Natrelle Inspira SoftTouch Breast Implants SSX-800Recalls & reported problems

Summary

The FDA's MAUDE database contains 84 adverse event reports that list this exact device (DI 10888628033467), received between May 23, 2019 and Sep 28, 2026 — classified as 80 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (46 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 84 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "Capsular contracture" Baker Grade unknown. This record is for the right side. Device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50914977 ↗
• InjurySep 17, 2026Migration

  Healthcare professional reported "migration". This record is for the left side. Device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50805240 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  Healthcare professional reported "seroma". This record is for the left side. Device was explanted.

  Patient problems: Seroma

  MAUDE report 50042072 ↗
• InjuryJul 17, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV", "PATIENT HAD AN INJURY", "HAD A BLEED" AND "IMPLANT IS GETTING HARD". THIS RECORD IS FOR LEFT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture; Hematoma

  MAUDE report 25851549 ↗
• InjuryJun 18, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "INTRACAPSULAR RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25555618 ↗
• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED "INFECTION" VIA NATIONAL BREAST IMPLANT REGISTRY. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 24452180 ↗
• InjuryFeb 9, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 24290183 ↗
• InjuryJan 7, 2026Device Appears to Trigger Rejection; Improper or Incorrect Procedure or Method

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN" AND "THE PATIENT HAD A PREVIOUS LEFT SIDE CAPSULAR CONTRACTURE AND THE CAPSULE WAS REMOVED (...) AND THE SAME DEVICE WAS IMPLANTED BACK ON THE SAME DAY". LATER HEALTHCARE PROFESSIONAL REPORTED "NO CONTRACTURE" SINCE PATIENT'S LAST VISIT. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23993801 ↗
• MalfunctionSep 25, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  HEALTHCARE PROFESSIONAL REPORTED "NOT ABLE TO REMOVE THE IMPLANT FROM THE BOX, AND IT WAS STUCK AT THE BOTTOM OF THE BOX". THE DEVICE WAS NOT IMPLANTED. THE DEVICE WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23145202 ↗
• InjuryAug 20, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 22857039 ↗
• InjuryJul 28, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 22636725 ↗
• InjuryJul 2, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "EXPLODED". HEALTHCARE PROFESSIONAL LATER REPORTED PATIENT "WAS REAR ENDED BY ANOTHER CAR AND WAS THE PASSENGER AND HAD [A] SEATBELT ON". THE DEVICE HAS BEEN EXPLANTED AND REPLACED. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 22383814 ↗
• MalfunctionJun 16, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  HEALTHCARE PROFESSIONAL REPORTED THAT THE DOCTOR "COULDN'T GET THE INNER PACK OUT OF THE OUTER PACK, GOT FRUSTRATED TRYING TO PULL IT OUT AND CONTAMINATED THE IMPLANT." PATIENT CONTACT WITH THE DEVICE DID NOT OCCUR. THE SURGERY WAS COMPLETED WITH A BACKUP IMPLANT. THE DEVICE WAS NOT IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22215570 ↗
• InjuryMay 28, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 22102562 ↗
• InjuryMay 6, 2025Nonstandard Device; Nonstandard Device

  ACCOUNT REPRESENTATIVE REPORTED: ¿IT HAS HAPPENED AGAIN, THE SAME SITUATION¿ AND ¿DISFIGURED AND HAD TAKEN ON A DIFFERENT SHAPE. LIKE SOMEONE TOOK A PIECE OF STRING AND PUT IT ON THE CENTER OF THE IMPLANT AND TIGHTENED IT UP, KIND OF LIKE A DOUBLE IMPLANT OR A DEPRESSED SECTION OF THE IMPLANT.¿ THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21968654 ↗
• InjuryApr 21, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  DEVICE HAS BEEN EXPLANTED, REPLACED WITH NON-ALLERGAN DEVICE, AND DISCARDED.

  Patient problems: Capsular Contracture

  MAUDE report 21878371 ↗
• MalfunctionApr 18, 2024Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  COMPANY REPRESENTATIVE REPORTED ON BEHALF OF PHYSICIAN, "HAD TROUBLE GETTING THESE TWO IMPLANTS OUT OF THEIR PACKAGING." DEVICE WAS NOT IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 19139918 ↗
• InjuryMar 8, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED, NO COMPLAINT AGAINST THE DEVICE. HEALTHCARE PROFESSIONAL, LATER REPORTED, CAPSULAR CONTRACTURE, BAKER GRADE III/IV. THIS RELATES TO THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 18867482 ↗
• InjuryNov 27, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 18210042 ↗
• InjuryNov 13, 2023Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  PHYSICIAN REPORTED, RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 18125298 ↗
• InjuryAug 22, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 17599544 ↗
• InjuryAug 22, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE III/IV". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 17596624 ↗
• InjuryAug 3, 2023Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROVIDER REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV, RUPTURE AND SEROMA-LATE. HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE ¿HOLE NON-SPECIFIC" OBSERVED DURING SURGERY VIA RGA. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture; Seroma

  MAUDE report 17455871 ↗
• InjuryJul 14, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED, RIGHT SIDE CAPSULAR CONTRACTURE III. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 17325030 ↗
• InjuryJun 20, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III/IV. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 17161667 ↗

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