Natrelle Inspira SoftTouch Breast Implants SSF-415Recalls & reported problems

Summary

The FDA's MAUDE database contains 330 adverse event reports that list this exact device (DI 10888628033160), received between May 16, 2019 and Sep 23, 2026 — classified as 325 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (232 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 330 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "tightness' and Capsular contracture Baker Grade III. This record is for the left side. Device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50863271 ↗
• InjurySep 21, 2026Device 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 50839504 ↗
• InjurySep 17, 2026Migration

  Healthcare professional reported "implant bottomed out and needed reinforcing". This record is for the left side. The device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50797325 ↗
• InjurySep 11, 2026Device Appears to Trigger Rejection

  HealthCare Professional reported ¿exchange with no complaint against the device¿. HealthCare Professional reported later capsular contracture Baker Grade Unknown. This record is for the left side. Device has been explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50737996 ↗
• InjurySep 11, 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 50736305 ↗
• InjurySep 8, 2026Device Appears to Trigger Rejection

  Patient problems: Capsular Contracture

  MAUDE report 50659053 ↗
• InjurySep 1, 2026Material Rupture

  The device has been explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50546042 ↗
• InjuryAug 25, 2026Device Appears to Trigger Rejection

  Patient reported "capsular contracture Baker grade unknown". Later healthcare professional reported "capsular contracture Baker grade III". Later patient reported "capsular contracture Baker grade III". This record is for the right side. Device remains implanted. Patient was prescribed Accolate.

  Patient problems: Capsular Contracture

  MAUDE report 50435225 ↗
• InjuryAug 24, 2026Device Appears to Trigger Rejection; Material Rupture

  Patient reported "rupture". Later Healthcare Professional reported Capsular Contracture, Baker Grade III-IV and "rupture". This record is for the left side. Device has been explanted.

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

  MAUDE report 50421494 ↗
• InjuryAug 19, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "Capsular Contracture Baker Grade III/IV". Later, healthcare professional reported "Capsular Contracture Baker grade III". Patient underwent capsulectomy. This record is for the right side. Device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50330923 ↗
• InjuryAug 6, 2026Device Appears to Trigger Rejection

  Healthcare professional reported exchange with no complaint against the device. Later patient reported exchange with no complaint against the device. Later 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 50166207 ↗
• InjuryJul 27, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "Grade 3 Capsular Contracture". This record is for the right side. Device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50016992 ↗
• InjuryJul 22, 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 25909243 ↗
• InjuryJul 21, 2026Device Appears to Trigger Rejection

  Device has been explanted and replaced.

  Patient problems: Capsular Contracture

  MAUDE report 25899516 ↗
• InjuryJul 20, 2026Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". LATER HEALTHCARE PROFESSIONAL REPORTED "GRADE III CAPSULAR CONTRACTURE" AND "A TEAR IN THE CAPSULE WAS NOTED". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED. PATIENT WAS PRESCRIBED SINGULAIR.

  Patient problems: Capsular Contracture

  MAUDE report 25882571 ↗
• InjuryJul 15, 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 25830525 ↗
• InjuryJun 26, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". LATER HEALTHCARE PROFESSIONAL REPORTED "BREAST IMPLANT DISPLAYS MALPOSITION", "INCREASED FIRMNESS CONSISTENT WITH A CAPSULAR CONTRACTURE BAKER GRADE III-IV WITH ASSOCIATED DISCOMFORT". CAPSULECTOMY AND ACCOLATE WAS PERFORMED AS TREATMENT. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25635087 ↗
• InjuryMay 18, 2026Device Appears to Trigger Rejection

  Healthcare professional reported of the left side device: capsular contracture Baker grade III. The device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 25207674 ↗
• InjuryMar 30, 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 24736808 ↗
• InjuryMar 30, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 24729404 ↗
• InjuryMar 6, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED ¿MRI WAS INTERPRETED AS SHOWING A RUPTURED IMPLANT. WHEN REMOVED THE IMPLANT, IT WAS FOUND TO BE INTACT¿. THIS RECORD IS FOR AN UNKNOWN SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 24533677 ↗
• InjuryJan 27, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED THROUGH DEVICE MANAGEMENT PORTAL "GRADE 3 CONTRACTURE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24189805 ↗
• InjuryDec 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 WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23892620 ↗
• InjuryDec 25, 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 UNKNOWN". THIS RECORD IS FOR UNKNOWN SIDE. DEVICE STATUS IS UNKNOWN.

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

  MAUDE report 23892568 ↗
• InjuryDec 1, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL VIA DEVICE RETURN REPORTED CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND RETURNED.

  Patient problems: Capsular Contracture

  MAUDE report 23682319 ↗

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