Natrelle Inspira SoftTouch Breast Implants SSLP-300Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10888628032736), received between Dec 4, 2019 and Sep 25, 2026 — classified as 35 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (25 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 35 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "Capsule contracture" Baker grade III. This record is for the left side. Device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50899113 ↗
• InjurySep 18, 2026Device Appears to Trigger Rejection

  Patient problems: Capsular Contracture

  MAUDE report 50831468 ↗
• InjuryJun 10, 2026Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "STABLE INTRACAPSULAR IMPLANT LEAK". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.

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

  MAUDE report 25461722 ↗
• InjuryApr 30, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 25049067 ↗
• InjuryAug 11, 2025Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 22772181 ↗
• InjuryAug 5, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "SUSPECTED/ACTUAL RUPTURE ... PTOSIS" VIA NBIR. THIS RECORD IS FOR THE "RIGHT" SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 22716482 ↗
• InjuryAug 4, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED VIA NBIR "SUSPECTED/ACTUAL RUPTURE/DEFLATION, PTOSIS". THIS RECORD IS FOR THE "LEFTT" SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 22709631 ↗
• InjuryJul 29, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 22644697 ↗
• InjuryOct 26, 2023Material Rupture; Material Rupture

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

  Patient problems: Failure of Implant

  MAUDE report 18016931 ↗
• InjuryAug 2, 2023Device 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 17439717 ↗
• InjuryAug 1, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 17438750 ↗
• InjuryAug 1, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 17435086 ↗
• InjuryJul 22, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 17375502 ↗
• InjuryJul 10, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 17287585 ↗
• InjuryJun 14, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE- 1, RUPTURE AND CHANGE IN SHAPE/SIZE/STYLE . DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 17130121 ↗
• InjuryMay 19, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III AND RUPTURE. DEVICE REMAINS IMPLANTED. THIS RELATES TO THE RIGHT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 16962941 ↗
• InjuryApr 26, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  ANY CREASES WERE OBSERVED, DURING SURGERY.

  Patient problems: Capsular Contracture

  MAUDE report 16815164 ↗
• InjuryMar 28, 2023Material Rupture; Material Rupture

  PATIENT REPORTED LEFT SIDE "LEAK, POSSIBLE RUPTURE¿, ¿EMOTIONAL PROBLEMS AND DEPRESSION PERSISTED WITH OCCASIONAL SUICIDAL THOUGHTS¿, AND ¿DIAGNOSED WITH A MRSA (METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS) INFECTION IN ARMPITS AS A RESULT OF CHEMICAL TOXINS LEAKING FROM HER LYMPH NODES¿. ADDITIONAL EVENTS OF ¿CHEMICAL ODOR FROM HER ARMPITS¿, ¿SKIN PROBLEMS, CYSTIC ACNE, HORMONE IMBALANCE PROBLEMS, INSOMNIA, CHRONIC FATIGUE, COGNITIVE PROBLEMS AND DIFFICULTY CONCENTRATING DURING BASIC CONVERSATIONS¿, ¿FATIGUE¿, ¿INCREASED ALCOHOL INTOLERANCE¿, ¿HYPOXIA¿, ¿ADRENAL FATIGUE¿, ¿NOW STRUGGLES WITH PTSD¿, WHICH ARE NOT DEVICE RELATED. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Drug Resistant Bacterial Infection

  MAUDE report 16627459 ↗
• InjuryJan 24, 2023Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL LATER REPORTED "RUPTURED." DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 16233785 ↗
• InjuryOct 27, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 15679384 ↗
• InjuryOct 20, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 15642545 ↗
• InjuryOct 17, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 15620149 ↗
• InjurySep 19, 2022Device 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 15446612 ↗
• InjurySep 6, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTION BAKER GRADE III/IV" AGAINST LEFT DEVICE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 15365544 ↗
• InjuryAug 23, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 15277102 ↗

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-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
• 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-