Natrelle Inspira SoftTouch Breast Implants SSX-445Recalls & reported problems

Summary

The FDA's MAUDE database contains 86 adverse event reports that list this exact device (DI 10888628033351), received between Jun 5, 2019 and Sep 9, 2026 — classified as 83 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (58 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 86 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2026Device Appears to Trigger Rejection

  Device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50695040 ↗
• InjurySep 8, 2026Malposition of Device

  Healthcare professional reported "flipped". This record is for the left side. Device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50669043 ↗
• InjurySep 8, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "Capsular contracture Baker grade III/IV". This record is for the left side. Device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50659409 ↗
• InjuryAug 25, 2026Device 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 50433946 ↗
• InjuryAug 21, 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 50383039 ↗
• MalfunctionJul 27, 2026Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50015570 ↗
• InjuryJun 2, 2026Device 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 25365382 ↗
• MalfunctionDec 8, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  HEALTHCARE PROFESSIONAL REPORTED "DEFECTIVE IMPLANT PACKAGE" AND "WHEN TRYING TO GET ONE OF THE IMPLANTS OUT OF THE PACKAGING, THE INNER PLASTIC SHELL WOULD NOT SEPARATE FROM THE OUTER PLASTIC SHELL PACKAGE SO THE STERILE PACKAGING WAS NO LONGER STERILE". THE DEVICE WAS NOT IMPLANTED. DEVICE WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23752170 ↗
• InjuryDec 4, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "PATIENT WAS TAKEN IN 4 DAYS PAST SURGERY FOR SUSPECTED HEMATOMA" AND "RUPTURED IMPLANT WAS DISCOVERED". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED. DEVICE WAS DISCARDED.

  Patient problems: Failure of Implant

  MAUDE report 23716178 ↗
• InjuryOct 2, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "EXPLANTED A DAMAGED IMPLANT TODAY" AND LATER REPORTED "RUPTURE" AND "BAKER GRADE : 3". THIS RECORD IS FOR THE LEFT-SIDE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23200916 ↗
• InjuryAug 20, 2025Material Rupture; No Apparent Adverse Event; Material Rupture; No Apparent Adverse Event

  HEALTHCARE PROFESSIONAL LATER REPORTED "IMPLANTS WERE INTACT AND NOT REPLACED". THIS REPORT IS NO LONGER CONSIDERED REPORTABLE TO THE FDA.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22850084 ↗
• InjuryJul 11, 2025Device Appears to Trigger Rejection; Migration; Device Appears to Trigger Rejection; Migration

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "CAPSULAR CONTRACTURE BAKER GRADE IV" AND "BREAST DISPLAYED SIGNIFICANT MOVEMENT WITH MUSCLE ENGAGEMENT". DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22485572 ↗
• InjuryJun 26, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 22342881 ↗
• InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "INFECTION." DEVICE REMAINS IMPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 22331968 ↗
• InjuryMay 27, 2025Device Handling Problem; Device Handling Problem

  HEALTHCARE PROFESSIONAL REPORTED "POKED A HOLE IN THE IMPLANT DURING INSERTION". DEVICE WAS NOT IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 22093105 ↗
• InjuryMay 26, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT CALLED TO REPORT "REALLY HARD", "CAN SEE ON TOP", AND CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. ¿CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN.¿ THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22085294 ↗
• InjuryMay 22, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED LEFT SIDE PAIN, REALLY HARD, CAN SEE ON TOP, AND CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22073001 ↗
• InjuryMay 22, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22071647 ↗
• InjuryApr 8, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 21802425 ↗
• InjuryApr 7, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. HEALTHCARE PROFESSIONAL LATER REPORTED CAPSULAR CONTRACTURE BAKER GRADE IV. PATIENT UNDERGONE CAPSULECTOMY. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 21793650 ↗
• InjurySep 17, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED VIA NBIR LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III, CORRECTION OF ASYMMETRY, CHANGE SHAPE/SIZE/STYLE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 20241327 ↗
• InjurySep 13, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED VIA NBIR RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 20213652 ↗
• InjuryNov 13, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED, "CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. WITH HARD, PAINFUL TO TOUCH". THIS RECORD IS FOR RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 18125727 ↗
• InjuryNov 13, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN WITH HARD, PAINFUL TO TOUCH". THIS RECORD IS FOR LEFT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 18125437 ↗
• InjuryOct 24, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED CAPSULAR CONTRACTURE BAKER III ¿ IV. HEALTHCARE PROFESSIONAL LATER REPORTED ENCAPSULATION. HEALTHCARE PROFESSIONAL LATER REPORTED CAPSULAR CONTRACTURE BAKER GRADE 4. THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 17999986 ↗

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