NATRELLE Silicone-Filled Breast Implants 115-435Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 10888628002425), received between Jun 6, 2019 and Sep 28, 2026 — classified as 47 injuries.

The most frequently reported specific device problem is “Material Rupture” (34 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 16, 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 47 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923765 ↗
• InjurySep 17, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "capsular contracture" baker grade unknown. This record is for the right side. The device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50800638 ↗
• InjurySep 15, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50766106 ↗
• InjurySep 12, 2026Device Appears to Trigger Rejection

  Patient problems: Capsular Contracture

  MAUDE report 50744864 ↗
• InjurySep 2, 2026Material Rupture

  Healthcare professional reported "exchange from textured to smooth". Healthcare professional later reported "rupture as well as exchange from textured to smooth". This record is for the right side. Device remains implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50571042 ↗
• InjuryAug 17, 2026Material Rupture

  Patient reported "not enough milk production". Healthcare Professional later reported "swelling and rupture". This record is for the right side. Device was explanted. Patient received Singulair as treatment.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50276341 ↗
• InjuryAug 14, 2026Material Rupture

  Patient reported "not enough milk production". Healthcare Professional later reported "possible rupture and radial folds". This record is for the left side. Device was explanted. Patient received Singulair as treatment.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50251496 ↗
• InjuryApr 21, 2026Material Rupture

  PATIENT REPORTED "RUPTURE & PAIN". THIS RECORD RELATES TO THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 24941511 ↗
• InjuryFeb 19, 2026Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 24387353 ↗
• InjuryDec 31, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN", "PAIN" AND "EXCHANGE FROM A TEXTURED TO SMOOTH". LATER THE HEALTHCARE PROFESSIONAL CONFIRMED "RUPTURE", "PAIN", "ASYMMETRY", "DIFFERENT", "CAPSULAR CONTRACTURE - BAKER GRADE III/IV" AND AN "EXCHANGE OF TEXTURED DEVICE" VIA MAMMOGRAM. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED. THE DEVICE WILL BE RETURNED.

  Patient problems: Capsular Contracture

  MAUDE report 23935224 ↗
• InjuryNov 17, 2025Material Rupture; Material Rupture

  PATIENT REPORTED LEFT SIDE "PAIN AND TENDERNESS". LATER HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" AND "EXCHANGE DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT". DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 23574482 ↗
• InjuryOct 9, 2025Material Rupture; Material Rupture

  PATIENT REPORTED LEFT SIDE "FLUID AROUND IMPLANT AND SMALL LEAK" (CAPTURED AS RUPTURE). LATER HEALTHCARE PROFESSIONAL REPORTED "TEXTURED RECALLED IMPLANTS". THIS WAS DIAGNOSED VIA MRI. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 23256979 ↗
• InjuryAug 18, 2025Material Rupture; Material Rupture

  PATIENT REPORTED RUPTURE. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED. PATIENT HAD CAPSULECTOMY TREATMENT.

  Patient problems: Failure of Implant

  MAUDE report 22834536 ↗
• InjuryJul 3, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "SEROMA, ASYMMETRIC AMOUNT OF FLUID, AND TWICE THE SIZE OF THE OTHER ONE", "RUPTURE" CONFIRMED VIA CT SCAN", AND "EXCHANGE OF TEXTURED DEVICE DUE TO PATIENT'S CONCERN WITH PRODUCT". DEVICE REMAINS IMPLANTED.

