Natrelle Inspira SoftTouch Breast Implants SSLP-235Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10888628032699), received between Jan 28, 2020 and Sep 22, 2026 — classified as 14 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (7 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2026Device Appears to Trigger Rejection; Material Rupture

  Healthcare professional reported "rupture" and "capsular contracture" Baker grade unknown. This record is for the right side. Device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50854026 ↗
• InjurySep 22, 2026Material Rupture; No Apparent Adverse Event

  Healthcare professional reported "rupture". Later, healthcare professional reported "non ruptured" and "ptosis" which is not device related. This record is for the left side. Device was explanted. This record is no longer reportable to FDA and will be un-reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50853882 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Wrinkling

  MAUDE report 50782065 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Wrinkling

  MAUDE report 50782038 ↗
• InjuryMar 30, 2026Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED VIA NATIONAL BREAST IMPLANT REGISTRY (NBIR) "CAPSULAR CONTRACTURE BAKER GRADE III-IV". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 24719120 ↗
• InjuryNov 6, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED, LEFT SIDE EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE. HEATHCARE PROFESSIONAL, LATER REPORTED, RUPTURE. AND "HOLE NON-SPECIFIC". DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 18074762 ↗
• InjurySep 26, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL CONFIRMED, THAT THERE IS NO RUPTURE IN RIGHT SIDE.

  Patient problems: Failure of Implant

  MAUDE report 17822202 ↗
• InjurySep 18, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 17769635 ↗
• InjuryJan 13, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 16160462 ↗
• InjuryJan 13, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 16157682 ↗
• InjuryDec 2, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III" AGAINST RIGHT DEVICE. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 12919097 ↗
• InjuryJun 29, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 12085691 ↗
• InjuryNov 18, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE WAS "EXPOSED". DEVICE HAS BEEN EXPLANTED

  Patient problems: Foreign Body Sensation in Eye

  MAUDE report 10863606 ↗
• InjuryJan 28, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED, "ANY CREASES". DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 9639677 ↗

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