SIENTRA Silicone Gel Breast Implant 10621-305MPRecalls & reported problems
Sientra, Inc. · Silicone Gel Breast Implant, Smooth Round, Moderate Plus Profile, 305 cc · Class 3
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00812790020973), received between Jun 5, 2019 and Jun 5, 2019 — classified as 1 injury.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Capsular Contracture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 5, 2019Adverse Event Without Identified Device or Use Problem
PATIENT DIAGNOSED WITH BILATERAL CAPSULAR CONTRACTURE, BAKER GRADE IV. THIS REPORT IS FOR THE LEFT-SIDE DEVICE.
Patient problems: Capsular Contracture
MAUDE report 8671098 ↗
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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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