NATRELLE Silicone-Filled Breast Implants 45-700Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10888628002135), received between Jul 29, 2019 and Aug 19, 2026 — classified as 21 injuries.

The most frequently reported specific device problem is “Material Rupture” (13 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryAug 19, 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 50331094 ↗
• InjuryJul 16, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" AGAINST THE LEFT SIDE RECORD. THE DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 25844815 ↗
• InjuryMay 1, 2026Material Rupture

  Healthcare professional reported "rupture discovered at surgery". This record is for the right side. Device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25055747 ↗
• InjuryJan 12, 2026Device Appears to Trigger Rejection; Material Rupture

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

  Patient problems: Capsular Contracture

  MAUDE report 24046171 ↗
• InjuryJan 12, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24045908 ↗
• InjuryDec 9, 2025Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 23762840 ↗
• InjuryOct 30, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" CONFIRMED VIA MRI. THIS RECORD IS FOR LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 23430319 ↗
• InjuryMay 5, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RUPTURE. THIS RECORD IS FOR RIGHT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 21964839 ↗
• InjuryNov 5, 2024Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 20611244 ↗
• InjuryOct 12, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 17922362 ↗
• InjurySep 18, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE. HEALTHCARE PROFESSIONAL LATER REPORTED "RUPTURE." THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 17769863 ↗
• InjuryJan 24, 2023Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture; Failure of Implant

  MAUDE report 16237819 ↗
• InjuryJan 3, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED, RIGHT-SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 16092111 ↗
• InjurySep 30, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 15520849 ↗
• InjuryAug 31, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III/IV. DEVICE HAS BEEN EXPLANTED AND DISCARDED.

  Patient problems: Capsular Contracture

  MAUDE report 15331595 ↗
• InjuryAug 29, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 15311681 ↗
• InjuryDec 29, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 13112096 ↗
• InjuryAug 2, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 12263873 ↗
• InjuryMar 30, 2021Material Rupture; Material Rupture

  PATIENT REPORTED LEFT-SIDE PAIN, SENSITIVITY, AND "BOTTOM FEELS AND LOOKS FLAT." ADDITIONALLY HEALTHCARE REPORTED RUPTURE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 11591099 ↗
• InjuryDec 12, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE REMOVAL DUE TO ¿DISPLACEMENT" AND "CONTRACTURE,¿ BAKER GRADE UNKNOWN. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 9458896 ↗
• InjuryJul 29, 2019Material Rupture; Material Rupture

  PATIENT REPORTED A LEFT SIDE RUPTURE. DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 8839865 ↗

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-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-