[Informedpatient21]

I appreciate your reply and your thoughtfulness. You might be surprised to hear that I’m over two years out since my Ovitex repair and seven years out from my mesh repair. They were both direct hernia’s. I’m currently 280 lbs and consider myself still an athlete however clearly in a lot poorer shape than I once was, which makes this an even more interesting “experiment”.

I also have a six year old autistic son that requires a lot of restraining, holding, picking up and playing/wrestling as he is non-verbal as well and activity is a lot of how we communicate. I work out regularly although its been on an off over the years. When I do it’s typically weight training and boxing work with a speed bag and heavy bag as well as light sparring and skiing especially. So a good experiment….that is true.

Again, the main difference I notice, is that there is noticeably more restriction sensation and occasional pain on the synthetic side that I have learned to deal with over time. My understanding was that the product had been on the market just under a year when I had my surgery, but it was the animal data that my surgeon shared with me and some other things I learned about the company, as well as my industry understanding of biologic materials. You might be right about the FDA, but it’s a complex problem. If we waited for long term patient data for every medical device innovation, by the time the products made it to market, they would be unaffordable, as I stated previously……and to that point, yes, to some degree, we are all living experiments. That is the case with the food we eat, the package the food is stored in, the exhaust that we breathe from the facility that makes the package the product is stored in, but over time, we learn and move forward based on knowledge and understanding.

I respectfully disagree with you that being on the inside of the industry does not give me an advantage, as I know how the system works. That being said, I can recognize more easily when a company is doing work well above that “bar on the floor” you mentioned. 510(k)’s do not require extensive primate research, but the Ovitex company chose to do it.

As far as the regenerative nature of biologic materials, that is something as I said, I have personal industry experience with which also influenced my decision. As you can gather, it’s much to much to delve into on this post, but would be happy to answer specific questions at another time. I need to get some sleep.