NATRELLE Silicone-Filled Breast Implants 20-400Recalls & reported problems

Summary

The FDA's MAUDE database contains 128 adverse event reports that list this exact device (DI 10888628001701), received between Oct 9, 2017 and Sep 29, 2026 — classified as 128 injuries.

The most frequently reported specific device problem is “Material Rupture” (78 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 128 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 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 50935027 ↗
• InjurySep 29, 2026Material Invagination

  Healthcare professional reported "fatigue, pain and rippling" (fatigue being not device related). This record is for the right side. Device was explanted.

  Patient problems: Wrinkling

  MAUDE report 50932798 ↗
• InjurySep 28, 2026Device Appears to Trigger Rejection

  Patient problems: Capsular Contracture

  MAUDE report 50926711 ↗
• InjurySep 28, 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 50915145 ↗
• InjurySep 24, 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 50884542 ↗
• InjurySep 24, 2026Material Rupture

  Healthcare professional reported no complaint against the device. Later patient reported "Rupture". This record is for the left side. The device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50881624 ↗
• InjurySep 23, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50875068 ↗
• InjurySep 23, 2026Device Appears to Trigger Rejection

  Patient problems: Capsular Contracture

  MAUDE report 50874659 ↗
• InjurySep 8, 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 50670491 ↗
• InjurySep 1, 2026Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50548010 ↗
• InjuryAug 19, 2026Device Appears to Trigger Rejection

  Patient reported ¿encapsulated/hardness progressively worsening over the years¿, Capsular Contracture Baker grade unknown. This record is for the left side. Device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50331663 ↗
• InjuryJul 27, 2026Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50028109 ↗
• InjuryJul 17, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". LATER HEALTHCARE PROFESSIONAL REPORTED "HOLE IN RADIUS" AND "TEAR". THIS RECORDS IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25857821 ↗
• InjuryJul 10, 2026Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25787811 ↗
• InjuryJul 8, 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 25753065 ↗
• InjuryJun 6, 2026Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25419541 ↗
• InjuryMay 14, 2026Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 25174741 ↗
• InjuryMay 6, 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 25107547 ↗
• InjuryApr 22, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN". THIS RECORD ID FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24956659 ↗
• InjuryMar 23, 2026Material Rupture

  PATIENT REPORTED "RUPTURE", "MUSCLE HAS BEEN WEIRD", "IMPLANT HAS BEEN UP HIGH" AND "WEIRD SHAPED". ULTRASOUND PERFORMED ON (B)(6) 2026 CONFIRMED THE INTRACAPSULAR RUPTURE. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24664713 ↗
• InjuryMar 18, 2026Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24626966 ↗
• InjuryMar 3, 2026Material Rupture

  PATIENT REPORTED "CAPSULE WITHIN A CAPSULE" AND "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24496744 ↗
• InjuryFeb 17, 2026Material Rupture

  PATIENT REPORTED "PAIN" AND "INTRA-CAPSULAR RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 24363155 ↗
• InjuryFeb 9, 2026Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 24300228 ↗
• InjuryFeb 3, 2026Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 24252917 ↗

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-