  Patient problems: Seroma

  MAUDE report 22398890 ↗
• InjurySep 26, 2024Material Rupture; Material Rupture

  PATIENT REPORTED LEFT SIDE "EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT". PATIENT ADDITIONALLY REPORTED "LEFT SIDE PINCH LIKE PAIN AND FEELING THE EDGE OF THE IMPLANT. I HAVEN'T HAD ISSUES EXCEPT RECENTLY THEY FEEL NOT AS FULL. I HAVE PAIN EVERY NOW AND THEN. I BELIEVE THEY ARE LEAKING." DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 20309668 ↗
• InjurySep 25, 2024Material Rupture; Material Rupture

  PATIENT REPORTED RIGHT SIDE "EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT". PATIENT ADDITIONALLY REPORTED "FEELING THE EDGE OF THE IMPLANT," "THEY FEEL NOT AS FULL, "PAIN EVERY NOW AND THEN" AND "THEY ARE LEAKING." DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 20306873 ↗
• InjuryFeb 23, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE EXCHANGE DUE TO PATIENT¿S CONCERNS WITH THE PRODUCT. HEALTHCARE PROFESSIONAL LATER REPORTED RUPTURE. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 16432914 ↗
• InjuryJan 30, 2023Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III/IV. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 16264223 ↗
• InjuryJan 23, 2023Material Rupture; Material Rupture

  DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 16230407 ↗
• InjuryJan 23, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE AND EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENT¿S CONCERN OF THE PRODUCT. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 16230289 ↗
• InjuryJun 14, 2022Material Rupture; Material Rupture

  PATIENT REPORTED A LEFT BREAST SORENESS AND EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT. HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 14686204 ↗
• InjuryJun 3, 2022Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 14595382 ↗
• InjuryAug 16, 2021Material Rupture; Material Rupture

  DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 12328446 ↗
• InjuryJun 17, 2021Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED FOR LEFT SIDE "EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT" AND "POSSIBLE RUPTURE". PATIENT REPORTED THE FOLLOWING EVENTS NOT RELATED TO THE DEVICE "BII - BREAST IMPLANT ILLNESS", "LOSING WEIGHT", "SORE THROAT". PATIENT REPORTED VIA VOLUNTARY MW "BREAST TENDERNESS, PAIN, PAIN IN CHEST", "INCREASED ANXIETY, "CHRONIC ANXIETY", "IMPLANTS WERE RECALLED AND KNOWN TO CAUSE A RARE FORM OF CANCER", "POCKETS OF FLUID", "LYMPH NODES WERE INFLAMED", "LEAKING SILICONE AND HAD LOST VOLUME". ALSO REPORTED THE FOLLOWING EVENTS DEEMED NOT RELATED TO THE DEVICE "STOMACH PROBLEMS, EXCESSIVE WEIGHT GAIN, ESTROGEN LEVELS OF 997", MASSIVE NIGHT SWEATS, MEMORY LAPSES, EXCESSIVE COLD LIMBS, INSOMNIA, SKYROCKETING BLOOD PRESSURE, "BEGAN TO DROP WEIGHT", "THYROID WAS ATTACKING ITSELF", DIAGNOSED WITH HASHIMOTOS LIKE ILLNESS¿,"RINGING IN EARS", "EXCESSIVE BRAIN FOG", "METAL TASTE IN MOUTH", "BLEEDING GUMS", "DEPRESSION", "DIAGNOSED WITH RAYNAUD'S STARTED A NEW MEDICATION FOR TWITCHING", "ULTRASOUND SHOWED A MASS", "MULTIPLE UTIS", "CONSTANT INFECTIONS", "PAIN IN THROAT AND JOINTS', "EXCESSIVE EXHAUSTION".DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant; Seroma; Swollen Lymph Nodes/Glands

  MAUDE report 12019213 ↗
• InjuryJun 16, 2021Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENT'S CONCERN WITH THE PRODUCT AND POSSIBLE RUPTURE. PATIENT ALSO REPORTED "SORE THROAT AND LOSING WEIGHT" - THESE ARE NOT DEVICE RELATED. DEVICE REMAINS IMPLANTED. THIS RECORD IS FOR THE RIGHT SIDE.

  Patient problems: Failure of Implant; Seroma; Swollen Lymph Nodes/Glands

  MAUDE report 12010024 ↗

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-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-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-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-