Natrelle Inspira Cohesive Breast Implants SCM-445Recalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 10888628029934), received between May 16, 2019 and Aug 18, 2026 — classified as 58 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (33 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 60 reports, in the reporter's own words as published by the FDA.

• InjuryAug 18, 2026Device Appears to Trigger Rejection

  Healthcare professional reported ¿Capsular Contracture Baker grade IV¿. This record is for the left side. Device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50305465 ↗
• InjuryJul 27, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "capsular contracture Baker grade III". This record is for the right side. The device has been explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50015536 ↗
• InjuryJun 3, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED THROUGH THE NATIONAL BREAST IMPLANT REGISTRY (NBIR) "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25385976 ↗
• InjuryMar 26, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "SUSPECTED/ACTUAL RUPTURE/DEFLATION" THROUGH NATIONAL BREAST IMPLANT REGISTRY (NBIR). THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24700447 ↗
• InjuryMar 25, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN¿. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24683626 ↗
• InjuryOct 2, 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 WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 23200518 ↗
• InjurySep 26, 2025Device Appears to Trigger Rejection; Material Deformation; Device Appears to Trigger Rejection; Material Deformation

  HEALTHCARE PROFESSIONAL REPORTED "DEFORMITY OF CONSTRUCTED BREAST". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture; Failure of Implant

  MAUDE report 23160489 ↗
• InjurySep 26, 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. THE DEVICE WAS EXPLANTED AND REPLACED

  Patient problems: Capsular Contracture

  MAUDE report 23157901 ↗
• MalfunctionSep 23, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  HEALTHCARE PROFESSIONAL REPORTED "TRIED TO OPEN AND SEPARATE THE STERILE TRAY FROM THE NON-STERILE TRAY AND THE IMPLANT WAS STUCK". THIS RECORD IS FOR AN UNKNOWN SIDE. DEVICE WAS NOT IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23121823 ↗
• InjurySep 22, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED ¿CAP CON BAKER GRADE III¿. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED. IT WAS RETURNED.

  Patient problems: Capsular Contracture

  MAUDE report 23111702 ↗
• InjurySep 17, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED ¿CAP CON BAKER GRADE III¿. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23074363 ↗
• InjuryJul 1, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL LATER REPORTED " CAPSULAR CONTRACTURE BAKER GRADE IV." THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22376488 ↗
• 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 LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22357148 ↗
• InjuryMay 20, 2025Material Invagination; Material Invagination

  HEALTHCARE PROFESSIONAL REPORTED "IMPLANT FULL FRACTURE", "MRI SHOWED RUPTURE" AND "[UPON SURGERY] IT WAS NOT RUPTURED, BUT HAD ALL THESE FOLDS". THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 22054672 ↗
• MalfunctionMay 8, 2025Material Rupture; Device Handling Problem; Material Rupture; Device Handling Problem

  PHYSICIAN REPORTED UNKNOWN SIDE "SURGEON PUNCTURED THE IMPLANT". DEVICE STATUS UNKNOWN.

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

  MAUDE report 21990977 ↗
• InjuryFeb 22, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED VIA NBIR LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED AND REPLACED WITH A NON-ALLERGAN DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 18764118 ↗
• InjuryFeb 22, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED VIA NBIR RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III, CHANGE SHAPE/SIZE/STYLE, PTOSIS. DEVICE STATUS UNKNOWN.

  Patient problems: Capsular Contracture

  MAUDE report 18757320 ↗
• InjuryJan 17, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE II. HEALTHCARE PROFESSIONAL LATER REPORTED THE BAKER GRADE TO BE III. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 18530945 ↗
• InjuryOct 18, 2023Device Appears to Trigger Rejection; Device Handling Problem; Device Appears to Trigger Rejection; Device Handling Problem

  THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 17961871 ↗
• InjuryOct 18, 2023Nonstandard Device; Nonstandard Device

  HEALTHCARE PROFESSIONAL REPORTED "RIPPLING APPEARANCE" AND "SHELL HAS A SHEERING ISSUE". DEVICE WAS NOT IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 17961406 ↗
• InjuryOct 6, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. HEALTHCARE PROFESSIONAL REPORTED "HOLE, NON-SPECIFIC" VIA RGA. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 17886057 ↗
• InjuryJun 21, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 17173067 ↗
• InjuryApr 18, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 16764375 ↗
• InjuryMar 20, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE ¿SWOLLEN", "LARGE HEMATOMA¿, ¿BECAME HYPOTENSIVE AND HEMOGLOBIN DROPPED BY OVER 4 POINTS¿, ¿SIGNIFICANT BLOOD LOSS¿, ¿DRAIN WAS CONSTANTLY FILLING UP WITH FRESH BLOOD SUGGEST A BLEEDER IN THE LATERAL GUTTER OF [THEIR] RIGHT BREAST¿ WHICH WAS NOT DEVICE RELATED. DEVICE WAS REMOVED AND "PLACED INTO GENTAMICIN SALINE SOLUTION" TO DRAIN THE HEMATOMA AND PLACED BACK IN. DEVICE REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16574101 ↗
• InjuryFeb 21, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 16410302 ↗

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-