Natrelle Inspira Cohesive Breast Implants SCF-415Recalls & reported problems

Summary

The FDA's MAUDE database contains 126 adverse event reports that list this exact device (DI 10888628030121), received between May 1, 2019 and Aug 7, 2026 — classified as 124 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (75 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 126 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2026Material Rupture

  Healthcare professional reported "Rupture/Deflation". This record is for the right side. The device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50178288 ↗
• InjuryJul 6, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". PATIENT WAS PRESCRIBED SINGULAIR. THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25718359 ↗
• InjuryJun 26, 2026Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE AND CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25641196 ↗
• InjuryJun 5, 2026Migration

  PATIENT REPORTED "BOTTOMING OUT", "FEELS LIKE ITS COMING OUT OF THE POCKET/CAPSULE", "MOVING/POPPING", "LOWER", "NEEDS CAPSULORRHAPHY" AND "DISCOMFORT". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 25409443 ↗
• InjuryJun 5, 2026Migration

  PATIENT REPORTED "STARTING TO COME OUT OF CAPSULE" AND "NEEDS CAPSULORRHAPHY". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25409352 ↗
• InjuryJun 3, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 25386489 ↗
• InjuryJun 3, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 25386481 ↗
• InjuryMay 25, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE", "HARDNESS TO THE TOUCH", "PAIN" AND "BREAST ASYMMETRY". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25271786 ↗
• InjuryMar 12, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24581777 ↗
• InjuryMar 9, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL THROUGH NATIONAL BREAST IMPLANT REGISTRY (NBIR) REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE III, DEVICE MIGRATION/IMPLANT MALPOSITION,CHANGE SHAPE/SIZE/STYLE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED BY A NON-ABBVIE DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 24547672 ↗
• InjuryFeb 24, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III" AND "WRINKLING/RIPPLING". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24434117 ↗
• InjuryFeb 12, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". LATER HEALTHCARE PROFESSIONAL REPORTED "RUPTURED". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24322651 ↗
• InjuryJan 29, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "FIRMNESS" AND "GRADE 3 CAPSULAR CONTRACTURE", SINGULAIR AND VITAMIN E WAS PRESCRIBED. THIS RECORD IS FOR THE LEFT SIDE. THE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24218594 ↗
• InjuryJan 7, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE III. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 23987888 ↗
• InjuryDec 23, 2025Malposition of Device; Migration; Malposition of Device; Migration

  HEALTHCARE PROFESSIONAL REPORTED THROUGH NATIONAL BREAST IMPLANT REGISTRY (NBIR) "DEVICE MIGRATION/IMPLANT MALPOSITION, CHANGE SHAPE/SIZE/STYLE, PTOSIS". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED, REPLACED AND IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23884415 ↗
• MalfunctionOct 22, 2025No Apparent Adverse Event; Insufficient Device Problem Information; Insufficient Device Problem Information

  HEALTHCARE PROFESSIONAL REPORTED "WHY THE IMPLANTS HE JUST EXPLANTED HAVE TURNED FOGGY IN COLOR". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND WILL BE RETURN.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23361450 ↗
• InjuryAug 24, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CONTRACTOR". HEALTHCARE PROFESSIONAL LATER REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III" THIS IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22881589 ↗
• InjuryAug 15, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  HEALTHCARE PROFESSIONAL REPORTED "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". THIS RECORD IS FOR UNKNOWN SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 22819180 ↗
• InjuryJul 15, 2025Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED "RUPTURE". THIS RECORD IS FOR AN UNKNOWN SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 22503863 ↗
• InjuryJul 8, 2025Device Appears to Trigger Rejection; Malposition of Device; Device Appears to Trigger Rejection; Malposition of Device

  UPON FURTHER REVIEW, EVENT OF "IMPLANT WAS FLIPPED¿ (MALPOSITION) IS ASSESSED AS MINOR IN SEVERITY AND WILL BE UNREPORTED.

  Patient problems: Capsular Contracture

  MAUDE report 22443626 ↗
• InjuryJul 1, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22370633 ↗
• InjuryJun 30, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22366711 ↗
• InjuryJun 16, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE IV. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22216416 ↗
• InjuryJun 12, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL LATER REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III.

  Patient problems: Capsular Contracture

  MAUDE report 22198320 ↗
• InjuryJun 11, 2025Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  HEALTHCARE PROFESSIONAL REPORTED ¿SEROMA, DELAYED HEALING¿. HEALTHCARE PROFESSIONAL REPORTED LATER BY FOLLOW UP "BREAST CANCER". THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Impaired Healing; No Clinical Signs, Symptoms or Conditions; Seroma

  MAUDE report 22185669 ↗

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 108
• 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, 110-210,
• 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,TRL-