NATRELLE Silicone-Filled Breast Implants 10-270Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 10888628001237), received between May 16, 2019 and Sep 28, 2026 — classified as 53 injuries.

The most frequently reported specific device problem is “Material Rupture” (44 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 53 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50913923 ↗
• InjurySep 17, 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 50799710 ↗
• InjurySep 17, 2026Material Rupture

  Healthcare professional reported "Rupture". This record is for the left side. Device remains implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50799318 ↗
• InjurySep 14, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "exchange with no complaint against the device". Later patient reported "Baker grade: Grade III" and "it is painful". This record is for the left side. Device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50754431 ↗
• InjuryAug 26, 2026Material Rupture

  Healthcare professional reported through distributor "rupture". This record is for the right side. Device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50455333 ↗
• InjuryAug 24, 2026Material Rupture

  Healthcare professional reported through Distributor ¿Rupture¿. This record is for the right side. Device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50421432 ↗
• InjuryAug 24, 2026Adverse Event Without Identified Device or Use Problem

  Patient reported, through Annual Questionnaire for the BIFS study, "moderate breast pain". This record is for the left side. Device was explanted.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 50420159 ↗
• InjuryAug 11, 2026Device Appears to Trigger Rejection; Material Rupture

  Healthcare professional reported "rupture". This record is for an unknown side. Device remains implanted.

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

  MAUDE report 50212944 ↗
• InjuryJul 29, 2026Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50073970 ↗
• InjuryJul 28, 2026Material Rupture

  Healthcare professional reported "rupture". This record is for the left side. Device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50059989 ↗
• InjuryJul 27, 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 50035593 ↗
• InjuryJul 27, 2026Material Rupture

  Healthcare professional reported "rupture". This record is for the left side. Device remains implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50035279 ↗
• InjuryJul 27, 2026Material Rupture

  Healthcare professional reported "rupture and exchange". This record is for the left side. Device remains implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50011213 ↗
• InjuryJul 27, 2026Material Rupture

  Healthcare professional reported "rupture and exchange". This record is for the right side. Device remains implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50008650 ↗
• InjuryJun 29, 2026Device Appears to Trigger Rejection; Material Rupture

  Healthcare professional reported "intracapsular rupture". Later, a healthcare professional reported "rupture," Capsular Contracture Baker grade Unknown, "silicone bleed," "leaking silicone," "square appearance," "pain," "hardening," "distortion," and "keyhole sign," and noted that, after a mammogram, the "breast is doing something weird" and the "shape looks off." Later, the healthcare professional reported capsular contracture Baker Grade III/IV. The patient underwent a capsulectomy. This record is for the right side. The device has been explanted.

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

  MAUDE report 25657755 ↗
• InjuryJun 25, 2026Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED.

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

  MAUDE report 25630042 ↗
• InjuryJun 2, 2026Material Rupture

  PATIENT REPORTED "RUPTURE". LATER HEALTHCARE PROFESSIONAL CONFIRMED "RUPTURE". "SIGNIFICANT COLLAPSE OF BREAST IMPLANT SHELL NOTING WAVY LINES ("LINGUINE SIGN")", "INTRACAPSULAR RUPTURE" AND "EXTRACAPSULAR RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25364843 ↗
• InjuryFeb 23, 2026Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 24412533 ↗
• InjuryFeb 17, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 24368153 ↗
• InjuryFeb 17, 2026Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" AND "CAPSULAR CONTRACTURE (UNKNOWN BAKER GRADE)". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24366939 ↗
• InjuryJan 5, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "INNER AND OUTER CAPSULAR RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 23958022 ↗
• InjuryDec 28, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "MILDLY SORE, CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23903638 ↗
• InjuryDec 22, 2025Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 23865810 ↗
• InjuryDec 10, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". HEALTHCARE PROFESSIONAL LATER REPORTED "HOLE, NON-SPECIFIC". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 23768551 ↗
• InjuryNov 25, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED. THE DEVICE WILL BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 23645162 ↗

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 108
• 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,TRL-
• 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, 110-210,