NATRELLE Silicone-Filled Breast Implants 115-185Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10888628002326), received between Sep 29, 2020 and Sep 10, 2026 — classified as 13 injuries.

The most frequently reported specific device problem is “Material Rupture” (10 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2026Material Rupture

  Healthcare professional reported "rupture". This record is for the right side. The device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50710841 ↗
• InjuryMay 8, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "DEVICE RUPTURE". LATER, HEALTHCARE PROFESSIONAL REPORTED "PROBABLE INTRACAPSULAR RUPTURE, RIGHT", THEN CONFIRMED THE RUPTURE AND REPORTED "CAPSULECTOMY". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 21986845 ↗
• InjuryAug 8, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 19938770 ↗
• InjuryNov 10, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL, LATER REPORTED, "MALIGNANT NEOPLASM OF BREAST". "SMALL MASSES" AND "DRAIN". THESE EVENTS ARE NOT DEVICE RELATED.

  Patient problems: Failure of Implant

  MAUDE report 18113536 ↗
• InjuryOct 18, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED, LEFT SIDE "CAPSULAR CONTRACTURE, BAKER GRADE IV". DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 17959143 ↗
• InjuryAug 28, 2023Material Rupture; Material Rupture

  PATIENT REPORTED RIGHT SIDE "RUPTURE," ¿LEFT 9 O'CLOCK DIRECTION 3 CM: 6.1X3.8 MM POSITIVE LIME COPPER LOW-SHADED NODULE,¿ AND "CALCIFICATION." THE EVENT OF ¿LEFT 9 O'CLOCK DIRECTION 3 CM: 6.1X3.8 MM POSITIVE LIME COPPER LOW-SHADED NODULE¿ IS NOT DEVICE RELATED. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 17632221 ↗
• InjuryJun 9, 2023Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  PATIENT REPORTED LEFT SIDE RUPTURE. PATIENT ADDITIONALLY REPORTED CAPSULAR CONTRACTURE BAKER GRADE III, AND PAIN. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 17099442 ↗
• InjuryMar 15, 2023Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 16549689 ↗
• InjurySep 22, 2022Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 15466249 ↗
• InjuryJan 10, 2022Material Rupture; Material Rupture

  PATIENT REPRESENTATIVE REPORTED LEFT SIDE RUPTURE. FURTHER REPORTED WAS "MALIGNANT NEOPLASM OF THE UNKNOWN BREAST" WHICH HAS BEEN DEEMED NOT RELATED TO THE DEVICE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant; Seroma

  MAUDE report 13206276 ↗
• InjuryDec 2, 2021Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant; Seroma

  MAUDE report 12917809 ↗
• InjuryFeb 9, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE (GRADE III). THE DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 11300389 ↗
• InjurySep 29, 2020Material Rupture; Material Rupture

  THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 10598847 ↗

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