EACTS 2014, page-47

Hi MB,

No macroscopic evidence of calcification or visible immunological responses was found in the explanted ADAPT-treated tissue in both the hernia and pelvic floor reconstructions at the end of the study period. Assessment of the physical properties of the explanted ADAPT-treated tissues after six months demonstrated a better outcome than the control in that the ADAPT-treated tissue remained stable and intact without any significant deformation of the original shape (configuration) and size (dimensions) compared to synthetic meshes which tended to contract and shrink. The independent validation of these results confirms the regenerative performance of the ADAPT treated tissue and provides an opportunity to confirm the efficiency of the ADAPT- treated tissue in surgical repairs and reconstructions. These results provide additional evidence that ADAPT prepared tissue shows no signs of calcification and supports tissue regeneration, clear advantages over existing tissue products available.

For hernia repair, the study demonstrated the outstanding performance of ADAPT-treated tissue as a substitute for abdominal hernia repairs compared to alternative synthetic controls which tend to fail due to tissue erosion, implant exposure and infections after implantation. For pelvic floor repairs, the macroscopic results with the ADAPT-treated tissue in the pelvic floor reconstructions demonstrated comparable results in the vaginal area with the synthetic controls. These results compared favorably in terms of maintaining significantly low rates of implant exposure, erosion of surrounding tissue and infection when compared to synthetic materials currently in the market place.

The study was undertaken in collaboration with world known Gynecologist, Professor Jan Deprest, from The University of Leuven in Belgium.

In addition to your response from Russ, Prof. Deprest made the following comments in a paper which he had published in December 2012, which appears to indicate an advocacy towards the continued use of problematic synthetic materials - His lab his also well funded by the manufacturers of said materials

In the United States, the Food and Drug Administration has issued public health notifications in 2008 and 2011 warning against the use of transvaginal mesh because of its association with unacceptably high rates of complications. This follows a continuing and emotional debate within the scientific community that has now evolved to the point of positioning us in ‘the midst of a perfect storm’.

Although it is clear that morbid complications are associated with the use of mesh, to consider all uses of mesh as aberrant or regulating vaginal mesh out of existence may be an overreaction. We should be mindful that the use of mesh in prolapse surgery was conceived because native tissue repairs carry a significant risk for recurrence and, to a lesser extent, local side effects. With an increasing lifetime risk for prolapse surgery, now already at 19%, and increased life expectancy and activity levels, the need for durable and functional repair will only continue to increase. Although novel alternatives are emerging, such as cell-based or tissue-engineered solutions, they are still in their infancy. For this reason, it seems to us that at least for the time being mesh is here to stay. However, this should lead to appropriate action to minimise the side effects of using mesh.


The need for preclinical research on pelvic floor reconstruction

http://clients2.weblink.com.au/clients/admedus/article