NATRELLE Silicone-Filled Breast Implants 120-340Recalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 10888628002548), received between Dec 10, 2014 and Sep 13, 2026 — classified as 60 injuries.

The most frequently reported specific device problem is “Material Rupture” (33 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 60 reports, in the reporter's own words as published by the FDA.

• InjurySep 13, 2026Material Rupture

  Patient problems: Nodule

  MAUDE report 50747341 ↗
• InjurySep 11, 2026Material Rupture

  Patient reported having experienced ¿a lump or thickening in or near the breast or in the underarm area¿. Later healthcare professional reported "double rupture" against the left side. The device remains implanted.

  Patient problems: Nodule

  MAUDE report 50736578 ↗
• InjuryAug 6, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "textured to smooth implant exchange". Later, healthcare professional reported Capsular Contracture Baker grade III. This record is for the right side. Device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50159280 ↗
• InjuryJul 21, 2026Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "EXCHANGE FROM TEXTURED TO SMOOTH". LATER HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN/RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25895914 ↗
• InjuryJul 21, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "EXCHANGE FROM TEXTURED TO SMOOTH". LATER HEALTHCARE PROFESSIONAL REPORTED " CAP CONTRACTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25891968 ↗
• InjuryFeb 19, 2026Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PRROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN, PAIN, RUPTURE, DISTORTED AGED PRODUCT AS WELL AS RECALLED DEVICE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24388400 ↗
• InjuryFeb 12, 2026Device Appears to Trigger Rejection; Material Rupture

  PATIENT REPORTED LEFT SIDE IMPLANT "FEELS TIGHTER AND MORE FIRM". PATIENT ADDITIONALLY REPORTED, "LEFT SIDE TENDERNESS" AND "FATIGUE". LATER HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN, PAIN, RUPTURE, DISTORTED AGED PRODUCT AS WELL AS RECALLED DEVICE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED. DEVICE DISCARDED.

  Patient problems: Capsular Contracture

  MAUDE report 24320873 ↗
• InjuryFeb 2, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III AND EXCHANGE FROM TEXTURED TO SMOOTH". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24236208 ↗
• InjuryJan 30, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "EXCHANGE WITH NO COMPLAINT AGAINST DEVICE". LATER HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 24228562 ↗
• InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED "EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENT'S CONCERNS WITH THE PRODUCT" AND "SWELLING". LATER, HEALTHCARE PROFESSIONAL REPORTED "FLUID". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Swelling/ Edema

  MAUDE report 24146483 ↗
• InjuryJan 12, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "PROTHESIS RUPTURED". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED WITH A NON-ABBVIE DEVICE. DEVICE WILL BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 24038787 ↗
• InjuryJan 6, 2026Material Rupture

  THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 23978084 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Seroma

  MAUDE report 23965348 ↗
• InjuryOct 17, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  Patient reported "leak", "one implant is leaking or has fluid around it", "extraordinarily exhausted and have had significant Mastalgia". Later Patient reported "Hodgkin¿s lymphoma that textured implants caused". Later, patient reported "exchange from textured to smooth due to the patients¿ concern of the product", "rupture" and "seroma". Later patient reported "pain", "seroma", "Capsular Contracture Baker Grade IV", and "rupture". Patient later reported "Rupture and free silicone", "breast implant illness", "arthritis", "emotional stability", "was sick", "couldn't remember words", "it was like having the flu every day", "joints hurt", and "moods were all over the place". This record is for the left side. Device has been explanted.

  Patient problems: Capsular Contracture; Lymphoma; Seroma

  MAUDE report 23325339 ↗
• InjuryJun 4, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE EXCHANGE OF ¿FROM TEXTURED TO SMOOTH AND CAPSULAR CONTRACTURE BAKER GRADE IV". DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22145995 ↗
• InjuryApr 11, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RUPTURE AND EXCHANGE FROM TEXTURED TO SMOOTH DUE TO CONCERN WITH THE PRODUCT. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 21825822 ↗
• InjuryOct 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "SWELLING WITH SMALL SEROMA POCKET" AND "BIOCELL DEVICE." DEVICE HAS BEEN EXPLANTED.

  Patient problems: Seroma

  MAUDE report 18015825 ↗
• InjuryAug 10, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED, RIGHT SIDE RUPTURE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 17504356 ↗
• InjuryJul 5, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 17262709 ↗
• InjuryJun 2, 2023Material Rupture; Material Rupture

  THE DEVICE WAS ADDITIONALLY REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 17052382 ↗
• InjuryJun 2, 2023Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE RUPTURE CONFIRMED WITH AN MRI. HEALTHCARE PROFESSIONAL ALSO REPORTED CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 17051737 ↗
• InjuryDec 13, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE EXCHANGE OF ¿TEXTURED SALINE¿ IMPLANT AND CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 15973620 ↗
• InjuryDec 6, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE IMPLANT REMOVAL FROM TEXTURED TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT. HEALTHCARE PROFESSIONAL LATER REPORTED RUPTURE. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 15925503 ↗
• InjurySep 9, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTS LEFT SIDE RUPTURE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 15395190 ↗
• InjuryJul 27, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE AND FEAR OF ALCL. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 15116303 ↗

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