Natrelle Inspira Cohesive Breast Implants SCF-450Recalls & reported problems

Summary

The FDA's MAUDE database contains 123 adverse event reports that list this exact device (DI 10888628030138), received between May 3, 2019 and Sep 28, 2026 — classified as 118 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (61 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 25 most recent of 123 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Healthcare professional reported "Back Pain - Downsize Implant." This record is for the right side. Device was explanted.

  Patient problems: Back pain

  MAUDE report 50920577 ↗
• InjurySep 8, 2026Material Rupture

  Healthcare professional reported "no complaint against the device¿. Healthcare professional reported later "ruptured implant". This record is for the left side. Device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50671511 ↗
• InjuryAug 31, 2026Device Appears to Trigger Rejection

  Healthcare professional reported Capsular Contracture Baker Grade III. Later healthcare professional reported "capsule". This record is for the left side. The device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50530516 ↗
• InjuryAug 28, 2026Device Appears to Trigger Rejection

  Healthcare Professional reported "Capsular contracture", Baker Grade Unknown. This record is for the left side. Device has been explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50500657 ↗
• InjuryAug 3, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "Capsular Contracture Baker grade III-IV". This record is for the left side. The device has been explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50114855 ↗
• InjuryJun 26, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED ¿RUPTURED¿. HEALTHCARE PROFESSIONAL LATER REPORTED "HOLE IN RADIUS (EDGE)". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25642641 ↗
• InjuryJun 8, 2026Malposition of Device

  HEALTHCARE PROFESSIONAL REPORTED "FLIPPED". THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25437859 ↗
• InjuryMar 26, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED VIA THE NATIONAL BREAST IMPLANT REGISTRY (NBIR) MANUFACTURER REGISTRY SPECIFIC DATA REPORT (MRSDR) " CAPSULAR CONTRACTURE BAKER GRADE III ". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24697968 ↗
• InjuryFeb 9, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "NO COMPLAINT AGAINST THE DEVICE". LATER HEALTHCARE PROFESSIONAL REPORTED "POSS RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 24298257 ↗
• InjuryJan 29, 2026Device Appears to Trigger Rejection; No Apparent Adverse Event

  HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE. LATER HEALTHCARE PROFESSIONAL REPORTED NO COMPLAINT AGAINST THE DEVICE. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED. THEREFORE, THIS RECORD IS NO LONGER REPORTABLE TO THE FDA AND WILL BE UNREPORTED.

  Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24209836 ↗
• InjuryJan 19, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED THROUGH NATIONAL BREAST IMPLANT REGISTRY (NBIR) A "SUSPECTED/ACTUAL RUPTURE/DEFLATION" AND "CHANGE SHAPE/SIZE/STYLE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 24108630 ↗
• InjuryOct 31, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED VIA NBIR "CAPSULAR CONTRACTURE BAKER GRADE IV, CORRECTION OF ASYMMETRY, CHANGE SHAPE/SIZE/STYLE". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 23438621 ↗
• InjurySep 8, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22998056 ↗
• InjuryAug 15, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  HEALTHCARE PROFESSIONAL REPORTED UNKNOWN SIDE "IMPLANT WAS INTACT AND STILL USED FOR THE CASE WITH NO OTHER ISSUES BESIDES THE TIVEK PAPER. THE PAPER WAS SHREDDING ON BOTH THE INNER AND OUTER PACKAGING UPON OPENING. THE PAPER LID DID NOT COME OFF IN ONE SOLID PIECE AS THE OTHER IMPLANTS DO WHEN OPENING. LEAVING FIBERS THAT END UP IN THE STERILE AREA WHERE THE IMPLANT IS". THE DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 22819088 ↗
• InjuryJul 23, 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 22576324 ↗
• InjuryJul 7, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED UNKNOWN SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. PATIENT WAS UNDERAGE AT THE TIME OF SILICONE DEVICE IMPLANT. THIS RECORD IS FOR AN UNKNOWN SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22412662 ↗
• InjuryJul 6, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT WAS UNDERAGE AT THE TIME OF SILICONE DEVICE IMPLANT. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22408457 ↗
• InjuryJun 27, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE/DEFLATION". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 22350308 ↗
• InjuryJun 23, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "CAPSULAR CONTRACTURE BAKER GRADE II AND A RUPTURE." THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 22311494 ↗
• InjuryJun 18, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  PATIENT REPORTED "RUPTURE". HEALTHCARE PROFESSIONAL LATER REPORTED "SUSPECT OF RUPTURE" WITH "ABNORMAL APPEARANCE AND PALPABLE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture; Failure of Implant

  MAUDE report 22286589 ↗
• InjuryJun 12, 2025Device Appears to Trigger Rejection; No Apparent Adverse Event; Device Appears to Trigger Rejection; No Apparent Adverse Event

  PHYSICIAN LATER CONFIRMED THE PREVIOUSLY REPORTED EVENT OF "CAPSULAR CONTRACTURE" HAS A BAKER GRADE II. THERE ARE NO REPORTABLE EVENTS AGAINST THE DEVICE. RECORD WILL BE UNREPORTED.

  Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22197599 ↗
• InjuryJun 4, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE, WITH IMAGING REPORTS". THIS RECORD IS FOR THE LEFT -SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 22145555 ↗
• InjuryJun 2, 2025Malposition of Device; Malposition of Device

  HEALTHCARE PROFESSIONAL REPORTED "FLIPPING". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 22126076 ↗
• InjuryJun 1, 2025Malposition of Device; Malposition of Device

  HEALTHCARE PROFESSIONAL REPORTED VIA DEVICE TRACKING "FLIPPING". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 22121262 ↗
• InjuryApr 29, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED RIGHT SIDE "CAPSULAR CONTRACTURE BAKER GRADE III." HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED ¿EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE.¿ HEALTHCARE PROFESSIONAL LATER REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III." DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 21931465 ↗

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