Natrelle Inspira SoftTouch Breast Implants SSF-345Recalls & reported problems

Summary

The FDA's MAUDE database contains 159 adverse event reports that list this exact device (DI 10888628033139), received between Jun 20, 2019 and Sep 30, 2026 — classified as 159 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (107 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 159 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

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

  MAUDE report 50950102 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

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

  MAUDE report 50937935 ↗
• InjurySep 22, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "Capsular Contracture Baker grade IV" and "having a lot of pain". This record is for the right side. Device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50853344 ↗
• InjurySep 21, 2026Material Rupture

  Healthcare Professional reported "lump" and "rupture". This record is for the right side. Device remains implanted.

  Patient problems: Breast Mass

  MAUDE report 50841997 ↗
• InjuryAug 19, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 50331307 ↗
• InjuryJul 27, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "Capsular Contracture Baker Grade IV". This record is for the right side. The device has been explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50048207 ↗
• InjuryJun 30, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 25664793 ↗
• InjuryJun 23, 2026Device Appears to Trigger Rejection

  Healthcare professional reported Capsular Contracture Baker grade IV. This record is for the right side. The device has been explanted.

  Patient problems: Capsular Contracture

  MAUDE report 25599211 ↗
• InjuryJun 15, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED OF THE RIGHT SIDE DEVICE: CAPSULAR CONTRACTURE BAKER GRADE III. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25503243 ↗
• InjuryMay 15, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED VIA NATIONAL BREAST IMPLANT REGISTRY (B)(6) 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 25192554 ↗
• InjuryMay 6, 2026Device Appears to Trigger Rejection; Material Rupture

  PATIENT REPORTED "REALLY BAD PAIN IN CENTER OF MY CHEST, THROUGH MY BACK, UP INTO MY COLLAR BONE, MY NECK, DOWN ON MY LEFT ARM", "IMPLANT IS GETTING SMALLER", "CAPSULAR CONTRACTURE" BAKER GRADE III", "PRESSING ON MY CHEST, GRAVITATING TO THE CENTER" AND "I CAN'T BREATH". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25104984 ↗
• InjuryApr 28, 2026Device Appears to Trigger Rejection

  Healthcare Professional reported "capsular contracture, Baker grade III". This record is for the right side. Device has been explanted.

  Patient problems: Capsular Contracture

  MAUDE report 25021708 ↗
• InjuryApr 28, 2026Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 25018264 ↗
• InjuryApr 7, 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 24800824 ↗
• InjuryApr 6, 2026Device Appears to Trigger Rejection

  DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 24791309 ↗
• InjuryJan 12, 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 24032969 ↗
• InjuryNov 19, 2025Device Appears to Trigger Rejection; Material Rupture; Malposition of Device; Device Appears to Trigger Rejection; Material Rupture; Malposition of Device

  HEALTHCARE PROFESSIONAL REPORTED "GRADE III CAPSULAR CONTRACTURE". LATER HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE WITH IMPLANT MALPOSITION (BAKER GRADE III)" AND "THE IMPLANT WAS FOUND TO BE RUPTURED". THIS RECORD IS FOR RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED AND WILL BE RETURNED.

  Patient problems: Capsular Contracture

  MAUDE report 23592834 ↗
• InjuryOct 22, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "IMPLANT RUPTURE LEFT". THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 23360123 ↗
• InjuryOct 16, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23319891 ↗
• InjuryOct 15, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23280156 ↗
• InjuryOct 7, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV, SUSPECTED/ACTUAL RUPTURE/DEFLATION" VIA NBIR. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23238518 ↗
• InjuryAug 20, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "RUPTURE" VIA NBIR. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 22855916 ↗
• InjuryAug 18, 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.

  Patient problems: Capsular Contracture

  MAUDE report 22828276 ↗
• InjuryAug 15, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "CAPSULAR CONTRACTURE BAKER GRADE IV". PATIENT LATER REPORTED "EXPERIENCED BII SYMPTOMS, WEIGHT LOSS, AND HAIR LOSS WITH THIS IMPLANT". THE EVENT OF WEIGHT LOSS AND HAIR LOSS ARE NOT DEVICE RELATED. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22820869 ↗
• InjuryAug 8, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 22747373 ↗

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-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-