Natrelle Inspira SoftTouch Breast Implants SSLP-360Recalls & reported problems
Allergan, Inc. · Natrelle Inspira SSLP 360cc 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 Natrelle Inspira SoftTouch silicone gel breast implant (360cc) is a soft, round implant used in breast reconstruction or augmentation. The 27 reports mostly describe the scar tissue around the implant tightening and contracting, sometimes severely enough to distort the breast, along with a few cases of the implant shell breaking or leaking gel. All 27 reports describe injuries, with no deaths, and 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
- 27
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10888628032767), received between Oct 25, 2019 and Sep 8, 2026 — classified as 27 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (20 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 Rejection20
- Material Rupture4
- Adverse Event Without Identified Device or Use Problem2
- Patient-Device Incompatibility2
- Biocompatibility1
- Gel Leak1
Patient problems
- Capsular Contracture21
- Failure of Implant4
- Erosion1
- No Clinical Signs, Symptoms or Conditions1
- Unspecified Infection1
- Wound Dehiscence1
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
InjurySep 8, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50680510 ↗InjuryOct 15, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "CAPSULAR CONTRACTURE BAKER GRADE IV". DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 23291104 ↗InjurySep 26, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 23155447 ↗InjuryJul 4, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT TREATED WITH SINGULAIR. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 22403736 ↗InjuryApr 9, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PHYSICIAN REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 21808666 ↗InjuryNov 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED "WOUND DEHISCENCE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Wound Dehiscence
MAUDE report 18094001 ↗InjuryNov 2, 2023Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "DEFECT IN IMPLANT¿. HEALTHCARE PROFESSIONAL LATER REPORTED RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 18062323 ↗InjurySep 20, 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 17779149 ↗InjuryJul 13, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED A UNILATERAL LEFT-SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 17319534 ↗InjuryApr 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED "DEVELOPED MRSA IN THE RIGHT BREAST IMPLANT EXCHANGE/CAPSULECTOMY SIDE REQUIRING THE REMOVAL OF HER IMPLANT SO THIS SURGERY WAS TO REPLACE IT." THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Unspecified Infection
MAUDE report 16724364 ↗InjuryMar 22, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE REMAINS IMPLANTED. THIS RELATES TO THE LEFT SIDE.
Patient problems: Capsular Contracture
MAUDE report 16593170 ↗InjuryJan 26, 2023Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL LATER REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN VIA DT FORM.
Patient problems: Capsular Contracture; Failure of Implant
MAUDE report 16251158 ↗InjuryJan 26, 2023Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture; Failure of Implant
MAUDE report 16247376 ↗InjuryNov 4, 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 15738325 ↗InjuryNov 4, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT-SIDE CAPSULAR CONTRACTURE BAKER III. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15736491 ↗InjuryJun 14, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE II, POSSIBLE III. PHYSICIAN LATER CONFIRMED A BAKER GRADE III. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 14688414 ↗InjuryJun 13, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE II, POSSIBLE III. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 14680352 ↗InjuryMay 18, 2022Device Appears to Trigger Rejection; Biocompatibility; Device Appears to Trigger Rejection; Biocompatibility
HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE, BAKER GRADE III AGAINST RIGHT DEVICE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 14431818 ↗InjuryMar 20, 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 13830839 ↗InjuryMar 20, 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 13830731 ↗InjuryFeb 9, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
InjuryFeb 9, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III / IV. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 13498482 ↗InjuryJan 14, 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 13258830 ↗InjuryMar 16, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DEVICE REMOVAL AS "IMPLANT EXTRUSION 2 MONTH POST-IMPLANTATION." DEVICE HAS BEEN EXPLANTED.
Patient problems: Erosion
MAUDE report 11499593 ↗InjuryMar 13, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 9829640 ↗
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 · 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-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-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
- 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-
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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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