Natrelle Inspira SoftTouch Breast Implants SSF-295Recalls & reported problems

Summary

The FDA's MAUDE database contains 121 adverse event reports that list this exact device (DI 10888628033108), received between Jul 4, 2019 and Sep 24, 2026 — classified as 121 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (95 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 121 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Device Appears to Trigger Rejection

  Patient problems: Capsular Contracture

  MAUDE report 50891905 ↗
• InjurySep 24, 2026Device Appears to Trigger Rejection

  Patient problems: Capsular Contracture

  MAUDE report 50891904 ↗
• InjurySep 17, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "hardness", "pain" and "capsular contracture" Baker grade unknown. This record is for the right side. Device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50803224 ↗
• InjurySep 11, 2026Device Appears to Trigger Rejection

  Patient problems: Capsular Contracture

  MAUDE report 50740398 ↗
• InjurySep 7, 2026Device Appears to Trigger Rejection

  Patient problems: Capsular Contracture

  MAUDE report 50652465 ↗
• InjuryAug 6, 2026Device Appears to Trigger Rejection; Material Rupture

  Healthcare professional reported "Rupture". Healthcare Professional later reported "capsulitis, free silicone in breast, induration of breast capsule, asymmetry, implant removed proving to be intact with no rupture, small silicone granuloma, a lot of indurated granulomas and calcification". This record is for the right side. Device was explanted. Patient undergo a capsulectomy.

  Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50167242 ↗
• InjuryJul 27, 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 50046652 ↗
• InjuryJul 27, 2026Device Appears to Trigger Rejection

  Healthcare professional reported capsular contracture Baker Grade unknown and "had to remove to do surgery". This record is for the left side. The device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50038885 ↗
• InjuryMay 13, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 25156920 ↗
• InjuryMay 13, 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 25156916 ↗
• InjuryApr 14, 2026Malposition of Device

  HEALTHCARE PROFESSIONAL REPORTED "MAL POSITION & MALPOSITION REVISION WITH MESH PLACEMENT". THIS RECORD IS FOR LEFT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24876430 ↗
• InjuryMar 13, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED THROUGH COMPANY REPRESENTATIVE "RECURRENT CAPSULAR CONTRACTURE (BAKER 3)". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24591641 ↗
• InjurySep 30, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED ¿CAPSULAR CONTRACTURE BAKER GRADE III¿. TREATMENT WAS SINGULAR. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED. DEVICE WILL BE RETURNED.

  Patient problems: Capsular Contracture

  MAUDE report 23180370 ↗
• InjurySep 24, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III", TREATMENT: MONTELUKAST. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 23140013 ↗
• InjurySep 15, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED ¿CAPSULAR CONTRACTURES, BAKER GRADE 3.5 TO IV, PAIN, HARDENING AND IMPLANTS HAVE RISEN¿. LATER HEALTHCARE PROFESSIONAL REPORTED "BAKER III", "VISIBLE DISTORTION" OF THE IMPLANT THAT IS "HIGHER IN POSITION" AND "NOTICEABLE DEFORMATION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED. DEVICE WAS RETURNED.

  Patient problems: Capsular Contracture

  MAUDE report 23051366 ↗
• InjuryAug 27, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED "CAPSULAR CONTRACTURE GRADE UNKNOWN". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22905359 ↗
• InjuryAug 23, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. PATIENT TREATED WITH MASSAGE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22880411 ↗
• InjuryAug 19, 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 22840986 ↗
• InjuryAug 11, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 22771613 ↗
• InjuryJul 21, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22559641 ↗
• InjuryJul 16, 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 AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22521854 ↗
• InjuryJul 15, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "GR3 CC" (CAPSULAR CONTRACTURE, BAKER GRADE III). THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22507920 ↗
• InjuryJun 24, 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 REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22324463 ↗
• InjuryJun 20, 2025Device 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 22298984 ↗
• InjuryJun 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 22286414 ↗

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