Natrelle Inspira Cohesive Breast Implants SCM-755Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10888628030008), received between Aug 20, 2019 and Jul 9, 2025 — classified as 8 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJul 9, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED " I HAVE ANOTHER PATIENT THAT CAME TO US WITH A RUPTURED IMPLANT" VIA "CT". THIS RECORD IS FOR THE "LEFT" SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 22458778 ↗
• MalfunctionMay 22, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  SALES REPRESENTATIVE REPORTED " THE INNER PLASTIC WAS ADHERED TO EACH OTHER". THIS RECORD IS FOR UNKNOWN SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 22069546 ↗
• MalfunctionMay 22, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  SALES REPRESENTATIVE REPORTED ON BEHALF OF HEALTHCARE PROFESSIONAL " THE INNER PLASTIC WAS ADHERED TO EACH OTHER". THIS RECORD IS FOR UNKNOWN SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 22067448 ↗
• InjuryApr 22, 2025Material Rupture; Patient-Device Incompatibility; No Apparent Adverse Event; Material Rupture; Patient-Device Incompatibility; No Apparent Adverse Event

  HEALTHCARE PROFESSIONAL REPORTED "EXPOSED RUPTURE". DEVICE WILL NOT BE RETURNED. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Foreign Body Reaction; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21883964 ↗
• InjuryJan 23, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 21216678 ↗
• InjurySep 18, 2023Break; Break

  HEALTHCARE PROFESSIONAL REPORTED, "ATTEMPTED TO PLACE AN IMPLANT. AND DISCOVERED A PUNCTURE, WITH GEL LEAKING PROFUSELY". THE DEVICE WAS NOT IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 17769868 ↗
• InjuryFeb 22, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 16421457 ↗
• InjuryFeb 22, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 16416404 ↗
• InjuryDec 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED VIA DEVICE TRACKING OOZING FROM THE INCISION SITE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Purulent Discharge; Unspecified Infection

  MAUDE report 13019562 ↗
• InjuryAug 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEVICE REMOVAL DUE TO AN "INFECTION." DEVICE HAS BEEN EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 8913788 ↗

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-