Natrelle Inspira SoftTouch Breast Implants SSX-525Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 10888628033382), received between May 10, 2019 and Sep 1, 2026 — classified as 57 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (37 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 58 reports, in the reporter's own words as published by the FDA.

• InjurySep 1, 2026Device Appears to Trigger Rejection; Malposition of Device

  Healthcare professional reported "muscle pain", "back pain", Capsular Contracture Baker grade III, "Malposition", "irregular outline", "flipped, noting a visible difference in shape with one side appearing flat", "residual pain in the lower breast area near the scarring", "asymmetric flatness" and "firmness and pain". This record is for the left side. Device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50546489 ↗
• InjuryAug 3, 2026Material Rupture

  Healthcare professional reported an "exchange with no complaint against device". Later another healthcare professional reported "possible rupture". This record is for the right side. Device remains implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50122833 ↗
• InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR) "INFECTION¿. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Unspecified Infection

  MAUDE report 25229415 ↗
• InjuryApr 9, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "IMPLANT EXCHANGE DUE TO A CAPSULAR CONTRACTURE" BAKER GRADE UNKNOWN. THIS RECORD IS FOR RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24832506 ↗
• InjuryMar 30, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 24715508 ↗
• InjuryMar 14, 2026Malposition of Device; Migration

  HEALTHCARE PROFESSIONAL REPORTED THROUGH NATIONAL BREAST IMPLANT REGISTRY "DEVICE MIGRATION" AND "IMPLANT MALPOSITION". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 24599743 ↗
• InjuryMar 13, 2026Malposition of Device; Migration

  HEALTHCARE PROFESSIONAL REPORTED THROUGH NATIONAL BREAST IMPLANT REGISTRY "DEVICE MIGRATION" AND "IMPLANT MALPOSITION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 24596390 ↗
• InjuryFeb 16, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" AND "HYPOMASTIA WITH BREAST PTOSIS". PTOSIS IS NOT CONSIDERED DEVICE RELATED. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 24345648 ↗
• InjuryDec 9, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED INSUFFICIENT INFORMATION. LATER HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED, REPLACED AND WILL NOT BE RETURNED.

  Patient problems: Capsular Contracture

  MAUDE report 23758083 ↗
• InjurySep 9, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULE CONTRACTURE". LATER HEALTHCARE PROFESSIONAL CONFIRMED "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 23003935 ↗
• InjuryAug 7, 2025Material Rupture; Material Rupture

  PATIENT REPORTED LEFT SIDE "FEELS HARD", HOT TO TOUCH, SWOLLEN, FATIGUE, MEMORY LOSS, ANXIETY, DEPRESSION, NAUSEA, VISION CHANGES, DIZZINESS, PANIC ATTACKS, ACHY JOINTS, CHANGES IN SLEEPING HABITS AND HOT FLASHES". LATER PATIENT REPORTED RUPTURE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 22739415 ↗
• InjuryAug 6, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED RIGHT SIDE "FEELS HARD", HOT TO TOUCH, SWOLLEN, FATIGUE, MEMORY LOSS, ANXIETY, DEPRESSION, NAUSEA, VISION CHANGES, DIZZINESS, PANIC ATTACKS, ACHY JOINTS, CHANGES IN SLEEPING HABITS AND HOT FLASHES". LATER PATIENT REPORTED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22731882 ↗
• InjuryJul 1, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT´S REPRESENTATIVE REPORTED "PAIN, RIPPLING, TOO BIG, HITTING RIBCAGE AND IMPLANT EXCHANGE". PATIENT LATER REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22376366 ↗
• InjuryJun 4, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 22142518 ↗
• InjuryMay 20, 2025Material Rupture; Migration; Material Rupture; Migration

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "FLIPPED/DISPLACEMENT" (CAPTURED AS MIGRATION). SURGERY WAS PERFORMED TO CORRECT PRODUCT DISPLACEMENT AND POCKET NARROWED. HEALTHCARE PROFESSIONAL LATER REPORTED RUPTURE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 22056880 ↗
• InjuryMay 16, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED VIA NBIR "DEVICE MIGRATION/IMPLANT MALPOSITION, SUSPECTED/ACTUAL RUPTURE/DEFLATION". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 22035823 ↗
• InjuryApr 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE INFECTION. LATER HEALTHCARE PROFESSIONAL REPORTED "INFECTION DEVELOPED 3 WEEKS POST SURGERY", "IMF INCISION OPENED AND STARTED DRAINING" "STAPHYLOCOCCUS AUREUS PAN SENSITIVE". DEVICE WAS EXPLANTED. INFECTION RESOLVED AFTER EXPLANTATION - 7 DAYS POST EXPLANT. THE DEVICE HAS BEEN DISCARDED.

  Patient problems: Unspecified Infection

  MAUDE report 21931534 ↗
• InjuryApr 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED VIA THE NATIONAL BREAST IMPLANT REGISTRY (NBIR) LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III AND DEVICE MIGRATION/MALPOSITION. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 21867730 ↗
• InjuryApr 4, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED VIA NBIR ¿CAPSULAR CONTRACTURE, BAKER GRADE IV¿. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 19046833 ↗
• InjuryApr 3, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 19033265 ↗
• InjuryMar 15, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED A LEFT BREAST CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 18918522 ↗
• InjuryNov 1, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL CALLED TO REPORT RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 18045478 ↗
• MalfunctionOct 25, 2023Unsealed Device Packaging; Unsealed Device Packaging

  HEALTHCARE PROFESSIONAL REPORTED "INNER BOX BEING SO STUCK THAT THE PAPER COVER WITH THE TAB TORE AND CONTAMINATED THE IMPLANT". SURGERY WAS COMPLETED USING BACKUP DEVICE.

  Patient problems: Failure of Implant

  MAUDE report 18001387 ↗
• InjuryOct 11, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "REMOVE AND REPLACE RIGHT BREAST IMPLANT WITH SMALLER IMPLANT TO CORRECT ASYMMETRY AND SILICONE SOFT TOUCH." HEALTHCARE PROFESSIONAL LATER REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III." DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 17914796 ↗
• InjuryMay 1, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 16845312 ↗

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