Natrelle Inspira SoftTouch Breast Implants SSF-695Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10888628033238), received between Oct 18, 2019 and Sep 30, 2026 — classified as 48 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (32 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 48 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "cloudy". Later, healthcare professional reported "capsular contracture Baker grade 4". This record is for the left side. The device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50948882 ↗
• InjurySep 21, 2026Device Appears to Trigger Rejection

  Patient reported "Capsular contracture" Baker Grade unknown, "top of breast feels hard", "Pain" and "nipple is sore". This record is for the left side. Device remains implanted. Patient was prescribed an unknown medication.

  Patient problems: Capsular Contracture

  MAUDE report 50836589 ↗
• InjurySep 16, 2026Device Appears to Trigger Rejection

  Patient problems: Capsular Contracture

  MAUDE report 50796757 ↗
• InjuryAug 21, 2026Device 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 50379777 ↗
• InjuryJun 9, 2026Device Appears to Trigger Rejection

  PATIENT REPORTED ¿CAPSULAR CONTRACTURE, BAKER GRADE III", "PTOSIS", AND "ASYMMETRY¿. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25445132 ↗
• InjuryJun 9, 2026Device Appears to Trigger Rejection

  PATIENT REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE IV", "PTOSIS", AND "ASYMMETRY". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25443558 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED THROUGH NATIONAL BREAST IMPLANT REGISTRY "INFECTION, SEROMA, SKIN NECROSIS AND WOUND PROBLEMS". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE STATUS IS UNKNOWN.

  Patient problems: Necrosis; Seroma; Unspecified Infection; Wound Infection

  MAUDE report 23996565 ↗
• InjuryAug 25, 2025Malposition of Device; Malposition of Device

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "IMPLANT FLIPPED". THE DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 22883208 ↗
• InjuryAug 8, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED ¿NON-DEVICE RELATED HEMATOMA THE DOCTOR ACCIDENTLY SLICED THE IMPLANT¿. LATER HEALTHCARE PROFESSIONAL REPORTED "RUPTURE. SURGEON RUPTURE ON REMOVAL". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 22759555 ↗
• InjuryJun 23, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22307265 ↗
• InjuryMay 26, 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 WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22085260 ↗
• InjuryApr 17, 2025Material Rupture; Patient-Device Incompatibility; Material Rupture; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED "IMPLANT POCKET ABSCESS AND INFECTED IMPLANT" AND "IMPLANT EXTRUSION WITH PURULENT DRAINAGE". LATER, PATIENT REPORTED RUPTURE AND "EXPOSED IMPLANT". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Abscess; Erosion; Fluid Discharge; Foreign Body Reaction; Unspecified Infection

  MAUDE report 21854971 ↗
• InjuryMar 4, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED PER NBIR RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 21518133 ↗
• InjuryNov 16, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL LATER REPORTED IMPLANT MALPOSITION.

  Patient problems: Capsular Contracture

  MAUDE report 18155433 ↗
• InjurySep 22, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED VIA NBIR A RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE II-III. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 17801305 ↗
• InjuryAug 15, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 17552324 ↗
• InjuryMay 23, 2023Material Rupture; Material Rupture

  PATIENT REPORTED LEFT SIDE RUPTURE. HEALTHCARE PROFESSIONAL REPORTED RUPTURE. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 16986062 ↗
• InjuryMay 4, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 16871480 ↗
• InjuryApr 26, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 16815712 ↗
• InjuryApr 26, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 16815710 ↗
• InjuryApr 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED SIDE INFECTION AND BREAST CANCER (NON DEVICE RELATED). THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 16763921 ↗
• InjuryApr 5, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED EVAC SEROMA, CAPSULAR CONTRACTURE BAKER GRADE III AND MALPOSITION. DEVICE WAS EXPLANTED. THIS RELATES TO THE LEFT SIDE.

  Patient problems: Capsular Contracture; Seroma

  MAUDE report 16683087 ↗
• InjuryMar 7, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 16499447 ↗
• InjuryFeb 14, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED HARDNESS TO THE TOUCH, IMPLANT SITTING HIGHER THAN NORMAL, BREAST ASYMMETRY, DISCOMFORT, AND CAPSULAR CONTRACTURE BAKER GRADE IV. THIS REPRESENTS THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 16376000 ↗
• InjuryJan 19, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 16204429 ↗

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