Here is the link to more supporting data, from your paper. I have seen the device before.
https://www.sciencedirect.com/science/article/pii/S2405857219300658?via%3Dihub
They said that they followed up “every subsequent year” but I cannot find any discussion about the patients’ satisfaction with the procedure, beyond six months. Only the six month chart is shown.
“Postoperative follow-ups were carried out at 7 days, 15 days,
then at 1, 3, 6, 12, 18 months and every subsequent year.”
The paper starts with a very good overview of the problem and some good ideas, in words, about how to address them. But the final product is really just another device made from stiff polypropylene fibers. It should cause the same foreign body response and fibrosis as a flat piece of mesh, over time.
The primary author is the inventor of the device.
“However, a factual limitation of this study arises from possible
bias deriving from the correspondent author, who is the developer
of the implant and the related surgical technique. Nevertheless, the evidence demonstrated and discussed in the report seems to
adequately balance said perception”
I think that the overview and ideas used at the start of the paper could be a great foundation for developing new products, if a group of people could get together who can think outside of the 510(k) process.