Natrelle Inspira SoftTouch Breast Implants SSM-330Recalls & reported problems

Summary

The FDA's MAUDE database contains 153 adverse event reports that list this exact device (DI 10888628032927), received between Oct 15, 2019 and Sep 24, 2026 — classified as 150 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (118 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 153 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Device Appears to Trigger Rejection

  Healthcare professional reported: "capsular contracture Baker grade II/III", "higher" and "asymmetry". The patient was prescribed Singulair. This record is for the left-side device. The device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50884650 ↗
• InjurySep 21, 2026Device Appears to Trigger Rejection

  Patient problems: Capsular Contracture

  MAUDE report 50847357 ↗
• InjuryAug 22, 2026Device Appears to Trigger Rejection

  Healthcare professional through National Breast Implant Registry reported "Capsular Contracture Baker Grade III, Correction of Asymmetry, Change shape/size/style". This record is for the left side. Device has been explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50384351 ↗
• InjuryAug 6, 2026Material Rupture

  Patient reported "Pain" and "rupture". This record is for the left side. Device remains implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50164176 ↗
• InjuryJul 14, 2026Device Appears to Trigger Rejection; Material Rupture

  Later, healthcare professional reported "Baker 4 capsule" discovered during surgery. The device has been explanted.

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

  MAUDE report 25817550 ↗
• InjuryJun 15, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 25509781 ↗
• InjuryJun 3, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 25386433 ↗
• InjuryJun 3, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 25386425 ↗
• InjuryJun 2, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED. PATIENT WAS PRESCRIBED ACCOLATE.

  Patient problems: Capsular Contracture

  MAUDE report 25364698 ↗
• InjuryMay 14, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 25176726 ↗
• InjuryMay 14, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 25167235 ↗
• InjuryApr 21, 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 24948166 ↗
• InjuryApr 1, 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 RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24753093 ↗
• InjuryMar 30, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR) "CAPSULAR CONTRACTURE BAKER GRADE III, CHANGE SHAPE/SIZE/STYLE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24730160 ↗
• InjuryFeb 26, 2026Malposition of Device

  PATIENT REPORTED "FALLEN" AND "LOOKS LOWER". HEALTHCARE PROFESSIONAL LATER REPORTED "NO COMPLAINTS AGAINST THE DEVICE". HEALTHCARE PROFESSIONAL LATER REPORTED "DISPLACEMENT" AND "UNACCEPTABLE APPEARANCE OF THE BREAST". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

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

  MAUDE report 24457759 ↗
• InjuryOct 31, 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 REMAINS IMPLANTED AND WILL BE RETURNED.

  Patient problems: Capsular Contracture

  MAUDE report 23434271 ↗
• InjuryOct 20, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED VIA NBIR "SUSPECTED/ACTUAL RUPTURE/DEFLATION, CORRECTION OF ASYMMETRY, CHANGE SHAPE/SIZE/STYLE". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.

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

  MAUDE report 23340466 ↗
• InjuryOct 16, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED VIA NBIR "CAPSULAR CONTRACTURE BAKER GRADE III, CHANGE SHAPE/SIZE/STYLE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 23307890 ↗
• MalfunctionJul 16, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  HEALTHCARE PROFESSIONAL REPORTED "ISSUES WITH THEIR PACKAGING". THE DEVICE WAS NOT IMPLANTED.

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

  MAUDE report 22524674 ↗
• InjuryJul 2, 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 22383393 ↗
• InjuryJul 1, 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 22378532 ↗
• InjuryJun 26, 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 22333989 ↗
• InjuryJun 26, 2025Device 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 22333981 ↗
• InjuryJun 25, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE HAS BEEN EXPLANTED AND REPLACED WITH A NON-ALLERGAN DEVICE.

  Patient problems: Capsular Contracture

  MAUDE report 22333044 ↗
• InjuryJun 24, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 22324613 ↗

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