Natrelle Inspira Cohesive Breast Implants SCF-695Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 10888628030190), received between Aug 3, 2018 and Sep 3, 2026 — classified as 49 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (21 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 49 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "capsule contraction" Baker grade unknown. This record is for the left side. Device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50592043 ↗
• InjuryJun 26, 2026Malposition of Device

  HEALTHCARE PROFESSIONAL REPORTED "FLIPPED IMPLANT". HEALTHCARE PROFESSIONAL LATER REPORTED "DEFORMITIES". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25635659 ↗
• InjuryJun 26, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". HEALTHCARE PROFESSIONAL LATER REPORTED "DEFORMITIES". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25635550 ↗
• InjuryJun 2, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 25367778 ↗
• InjuryMay 15, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED VIA 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 25192385 ↗
• InjuryMay 1, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 25060079 ↗
• InjuryApr 20, 2026Malposition of Device; Migration

  HEALTHCARE PROFESSIONAL REPORTED "DEVICE MIGRATION/IMPLANT MALPOSITION" VIA THE NATIONAL BREAST IMPLANT REGISTRY (NBIR). THIS RECORD IS FOR LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24924363 ↗
• InjuryJan 9, 2026Device Appears to Trigger Rejection

  PATIENT WAS PRESCRIBED ANTIBIOTICS IN PREVENTION.

  Patient problems: Capsular Contracture

  MAUDE report 24030637 ↗
• InjuryOct 30, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "NO COMPLAINT AGAINST THE DEVICE." LATER HEALTHCARE PROFESSIONAL REPORTED "BAKER GRADE 3 CONTRACTOR". MEDICATION PRESCRIBED FOR CAPSULAR CONTRACTURES: SINGULAIR. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED. DEVICE IS AVAILABLE FOR RETURN.

  Patient problems: Capsular Contracture

  MAUDE report 23432228 ↗
• InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED "WOUND PROBLEMS" VIA NBIR. THIS RECORD IS FOR RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 22797241 ↗
• InjuryAug 13, 2025Malposition of Device; Malposition of Device

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

  Patient problems: Failure of Implant

  MAUDE report 22795073 ↗
• InjuryJul 18, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE AND CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22545725 ↗
• InjuryJun 2, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 22128811 ↗
• InjuryMay 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED "NECROTIC SKIN". THIS REPORT IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Necrosis

  MAUDE report 22068458 ↗
• InjuryJan 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED "SEROMA", VIA THE NATIONAL BREAST IMPLANT REGISTRY (NBIR). RECORD IS FOR RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Seroma

  MAUDE report 21208955 ↗
• InjuryJan 21, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED VIA NBIR LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 21197525 ↗
• InjuryNov 14, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. THE DEVICE HAS BEEN EXPLANTED. THIS RELATES TO THE LEFT SIDE.

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

  MAUDE report 18133181 ↗
• InjurySep 11, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 17725021 ↗
• InjuryJul 14, 2023Device Handling Problem; Device Handling Problem

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE "IMPLANT RUPTURED WHEN PUTTING BACK INTO PATIENT". DEVICE HAS BEEN EXPLANTED.

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

  MAUDE report 17330072 ↗
• InjuryApr 5, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 16685843 ↗
• InjuryJan 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED VIA DEVICE TRACKING INFECTION WITHIN 90 DAYS OF IMPLANT. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 16205711 ↗
• InjuryNov 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED "INFECTION". DEVICE HAS BEEN EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 15777030 ↗
• InjurySep 30, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 15522021 ↗
• InjurySep 24, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED A LEFT-SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 15480534 ↗
• InjurySep 24, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED VIA NBIR LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 15477379 ↗

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