Natrelle Inspira SoftTouch Breast Implants SSM-445Recalls & reported problems

Summary

The FDA's MAUDE database contains 195 adverse event reports that list this exact device (DI 10888628032972), received between May 16, 2019 and Sep 30, 2026 — classified as 192 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (130 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 195 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 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 Singulair and Massages.

  Patient problems: Capsular Contracture

  MAUDE report 50946034 ↗
• InjurySep 9, 2026Device Appears to Trigger Rejection; Material Rupture

  Patient problems: Capsular Contracture

  MAUDE report 50702893 ↗
• InjuryAug 28, 2026Device Appears to Trigger Rejection

  Later healthcare professional reported "Baker Grade III capsule (palpable and visible deformity)". This record is for the right side. Device remains implanted. Patient was prescribed Singulair.

  Patient problems: Capsular Contracture

  MAUDE report 50502047 ↗
• InjuryAug 28, 2026Device Appears to Trigger Rejection; No Apparent Adverse Event

  Later healthcare professional reported "no complaint". This record is no longer reportable to FDA and will be unreported.

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

  MAUDE report 50501974 ↗
• InjuryAug 20, 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 50347248 ↗
• InjuryMay 22, 2026Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  Patient reported "infection, swelling and exposure on the new device", "hospitalized for 3 days and was on IV antibiotics, prescribed levofloxacin", "infection tested positive for Acute cellulitis". Later healthcare professional reported " Acute Cellulitis, tenderness, swelling, fever, redness, patient was then sent to hospital for IV antibiotics". This record is for the record is for the right side. Device remains implanted.

  Patient problems: Cellulitis; Foreign Body Reaction; Impaired Healing; Wound Dehiscence

  MAUDE report 25259008 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 24861023 ↗
• InjuryMar 12, 2026Malposition of Device; Migration

  HEALTHCARE PROFESSIONAL REPORTED VIA NATIONAL BREAST IMPLANT REGISTRY "WRINKLING/RIPPLING", "MALPOSITION" AND "CORRECTION OF ASYMMETRY". THIS RECORD IS FOR LEFT SIDE. THE DEVICE WAS EXPLANTED.

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

  MAUDE report 24586899 ↗
• InjuryFeb 17, 2026Device Appears to Trigger Rejection

  THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24372104 ↗
• InjuryFeb 17, 2026Malposition of Device; Migration

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

  Patient problems: Failure of Implant

  MAUDE report 24362271 ↗
• InjuryFeb 13, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III" VIA THE NATIONAL BREAST IMPLANT REGISTRY (NBIR). THIS RECORD IS FOR LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24331817 ↗
• InjuryFeb 5, 2026Device Appears to Trigger Rejection

  DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 24270417 ↗
• InjuryJan 22, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR RIGHT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 24149489 ↗
• InjuryNov 21, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. LATER, HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE IV. SURGICAL INTERVENTION: CAPSULECTOMY. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 23623574 ↗
• InjuryOct 23, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED NEEDING TO START A CLAIM. LATER HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III" AND "SUPERIOR MALPOSITION". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23373749 ↗
• MalfunctionSep 8, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  HEALTHCARE PROFESSIONAL REPORTED "THE OUTSIDE WRAPPER WASN'T COMING OFF AND WAS STUCK TO THE PRODUCT¿. THE DEVICE WAS NOT IMPLANTED. THE IMPLANT DIDN'T MAKE CONTACT WITH THE PATIENT. THE SURGERY WAS COMPLETED WITH A BACKUP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22995576 ↗
• InjuryAug 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED "DELAYED WOUND HEALING, NO SIGN OF INFECTION" AND "DEHISCENCE WITH DELAYED WOUND HEALING". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED. TREATMENT: WOUND DEHISCENCE REQUIRING EXCISIONAL IMPLANTS, WASHOUT, RECLOSURE.

  Patient problems: Impaired Healing; Wound Dehiscence

  MAUDE report 22784143 ↗
• InjuryAug 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DELAYED WOUND HEALING, NO SIGN OF INFECTION (WOUND DEHISCENCE). THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Impaired Healing; Wound Dehiscence

  MAUDE report 22779771 ↗
• InjuryJul 23, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "NO COMPLAINT, NO EXCHANGE". HEALTHCARE PROFESSIONAL LATER REPORTED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN". THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22580673 ↗
• InjuryJul 21, 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 22556034 ↗
• InjuryJul 14, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  HEALTHCARE PROFESSIONAL REPORTED "DEFORMITY OF BREAST GAPPING". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22495879 ↗
• InjuryJun 27, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE III. THE DEVICE REMAINS IMPLANTED. THIS RELATES TO THE LEFT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 22344699 ↗
• InjuryJun 26, 2025Fluid/Blood Leak; Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "DEFLATION". THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 22333979 ↗
• InjuryJun 24, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" DIAGNOSED VIA ULTRASOUND. THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 22312864 ↗
• InjuryJun 23, 2025Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 22305050 ↗

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 108
• 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,TRL-
• 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, 110-210,