Natrelle Inspira Cohesive Breast Implants SCX-420Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10888628030305), received between May 13, 2019 and Aug 31, 2026 — classified as 17 injuries, 1 malfunction.

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.

• InjuryAug 31, 2026Material Rupture

  Healthcare professional reported "rupture". Later, healthcare professional reported "reactive appearing of lymph nodes", "implant material in the breast parenchyma" and "implant leakage". This record is for the left side. Device remains implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50532747 ↗
• InjuryAug 18, 2026Contamination

  Healthcare Professional reported defected implant. Healthcare Professional later reported "there were markings on the implant". The device was not implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50308452 ↗
• MalfunctionMay 7, 2026Improper or Incorrect Procedure or Method; Difficult to Open or Remove Packaging Material

  HEALTHCARE PROFESSIONAL REPORTED THROUGH SALES REPRESENTATIVE "CONCERNS WITH STERILITY OF THE PACKAGING". THIS RECORD IS FOR LEFT SIDE. DEVICE WAS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 25117077 ↗
• InjurySep 19, 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 REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23095231 ↗
• InjurySep 5, 2025Device 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 22983812 ↗
• InjuryNov 23, 2023Device 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 18198931 ↗
• InjuryJun 26, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 17200034 ↗
• InjuryJun 9, 2023Device 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 17101303 ↗
• InjuryApr 20, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RUPTURE. THE DEVICE HAS BEEN EXPLANTED. HIS RELATES TO THE RIGHT SIDE.

  Patient problems: Failure of Implant

  MAUDE report 16777092 ↗
• InjuryFeb 10, 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 16357399 ↗
• InjuryAug 4, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 15168353 ↗
• InjuryFeb 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE REMOVAL WAS NOTED AS ¿RIPPLE NECROSIS,¿. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Necrosis

  MAUDE report 13429287 ↗
• InjuryJun 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ADDITIONALLY REPORTED, "ONGOING ISSUES WITH THE HEALING OF THE WOUNDS". HEALTHCARE PROFESSIONAL REPORTED, BURN. NOT RELATED TO THE DEVICE.

  Patient problems: Burn(s); Impaired Healing

  MAUDE report 12075548 ↗
• InjuryDec 15, 2020Material Rupture; Patient-Device Incompatibility; Material Rupture; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED "PROBABLE INFECTION" AND "PURULENT TYPE, THICKENED MILKY FLUID EXPRESSED FROM THE RIGHT BREAST PREPECTORAL SPACE." DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture; Unspecified Infection

  MAUDE report 11008632 ↗
• InjuryOct 19, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED "LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE 3/4." DEVICE EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 10697028 ↗
• InjuryNov 25, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  DEVICE HAS BEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 9368788 ↗
• InjuryOct 17, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 9204249 ↗
• InjuryMay 13, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTH PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV, AND CREASE/FOLDING OF THE IMPLANT. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 8605054 ↗

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-