NATRELLE Silicone-Filled Breast Implants 10-510Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10888628001312), received between May 23, 2019 and Sep 9, 2026 — classified as 17 injuries.

The most frequently reported specific device problem is “Material Rupture” (14 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2026Material Rupture

  Healthcare professional reported "prosthesis rupture". This record is for the right side. Healthcare professional later reported "Malignant neoplasm". The device was explanted. Patient was hospitalized.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50693353 ↗
• InjurySep 6, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50641340 ↗
• InjuryJun 16, 2026Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25522540 ↗
• InjuryMay 18, 2026Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25203364 ↗
• InjuryMay 18, 2026Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25201065 ↗
• InjuryJan 27, 2026Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". PATIENT LATER REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24193597 ↗
• InjuryDec 29, 2025Material Rupture; No Apparent Adverse Event; Material Rupture; No Apparent Adverse Event

  PREVIOUS MEDWATCH SUBMISSION NOTED RUPTURE. UPON FURTHER INFORMATION, ALLERGAN HAS DETERMINED THAT THE EVENT OF RUPTURE DID NOT OCCUR.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23918504 ↗
• InjuryNov 21, 2024Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" CONFIRMED VIA MRI. THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 20747951 ↗
• InjuryNov 20, 2024Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE CONFIRMED VIA MRI. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 20739686 ↗
• InjuryJan 30, 2023Material Rupture; Material Rupture

  PATIENT REPORTED A LEFT SIDE EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE. HEALTHCARE PROFESSIONAL LATER REPORTED LEFT SIDE RUPTURE AND "ANY CREASES". DEVICE HAS BEEN EXPLANTED AND DISCARDED.

  Patient problems: Failure of Implant

  MAUDE report 16269034 ↗
• InjuryJan 30, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 16269015 ↗
• InjuryJul 7, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 14951052 ↗
• InjuryJul 7, 2022Material Rupture; Material Rupture

  PATIENT REPORTED RIGHT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 14950410 ↗
• InjuryMay 6, 2022Material Rupture; Material Rupture

  HEALTHCARE PROVIDER REPORTED RIGHT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 14306435 ↗
• InjuryDec 13, 2019Migration; Migration

  HEALTHCARE PROFESSIONAL REPORTED "LEFT SIDE HAS INFEROLATERAL DESCENT OF THE IMPLANT". DEVICE HAS BEEN EXPLANTED.

  Patient problems: Injury

  MAUDE report 9465997 ↗
• InjuryAug 4, 2019Material Rupture; Material Rupture

  HEALTHCARE PROVIDER REPORTED LEFT SIDE RUPTURE. DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 8858357 ↗
• InjuryMay 23, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

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

  Patient problems: Capsular Contracture

  MAUDE report 8637426 ↗

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