NATRELLE Silicone-Filled Breast Implants 20-350Recalls & reported problems

Summary

The FDA's MAUDE database contains 98 adverse event reports that list this exact device (DI 10888628001688), received between May 29, 2019 and Sep 30, 2026 — classified as 98 injuries.

The most frequently reported specific device problem is “Material Rupture” (55 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 98 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Material Rupture

  Healthcare professional, through company representative, reported "rupture". The inner silicone gel touch the patient. This record is for the right side. Device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951661 ↗
• InjurySep 29, 2026Material Rupture

  Patient reported "lump or thickening in or near the breast or in the underarm area". Later, patient reported "rupture". This record is for the left side. The device remains implanted.

  Patient problems: Breast Mass

  MAUDE report 50936806 ↗
• InjurySep 21, 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 50842624 ↗
• InjuryAug 19, 2026Material Rupture; Material Deformation

  Patient reported "wrinkling/rippling." Patient additionally reported having "a lump or thickening in or near the breast or in the underarm area". Healthcare professional then reported "Rupture". This record is for the right side. Device was explanted.

  Patient problems: Nodule

  MAUDE report 50331256 ↗
• InjuryAug 16, 2026Material Rupture

  Healthcare professional reported "Rupture" against the left side. The device remains implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50266792 ↗
• InjuryAug 7, 2026Material Rupture

  Healthcare professional reported "intracapsular rupture". This record is for the left side. Device has been explanted and replaced.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50173350 ↗
• InjuryAug 6, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "capsulation". This record is for the left side. The device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50160564 ↗
• InjuryJul 29, 2026Material Rupture

  Healthcare professional reported "rupture" and "exchange". Later healthcare professional reported "hole, non specific" and "capsules were seen to be densely calcified". This record is for the left side. Device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50070573 ↗
• InjuryJul 27, 2026Material Rupture

  Healthcare professional reported "rupture" and "exchange". Later healthcare professional reported "hole, non specific" and "capsules were seen to be densely calcified". This record is for the right side. Device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50046904 ↗
• InjuryJul 21, 2026Device Appears to Trigger Rejection; Material Rupture

  Healthcare professional reported "rupture", "hardening of the breast", "asymmetry" and "capsular contracture Baker grade IV". This record is for the left side. Device has been explanted.

  Patient problems: Capsular Contracture

  MAUDE report 25895036 ↗
• InjuryJul 21, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "HARDENING OF THE BREAST", "ASYMMETRY" AND "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25891355 ↗
• InjuryJun 10, 2026Malposition of Device; Migration

  HEALTHCARE PROFESSIONAL REPORTED VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR) MANUFACTURER REGISTRY SPECIFIC DATA REPORT (MRSDR) "DEVICE MIGRATION/IMPLANT MALPOSITION". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 25460343 ↗
• InjuryJun 3, 2026Material Rupture

  PATIENT REPORTED MALPOSITION. PHYSICIAN REPORTED ASYMMETRY. PER FOLLOW-UP, THERE IS NO MALPOSITION AND THE ASYMMETRY IS NOT DEVICE RELATED. LATER HEALTHCARE PROFESSIONAL REPORTED ¿INTRACAPSULAR RUPTURE¿ AND ¿CAPSULAR CONTRACTURE BAKER GRADE I¿. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25383042 ↗
• InjuryJun 3, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED ¿INTRACAPSULAR RUPTURE¿ AND ¿CAPSULAR CONTRACTURE BAKER GRADE I¿. THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25380291 ↗
• InjuryApr 21, 2026Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 24945480 ↗
• InjuryApr 21, 2026Device Appears to Trigger Rejection

  PATIENT REPORTED CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN, "SHIFTING AND FEELING DIFFERENT LATELY", "SIZE OF A SOFTBALL", "DISCOMFORT TOWARDS ARMPIT" AND "VERY HARD". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24945411 ↗
• InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED "SQUAMOUS CELL SKIN CANCER". LATER HEALTHCARE PROFESSIONAL REPORTED "WENT SMALLER". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Cancer

  MAUDE report 24937343 ↗
• InjuryApr 3, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "PAIN PROMINENT FOR THE LAST YEAR AND CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24776130 ↗
• InjuryApr 2, 2026Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE, PAIN PROMINENT FOR THE LAST YEAR AND CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24771970 ↗
• InjuryMar 26, 2026Off-Label Use; Material 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 24706145 ↗
• InjuryMar 25, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "POST-TRAUMATIC CAPSULAR CONTRACTURE RELEASE FOLLOWING FALL. HISTORY OF CAPSULAR CONTRACTURE.", "FALL APPROXIMATELY ONE MONTH AGO FROM A COUNTER, LANDING FLAT ON THE CHEST. REPORTS IMMEDIATE SWELLING AND HEAT, UNABLE TO TOUCH BREASTS FOR WEEKS. EXPERIENCED A SENSATION OF THE CAPSULE "PEELING OFF' WITH CERTAIN MOVEMENTS" AND "BAKER I". LATER HEALTHCARE PROFESSIONAL REPORTED "REPORTS A CONSTANT GRABBING SENSATION IN THE ARMS SINCE THE FALL". HEALTHCARE PROFESSIONAL REPORTED "SILICONE IMPLANTS WITHOUT RUPTURE, MINIMAL FLUID COLLECTION" . THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Contracture; Inflammation

  MAUDE report 24685676 ↗
• InjuryMar 9, 2026Material Rupture

  PATIENT REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 24552537 ↗
• InjuryMar 9, 2026Material Rupture

  PATIENT REPORTED "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 24552485 ↗
• InjuryMar 2, 2026Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 24489846 ↗
• InjuryFeb 26, 2026Material Rupture; No Apparent Adverse Event

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

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

  MAUDE report 24462555 ↗

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-