Natrelle Inspira SoftTouch Breast Implants SSLP-220Recalls & reported problems
Allergan, Inc. · Natrelle Inspira SSLP 220cc 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 an Allergan Natrelle Inspira SoftTouch silicone gel breast implant. The 27 reports mostly describe the scar tissue tightening around the implant (capsular contracture) and breast pain, plus some cases of the implant rupturing and one report of the body rejecting the implant; 25 reports involved injuries and no deaths. There are no recalls naming this device. Reports fell from 8 in the earlier 12 months to 2 in the most recent 12 months.
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
- 25
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10888628032682), received between Aug 15, 2019 and Jul 27, 2026 — classified as 25 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (17 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 Rejection17
- Material Rupture5
- Patient-Device Incompatibility4
- Adverse Event Without Identified Device or Use Problem2
- Break1
- Difficult to Open or Remove Packaging Material1
- No Apparent Adverse Event1
Patient problems
- Capsular Contracture21
- No Clinical Signs, Symptoms or Conditions3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Failure of Implant2
- Deformity/ Disfigurement1
- Pain1
- Seroma1
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 27, 2026Difficult to Open or Remove Packaging Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50014928 ↗InjuryApr 7, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED THROUGH "CAPSULAR CONTRACTURE". LATER HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE III AND "INTACT IMPLANT". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24808835 ↗InjurySep 3, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED VIA NBIR ¨SUSPECTED/ACTUAL RUPTURE/DEFLATION¨. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 22956668 ↗InjuryAug 1, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
PATIENT REPORTED " "BUBBLES" ON THE TOP AND BOTTOM OF THE RIGHT-SIDE BREAST", "LOOKED LIKE A FREAK", AND LOOKED "ELONGATED AND TWISTED". LATER, REPORTED "HAVE YOU BEEN DIAGNOSED WITH IMPLANT RUPTURE, CAPSULAR CONTRACTURE OR OTHER DEVISE MALFUNCTION? YES". THIS RELATES TO THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Contracture
MAUDE report 22685026 ↗InjuryJul 30, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
PATIENT REPORTED "PAIN" AND "ELONGATED AND TWISTED". PATIENT LATER, REPORTED IMPLANT RUPTURE, CAPSULAR CONTRACTURE AND OTHER DEVISE MALFUNCTION. THIS RELATES TO THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Contracture; Pain
MAUDE report 22668426 ↗InjuryJul 14, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE II". LATER, HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22503702 ↗InjuryJul 13, 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. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22490733 ↗InjuryJul 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "SIZE EXCHANGE/ANIMATION DEFORMITY". THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Deformity/ Disfigurement
MAUDE report 22469736 ↗InjuryJul 9, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED "CAPSULAR CONTRACTURE, BAKER GRADE IV". LATER, HEALTHCARE PROFESSIONAL CONFIRMED THE EVENT. THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22459020 ↗InjuryMay 19, 2025Device Appears to Trigger Rejection; No Apparent Adverse Event; Device Appears to Trigger Rejection; No Apparent Adverse Event
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture; No Clinical Signs, Symptoms or Conditions
MAUDE report 22044673 ↗InjuryNov 8, 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 18097719 ↗MalfunctionJul 27, 2023Break; Break
HEALTHCARE PROFESSIONAL REPORTED "THE IMPLANT DEFLATED DURING IMPLANTATION". THE DEVICE WAS NOT IMPLANTED. THE DEVICE MADE CONTACT WITH THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17410623 ↗InjuryOct 4, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
PATIENT REPORTED "RIGHT SIDE IS A CONTRACTURE," AND "BOTH BREASTS ARE MISSHAPEN." DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15539893 ↗InjuryAug 2, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE 3. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 15147081 ↗InjuryJul 13, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV" AGAINST RIGHT DEVICE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 15008981 ↗InjuryMay 4, 2022Material Rupture; Material Rupture
PATIENT REPORTED LEFT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 14282702 ↗InjuryApr 7, 2022Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED VIA DEVICE TRACKING, RIGHT SIDE ¿CAPSULAR CONTRACTURE/DEFLATION,¿ BAKER GRADE NOT SPECIFIED. DEVICE EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 14046157 ↗InjuryMar 8, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV" AGAINST RIGHT DEVICE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 13691327 ↗InjuryDec 21, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED VIA NBIR A LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 13055980 ↗InjuryDec 15, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED VIA NBIR RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 13013990 ↗InjuryMar 25, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 11567032 ↗InjuryMar 25, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 11567026 ↗InjuryJul 23, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "CAPSULAR CONTRACTURE, BAKER GRADE III". DEVICE HAS BEEN EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 10318140 ↗InjuryJul 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE ¿SEROMA AND SIZE.¿ DEVICE HAS BEEN EXPLANTED.
Patient problems: Seroma
MAUDE report 10228442 ↗InjuryJun 30, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
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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