Natrelle Inspira SoftTouch Breast Implants SSM-360Recalls & reported problems

Summary

The FDA's MAUDE database contains 135 adverse event reports that list this exact device (DI 10888628032941), received between May 17, 2019 and Sep 21, 2026 — classified as 135 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (85 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 135 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2026Material Rupture

  Healthcare professional reported "cyst and clusters of microcyst", "thickening of the capsule-shell complex", "appearance and irregularity of the implant shell" and "rupture". This record is for right side. The device remains implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50846199 ↗
• InjurySep 10, 2026Device Appears to Trigger Rejection

  Patient problems: Capsular Contracture

  MAUDE report 50724995 ↗
• InjuryAug 26, 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 50456822 ↗
• InjuryAug 19, 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 50331904 ↗
• InjuryAug 19, 2026Material Protrusion/Extrusion

  Healthcare professional reported ¿implant is exposed on her chest due to a wound¿, ¿developed a wound on her breast¿, ¿she was hospitalized with sepsis¿, ¿wound came back and reopened¿, ¿implant exposed and and everything leaked out¿. This record is for an unknown side. Device remains implanted.

  Patient problems: Pocket Erosion; Post Operative Wound Infection; Sepsis

  MAUDE report 50331232 ↗
• InjuryAug 6, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "capsular contracture, baker grade IV". This record is for the left side. The device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50165025 ↗
• InjuryJul 30, 2026Device Appears to Trigger Rejection

  Healthcare Professional reported reported via the National Breast Implant Registry (NBIR) ¿Capsular Contracture Baker Grade IV". This record is for the left side. Device has been explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50091438 ↗
• InjuryJul 21, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "PAIN, HARDENING", "CAPSULAR CONTRACTURE BAKER GRADE IV". PATIENT WAS PRESCRIBED WITH SINGULAIR (400 UNITS TWICE PER DAY FOR 3 MONTHS) AND VITAMIN E. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25893627 ↗
• InjuryJun 19, 2026Device Appears to Trigger Rejection

  .Healthcare professional reported "Baker Grade III capsular contracture and implant exchange". This record is for the left side. The device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 25563033 ↗
• InjuryJun 5, 2026Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25417605 ↗
• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Seroma; Unspecified Infection

  MAUDE report 25185582 ↗
• InjuryApr 23, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE, BAKER III". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24972215 ↗
• InjuryApr 15, 2026Device Appears to Trigger Rejection

  Device has been explanted.

  Patient problems: Capsular Contracture

  MAUDE report 24889570 ↗
• InjuryApr 1, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV" THROUGH THE NATIONAL BREAST IMPLANT REGISTRY (NBIR). THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24758006 ↗
• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED THROUGH THE NATIONAL BREAST IMPLANT REGISTRY (NBIR) "SEROMA". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Seroma

  MAUDE report 24442064 ↗
• InjuryFeb 3, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED ¿FALL WITH HIT TO HEAD¿ AND ¿RUPTURE¿. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED WITH A NON-ABBVIE DEVICE.

  Patient problems: Failure of Implant

  MAUDE report 24248786 ↗
• InjuryJan 14, 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 24067266 ↗
• InjuryDec 12, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE". LATER THE HEALTHCARE PROFESSIONAL CONFIRMED "GRADE 4 CAPSULAR CONTRACTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23793499 ↗
• InjuryDec 10, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE". LATER THE HEALTHCARE PROFESSIONAL CONFIRMED "GRADE 4 CAPSULAR CONTRACTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23773870 ↗
• InjurySep 10, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". HEALTHCARE PROFESSIONAL LATER REPORTED "III/IV AND SLIVER OF FLUID". PATIENT RECEIVED ONE SESSION OF ULTRASOUND THERAPY AND SINGULAIR WAS PRESCRIBED. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23016783 ↗
• InjuryAug 28, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAP CON" AND "CAPSULAR CONTRACTURE BAKER GRADE III ". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22910204 ↗
• InjuryAug 26, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RUPTURE. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 22894164 ↗
• InjuryJul 10, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 22469738 ↗
• InjuryJul 10, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22468302 ↗
• InjuryJun 4, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 22143962 ↗

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