Natrelle Inspira SoftTouch Breast Implants SSF-335Recalls & reported problems

Summary

The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 10888628033122), received between Jun 11, 2019 and Sep 29, 2026 — classified as 61 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (44 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 63 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936219 ↗
• InjurySep 24, 2026Device Appears to Trigger Rejection

  Patient problems: Capsular Contracture

  MAUDE report 50890253 ↗
• InjurySep 17, 2026Device Appears to Trigger Rejection

  Patient reported "no complaint against the device". Later patient reported "a little hard". Patient later reported "Capsular contracture Baker grade unknown". This record is for the right side. Device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50798615 ↗
• InjuryAug 19, 2026Device 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 50314713 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  Healthcare professional reported the implant infection was positive for the bacteria "Pseudomonas aeruginosa". After irrigation, it was reported ¿no infection present¿. This record is for the right side. The device was explanted.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 50015624 ↗
• InjuryApr 13, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "capsular contracture, Baker grade IV, pain". This record is for the right side. Device has been explanted and replaced.

  Patient problems: Capsular Contracture

  MAUDE report 24859690 ↗
• MalfunctionMar 23, 2026Difficult to Open or Remove Packaging Material

  SALES REPRESENTATIVE REPORTED "ISSUE WITH THE TYVEK WRAPPER". THIS RECORD IS FOR AN UNKNOWN SIDE. THE DEVICE IS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24670169 ↗
• InjuryMar 9, 2026Device Appears to Trigger Rejection; Material Rupture

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

  Patient problems: Capsular Contracture; Seroma

  MAUDE report 24543347 ↗
• InjuryMar 3, 2026Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III. CAPSULOTOMY WAS PERFORMED. HEALTHCARE PROFESSIONAL LATER REPORTED "RUPTURE" AND "MALPOSITION". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24496747 ↗
• InjuryJan 21, 2026Migration

  HEALTHCARE PROFESSIONAL VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR) REPORTED "DEVICE MIGRATION/IMPLANT MALPOSITION". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 24136691 ↗
• InjuryOct 6, 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 WILL BE RETURNED.

  Patient problems: Capsular Contracture

  MAUDE report 23227724 ↗
• InjuryOct 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 WAS EXPLANTED AND WILL BE RETURNED.

  Patient problems: Capsular Contracture

  MAUDE report 23218004 ↗
• InjurySep 19, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAP CON III". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 23096869 ↗
• InjuryJul 25, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 22608762 ↗
• InjuryJul 7, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 22410810 ↗
• InjuryJun 11, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" AND "CAPSULAR CONTRACTURE GRADE 4". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22187056 ↗
• InjuryMay 5, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 21964404 ↗
• InjuryMay 5, 2025Device Appears to Trigger Rejection; No Apparent Adverse Event; Device Appears to Trigger Rejection; No Apparent Adverse Event

  PATIENT REPORTED "CAPSULAR CONTRACTURE¿, BAKER GRADE UNKNOWN". HEALTH PROFESSIONAL CONFIRMED REPORTED EVENT. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.

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

  MAUDE report 21963801 ↗
• InjuryApr 1, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN." THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 21740879 ↗
• InjuryFeb 10, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 21350966 ↗
• InjuryOct 31, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 18044054 ↗
• InjurySep 11, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL LATER REPORTED A LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 17718058 ↗
• InjuryAug 30, 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 17655956 ↗
• InjuryJul 11, 2023Material Rupture; Material Rupture

  PATIENT REPORTED A RIGHT SIDE PAIN/BURNING SENSATION. HEALTHCARE PROFESSIONAL LATER REPORTED "THE PATIENT MAY HAVE A RUPTURE BUT THEY WONT BE SURE UNTIL AFTER SURGERY." DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 17297770 ↗
• InjuryApr 20, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 16780921 ↗

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-