Natrelle INSPIRA Breast Implants SRL-460Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10888628006768), received between Aug 7, 2019 and Aug 31, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Material Rupture” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryAug 31, 2026Material Rupture

  Healthcare professional reported "Rupture". This record is for the right side. The device has been explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50533248 ↗
• InjuryOct 3, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED ¿CAPSULAR CONTRACTURE¿ BAKER GRADE UNKNOWN. LATER HEALTHCARE PROFESSIONAL REPORTED SIDE CAPSULAR CONTRACTURE BAKER GRADE III IMPLANT EXCHANGE. HEALTHCARE PROFESSIONAL LATER REPORTED "ANY CREASES". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED AND IT WILL BE RETURN.

  Patient problems: Capsular Contracture

  MAUDE report 23210166 ↗
• InjurySep 29, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED ¿CAPSULAR CONTRACTURE¿ BAKER GRADE UNKNOWN. LATER HEALTHCARE PROFESSIONAL REPORTED SIDE CAPSULAR CONTRACTURE BAKER GRADE IV IMPLANT EXCHANGE. HEALTHCARE PROFESSIONAL LATER REPORTED "ANY CREASES". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED AND IT WILL BE RETURN.

  Patient problems: Capsular Contracture

  MAUDE report 23175790 ↗
• InjuryApr 21, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RUPTURE. THIS RECORD IS FOR A RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 21873694 ↗
• InjuryAug 29, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 17643619 ↗
• InjuryFeb 2, 2021Material Rupture; Material Rupture

  PATIENT REPORTED LEFT SIDE "RUPTURED." HEALTHCARE PROFESSIONAL CONFIRMED LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 11267727 ↗
• InjuryFeb 2, 2021Material Rupture; Material Rupture

  PATIENT AND HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED DISCARDED.

  Patient problems: Failure of Implant

  MAUDE report 11267033 ↗
• InjuryAug 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED TO REGULATORY AGENCY (MW5085156) "HOSPITALIZED 2 WEEKS AFTER [IMPLANTATION] FOR INFECTION, "SEPSIS," "DEVELOPED C. DIFF," "POSSIBLE SEPSIS," "CELLULITIS," ENLARGED MESENTERIC LYMPH NODES, INGUINAL LYMPH NODES, ELEOCOLIC LYMPH NODES, "NECK PAIN" "BACK PAIN," "GENERAL BODY ACHES," "PITYRIASIS ROSEA," "DERMATITIS," "INFLAMMATORY MARKERS," FATIGUE, DEPRESSION, HAIR LOSS, "EXCESSIVE THIRST," WEIGHT LOSS, "AUTOIMMUNE RESPONSES," "BREASTS ARE RED AND SPLOTCHY." THE DEVICE WAS EXPLANTED. THIS RECORD IS FOR THE RIGHT SIDE.

  Patient problems: Cellulitis; Unspecified Infection

  MAUDE report 8872165 ↗
• InjuryAug 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED TO REGULATORY AGENCY (MW5085156) "HOSPITALIZED 2 WEEKS AFTER [IMPLANTATION] FOR INFECTION, "SEPSIS," "DEVELOPED C. DIFF," "POSSIBLE SEPSIS," "CELLULITIS," ENLARGED MESENTERIC LYMPH NODES, INGUINAL LYMPH NODES, ELEOCOLIC LYMPH NODES, "NECK PAIN" "BACK PAIN," "GENERAL BODY ACHES," "PITYRIASIS ROSEA," "DERMATITIS," "INFLAMMATORY MARKERS," FATIGUE, DEPRESSION, HAIR LOSS, "EXCESSIVE THIRST," WEIGHT LOSS, "AUTOIMMUNE RESPONSES," "BREASTS ARE RED AND SPLOTCHY." THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Cellulitis; Unspecified Infection

  MAUDE report 8870711 ↗

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-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-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-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