SIENTRA SILICONE GEL BREAST IMPLANTS
by SIENTRA INC
The SIENTRA SILICONE GEL BREAST IMPLANTS by SIENTRA INC has a safety score of 65 out of 100, placing it in the moderate-risk category. Based on FDA MAUDE data, there have been 5,615 adverse event reports since its introduction in 2015. With an estimated 0 units in use, the incident rate is 0 per 10,000 units. It ranks #65 out of 79 devices in the Women's Health category.
Should you be concerned? A score of 65/100 indicates moderate safety. The 5,615 adverse event reports should be viewed in context — higher reporting doesn't always mean a more dangerous device, as popular devices naturally accumulate more reports. However, discuss the specific risks with your doctor before your procedure.
No recalls have been issued for this device — a positive indicator of manufacturing quality and design safety. On the market since 2015, this device has 11 years of real-world data — enough for long-term safety patterns to emerge.
Questions to Ask Your Doctor About the SIENTRA SILICONE GEL BREAST IMPLANTS
1. “What alternatives exist to the SIENTRA SILICONE GEL BREAST IMPLANTS?”This device ranks #65 of 79 in the Women's Health category. There are 64 devices with better safety scores — ask if any are appropriate for your case.
2. “How many of these have you personally implanted or used?”Surgeon experience with a specific device significantly impacts outcomes. Higher procedure volume correlates with fewer complications.
3. “What are the specific risks for my case?”Overall adverse event rates (0 per 10,000) are averages — your individual risk depends on age, health conditions, and anatomy.
4. “Is there a newer generation of this device available?”The SIENTRA SILICONE GEL BREAST IMPLANTS has been on the market since 2015 (11 years). Newer versions may have improved safety profiles based on lessons from earlier models.
Adverse Events
Total reports filed with FDA MAUDE
Death Reports
Death reports associated with device
Incident Rate
Per 10,000 units in use
Recalls
No recalls on record
Estimated Units in Use
Based on market data estimates
Category Ranking
In Women's Health by safety score
How This Compares
Other Women's Health Devices
SURGITEK BREAST IMPLANT
Unknown
SILICONE GEL BREAST IMPLANTS
Unknown
MARLEX MESH
Unknown
MESH
Unknown
Important Context
Adverse event reports reflect reported incidents, not confirmed device failures. Higher numbers may indicate greater device usage, better reporting systems, or increased awareness. This data should be one factor in your research — always consult your physician.