Natrelle INSPIRA Breast Implants TRF-485Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10888628008359), received between Oct 11, 2019 and Aug 20, 2026 — classified as 22 injuries.

The most frequently reported specific device problem is “Material Rupture” (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-2453-2019 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryAug 20, 2026Material Rupture

  Healthcare professional reported "Patient with textured implants". Healthcare professional later reported "textured /ruptured". This record is for the left side. Device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50350998 ↗
• InjuryAug 20, 2026Material Rupture; No Apparent Adverse Event

  Healthcare professional reported "Patient with textured implants". Healthcare professional later reported "textured /ruptured". This record is for the right side. Device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50350821 ↗
• InjuryMay 16, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE "RUPTURE, AND TEXTURED IMPLANT" CONFIRMED VIA CT AND MRI. HEALTHCARE PROFESSIONAL LATER REPORTED "HOLE, NON-SPECIFIC," AND "HOLE ON PATCH SIDE." HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED "TRACE AMOUNT OF SIMPLE FLUID NOTED WITHIN THE CAPSULE." PATIENT UNDERGONE PARTIAL CAPSULECTOMY. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Seroma

  MAUDE report 22035075 ↗
• InjuryAug 1, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 17438325 ↗
• InjurySep 29, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "EXCHANGE FROM TEXTURED TO SMOOTH DUE TO THE PATIENTS CONCERN WITH THE PRODUCT" AND LATER RUPTURE. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 15502120 ↗
• InjuryOct 21, 2021Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE RUPTURE. THE DEVICE STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 12674941 ↗
• InjuryOct 19, 2021Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 12656382 ↗
• InjuryAug 20, 2021Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  PATIENT REPRESENTATIVE REPORTED LEFT SIDE "LEAK OF LEFT IMPLANT, CHRONIC INFLAMMATION", "SWELLING, GRADE IV CAPSULAR CONTRACTURE", "HARDENING AND PAIN, FIBROUS TISSUE IN LEFT BREAST, CAPSULE AROUND IMPLANT, RUPTURE OF LEFT IMPLANT, CYSTS ON LEFT BREAST, ANXIETY FOR INCREASED RISK OF ALCL, MENTAL ANGUISH AND FEAR OF ALCL, AND ANY CONDITION OR SYMPTOMS ASSOCIATED WITH ALCL OR THE PREVENTION OF THAT ISSUE, PAST AND FUTURE MEDICAL EXPENSES, AND OTHER PHYSICAL AND EMOTIONAL MANIFESTATIONS THAT ARE SEVER AND ONGOING." AS WELL AS "SUSTAINED PAINFUL REMOVAL SURGERY, DEBILITATING PHYSICAL PAIN, MENTAL SUFFERING, AND PERMANENT SCARRING". PATIENT REPRESENTATIVE ADDITIONALLY REPORTED NON-DEVICE RELATED EVENTS AS FOLLOWS: LEFT CHEST MASS, LESION UNDERNEATH LEFT IMPLANT. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture; Failure of Implant

  MAUDE report 12350923 ↗
• InjuryMar 22, 2021Material Rupture; Material Rupture

  DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 11539990 ↗
• InjuryNov 25, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED ¿REASON FOR LEFT SIDE DEVICE REMOVAL IS NOTED AS ¿CAPSULAR CONTRACTURE,¿ BAKER GRADE NOT SPECIFIED. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 10900647 ↗
• InjuryNov 24, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED REASON FOR RIGHT SIDE DEVICE REMOVAL AS ¿CAPSULAR CONTRACTURE,¿ BAKER GRADE NOT SPECIFIED. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 10896985 ↗
• InjuryNov 20, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE IMPLANT EXCHANGE DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT AND CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 10874083 ↗
• InjuryOct 9, 2020Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE AND EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENTS CONCERN WITH THE PRODUCT. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 10657119 ↗
• InjurySep 4, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 10497042 ↗
• InjurySep 4, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 10497009 ↗
• InjuryJun 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE "FLUID WAS COLLECTED FROM LEFT BREAST¿. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Seroma

  MAUDE report 10175439 ↗
• InjuryJun 17, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. HEALTHCARE PROFESSIONAL REPORTED ADDITIONAL EVENT OF "MILD CHRONIC INFLAMMATION". DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 10165252 ↗
• InjuryMay 6, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  PATIENT REPORTED LEFT SIDE "CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN". DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 10030948 ↗
• InjuryApr 14, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

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

  Patient problems: Capsular Contracture

  MAUDE report 9957276 ↗
• InjuryFeb 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED "PERSISTENT PAIN, LIMITED MOBILITY DUE TO THE CONSTANT PAIN." DEVICE HAS BEEN EXPLANTED. THIS RECORD IS FOR THE LEFT SIDE.

  Patient problems: Pain

  MAUDE report 9656272 ↗
• InjuryJan 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED RIGHT SIDE "PERSISTENT PAIN, LIMITED MOBILITY DUE TO THE CONSTANT PAIN." DEVICE HAS BEEN EXPLANTED.

  Patient problems: Pain

  MAUDE report 9622013 ↗
• InjuryOct 11, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 9179564 ↗

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-2454-2019 · Jul 24, 2019 · Open, Classified
  Natrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate Profile, Sterile, for the following style numbers: Style 110:110-090, 110-120, 110-150, 110-180, 110-