Natrelle Inspira SoftTouch Breast Implants SSF-650Recalls & reported problems

Summary

The FDA's MAUDE database contains 101 adverse event reports that list this exact device (DI 10888628033221), received between Jul 4, 2019 and Sep 30, 2026 — classified as 98 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (63 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 101 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "Capsular Contracture". Later Healthcare professional reported "Capsular Contracture Baker Grade III". This record is for the left side. Device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50947821 ↗
• InjurySep 22, 2026Device Appears to Trigger Rejection; Material Rupture

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

  Patient problems: Capsular Contracture

  MAUDE report 50860249 ↗
• InjurySep 13, 2026Device Appears to Trigger Rejection

  Patient problems: Capsular Contracture

  MAUDE report 50747585 ↗
• InjuryAug 14, 2026Device Appears to Trigger Rejection

  Patient reported "Capsular contracture" Baker Grade unknown. This record is for the left side. Device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50261804 ↗
• InjuryAug 14, 2026Device Appears to Trigger Rejection

  Patient reported "Capsular contracture" Baker Grade unknown. This record is for the right side. Device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50261722 ↗
• InjuryAug 6, 2026Device Appears to Trigger Rejection

  Healthcare professional reported ¿Capsular Contracture Baker grade III¿ and ¿Visible asymmetry¿. This record is for the left side. Device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50163389 ↗
• InjuryJul 30, 2026Material Rupture

  Healthcare professional reported "Rupture". Healthcare professional later reported "hole, non-specific" and "hole in radius (edge)". This record is for the right side. Device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50091660 ↗
• InjuryJun 16, 2026Material Rupture

  PATIENT REPORTED ¿ENCAPSULATED¿. LATER HEALTHCARE PROFESSIONAL REPORTED ¿RUPTURE¿. LATER PATIENT REPORTED "NIPPLE DISCHARGE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25523324 ↗
• InjuryJun 7, 2026Material Rupture

  Healthcare professional reported a rupture. Capsulotomy was performed. This record is for the left side. The device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25422312 ↗
• InjuryJun 6, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED ¿BODY REJECTED THE IMPLANT AGAIN¿. LATER PATIENT PROVIDED OPERATIVE REPORTS STATING "ENLARGEMENT OF BREAST POCKET WITH LATERALIZATION OF IMPLANTS", "THINNED AND STRETCHED OUT PERI-PROSTHETIC CAPSULE", AND "COMPLICATED BY INFECTION". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

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

  MAUDE report 25419620 ↗
• InjuryJun 6, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED ¿BODY REJECTED THE IMPLANT AGAIN¿. LATER PATIENT PROVIDED OPERATIVE REPORTS STATING "ENLARGEMENT OF BREAST POCKET WITH LATERALIZATION OF IMPLANTS", "THINNED AND STRETCHED OUT PERI-PROSTHETIC CAPSULE", AND "COMPLICATED BY INFECTION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

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

  MAUDE report 25419605 ↗
• InjuryJun 3, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 25371883 ↗
• InjuryApr 13, 2026Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24860333 ↗
• InjuryMar 31, 2026Malposition of Device

  HEALTHCARE PROFESSIONAL REPORTED "MALPOSITION". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 24747827 ↗
• InjuryMar 31, 2026Malposition of Device

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

  Patient problems: Failure of Implant

  MAUDE report 24747583 ↗
• InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 23612012 ↗
• InjuryNov 11, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE 3". THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 23523015 ↗
• InjuryOct 29, 2025Migration; Migration

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

  Patient problems: Failure of Implant

  MAUDE report 23415626 ↗
• InjuryOct 29, 2025Migration; Migration

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

  Patient problems: Failure of Implant

  MAUDE report 23412024 ↗
• InjurySep 28, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 23164073 ↗
• InjurySep 10, 2025Migration; Migration

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE IS "TOO BIG, BOTTOMED OUT". THE DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 23016901 ↗
• InjuryAug 6, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 22731475 ↗
• MalfunctionJul 31, 2025Difficult to Open or Remove Packaging Material; Device Contaminated During Manufacture or Shipping; Difficult to Open or Remove Packaging Material; Device Contaminated During Manufacture or Shipping

  HEALTHCARE PROFESSIONAL REPORTED VIA SALES REPRESENTATIVE IMPLANT WAS STUCK TO THE PLASTIC LINER AND A PIECE OF PAPER WAS ALSO IN THE STERILE CONTAINER. THE 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 22676361 ↗
• InjuryJul 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED "INFECTION CONCERN" AND "MASTITIS". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 22509371 ↗
• InjuryJul 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED "INFECTION CONCERN" AND "MASTITIS". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 22506107 ↗

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-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