Vagenius

Essure Coils Should They Be Removed?

July 25, 2021 Elena
Vagenius
Essure Coils Should They Be Removed?
Chapters
Vagenius
Essure Coils Should They Be Removed?
Jul 25, 2021
Elena

Permanent sterilization using a hysteroscopic technique was unique to the Essure and Adiana systems.  Both seemed like a dream come true for many providers because it allowed patients to be offered a minimally invasive approach to contraception that was both non-hormonal and permanent. 

I remember when it was first introduced, it was marketed as a revolutionary treatment for permanent sterilization.  The reason why this procedure gained popularity so fast was because it could be done in the office, transvaginal with minimal to no downtime.  

Previously permanent sterilization could only be offered either immediately after a vaginal delivery, c-section or via a laparoscopy or abdominal approach.  All of these modalities could only access the fallopian tubes by entering the abdominal cavity, meaning higher risk and greater downtime.  

So it is no wonder that many physicians jumped on the band wagon and trusted that the manufacturer, Bayer, had done their due diligence by evaluating the efficacy and safety of this permanent contraceptive device.  

The truth is that no one understands how FDA approval was granted with such low quality data that overly relied on retrospective claims-based database analysis. There was a complete absence of adequate perspective, comparative, post market data collection and analysis.  Unfortunately, this is a trend that we see over and over again in many implantable devices.  How do we know which ones we can trust?

Share this podcast with someone you know is having issues with their implantable device.  You can reach me online:
Website: www.drelenarodriguez.com
Instagram: @dr.elenarodriguez
YouTube: Dr. Elena Rodriguez

Show Notes

Permanent sterilization using a hysteroscopic technique was unique to the Essure and Adiana systems.  Both seemed like a dream come true for many providers because it allowed patients to be offered a minimally invasive approach to contraception that was both non-hormonal and permanent. 

I remember when it was first introduced, it was marketed as a revolutionary treatment for permanent sterilization.  The reason why this procedure gained popularity so fast was because it could be done in the office, transvaginal with minimal to no downtime.  

Previously permanent sterilization could only be offered either immediately after a vaginal delivery, c-section or via a laparoscopy or abdominal approach.  All of these modalities could only access the fallopian tubes by entering the abdominal cavity, meaning higher risk and greater downtime.  

So it is no wonder that many physicians jumped on the band wagon and trusted that the manufacturer, Bayer, had done their due diligence by evaluating the efficacy and safety of this permanent contraceptive device.  

The truth is that no one understands how FDA approval was granted with such low quality data that overly relied on retrospective claims-based database analysis. There was a complete absence of adequate perspective, comparative, post market data collection and analysis.  Unfortunately, this is a trend that we see over and over again in many implantable devices.  How do we know which ones we can trust?

Share this podcast with someone you know is having issues with their implantable device.  You can reach me online:
Website: www.drelenarodriguez.com
Instagram: @dr.elenarodriguez
YouTube: Dr. Elena Rodriguez