NATRELLE Silicone-Filled Breast Implants 115-322Recalls & reported problems

Summary

The FDA's MAUDE database contains 137 adverse event reports that list this exact device (DI 10888628002388), received between May 17, 2019 and Sep 24, 2026 — classified as 137 injuries.

The most frequently reported specific device problem is “Material Rupture” (110 reports).

1 FDA recall record name this device's identifier, 1 still open.

3 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.

Recalls naming this device

1. Jul 24, 2019Class IOpen, Classified

   The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.

   Z-2454-2019 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 137 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884304 ↗
• InjurySep 10, 2026Material Rupture

  Healthcare professional reported "intracapsular rupture" and "continuous wavy lines". This record is for the right side. Device has been explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50713372 ↗
• InjurySep 7, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50657618 ↗
• InjuryAug 17, 2026Material Rupture

  Healthcare professional reported "Rupture". Later Healthcare professional reported "multiple benign nodules and cysts less than 0.5 cm in size". This record is for the right side. The device has been explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50285840 ↗
• InjuryAug 17, 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 50280323 ↗
• InjuryJul 27, 2026Material Rupture

  Healthcare professional reported "Rupture" and "Breast ptosis grade 3" not device related. This record is for the left side. Device has been explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50008837 ↗
• InjuryMay 7, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "EXCHANGE FROM TEXTURED TO SMOOTH DUE TO CONCERN WITH THE PRODUCT" AND DOUBLE CAPSULE. AND LATER REPORTED VIA NBIR "CONTRACTURE/TEXTURED", BAKER GRADE UNKNOWN. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25113674 ↗
• InjuryMar 25, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III" AND "SMALL BREASTS AND DROOPY BREAST". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24690335 ↗
• InjuryMar 24, 2026Material Rupture; No Apparent Adverse Event

  PATIENT REPORTED "ANXIOUS" AND "RUPTURE" ON AN UNKNOWN SIDE. HEALTHCARE PROFESSIONAL LATER CONFIRMED NO COMPLAINT AGAINST THE LEFT SIDE. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24681335 ↗
• InjuryMar 24, 2026Material Rupture

  DEVICE HAS BEEN EXPLANTED AND REPLACED WITH A NON-ABBVIE DEVICE.

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

  MAUDE report 24680234 ↗
• InjuryMar 10, 2026Device Appears to Trigger Rejection

  PATIENT REPORTED "SWELLING WITH MY IMPLANTS". LATER CONTACTED BACK REPORTING "ENCAPSULATION, IT'S HARDENED", BAKER GRADE UNKNOWN. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24558341 ↗
• InjuryFeb 26, 2026Material Rupture; No Apparent Adverse Event

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

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

  MAUDE report 24456090 ↗
• InjuryFeb 24, 2026Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 24425985 ↗
• InjuryFeb 10, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" AND "FIBROUS CAPSULE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 24308503 ↗
• InjuryFeb 5, 2026Material Rupture

  HEALTHCARE PROFESSIONAL, THROUGH DISTRIBUTOR, REPORTED OF THE LEFT SIDE DEVICE: "IMPLANT RUPTURE" AND "FOCAL LESION AT THE 12¿1 O¿CLOCK POSITION". THE DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 24268686 ↗
• InjuryFeb 3, 2026Material Rupture

  HEALTHCARE PROFESSIONAL, THROUGH DISTRIBUTOR, REPORTED OF THE RIGHT-SIDE DEVICE: "IMPLANT RUPTURE". THE DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 24251427 ↗
• InjuryFeb 2, 2026Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 24240107 ↗
• InjuryJan 27, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE", "DEFORMED AND FOLDED" AND "EXTRA-SAC FLUID". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 24191043 ↗
• InjuryJan 22, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "EXCHANGE DUE TO CONCERNS WITH THE PRODUCT" AND "RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 24153040 ↗
• InjuryJan 12, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "IMPLANT RUPTURE" "AND" PER ULTRASOUND REPORT "THE CONTENTS OF THE CYST SHOW HETEROGENEOUS ECHOES, WITH IRREGULAR MARGINS", "MULTIPLE SMALL CYSTIC STRUCTURES MEASURING 3¿5 MM, CONTAINING HETEROGENEOUS FLUID, WITH REGULAR MARGINS", "CYSTIC LESIONS WITH HETEROGENEOUS FLUID" AND "ULTRASOUND FINDINGS CONSISTENT WITH A RIGHT BREAST CYST". THIS RECORD IS FOR RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURER¿S DEVICE. IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 24045040 ↗
• InjuryDec 29, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". HEALTHCARE PROFESSIONAL LATER REPORTED "CAPSULAR CONTRACTURE BAKER GRADE I". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 23917887 ↗
• InjuryDec 29, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". HEALTHCARE PROFESSIONAL LATER REPORTED "CAPSULAR CONTRACTURE BAKER GRADE I". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 23917614 ↗
• InjuryDec 1, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED NO COMPLAINT AGAINST THE DEVICE. LATER HEALTHCARE PROFESSIONAL REPORTED "BENIGN CALCIFICATION" AND "LYMPH NODES IN THE RIGHT AXILLA". LATER HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" AND "EXCHANGE OF TEXTURED DEVICE DUE TO PATIENT'S CONCERN WITH PRODUCT". LATER HEALTHCARE PROFESSIONAL REPORTED "IMPLANT CAPSULES SENT TO PATHOLOGY", "CAPSULAR CONTRACTURE BAKER GRADE I", "GLANDULAR PTOSIS", FIBROGLANDULAR TISSUE" AND BENIGN CALCIFICATION". CONFIRM WHIT MAMMOGRAPHY. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 23686773 ↗
• InjuryNov 18, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED BY ANOTHER MANUFACTURER'S DEVICE. DEVICE HAS BEEN DISPOSED.

  Patient problems: Failure of Implant

  MAUDE report 23579713 ↗
• InjuryNov 5, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "FOUND SUSPECTED INFLAMMATORY DISORDER IN LDCT", "FOUND SUSPECTED RUPTURED", "PROSTHESIS RUPTURED". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND IT WILL BE RETURN.

  Patient problems: Failure of Implant

  MAUDE report 23482976 ↗

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