Natrelle INSPIRA Breast Implants SRX-650Recalls & reported problems

Summary

The FDA's MAUDE database contains 157 adverse event reports that list this exact device (DI 10888628007604), received between May 7, 2019 and Jul 17, 2026 — classified as 155 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (92 reports).

4 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 157 reports, in the reporter's own words as published by the FDA.

• InjuryJul 17, 2026Device Appears to Trigger Rejection; Migration

  PATIENT REPORTED "CAPSULAR CONTRACTURE UNKNOWN BAKER GRADE¿, "SITTING IN ARMPIT", AND FEELING "UNCOMFORTABLE." LATER HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25863606 ↗
• InjuryMay 14, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR) MANUFACTURER REGISTRY SPECIFIC DATA REPORT (MRSDR) "CAPSULAR CONTRACTURE, BAKER GRADE III AND DEVICE MIGRATION/IMPLANT MALPOSITION". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25177208 ↗
• InjuryMay 14, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR) MANUFACTURER REGISTRY SPECIFIC DATA REPORT (MRSDR) "CAPSULAR CONTRACTURE, BAKER GRADE III AND DEVICE MIGRATION/IMPLANT MALPOSITION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25177183 ↗
• InjuryApr 3, 2026Material Rupture; No Apparent Adverse Event

  HEALTHCARE PROFESSIONAL REPORTED "UNKNOWN RUPTURE". LATER HEALTHCARE PROFESSIONAL REPORTED "RUPTURE WAS FOR CONTRALATERAL SIDE". LATER PATIENT REPORTED "IT WAS RUPTURED". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24776669 ↗
• InjuryJan 6, 2026Material Rupture; No Apparent Adverse Event

  HEALTHCARE PROFESSIONAL REPORTED "UNKNOWN RUPTURE" AND LATER CONFIRMED "IMPLANT THAT WAS RUPTURED WAS ON [THE] RIGHT SIDE". LATER PATIENT REPORTED RUPTURE DIAGNOSED VIA ULTRASOUND. THIS RECORD IS FOR RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23973660 ↗
• InjuryOct 20, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL VIA NBIR (NATIONAL BREAST IMPLANT REGISTRY) REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III", "DEVICE MIGRATION/IMPLANT MALPOSITION", AND "CORRECTION OF ASYMMETRY". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED. CAPSULOTOMY/CAPSULECTOMY PERFORMED.

  Patient problems: Capsular Contracture

  MAUDE report 23343727 ↗
• InjurySep 2, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22939605 ↗
• InjuryAug 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "CAPSULAR CONTRACTURE BAKER GRADE III" WITH MRI. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22835156 ↗
• InjuryJul 24, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE III ". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22595314 ↗
• InjuryJul 23, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22577159 ↗
• InjuryJul 21, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RELATES TO THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 22560251 ↗
• InjuryJul 18, 2025Migration; Migration

  PATIENT REPORTED LEFT SIDE "DIFFICULTY BREATHING, IMPLANTS ARE VERY HARD, PAINFUL, JOINT PAIN" "WEIRD BLOOD COUNTS" AND "NECROSIS IN NIPPLES, LEFT SIDE MIGRATION." DEVICE REMAINS IMPLANTED.

  Patient problems: Necrosis

  MAUDE report 22541813 ↗
• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED RIGHT SIDE "DIFFICULTY BREATHING, IMPLANTS ARE VERY HARD, PAINFUL, JOINT PAIN" "WEIRD BLOOD COUNTS" AND "NECROSIS IN NIPPLES." DEVICE REMAINS IMPLANTED.

  Patient problems: Inflammation; Necrosis

  MAUDE report 22541640 ↗
• InjuryJul 9, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED "CAPSULAR CONTRACTURE" BAKER GRADE UNKNOWN. PATIENT ALSO REPORTED THE FOLLOWING EVENTS, WHICH ARE ALL NOT DEVICE-RELATED: "SEVERE FOOD INTOLERANCES, WIDE SPREAD CONNECTIVE TISSUE PAIN, TRIGGERS POINTS, CHRONIC TENSION HEADACHES, MEMORY FOG, LOSS OF MUSCLE STRENGTH, HAIR LOSS AND FATIGUE", ¿STOMACH ISSUES¿, ¿LOST 30LBS IN 6 MONTHS¿, ¿COULDN'T EAT WITHOUT SEVERE STOMACH ISSUES¿, ¿DIAGNOSED WITH IBS (IRRITABLE BOWEL SYNDROME)¿, ¿STARTED HAVING WIDESPREAD MUSCLE/CONNECTIVE TISSUE PAIN¿, ¿CHRONIC TENSION HEADACHES¿, AND ¿DIAGNOSED WITH FIBROMYALGIA¿. PATIENT WAS PRESCRIBED THE FOLLOWING MEDICATIONS, WHICH "ONLY PARTIALLY HELP": ACETAMINOPHEN, FLEXORIL, GABAPENTIN, IBUPROFEN, SIMETHICONE, WELLBUTRIN AND ZEOLITE. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22458429 ↗
• InjuryJun 10, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22180227 ↗
• InjuryMay 19, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III. RECORD IS FOR LEFT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22044304 ↗
• InjuryMay 5, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 21960497 ↗
• InjuryApr 17, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "BAKER III". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 21860813 ↗
• InjuryDec 5, 2023Material Rupture; Material Rupture

  PATIENT REPORTED RIGHT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 18269560 ↗
• InjuryNov 10, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV.

  Patient problems: Capsular Contracture

  MAUDE report 18111527 ↗
• InjuryOct 17, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 17951412 ↗
• InjurySep 11, 2023Material Rupture; Material Rupture

  DEVICE WAS EXPLANTED.

  Patient problems: Swollen Lymph Nodes/Glands

  MAUDE report 17725687 ↗
• InjurySep 11, 2023Material Rupture; Material Rupture

  DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 17725589 ↗
• InjuryAug 25, 2023Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 17627854 ↗
• InjuryAug 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED DRAINAGE, ABSCESS, AND HOLE NEAR STITCHES. DEVICE REMAINS IMPLANTED. THIS RELATES TO THE LEFT SIDE.

  Patient problems: Abscess; Fluid Discharge; Wound Dehiscence

  MAUDE report 17514686 ↗

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-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-
• 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