Natrelle Inspira SoftTouch Breast Implants SSL-290Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10888628032545), received between Dec 15, 2020 and Sep 23, 2026 — classified as 18 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (10 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Device Appears to Trigger Rejection; Material Rupture

  Patient problems: Capsular Contracture

  MAUDE report 50874172 ↗
• InjurySep 16, 2026Device 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 50786657 ↗
• InjurySep 16, 2026Device 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 50786455 ↗
• InjuryJul 27, 2026Material Rupture

  Healthcare professional reported "Suspected/Actual Rupture/Deflation, Need for Biopsy/Tumor". This record is for the right side. Device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50000900 ↗
• InjuryJun 3, 2026Device Appears to Trigger Rejection

  Healthcare professional reported " capsular contracture baker grade III". Later healthcare professional reported "any creases" on RGA form. This record is for the right side. Device has been explanted and replaced.

  Patient problems: Capsular Contracture

  MAUDE report 25378011 ↗
• InjuryJun 13, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22207312 ↗
• InjuryFeb 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTS LEFT SIDE RUPTURE. HEALTHCARE PROFESSIONAL LATER REPORTED LEFT SIDE IMPLANT EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE. PATIENT LATER REPORTED WENT SEPTIC AFTER SURGERY. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 21446070 ↗
• InjuryOct 23, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED, CAPSULAR CONTRACTURE, BAKER GRADE III/IV. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 17985315 ↗
• InjuryJul 11, 2023Material Rupture; Material Rupture

  PATIENT LATER REPORTED RIGHT SIDE RUPTURE. HEALTHCARE PROFESSIONAL LATER CONFIRMED RIGHT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 17302758 ↗
• InjuryApr 26, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 16820404 ↗
• InjuryJan 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE INFECTION VIA NBIR. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 16237546 ↗
• InjuryOct 11, 2022Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  PATIENT REPORTED RIGHT SIDE GEL IMPLANT "CAPSULAR CONTRACTURE GRADE IV" AND PAIN. HEALTHCARE PROFESSIONAL LATER REPORTED RIGHT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture; Erosion; Sepsis

  MAUDE report 15577856 ↗
• InjuryMay 4, 2022Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "LEFT SIDE RUPTURE." DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 14281902 ↗
• InjuryNov 2, 2021Device 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 12739910 ↗
• InjuryOct 28, 2021Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED, RIGHT SIDE RUPTURE. AND IMPLANT HAD FOLDED OVER. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 12712348 ↗
• InjuryMar 22, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 11546048 ↗
• InjuryJan 13, 2021Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 11165687 ↗
• InjuryDec 15, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  PATIENT REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE I. ADDITIONALLY, HEALTHCARE PROFESSIONAL REPORTED AND CONFIRMED BAKER GRADE III. DEVICE HAS BEEN EXPLANTED AND DISCARDED AFTER SURGERY.

  Patient problems: Capsular Contracture

  MAUDE report 11010906 ↗

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