Natrelle Inspira SoftTouch Breast Implants SSX-495Recalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 10888628033375), received between May 21, 2019 and Apr 14, 2026 — classified as 65 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (38 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 65 reports, in the reporter's own words as published by the FDA.

• InjuryApr 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 III". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24876724 ↗
• InjuryFeb 25, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 24443837 ↗
• InjuryAug 25, 2025Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 22885743 ↗
• InjuryAug 20, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "RUPTURE". THE DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 22855156 ↗
• InjuryAug 8, 2025Migration; Migration

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "IMPLANT DISPLACED LATERALLY AND INFERIORLY." PATIENT UNDERGONE CAPSULECTOMY. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 22756636 ↗
• InjuryJul 14, 2025Malposition of Device; Malposition of Device

  HEALTHCARE PROFESSIONAL REPORTED "IMPLANT FLIP." LATER REPORTED "WOUND." THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Wound Infection

  MAUDE report 22501351 ↗
• InjuryJul 2, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PHYSICIAN REPORTED CAPSULAR CONTRACTURE BAKER GRADE III. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22383584 ↗
• InjuryJun 25, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22333282 ↗
• InjuryJun 12, 2025Fluid/Blood Leak; Device Appears to Trigger Rejection; Material Rupture; Fluid/Blood Leak; Device Appears to Trigger Rejection; Material Rupture

  PATIENT REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. HEALTHCARE PROFESSIONAL LATER CONFIRMED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III-IV, "RIGHT BREAST WAS HARD AND PAINFUL, WITH LATERAL DRIFTING", AND RUPTURE "SEEN ON OFFICE VISIT". PATIENT UNDERGONE CAPSULECTOMY. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22199346 ↗
• InjuryJun 11, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED VIA NBIR "SUSPECTED/ACTUAL RUPTURE/DEFLATION, CHANGE SHAPE/SIZE/STYLE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 22190591 ↗
• InjuryOct 8, 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 20404446 ↗
• InjuryJul 25, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 19828044 ↗
• InjuryMar 26, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  ALLERGAN AESTHETICS RECEIVED A REPORT VIA NBIR OF A LEFT SIDE "CAPSULAR CONTRACTURE BAKER GRADE IV, CORRECTION OF ASYMMETRY". THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 18980527 ↗
• InjuryJan 12, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 18505859 ↗
• InjuryNov 20, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROVIDER REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE UNKNOWN BAKER GRADE. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 18168016 ↗
• InjuryNov 14, 2023Device Handling Problem; Device Handling Problem

  HEALTHCARE PROFESSIONAL REPORTED NICKED WITH NEEDLE DURING CASE FOR RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 18132144 ↗
• InjuryNov 8, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 18095645 ↗
• InjuryOct 6, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN WITH "SUPER TIGHT, BACK WAS REALLY TIGHT, MY POSTURE WAS BEING PULLED FORWARD DUE TO THE CAPSULAR CONTRACTURE, IMPLANTS NOT BEING ABLE TO DROP, CREATED MY CHEST MUSCLE TO CONTINUOUSLY BE TIGHT AND NEVER RELAX, FELT HARD". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 17888776 ↗
• InjuryOct 6, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN WITH "SUPER TIGHT, BACK WAS REALLY TIGHT, MY POSTURE WAS BEING PULLED FORWARD DUE TO THE CAPSULAR CONTRACTURE, IMPLANTS NOT BEING ABLE TO DROP, CREATED MY CHEST MUSCLE TO CONTINUOUSLY BE TIGHT AND NEVER RELAX, FELT HARD". THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 17888715 ↗
• InjurySep 29, 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 17844410 ↗
• InjurySep 12, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED "IMPLANT EXPOSURE.¿ THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Foreign Body Reaction

  MAUDE report 17733431 ↗
• InjuryJul 21, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 17374995 ↗
• InjuryMay 2, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 16855091 ↗
• InjuryApr 26, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III/IV. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 16819393 ↗
• InjuryMar 9, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE-3. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 16516899 ↗

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-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
• 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-