Natrelle Inspira SoftTouch Breast Implants SSF-485Recalls & reported problems

Summary

The FDA's MAUDE database contains 235 adverse event reports that list this exact device (DI 10888628033184), received between May 14, 2019 and Sep 15, 2026 — classified as 232 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (159 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 235 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2026Material Rupture

  Healthcare professional reported "rupture". This record is for the right side. The device remains implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50769373 ↗
• InjurySep 7, 2026Material Rupture

  The device has been explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50652400 ↗
• InjuryAug 27, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "Capsular Contracture Baker grade 3". Patient received Accolate as treatment. This record is for the left side. Device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50478024 ↗
• InjuryJul 27, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 50040796 ↗
• InjuryJul 27, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "capsular contracture, baker grade IV" and "patient prescribed Vitamin E (1000 mg) and Singulair". This record is for the right side. The device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50031620 ↗
• InjuryJul 9, 2026Device Appears to Trigger Rejection

  Healthcare Professional reported "Capsular Contracture Baker grade III". This record is for the right side. Device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 25762059 ↗
• InjuryJul 7, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "HARDNESS TO THE TOUCH", "BREAST ASYMMETRY", "DISCOMFORT" AND "CAPSULAR CONTRACTURE" BAKER GRADE UNKNOWN. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25742944 ↗
• InjuryJul 7, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "HARDNESS TO THE TOUCH", "BREAST ASYMMETRY", "DISCOMFORT" AND "CAPSULAR CONTRACTURE" BAKER GRADE UNKNOWN. THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25734796 ↗
• InjuryJul 7, 2026Difficult to Open or Remove Packaging Material

  HEALTHCARE PROFESSIONAL, THROUGH SALES REPRESENTATIVE, REPORTED "TOP LAYER PEEL OFF WAS STUCK TO AND PULLING THE NEXT LAYER OFF". THE DEVICE WAS NOT IMPLANTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25733827 ↗
• InjuryJun 10, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE GRADE 3". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25464344 ↗
• InjuryJun 1, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE 4". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25355365 ↗
• InjuryMay 14, 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 25167126 ↗
• InjuryMay 14, 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 25167123 ↗
• InjuryMay 1, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED A "CAPSULAR CONTRACTURE BAKER GRADE 3,4". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25058204 ↗
• InjuryApr 22, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR) REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV¿ AND ¿DEVICE MIGRATION/IMPLANT MALPOSITION". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24957921 ↗
• InjuryApr 13, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 24859855 ↗
• InjuryApr 11, 2026Malposition of Device

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

  Patient problems: Failure of Implant

  MAUDE report 24851870 ↗
• InjuryApr 3, 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 24782003 ↗
• InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED "BREAST DIDN'T DROP". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

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

  MAUDE report 24765850 ↗
• InjuryApr 2, 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 24765271 ↗
• InjuryMar 25, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL, THROUGH SALES REPRESENTATIVE, REPORTED "CAPSULAR CONTRACTURE", BAKER GRADE III. CAPSULECTOMY WAS PERFORMED. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24688814 ↗
• InjuryJan 13, 2026Malposition of Device; Migration

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

  Patient problems: Failure of Implant

  MAUDE report 24055931 ↗
• InjuryJan 4, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture; Unspecified Infection

  MAUDE report 23954356 ↗
• InjuryJan 2, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III" CONFIRMED BY PHYSICAL EXAMINATION. THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED AND WILL BE RETURNED.

  Patient problems: Capsular Contracture

  MAUDE report 23951807 ↗
• InjurySep 4, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED "PAIN, CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22968898 ↗

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
• 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