Natrelle Inspira SoftTouch Breast Implants SSM-375Recalls & reported problems

Summary

The FDA's MAUDE database contains 205 adverse event reports that list this exact device (DI 10888628032958), received between Apr 9, 2018 and Sep 22, 2026 — classified as 204 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (132 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 205 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2026Device Appears to Trigger Rejection

  Healthcare professional reported Capsular Contracture Baker grade Unknown. This record is for the left side. The device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50856432 ↗
• InjurySep 21, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "Baker grade III capsular contracture". This record is for the left side. Device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50840656 ↗
• InjurySep 18, 2026Device Appears to Trigger Rejection

  Patient problems: Capsular Contracture

  MAUDE report 50830973 ↗
• InjuryAug 29, 2026Device Appears to Trigger Rejection

  Device has been explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50509820 ↗
• InjuryAug 5, 2026Device Appears to Trigger Rejection

  Healthcare professional reported of the left side device: "hardness to the touch, pain, implant sitting higher than normal, breast asymmetry", and "diagnosis of capsular contracture was made." The device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50147713 ↗
• InjuryAug 3, 2026Device Appears to Trigger Rejection

  Healthcare professional reported Capsular Contracture Baker grade III. This record is for the right side. Device remains implanted.

  Patient problems: Seroma

  MAUDE report 50123148 ↗
• InjuryJul 27, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "capsular contracture, Baker grade unknown". Later healthcare professional reported capsular contracture, Baker grade III. This record is for the left side. Device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50041888 ↗
• InjuryJul 8, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURED". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25746605 ↗
• InjuryMay 14, 2026Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR) MANUFACTURER REGISTRY SPECIFIC DATA REPORT (MRSDR) "CAPSULAR CONTRACTURE, BAKER GRADE III, DEVICE MIGRATION/IMPLANT MALPOSITION AND SUSPECTED/ACTUAL RUPTURE/DEFLATION". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25167220 ↗
• InjuryApr 30, 2026Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25046015 ↗
• InjuryApr 15, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED A "CAPSULAR CONTRACTURE BAKER GRADE IV" AND A "CHANGE SHAPE/SIZE/STYLE" VIA NBIR. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24887523 ↗
• InjuryApr 11, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE FOUND UPON EXAMINATION". HEALTHCARE PROFESSIONAL LATER REPORTED CAPSULAR CONTRACTURE, BAKER GRADE IV. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24849316 ↗
• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED ¿DEFORMITY REC. BREAST¿. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

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

  MAUDE report 24821055 ↗
• InjuryJan 12, 2026Malposition of Device; Migration

  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. UNKNOWN IF THE DEVICE WILL BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 24045631 ↗
• InjuryDec 16, 2025Migration; Migration

  HEALTHCARE PROFESSIONAL REPORTED VIA THE NATIONAL BREAST IMPLANT REGISTRY (NBIR) "DEVICE MIGRATION/IMPLANT MALPOSITION". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED. IT IS UNKNOWN IF IT WILL BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 23814400 ↗
• InjuryDec 15, 2025Device Appears to Trigger Rejection; Malposition of Device; Migration; Device Appears to Trigger Rejection; Malposition of Device; Migration

  HEALTHCARE PROFESSIONAL VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR) REPORTED "CAPSULAR CONTRACTURE BAKER GRADE 3, DEVICE MIGRATION/IMPLANT MALPOSITION, CORRECTION OF ASYMMETRY". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED. UNKNOWN IF THE DEVICE WILL BE RETURNED.

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

  MAUDE report 23810897 ↗
• InjuryDec 11, 2025Migration; Migration

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

  Patient problems: Failure of Implant

  MAUDE report 23781968 ↗
• InjuryOct 6, 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. THE DEVICE HAS BEEN EXPLANTED AND REPLACED. DEVICE WILL BE RETURNED.

  Patient problems: Capsular Contracture

  MAUDE report 23227810 ↗
• InjurySep 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 HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23142080 ↗
• InjurySep 17, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "BREAST HARDNESS AND PAIN", "FIRMNESS, DISCOMFORT, BREAST DISTORTION" AND "CAPSULAR CONTRACTURE," BAKER GRADE UNKNOWN. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23080407 ↗
• InjurySep 3, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 22956448 ↗
• InjuryAug 27, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED ¿RUPTURE¿. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 22904932 ↗
• InjuryJul 29, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 22644551 ↗
• InjuryJul 25, 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 22609968 ↗
• InjuryJul 24, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22601392 ↗

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-