Natrelle Inspira Cohesive Breast Implants SCM-640Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10888628029989), received between Jun 13, 2019 and Jul 27, 2026 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (6 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  Healthcare professional reported "Failure To heal". This record is for the right side. Device was explanted.

  Patient problems: Impaired Healing

  MAUDE report 50015294 ↗
• MalfunctionMar 10, 2026Difficult to Open or Remove Packaging Material; Device Handling Problem

  HEALTHCARE PROFESSIONAL REPORTED "DURING IMPLANT SURGERY WHEN THE DOCTOR WENT TO OPEN THE OUTER PLASTIC PACKAGE OR OUTER SEAL THE INNER PLASTIC DID NOT FALL OUT AS IT SHOULD. IT WAS SUPER STUCK RESULTING IN DOCTOR HAVING TO MANUALLY OPEN IT AGAIN AND THEN TOUCH THE BREAST AND THEN DO A BUNCH OF OTHER THINGS. THE INNER PLASTIC THAT HOLDS THE IMPLANT WOULD NOT POP OUT". THIS RECORD IS FOR AN UNKNOWN SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 24560783 ↗
• InjuryAug 20, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "INTRACAPSULAR RUPTURE WITH MRI DONE". HEALTHCARE PROFESSIONAL REPORTED LATER BY OPERATIVE REPORT "LYMPH NODES". THIS RECORD IS FOR THE LEFT-SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant; Swollen Lymph Nodes/Glands

  MAUDE report 22853487 ↗
• InjuryMar 1, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED NO COMPLAINT AGAINST LEFT DEVICE. LATER, HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE III. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 18817431 ↗
• InjuryNov 30, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 18236994 ↗
• InjuryOct 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE POSSIBLE INFECTION. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 17990058 ↗
• InjuryApr 14, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 16743422 ↗
• InjuryApr 14, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 16743287 ↗
• InjuryAug 25, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV" AGAINST RIGHT DEVICE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 15293099 ↗
• InjuryOct 8, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 12601376 ↗
• InjuryAug 5, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "IMPLANT EXPOSURE". DEVICE HAS BEEN EXPLANTED.

  Patient problems: Foreign Body Sensation in Eye

  MAUDE report 8862377 ↗
• InjuryJun 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED REASON FOR LEFT SIDE DEVICE REMOVAL IS NOTED AS "INFECTION''.

  Patient problems: Unspecified Infection

  MAUDE report 8696642 ↗

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