NATRELLE Silicone-Filled Breast Implants 110-390Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10888628002258), received between Aug 10, 2021 and Sep 25, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (9 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Device Appears to Trigger Rejection; Material Rupture

  Patient reported "Rupture". Later Healthcare professional reported "Capsular Contracture" Baker Grade unknown and "Extracapsular Rupture". This report is for the left side. The device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50898037 ↗
• InjurySep 24, 2026Device Appears to Trigger Rejection; Material Rupture

  Patient problems: Capsular Contracture

  MAUDE report 50890891 ↗
• InjurySep 24, 2026Device Appears to Trigger Rejection; Material Rupture

  Patient problems: Capsular Contracture

  MAUDE report 50890890 ↗
• InjuryMay 11, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "EXCHANGE FROM TEXTURED TO SMOOTH DEVICES DUE TO THE PATIENTS CONCERN". LATER HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25144137 ↗
• InjuryMay 11, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "EXCHANGE FROM TEXTURED TO SMOOTH DEVICES DUE TO THE PATIENTS CONCERN". LATER HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III/IV". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25144108 ↗
• InjuryFeb 17, 2026Device Appears to Trigger Rejection

  THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 24367093 ↗
• InjuryFeb 17, 2026Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED A "RUPTURE", "CAPSULAR CONTRACTURE, BAKER GRADES III" AND A "EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24364893 ↗
• InjuryJan 12, 2026Device Appears to Trigger Rejection; No Apparent Adverse Event

  LATER HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE II, RECORD IS NO LONGER REPORTABLE. UN-REPORTING.

  Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24045732 ↗
• InjuryApr 3, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURES, BAKER GRADE IV. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 21766738 ↗
• InjuryAug 10, 2021Material Rupture; Material Rupture

  PATIENT REPORTED LEFT SIDE "RUPTURE". HEALTHCARE PROFESSIONAL REPORTED "SEROMA" AND "MANY LYMPHOCYTES." DEVICE WAS EXPLANTED.

  Patient problems: Seroma

  MAUDE report 12305505 ↗
• InjuryAug 10, 2021Material Rupture; Material Rupture

  PATIENT REPORTED LEFT SIDE "RUPTURE". HEALTHCARE PROFESSIONAL REPORTED "RUPTURED INTESTINAL FLUID AND PROSTHESIS ON BOTH SIDES DURING THE PREOPERATIVE EXAMINATION" AND "WAS FOUND TO BE CD30 NEGATIVE IN THE EXAMINATION CONDUCTED AFTER COLLECTING INTESTINAL FLUID DURING SURGERY", "MANY LYMPHOCYTES", "VAGUE GRANULOMA". DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Granuloma; Seroma

  MAUDE report 12303615 ↗

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