NATRELLE Silicone-Filled Breast Implants 45-600Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10888628002111), received between May 19, 2019 and Sep 10, 2026 — classified as 27 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (15 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 27 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2026Material Rupture

  Healthcare professional reported "intracapsular rupture", "pain", "breast arterial calcification", "lumps", "palpable nodules", "possible swelling", "indentation" and "ptosis" which is not device related. This record is for the left side. Device remains implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50718374 ↗
• InjurySep 4, 2026Device Appears to Trigger Rejection; Material Rupture

  Healthcare professional reported "rupture" and "textured devices". This record is for left side. The device remains implanted.

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

  MAUDE report 50613640 ↗
• InjuryAug 24, 2026Device Appears to Trigger Rejection

  Patient reported "capsulated", and "Baker Grade unknown." Patient later reported "capsular contracture Baker grade III." This record is for the left side. Device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50421658 ↗
• InjuryMar 6, 2026Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "INTRACAPSULAR RUPTURE" AND CAPSULAR CONTRACTURE BAKER III. PATIENT WAS PRESCRIBED MEDICATION FOR CAPSULAR CONTRACTURE. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24531326 ↗
• InjuryFeb 9, 2026Device Appears to Trigger Rejection; Material Rupture

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

  Patient problems: Capsular Contracture

  MAUDE report 24294662 ↗
• InjuryFeb 3, 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 24251815 ↗
• InjuryJan 29, 2026Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 24211075 ↗
• InjuryNov 3, 2025Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 23451718 ↗
• InjuryOct 15, 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 REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23292249 ↗
• InjuryAug 25, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE AND EXCHANGE". HEALTHCARE PROFESSIONAL LATER REPORTED "INTRACAPSULAR RUPTURE AND RUPTURED WITH FLOATING SHELL" AND "EDEMA AND ENHANCEMENT INVOLVING THE STERNUM AND RIBS MAY BE SECONDARY TO KNOWN FRACTURE FROM TRAUMA" CONFIRMED VIA MRI. THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant; Seroma

  MAUDE report 22889297 ↗
• InjuryOct 11, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 17912925 ↗
• InjurySep 7, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED "SHELL MIXED IN GEL."

  Patient problems: Failure of Implant

  MAUDE report 17698407 ↗
• InjuryJan 13, 2023Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED RUPTURE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 16164716 ↗
• InjuryNov 28, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 15870675 ↗
• InjurySep 20, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 15456496 ↗
• InjuryJun 14, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROVIDER REPORTED A LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III/IV. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 14684960 ↗
• InjuryMay 9, 2022Material Rupture; Material Rupture

  PATIENT REPORTED RIGHT SIDE DEVICE "COLLAPSED." THE DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 14339299 ↗
• InjuryApr 13, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "PAIN, HARDENING, AND CAPSULAR CONTRACTURE, BAKER GRADE IV" AGAINST RIGHT DEVICE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 14091537 ↗
• InjuryMar 24, 2022Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  PATIENT REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III AND RUPTURE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 13893028 ↗
• InjuryFeb 15, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED LEFT SIDE CAPSULAR CONTRACTURES, BAKER GRADES III. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 13535793 ↗
• InjuryMar 22, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. HEALTHCARE PROFESSIONAL LATER CONFIRMED CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 11546834 ↗
• InjuryAug 14, 2020Material Rupture; Material Rupture

  DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 10408504 ↗
• InjuryFeb 10, 2020Material Rupture; Patient-Device Incompatibility; Material Rupture; Patient-Device Incompatibility

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

  Patient problems: Capsular Contracture

  MAUDE report 9688959 ↗
• InjuryFeb 2, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULE CONTRACTURE," BAKER'S GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED. THIS IS THE LEFT SIDE RECORD.

  Patient problems: Capsular Contracture

  MAUDE report 9656963 ↗
• InjuryOct 17, 2019Material Rupture; Patient-Device Incompatibility; Material Rupture; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE AND CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 9202806 ↗

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-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
• 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-