Natrelle Inspira Cohesive Breast Implants SCF-365Recalls & reported problems

Summary

The FDA's MAUDE database contains 90 adverse event reports that list this exact device (DI 10888628030107), received between Jun 25, 2019 and Sep 30, 2026 — classified as 88 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (59 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 90 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Material Rupture

  Healthcare professional reported "rupture". This record is for the left side. The device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949061 ↗
• InjurySep 16, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "breast hardness", "pain" and "capsular contracture Baker grade lll/IV". This record is for left side. The device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50785959 ↗
• InjuryAug 5, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "capsular contracture, Baker grade III". This record is for the left side. The device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50147896 ↗
• InjuryJul 9, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 25773611 ↗
• InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED "INFECTION". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 25057505 ↗
• InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED "BLEEDING". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24990744 ↗
• MalfunctionMar 11, 2026Difficult to Open or Remove Packaging Material

  HEALTHCARE PROFESSIONAL REPORTED "IT IS DIFFICULT TO REMOVE THE IMPLANTS". THIS RECORD IS FOR AN UNKNOWN SIDE. DEVICE STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 24567697 ↗
• InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED THROUGH NATIONAL BREAST IMPLANT REGISTRY "INFECTION, SKIN NECROSIS, WOUND PROBLEMS". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Impaired Healing; Necrosis; Unspecified Infection

  MAUDE report 24560648 ↗
• InjuryJan 24, 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 24173311 ↗
• InjuryJan 3, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED THROUGH COMPANY REPRESENTATIVE "INSUFFICIENT INFORMATION". HEALTHCARE PROFESSIONAL LATER REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED. DEVICE WILL NOT BE RETURNED.

  Patient problems: Capsular Contracture

  MAUDE report 23953583 ↗
• InjuryDec 22, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED THROUGH NATIONAL BREAST IMPLANT REGISTRY (NBIR) "CAPSULAR CONTRACTURE BAKER GRADE III, DEVICE MIGRATION/IMPLANT MALPOSITION, CORRECTION OF ASYMMETRY, CHANGE SHAPE/SIZE/STYLE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED, REPLACED AND IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED.

  Patient problems: Capsular Contracture

  MAUDE report 23873865 ↗
• InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED "INFECTION". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED. DEVICE SHIPMENT STATUS IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 23811577 ↗
• InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED "INFECTION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED. DEVICE SHIPMENT STATUS IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 23811479 ↗
• InjurySep 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 23084732 ↗
• InjurySep 8, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 22993114 ↗
• InjuryAug 27, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "CAPSULE RECONTRACTURE BAKER GRADE UNKNOWN". DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22907956 ↗
• InjuryAug 8, 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. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22746445 ↗
• MalfunctionAug 6, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  HEALTHCARE PROFESSIONAL REPORTED "ADHESIVE HARD TO OPEN, HIGH CHANCE OF INFECTION". THE DEVICE WAS NOT IMPLANTED. DEVICE WAS DISCARDED. SURGERY WAS COMPLETED WITH A BACKUP DEVICE.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22730617 ↗
• InjuryJul 16, 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 REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22518922 ↗
• InjuryJul 14, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "NO COMPLAINT AGAINST THE DEVICE." HEALTHCARE PROFESSIONAL LATER REPORTED "CAPS CON III". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22502965 ↗
• InjuryJul 1, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "SIZE EXCHANGE." LATER REPORTED "LEFT BREAST." LATER REPORTED "ANIMATION DEFORMITY AND CAPSULAR CONTRACTURE DEFORMITY." THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22375656 ↗
• InjuryJun 26, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 22341824 ↗
• InjuryJun 25, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 22330862 ↗
• InjuryJun 9, 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. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22168841 ↗
• InjuryMay 14, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

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

  Patient problems: Capsular Contracture

  MAUDE report 22021273 ↗

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