Natrelle Inspira SoftTouch Breast Implants SSF-325Recalls & reported problems

Summary

The FDA's MAUDE database contains 143 adverse event reports that list this exact device (DI 10888628033115), received between Jun 4, 2019 and Sep 30, 2026 — classified as 143 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (94 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 143 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "Capsular contracture". Healthcare professional then reported "Baker Grade 2" and then reported "Baker Grade 3". This record is for the left side. Device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50951043 ↗
• InjurySep 15, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 50777290 ↗
• InjurySep 11, 2026Device Appears to Trigger Rejection

  Patient problems: Capsular Contracture

  MAUDE report 50740361 ↗
• InjurySep 8, 2026Device 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 50668195 ↗
• InjurySep 7, 2026Device Appears to Trigger Rejection

  Patient problems: Capsular Contracture

  MAUDE report 50652809 ↗
• InjuryAug 21, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "slight hardening of the implant could be early capsular contracture", "mild breast asymmetry is present", "breast is softer, still tight laterally and not fully rounded", "implant still up higher on chest well and with more projection", "breast stiffness, discomfort", "breast is firm-more so than her last visit, now back to grade 3 capsular contracture, she states its painful more consistent with grade 4". This record is for the left side. Device remains implanted. Patient was prescribed Celebrex and Singulair.

  Patient problems: Capsular Contracture

  MAUDE report 50379091 ↗
• InjuryJul 27, 2026Material Rupture

  Healthcare professional reported "Rupture/Deflation". This record is for the left side. Device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50009414 ↗
• InjuryJul 9, 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 25770842 ↗
• InjuryJul 8, 2026Device Appears to Trigger Rejection; Material Rupture

  Healthcare professional reported "capsular contracture, Baker grade III¿. Healthcare professional reported "hole, non-specific". This record is for the left side. Device has been explanted.

  Patient problems: Capsular Contracture

  MAUDE report 25748742 ↗
• InjuryJun 30, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULE CONTRACTURE BAKER GRADE 3". LATER HEALTHCARE PROFESSIONAL REPORTED "HIGH, TIGHT PAIN". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED. PATIENT WAS PRESCRIBED SINGULAIR.

  Patient problems: Capsular Contracture

  MAUDE report 25665610 ↗
• InjuryJun 26, 2026Device Appears to Trigger Rejection

  Healthcare professional reported Capsular Contracture, hardness and pain. Later through operative report was noted a Grade IV. This record is for the right side. The device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 25641956 ↗
• InjuryJun 1, 2026Patient-Device Incompatibility

  PATIENT REPORTED ¿DROPPED REALLY LOW AND SKIN BREAKDOWN IS THERE¿. LATER HEALTHCARE PROFESSIONAL REPORTED ¿RUPTURE¿ AND ¿IMPLANT EXPOSURE¿. LATER HEALTHCARE PROFESSIONAL REPORTED NO RUPTURE. THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Foreign Body Reaction

  MAUDE report 25351481 ↗
• InjuryMay 13, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED ¿CAPSULAR CONTRACTURE BAKER GRADE III AND IMPLANT MALPOSITION¿. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25162671 ↗
• InjuryJan 8, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "FLANK PAIN" AND "INTRACAPSULAR RUPTURE". LATER THE HEALTHCARE PROFESSIONAL CONFIRMED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 24014857 ↗
• InjuryNov 29, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 23675877 ↗
• InjuryNov 28, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE LLL". THIS RECORD IS FOR RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23671379 ↗
• InjuryNov 7, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" AND CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. LATER HEALTHCARE PROFESSIONAL REPORTED "RUPTURE", "CAPSULAR CONTRACTURE", "BAKER GRADE FOR CAPSULAR CONTRACTURE: 3" AND "VERY EARLY RUPTURE IN AN IMPLANT LEADING TO CAPSULAR CONTRACTURE. I THOUGHT THE DEVICE MIGHT HAVE BEEN HIGH-RIDING DUE TO AN UN-RELEASED PEC MUSCLE. I FOUND A SIGNIFICANT RUPTURE INTRA-OPERATIVELY WITH CAPSULAR CONTRACTURE". THIS RECORD IS FOR RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED. DEVICE IS AVAILABLE FOR RETURN.

  Patient problems: Capsular Contracture

  MAUDE report 23497720 ↗
• InjuryOct 20, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV, CORRECTION OF ASYMMETRY". THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 23337253 ↗
• InjuryOct 10, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 23267314 ↗
• InjurySep 8, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR "CONTRACTURE, BAKER GRADE IV"; SINGULAIR¿ WAS PRESCRIBED AS TREATMENT. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22993243 ↗
• InjuryAug 26, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III WITH A RUPTURE FOUND DURING EXPLANT SURGERY". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22900459 ↗
• InjuryAug 11, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 22771357 ↗
• InjuryAug 1, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 22690589 ↗
• InjuryJul 21, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED LEFT SIDE "IS HIGHER, CAPSULAR CONTRACTURE, BAKER GRADE III, SWELLING". THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22555208 ↗
• InjuryJul 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CONTRACTURE GRADE 4". THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22548902 ↗

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