Natrelle Inspira Cohesive Breast Implants SCL-320Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10888628029514), received between Oct 20, 2020 and Jul 29, 2025 — classified as 9 injuries.

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJul 29, 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 22650027 ↗
• InjuryMay 21, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  PATIENT REPORTED "THE IMPLANT WAS POKING THROUGH SKIN/HARDNESS/FOLDED/RUPTURE/DEFECTIVE/. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Erosion

  MAUDE report 22066539 ↗
• InjuryMay 19, 2025Material Rupture; Material Rupture

  PATIENT REPORTED "THE IMPLANT WAS POKING THROUGH SKIN/HARDNESS/FOLDED/RUPTURE/DEFECTIVE/. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 22043255 ↗
• InjuryMay 15, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  PATIENT'S REPRESENTATIVE REPORTED RIGHT SIDE RUPTURE AND CAPSULAR CONTRACTURE BAKER GRADE III. LATER HEALTHCARE PROFESSIONAL CONFIRMS THE EVENTS VIA CT SCAN. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22030181 ↗
• InjuryMay 13, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  PATIENT'S REPRESENTATIVE REPORTED "RUPTURE AND CAPSULAR CONTRACTURE BAKER GRADE III". LATER HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" CONFIRMED VIA CT SCAN AND "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22011061 ↗
• InjuryFeb 9, 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 16334764 ↗
• InjuryFeb 7, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 16314934 ↗
• InjuryMar 18, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  BAKER GRADE IV.

  Patient problems: Capsular Contracture

  MAUDE report 11520188 ↗
• InjuryOct 20, 2020Material Rupture; Material Rupture

  PATIENT REPORTED LEFT SIDE RUPTURE. HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED "ANY CREASES." DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 10706868 ↗

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-