Natrelle Inspira Cohesive Breast Implants SCM-560Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10888628029965), received between Aug 14, 2020 and Sep 8, 2026 — classified as 15 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (5 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem

  Healthcare professional reported "Hematoma/Recon". This record is for the right side. Device was explanted.

  Patient problems: Hematoma

  MAUDE report 50668452 ↗
• InjuryApr 26, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED A "SUSPECTED/ACTUAL RUPTURE/DEFLATION". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 24993447 ↗
• InjuryApr 24, 2026No Apparent Adverse Event

  HEALTHCARE PROFESSIONAL REPORTED VIA THE NATIONAL BREAST IMPLANT REGISTRY (NBIR) MANUFACTURER REGISTRY SPECIFIC DATA REPORT (MRSDR) "WOUND PROBLEMS, INFECTION". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Impaired Healing; Unspecified Infection

  MAUDE report 24988541 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR) MANUFACTURER REGISTRY SPECIFIC DATA REPORT (MRSDR) "INFECTION", "SEROMA" AND "SKIN NECROSIS". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Necrosis; Seroma; Unspecified Infection

  MAUDE report 24873924 ↗
• InjurySep 12, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 23042476 ↗
• InjurySep 8, 2025Material Rupture; Material Rupture

  PATIENT REPORTED RIGHT SIDE RUPTURE, AND "LUMP OF SILICONE." DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 22994189 ↗
• InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED "ABSCESS, THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REASON FOR REMOVAL". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Abscess

  MAUDE report 22332003 ↗
• InjuryApr 22, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 21883778 ↗
• InjuryOct 4, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 17867539 ↗
• InjuryApr 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED A "LEFT BREAST WOUND DEHISCENCE." DEVICE HAS BEEN EXPLANTED.

  Patient problems: Wound Dehiscence

  MAUDE report 16762533 ↗
• InjuryFeb 21, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE IMPLANT EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE. HEALTHCARE PROFESSIONAL LATER REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 16406555 ↗
• InjuryDec 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED VIA NBIR AN INFECTION IN LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 13084542 ↗
• InjuryJul 28, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  CAPSULAR CONTRACTURE BAKER GRADE IV.

  Patient problems: Capsular Contracture

  MAUDE report 12242137 ↗
• InjuryOct 13, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

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

  Patient problems: Capsular Contracture

  MAUDE report 10673523 ↗
• InjuryAug 14, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 10408183 ↗

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-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