Natrelle Inspira SoftTouch Breast Implants SSM-275Recalls & reported problems

Summary

The FDA's MAUDE database contains 129 adverse event reports that list this exact device (DI 10888628032897), received between May 15, 2019 and Aug 14, 2026 — classified as 126 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (96 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 129 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "capsular contracture grade 3". This record is for the right side. Device was explanted. Patient was prescribed Accolate.

  Patient problems: Capsular Contracture

  MAUDE report 50262719 ↗
• InjuryJul 9, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 25765550 ↗
• InjuryJun 29, 2026Device Appears to Trigger Rejection; Material Rupture

  Healthcare professional reported "Capsule Contracture Baker grade 3". Healthcare professional later reported "Hole in radius (edge)". This record is for the left side. The device was explanted. Patient was prescribed Singulair.

  Patient problems: Capsular Contracture

  MAUDE report 25652349 ↗
• InjuryJun 17, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 25534953 ↗
• InjuryJun 17, 2026Device 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 25530531 ↗
• InjuryJun 3, 2026Malposition of Device; Migration

  HEALTHCARE PROFESSIONAL REPORTED VIA THE NATIONAL BREAST IMPLANT REGISTRY (NBIR) MANUFACTURER REGISTRY SPECIFIC DATA REPORT (MRSDR) "MIGRATION/MALPOSITION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25385079 ↗
• InjuryFeb 6, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 24277892 ↗
• MalfunctionDec 12, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  HEALTHCARE PROFESSIONAL REPORTED "IMPLANT BEING CONTAMINATED" AND "STRUGGLED TO OPEN". HEALTHCARE PROFESSIONAL REPORTED "IMPLANT STUCK TO THE CASE (PACKAGING), ALLERGAN DEFECT, CONTAMINATED DURING OPENING" AND "THIS IMPLANT WAS DAMAGED DUE TO GLUE AROUND THE CASE". THE DEVICE WAS NOT IMPLANTED. THE DEVICE WILL NOT BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23791158 ↗
• InjuryOct 9, 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. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23256290 ↗
• InjuryAug 15, 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 AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22816462 ↗
• InjuryAug 15, 2025Device Appears to Trigger Rejection; No Apparent Adverse Event; Device Appears to Trigger Rejection; No Apparent Adverse Event

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

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

  MAUDE report 22813082 ↗
• InjuryAug 12, 2025Device Appears to Trigger Rejection; Device 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 22783332 ↗
• InjuryAug 11, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL DIDN´T REPORTED A COMPLAINT AGAINST THE DEVICE. LATER HEALTHCARE PROFESSIONAL REPORTED ¿NO COMPLAINT¿. LATER HEALTHCARE PROFESSIONAL REPORTED ¿CAPSULAR CONTRACTURE¿. LATER HEALTHCARE PROFESSIONAL REPORTED BAKER GRADE III. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22768424 ↗
• InjuryAug 8, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22756274 ↗
• MalfunctionJul 21, 2025Unsealed Device Packaging; Unsealed Device Packaging

  HEALTHCARE PROFESSIONAL REPORTED VIA COMPANY REPRESENTATIVE "DAMAGED CONSIGNMENT IMPLANT", "OUTER THERMOFORM OF THE INNER PACKAGING IS BENT, SO YES DAMAGED". HEALTHCARE PROFESSIONAL FURTHER REPORTED " THE PLASTIC CONTAINER THAT HOLDS THE ACTUAL IMPLANT IS DAMAGED AS WELL. WE DID NOT FEEL LIKE IT WAS SAFE TO USE THIS ON A PATIENT DUE TO POSSIBLE CONTAMINATION". DEVICE WAS NOT IMPLANTED. IT IS UNKNOWN IF SURGERY WAS COMPLETED WITH A BACKUP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22555047 ↗
• InjuryMay 30, 2025Device 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 22120086 ↗
• InjuryMay 14, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 22021264 ↗
• InjuryApr 17, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE DEVICE HAS BEEN EXPLANTED AND REPLACED. PREDNISONE TAPER AND SINGULAIR WERE USED AS TREATMENT.

  Patient problems: Capsular Contracture

  MAUDE report 21853750 ↗
• InjuryApr 10, 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. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 21817905 ↗
• InjuryFeb 9, 2024Device Appears to Trigger Rejection; Migration; Device Appears to Trigger Rejection; Migration

  PATIENT REPORTED "RIGHT SIDE IMPLANT IS DEFORMED, DAMAGED, HAS A PING PONG SIZED DENT, IS WARPED AND LOPSIDED, AND IS DRAMATICALLY SMALLER THAN THE LEFT. THE PATIENT ALSO STATED THAT BOTH IMPLANTS LIFTED UP AND ARE SUPER WIDE.". PATIENT LATER REPORTED "FREE FLOATING SILICONE SURROUNDING LYMPH NODES WAS FOUND BY ULTRASOUND AND X-RAY" AND "PROBLEM WITH LIFTING ARM". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture; Failure of Implant

  MAUDE report 18676891 ↗
• InjuryNov 21, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "CAPSULAR CONTRACTURE, BAKER GRADE III". DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 18187283 ↗
• InjuryNov 7, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULECTOMY. HEALTHCARE PROFESSIONAL LATER REPORTED CAPSULAR CONTRACTURE, BAKER GRADE IV AND "THE ENTIRE SCAR TISSUE AROUND BREAST IMPLANT IS REMOVED". HEALTHCARE PROFESSIONAL LATER REPORTED CAPSULAR CONTRACTURE BAKER GRADE III. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 18082703 ↗
• InjuryOct 16, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. HEALTHCARE PROFESSIONAL LATER REPORTED "ANY CREASES". DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 17943857 ↗
• InjuryOct 16, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. HEALTHCARE PROFESSIONAL LATER REPORTED "ANY CREASES". DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 17943489 ↗
• InjurySep 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED, A RIGHT SIDE "INFECTION". DEVICE HAS BEEN EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 17795216 ↗

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