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Hernia Repair Study Volunteers Needed by FDA
Study Topic: Patient Experience after Ventral Hernia Repair using Mesh
Conducted by: The U.S. Food and Drug Administration Center for Devices and Radiological HealthBackground
The Americas Hernia Society Quality Collaborative (AHSQC) established a hernia registry in 2013 to collect data on patient experiences after hernia surgery. The information gathered directly from patients is studied for ways to improve health outcomes for hernia patients. Our research team wants to improve this data collection method, and is looking for patients who are interested to join this study. Helping researchers learn from your experiences can lead to improvements in the quality of life for other patients after hernia repair.You are invited to join if you…
- Have had a ventral hernia surgery with mesh
- Are over 18 years of age
- Are willing to share your experiences and quality of life after your hernia surgery
- Your surgeon is participating in the AHSQC
Goals of the study
- Learn what hernia patients think is important for quality of life after their procedure
- Understand the real-life experience people have had with hernia repair during or after treatment
Study procedure
You will either be part of a one to one interview lasting 40-60 minutes, OR a focus group of 5-8 people that will take 1.5-2 hours. In both cases you will be asked about your hernia surgery experience. When you sign up to volunteer (please see below), you’ll be told which activity you will participate in.Contact
To sign-up or to find out more about this study please contact the study researcher Joyce Lee at MedSunHernia@fda.hhs.gov or by phone at 240-402-0716.(Please see attachment)
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2 Replies
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Denise Schrader started a topic 15×20″ physiomesh removal before 2 weeks.. DR’S LAB RAT
in Hernia Discussionhere is my story… before finding out that the 510k loophole was letting manufacturers do this to everyone all over the world…. Mesh facebook sites and blogs are popping up more and more, didn’t have anything to tell me about it in 2010 when I found out about the COMPLICATIONS THAT ARE SO TRUE AND REAL TO EVERYONE THAT HAS HAD REALLY ANY TYPE OF MESH PUT IN THEM…. THINGS THAT I’VE FOUND OUT THEY KNEW ABOUT MORE THAN 5YRS BEFORE MY SURGERY… FDA GAVE OK’S TO PUT INTO HUMAN BODIES WITHOUT TESTING IT IN HUMAN BODIES, AND WHEN DRS KNEW IT HAD COMPLICATIONS, FDA DIDN’T CARE ENOUGH TO HAVE DRS RESPOND WITH COMPLICATIONS OF THE MESH TO GET THE 510k LOOPHOLE…..
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Study Volunteers Needed
I highly support this!
The patient must be enrolled in the AHSQC, which is a quality collaborative that I and other surgeons belong to. You can ask your surgeon to enroll here: http://www.AHSQC.org
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