NATRELLE Silicone-Filled Breast Implants 115-150Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10888628002302), received between Jul 1, 2020 and Dec 4, 2023 — classified as 9 injuries.

The most frequently reported specific device problem is “Material Rupture” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryDec 4, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED, RUPTURE. SEROMA-LATE WAS LATER REPORTED, BASED ON ULTRASOUND RESULTS. DEVICE WAS EXPLANTED. THIS RELATES TO THE LEFT SIDE.

  Patient problems: Failure of Implant; Seroma

  MAUDE report 18256613 ↗
• InjuryOct 7, 2022Material Rupture; Material Rupture

  PATIENT REPORTED NO COMPLAINT AGAINST THE RIGHT DEVICE. PHYSICIAN LATER REPORTED RIGHT SIDE RUPTURE. THE EVENTS OF "ISOECHOIC FLUID COLLECTION BETWEEN IMPLANT BAG AND CAPSULE", "FOCAL DETACHMENT OF IMPLANT C SEVERAL FOLDING OF IMPLANT BAG", "SEVER CAPSULE THICKENING C IRREGULAR IMPLANT CONTOUR" AND "DOUBLE CAPSULE C CONTRACTURE" BAKER GRADE UNKNOWN WERE REPORTED VIA US REPORT. THE EVENT OF "SEVERAL CYSTS AND HYPOECHOIC NODULES" IS NOT DEVICE RELATED. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture; Seroma

  MAUDE report 15562067 ↗
• InjuryAug 4, 2022Material Rupture; Material Rupture

  PATIENT REPORTED RUPTURE AGAINST LEFT SIDE DEVICE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 15169044 ↗
• InjuryJun 23, 2022Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  PATIENT REPORTED LEFT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture; Failure of Implant; Seroma

  MAUDE report 14792216 ↗
• InjuryApr 27, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE (BAKER GRADE) III FOR LEFT SIDE." DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 14226445 ↗
• InjuryJan 12, 2022Material Rupture; Material Rupture

  PATIENT REPORTED RIGHT SIDE RUPTURE. HEALTHCARE PROFESSIONAL LATER REPORTED "INNER PORTION FOLDING," AND "FLUID COLLECTION" DEVICE HAS BEEN EXPLANTED.

  Patient problems: Seroma

  MAUDE report 13237951 ↗
• InjurySep 15, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE III AND ANXIETY. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 10534435 ↗
• InjuryAug 14, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

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

  Patient problems: Capsular Contracture

  MAUDE report 10408196 ↗
• InjuryJul 1, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  THE DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 10217830 ↗

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
• 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,TR