REGISTRY (NBIR). PATIENT UNDERGONE CAPSULECTOMY. THIS RECORD IS FOR LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24811722 ↗
• InjuryMar 18, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED THROUGH DEVICE TRACKING "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24634658 ↗
• MalfunctionMar 11, 2026Contamination

  HEALTHCARE PROFESSIONAL REPORTED "WHEN OPENING A NATRELLE IMPLANT, THE ASSISTING NP NOTICED SOMETHING INSIDE THE IMPLANT". THIS DEVICE WAS NOT IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24567793 ↗
• InjuryAug 23, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22881309 ↗
• InjuryAug 20, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "INCISION AND DRAINAGE, ABSCESS, COMPLICATED OR MULTIPLE [1075917217], INSERTION OR REPLACEMENT OF BRE". LATER, HEALTHCARE PROFESSIONAL REPORTED "EXTRUSION OF BREAST IMPLANT". THIS IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Pocket Erosion

  MAUDE report 22849277 ↗
• InjuryJul 23, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN". LATER HEALTHCARE PROFESSIONAL REPORTED BAKER GRADE III, "PAIN/REDNESS,TENDERNESS" AND "MILD DIFFUSE EDEMA... TRACE PERICAPSULAR FLUID" CONFIRMED VIA MRI, "IMPLANT INFECTION" AND "DISPLACEMENT AND FIRMNESS". THIS REPORT IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture; Unspecified Infection

  MAUDE report 22584111 ↗
• InjuryJul 23, 2025Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 22583916 ↗
• InjuryJul 21, 2025Device Appears to Trigger Rejection; Patient-Device Incompatibility; Device Appears to Trigger Rejection; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture; Foreign Body Reaction

  MAUDE report 22556733 ↗
• InjuryJul 11, 2025Malposition of Device; Malposition of Device

  PATIENT REPORTED ¿FLAT AS A BEAGLE AND ROUND". HEALTHCARE PROFESSIONAL REPORTED LATER "IMPLANT MALROTATION -FLIPPED". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 22484374 ↗
• InjuryJun 30, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 22353175 ↗
• InjuryJun 24, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 22322268 ↗
• InjuryJun 5, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22149026 ↗
• InjuryMay 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE REVISION BECAUSE OF SKIN NECROSIS. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Necrosis

  MAUDE report 22038617 ↗
• InjuryApr 15, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL LATER REPORTED BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 21843068 ↗
• InjuryApr 8, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PHYSICIAN REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III/IV. DEVICE EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 21798752 ↗
• InjuryMar 25, 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 21692834 ↗
• InjuryMar 24, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 21683478 ↗
• InjuryNov 21, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 18187381 ↗

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-