Natrelle Inspira Cohesive Breast Implants SCX-800Recalls & reported problems

Summary

The FDA's MAUDE database contains 126 adverse event reports that list this exact device (DI 10888628030428), received between May 29, 2019 and Sep 29, 2026 — classified as 125 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (56 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 126 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Malposition of Device

  Healthcare professional reported "Flipping¿. This record is for the left side. Device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933550 ↗
• InjuryAug 21, 2026Malposition of Device; Migration

  Healthcare professional reported through National Breast Implant Registry "Device Migration/Implant Malposition" and "Ptosis (-not device related-)". This record is for the left side. Device has been explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50379914 ↗
• InjuryAug 3, 2026Malposition of Device

  Healthcare professional reported "Malposition". This record is for the left side. Device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50117596 ↗
• InjuryApr 23, 2026Malposition of Device

  HEALTHCARE PROFESSIONAL REPORTED A "IMPROPER PLACEMENT". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24968809 ↗
• InjuryApr 22, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 24957267 ↗
• InjuryApr 21, 2026Malposition of Device; Migration

  HEALTHCARE PROFESSIONAL REPORTED THROUGH THE NATIONAL BREAST IMPLANT REGISTRY (NBIR) "DEVICE MIGRATION/IMPLANT MALPOSITION". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24940598 ↗
• InjuryApr 21, 2026Malposition of Device; Migration

  HEALTHCARE PROFESSIONAL REPORTED THROUGH THE NATIONAL BREAST IMPLANT REGISTRY (NBIR) "DEVICE MIGRATION/IMPLANT MALPOSITION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24940536 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 24867528 ↗
• InjuryApr 7, 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 24811360 ↗
• InjuryFeb 26, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 24461990 ↗
• InjuryJan 23, 2026Device Appears to Trigger Rejection; Malposition of Device; Migration

  HEALTHCARE PROFESSIONAL REPORTED THROUGH NATIONAL BREAST IMPLANT REGISTRY "CAPSULAR CONTRACTURE BAKER GRADE III, DEVICE MIGRATION/IMPLANT MALPOSITION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24168726 ↗
• InjuryDec 9, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 23760925 ↗
• InjuryDec 9, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III" VIA NBIR. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 23760856 ↗
• InjuryNov 17, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE III" VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR). THIS RECORD IS FOR LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED AND IS UNKNOWN IF THE DEVICE WILL BE RETURNED.

  Patient problems: Capsular Contracture

  MAUDE report 23569698 ↗
• InjuryOct 10, 2025Migration; Migration

  HEALTHCARE PROFESSIONAL REPORTED "DEVICE MIGRATION/IMPLANT MALPOSITION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 23268228 ↗
• InjurySep 16, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED VIA NBIR "CAPSULAR CONTRACTURE BAKER GRADE 3". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 23066520 ↗
• InjuryAug 13, 2025Malposition of Device; Malposition of Device

  HEALTHCARE PROFESSIONAL REPORTED "IMPLANT MALPOSITION". THIS RECORD IS FOR THE LEFT -SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 22793196 ↗
• InjuryJul 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED "INFLAMMATION AND AN BLEEDING INSIDE" (WITH ULTRASOUND). LATER HEALTHCARE PROFESSIONAL REPORTED "CAPSULE WAS ADHERENT TO DERMIS". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Inflammation

  MAUDE report 22512193 ↗
• InjuryJul 9, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III, DEVICE MIGRATION/IMPLANT MALPOSITION". THE DEVICE WAS EXPLANTED. THIS RELATES TO THE RIGHT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 22461675 ↗
• InjuryJun 30, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 22367995 ↗
• InjuryMay 21, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED NO COMPLAINT AGAINST THE DEVICE. LATER, HEALTHCARE PROFESSIONAL CONFIRMED CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. THIS RECORD IS FOR LEFT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22062454 ↗
• InjuryMay 7, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. HEALTHCARE PROFESSIONAL LATER REPORTED CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 21980590 ↗
• InjuryMay 7, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "POSSIBLE RIGHT-SIDE RUPTURE (WITH ULTRASOUND), INFLAMMATION AND AN BLEEDING INSIDE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 21975923 ↗
• InjuryOct 23, 2024Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR) RIGHT SIDE RUPTURE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 20518750 ↗
• InjuryJul 18, 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.

  Patient problems: Capsular Contracture

  MAUDE report 19778633 ↗

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-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-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-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-