Natrelle Inspira SoftTouch Breast Implants SSM-310Recalls & reported problems

Summary

The FDA's MAUDE database contains 211 adverse event reports that list this exact device (DI 10888628032910), received between Jun 11, 2019 and Sep 29, 2026 — classified as 209 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (160 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 211 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 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 50935199 ↗
• InjurySep 22, 2026Device Appears to Trigger Rejection

  Patient problems: Capsular Contracture

  MAUDE report 50862453 ↗
• InjurySep 22, 2026Device Appears to Trigger Rejection

  Patient problems: Capsular Contracture

  MAUDE report 50862184 ↗
• InjurySep 21, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "Capsular Contracture Baker Grade III and exchange". This record is for the left side. The device was explanted. Patient was prescribed Accolate.

  Patient problems: Capsular Contracture

  MAUDE report 50836543 ↗
• InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem

  Healthcare professional reported "breast larger" than the other side. This record is for the right side. The device was explanted.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50721674 ↗
• InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem

  Healthcare professional reported "nipple higher" than the other side. This record is for the left side. The device was explanted.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50721436 ↗
• InjurySep 9, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "capsular contracture baker grade IV". This record is for the left side. The device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50694827 ↗
• InjurySep 9, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "capsular contracture baker grade IV". This record is for the right side. The device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50694265 ↗
• InjuryAug 21, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "capsular contracture, Baker grade III". Singulair was prescribed to treat the event but "the issues remain". This record is for the left side. Device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50370944 ↗
• InjuryAug 19, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "grade 3 capsular contracture" against the right side. Later, healthcare professional reported patient was treated with antibiotics and "it only worsened to a Baker grade IV". The device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50332489 ↗
• InjuryAug 7, 2026Device Appears to Trigger Rejection

  Device has been explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50175488 ↗
• InjuryJul 5, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER 3". LATER HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25712351 ↗
• InjuryJul 5, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL DID NOT REPORT AN EVENT. LATER HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25712313 ↗
• InjuryJun 11, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". PATIENT WAS PRESCRIBED MEDROL DOSE PACK. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25472801 ↗
• InjuryJun 3, 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 25375888 ↗
• InjuryJun 3, 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 25375632 ↗
• InjuryJun 2, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED ¿RUPTURE¿. THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 25364725 ↗
• InjuryMay 13, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 25163037 ↗
• InjuryMay 13, 2026Device Appears to Trigger Rejection

  PHYSICIAN REPORTED "BAKER III CAP CONTRACTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25163034 ↗
• InjuryMay 4, 2026Device Appears to Trigger Rejection; Malposition of Device

  HEALTHCARE PROFESSIONAL REPORTED THROUGH NATIONAL BREAST IMPLANT REGISTRY "DEVICE MIGRATION/IMPLANT MALPOSITION" AND "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25075709 ↗
• InjuryMay 4, 2026Malposition of Device

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

  Patient problems: Failure of Implant

  MAUDE report 25075705 ↗
• InjuryMay 4, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 25073035 ↗
• InjuryApr 21, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 24941113 ↗
• InjuryMar 18, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "Capsular Contracture Baker grade IV". Capsulectomy was performed. This record is for the left side. The device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 24626159 ↗
• InjuryMar 6, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 24533944 ↗

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-