Natrelle Inspira SoftTouch Breast Implants SSLP-250Recalls & reported problems
Allergan, Inc. · Natrelle Inspira SSLP 250cc Low plus profile |smooth|round|silicone · Class 3 · Implant
All models of Natrelle Breast Implants (1167) · Natrelle Inspira SoftTouch Breast Implants (195)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a Natrelle Inspira SoftTouch silicone breast implant. The 27 reports mostly describe the scar tissue around the implant tightening and hardening, which can make the breast stiff, painful and misshapen, and some mention the implant shell breaking or the body rejecting it. There are no deaths and 26 injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 27
- Deaths reported
- 0
- Injuries reported
- 26
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10888628032705), received between Aug 16, 2019 and Sep 22, 2026 — classified as 26 injuries, 1 malfunction.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (19 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.
Reports received per month
Most reported problems
Device problems
- Device Appears to Trigger Rejection19
- Material Rupture4
- Patient-Device Incompatibility2
- Device Contaminated During Manufacture or Shipping1
- Difficult to Open or Remove Packaging Material1
Patient problems
- Capsular Contracture21
- Failure of Implant4
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
InjurySep 22, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture
MAUDE report 50849433 ↗InjurySep 22, 2026Device Appears to Trigger Rejection
Patient problems: Capsular Contracture
MAUDE report 50849431 ↗InjuryDec 18, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED "HAD HER IMPLANTS REMOVED AND A RUPTURE WAS FOUND" AND LATER REPORTED "MASTODYNIA" AND "PAIN IN THE BREASTS". THIS RECORD IS FOR THE RIGHT-SIDE. DEVICE HAS BEEN EXPLANTED. DEVICE HAS BEEN DISCARDED.
Patient problems: Failure of Implant
MAUDE report 23840549 ↗InjurySep 8, 2025Device Appears to Trigger Rejection; Device 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 22993654 ↗InjuryAug 21, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". TREATMENT: SINGULAIR AND ACCOLATE. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED. DEVICE WILL NOT BE RETURNED.
Patient problems: Capsular Contracture
MAUDE report 22861244 ↗InjuryAug 14, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV AND EXCHANGE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22805539 ↗InjuryJul 2, 2025Device 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 22381337 ↗MalfunctionMay 28, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material
HEALTHCARE PROFESSIONAL REPORTED "COULD NOT OPEN AN IMPLANT BOX TO RETRIEVE AN IMPLANT." DEVICE WAS NOT IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22099670 ↗InjuryOct 18, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "CAPSULAR CONTRACTURE, BAKER 3". DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17962090 ↗InjuryOct 18, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "CAPSULAR CONTRACTURE, BAKER III". DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 17958469 ↗InjuryOct 12, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
HEALTHCARE PROFESSIONAL REPORTED "SOMETHING¿ IN THE BOX" AND "DEFINITELY INSIDE WHERE THE IMPLANT SITS". DEVICE WAS NOT IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17926118 ↗InjurySep 13, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE VIA MRI. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 17739129 ↗InjurySep 13, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE VIA MRI. DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 17738331 ↗InjuryMay 17, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 16948163 ↗InjuryApr 24, 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 16801579 ↗InjuryMar 27, 2023Material Rupture; Material Rupture
PATIENT REPORTED A BILATERAL "LEAK" AND POSSIBLE RUPTURE. DEVICE EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 16619638 ↗InjuryMar 1, 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 16461771 ↗InjuryNov 10, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15777080 ↗InjurySep 12, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED AGAINST RIGHT SIDE "LEFT SIDE IS LOWER THAN THE RIGHT SIDE". HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15401249 ↗InjuryMay 28, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III/IV AGAINST RIGHT DEVICE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 14538667 ↗InjuryMay 17, 2022Device 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 14416934 ↗InjuryFeb 18, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTH CARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 13562212 ↗InjuryFeb 17, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTH CARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 13550344 ↗InjuryNov 23, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTH CARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 12861510 ↗InjuryApr 19, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
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 · TerminatedNatrelle 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 · TerminatedNatrelle 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, ClassifiedNatrelle 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, ClassifiedNatrelle 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
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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