Natrelle Inspira SoftTouch Breast Implants SSL-320Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10888628032552), received between Mar 24, 2021 and Sep 17, 2026 — classified as 17 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (9 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50812694 ↗
• InjuryAug 20, 2026Material Rupture

  Healthcare professional reported "tender, palpable lump at bottom of inframammary fold", "popping sound" and "rupture". This record is for the right side. Device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50346898 ↗
• InjuryAug 19, 2026Material Rupture

  Healthcare professional reported "rupture". This record is for the left side. The device remains implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50332158 ↗
• InjuryJun 9, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR) MANUFACTURER REGISTRY SPECIFIC DATA REPORT (MRSDR) "SUSPECTED/ACTUAL RUPTURE/DEFLATION" AND "WRINKLING/RIPPLING". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

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

  MAUDE report 25443458 ↗
• InjuryNov 6, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE". HEALTHCARE PROFESSIONAL LATER REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III" THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED. DEVICE WILL BE RETURNED.

  Patient problems: Capsular Contracture

  MAUDE report 23493583 ↗
• InjuryMay 22, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE I. HEALTHCARE PROFESSIONAL LATER REPORTED RUPTURE. THIS RECORD IS FOR RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 22068350 ↗
• InjuryMay 20, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". HEALTHCARE PROFESSIONAL LATER REPORTED "#1 HISTORY OF BILATERAL AUGMENTATION MAMMOPLASTY, #2 CAPSULAR CONTRACTURE WITH IMPLANT DISPLACEMENT BILATERALLY, #3 PTOSIS BILATERAL BREAST. HEALTHCARE PROFESSIONAL LATER REPORTED "OBVIOUS DISPLACEMENT WITH SUSPECTED CAPSULAR CONTRACTURE GENERATING THAT IMPLANT DISPLACEMENT PALPABLE AND VISIBLE PARTICULARLY IN THE SUPERIOR POLES BILATERALLY WITH AN APPROPRIATE NEED FOR REMOVAL AND REPLACEMENT AND CONSIDERATIONS FOR CONVERSION EITHER WHOLE OR IN PART INTO A NEW POCKET OF MUSCULAR SPACE. SHE HAS HAD AND IN FACT HAS HAD SUGGESTIONS FOR MASTOPEXY IN THE PAST AS WELL AS RECENTLY AND ELECTED TO PROCEED WITH THE AFTER MENTIONED PROCEDURE TO RECTAL CAPSULAR CONTRACTURE AS WELL AS ASCERTAIN THE NEED FOR REMOVAL AND REPLACEMENT GIVEN THE OBVIOUS IMPLANT DISPLACEMENT AND SUSPECTED INCIPIENT IMPLANT RUPTURE WITH CREASE FOLD FAILURE OF THE IMPLANT GENERATED BY CAPSULAR TISSUE." CAPSULAR CONTRACTURE BAKER GRADE III CONFIRMED VIA MAMMOGRAM. THIS RECORD IS FOR LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22057263 ↗
• InjuryMay 2, 2025Device Appears to Trigger Rejection; No Apparent Adverse Event; Device Appears to Trigger Rejection; No Apparent Adverse Event

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED

  Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21955176 ↗
• InjuryJul 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "NECROTIC NIPPLE/BREAST REVISION". DEVICE HAS BEEN EXPLANTED.

  Patient problems: Necrosis

  MAUDE report 17260042 ↗
• InjuryApr 3, 2023Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture; Failure of Implant

  MAUDE report 16671157 ↗
• InjuryApr 3, 2023Material Rupture; No Apparent Adverse Event; Material Rupture; No Apparent Adverse Event

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.

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

  MAUDE report 16671129 ↗
• InjuryOct 11, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 15577439 ↗
• InjuryAug 18, 2022Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURED, SWELLING AND CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 15253771 ↗
• InjuryJun 10, 2022Device Handling Problem; Device Handling Problem

  HEALTHCARE PROFESSIONAL REPORTED THAT A DEVICE WAS OPENED AND DISCARDED OR DESTROYED DUE TO "ACCIDENTAL HOLE.¿ EXPLANT SURGERY WAS COMPLETED WITH A BACK-UP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14654339 ↗
• InjuryJan 21, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 13314005 ↗
• InjuryApr 21, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 11700098 ↗
• InjuryMar 24, 2021Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV.

  Patient problems: Capsular Contracture; Failure of Implant

  MAUDE report 11562422 ↗

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-
• 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