Natrelle Inspira SoftTouch Breast Implants SSX-650Recalls & reported problems

Summary

The FDA's MAUDE database contains 83 adverse event reports that list this exact device (DI 10888628033436), received between Dec 13, 2019 and Sep 8, 2026 — classified as 80 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (52 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 83 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2026Device Appears to Trigger Rejection

  Healthcare professional reported Capsular Contracture Baker Grade IV. This record is for the left side. The device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50668869 ↗
• InjuryAug 6, 2026Contamination

  Healthcare professional reported "breast hematoma" and "film on the explant". This record is for the right side. The device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50163314 ↗
• InjuryJul 27, 2026Malposition of Device

  Healthcare professional reported "flipping and age". This record is for the right side. The device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50036347 ↗
• InjuryJul 27, 2026Malposition of Device

  Healthcare professional reported "flipping and age". This record is for the left side. The device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50036102 ↗
• InjuryJun 17, 2026Device Appears to Trigger Rejection

  Healthcare professional reported Capsular Contracture Baker grade Unknown. Healthcare professional reported Capsular Contracture Baker grade III. Patient has undergone capsulectomy. This record is for the right side. Device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 25541649 ↗
• InjuryMar 25, 2026Malposition of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24693897 ↗
• InjuryMar 25, 2026Malposition of Device

  HEALTHCARE PROFESSIONAL REPORTED "MALPOSITIONED" AND "RIPPLING". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24693859 ↗
• InjuryMar 24, 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 24682454 ↗
• InjuryMar 20, 2026Malposition of Device; Migration

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

  Patient problems: Failure of Implant

  MAUDE report 24650566 ↗
• InjuryMar 19, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED REPORTED VIA THE NATIONAL BREAST IMPLANT REGISTRY (NBIR) "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24641373 ↗
• MalfunctionMar 3, 2026Difficult to Open or Remove Packaging Material

  SALES REPRESENTATIVE REPORTED ON BEHALF OF HEALTHCARE PROFESSIONAL "ISSUE WITH IMPLANT UPON OPENING PLASTIC CONTAINER". DEVICE WAS NOT IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24497054 ↗
• InjuryJan 26, 2026Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 24184400 ↗
• InjurySep 16, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 23063010 ↗
• InjurySep 12, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 23039381 ↗
• InjuryAug 26, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED. THE PATIENT WAS PRESCRIBED SINGULAIR TO TRY AND TREAT THE CAPSULAR CONTRACTION ON UNKNOWN DATE.

  Patient problems: Capsular Contracture

  MAUDE report 22900336 ↗
• InjuryAug 21, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 22861319 ↗
• MalfunctionAug 14, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  HEALTHCARE PROFESSIONAL REPORTED IMPLANT THAT HAS A HAIR ON THE INNER PACKAGING. THE DEVICE WAS NOT IMPLANTED. IT IS UNKNOWN IF SURGERY WAS COMPLETED WITH A BACK UP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22812892 ↗
• InjuryAug 4, 2025Malposition of Device; Migration; Malposition of Device; Migration

  HEALTHCARE PROFESSIONAL REPORTED VIA NBIR "DEVICE MIGRATION/IMPLANT MALPOSITION, CORRECTION OF ASYMMETRY, PTOSIS". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

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

  MAUDE report 22709950 ↗
• InjuryJul 17, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 22532205 ↗
• InjuryJul 9, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED "CAPSULAR CONTRACTURE WITH UNKNOWN BAKER GRADE, DRY EYES, DRY MOUTH, SKIN RASH AND PAIN". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22456773 ↗
• InjuryJun 15, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 22208647 ↗
• MalfunctionJun 9, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  HEALTHCARE PROFESSIONAL REPORTED "UNABLE TO OPEN AN IMPLANT BOX IN A STERILE WAY AS THE PACKAGING DID NOT OPEN CORRECTLY. THEY DEEMED IT A DEFECT". THE DEVICE WAS NOT IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22165494 ↗
• InjuryMay 26, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 22084484 ↗
• InjuryJan 7, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 21098377 ↗
• InjuryMay 13, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PHYSICIAN REPORTED VIA NBIR LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 19298012 ↗

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