NATRELLE Silicone-Filled Breast Implants 20-300Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10888628001664), received between Jun 14, 2013 and Sep 12, 2026 — classified as 39 injuries.

The most frequently reported specific device problem is “Material Rupture” (21 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 39 reports, in the reporter's own words as published by the FDA.

• InjurySep 12, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50744732 ↗
• InjuryAug 25, 2026Device Appears to Trigger Rejection; Material Rupture

  Healthcare professional reported "rupture and capsular contracture Baker grade IV". This record is for the right side. Device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50442061 ↗
• InjuryJul 28, 2026Off-Label Use; Device Appears to Trigger Rejection; Material Rupture

  Patient reported "capsular contracture Baker grade unknown" and "rupture". This record is for the left side. Device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50058500 ↗
• InjuryJul 27, 2026Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50024866 ↗
• InjuryJun 30, 2026Material Rupture

  Healthcare professional reported "Ruptured Implant". This record is for the right side. Device has been explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25664902 ↗
• InjuryJun 3, 2026Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25383278 ↗
• InjuryJan 30, 2026Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 24225964 ↗
• InjuryDec 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED "METASTATIC BREAST CANCER: METS TO BONE AND LUNGS". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Breast Cancer

  MAUDE report 23681443 ↗
• InjuryNov 26, 2025Material Rupture; Material Rupture

  PATIENT REPORTED "RUPTURE" CONFIRMED VIA MRI. THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED AND IT IS UNKNOWN IF IT WILL BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 23658614 ↗
• InjuryNov 20, 2025Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 23610134 ↗
• InjuryNov 6, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "INTRACAPSULAR RUPTURE" CONFIRMED VIA MRI. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED. DEVICE WILL BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 23492182 ↗
• InjuryNov 4, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE II, RUPTURE AND CALCIFICATION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED. DEVICE IS AVAILABLE FOR RETURN.

  Patient problems: Failure of Implant

  MAUDE report 23472782 ↗
• InjuryOct 29, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE II, RUPTURE AND CALCIFICATION". THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED. DEVICE IS AVAILABLE FOR RETURN.

  Patient problems: Failure of Implant

  MAUDE report 23415414 ↗
• InjuryOct 23, 2025Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 23372382 ↗
• InjuryOct 23, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL "HEADACHES AND PAIN IN THE AREA" AND "IMPLANT RUPTURE WITH SILICONE EXTENDING INTO THE AXILLA" CONFIRMED VIA CT SCAN. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 23368823 ↗
• InjuryOct 16, 2025Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 23311590 ↗
• InjuryOct 15, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED "CAPSULAR CONTRACTURE", BAKER GRADE UNKNOWN. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE STATUS IS UNKNOWN.

  Patient problems: Capsular Contracture

  MAUDE report 23279759 ↗
• InjuryApr 29, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED LEFT SIDE PAIN, "FEELS LIKE THERE IS AN AIR POCKET" INSIDE OF THE BREAST, CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN, "LINE ON THE BREAST," "HIGHER ON THE LEFT," HARDNESS, AND FIRMNESS. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 21931598 ↗
• InjuryJan 22, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV", "PAIN" AND AND "IMPLANT POSITIONING ISSUE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 21210901 ↗
• InjuryJan 2, 2025Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 21063489 ↗
• InjuryDec 29, 2024Material Rupture; Material Rupture

  DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 21032177 ↗
• InjuryAug 25, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 17623156 ↗
• InjuryMar 6, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED, A RIGHT SIDE RUPTURE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 16491815 ↗
• InjuryNov 15, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 15799001 ↗
• InjuryOct 5, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 15543681 ↗

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-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