Did you know that in the US, the pharmaceutical and medical device industry now funds six times more clinical trials than the federal government? It is hard to trust scientific studies with such large conflicts of interest at play. Not only are there conflicts of interest but there are also massive conflicts in the results.
Scientific studies regarding medical devices should show the outcomes and risks associated with those devices. When a study is released, it should be followed by a replication study, where other scientists and institutions replicate the study to see if they get similar results. In order to actually show statistical significance, sample sizes (number of people) should be large. To help reduce bias, studies should also be randomised controlled trials (RCT’s), where the sample is split into two groups where one group is given the treatment being tested and the other group (the control group) is given a standard treatment or placebo. Studies into medical devices should also be carried out with long term follow-up to ensure that complications are picked up even if they occur many years after the original surgery.
Unfortunately, the majority of studies into mesh have been funded by the mesh manufactures. RCT’s have been few and far between, with many of the studies (on which decisions to implant mesh are based) being retrospective short term studies. Sample sizes are often small and studies are even subject to p-hacking – where the data is mined or broken into a smaller dataset in order to select outcomes that are in favour of the desired outcome.
A simplified explanation of P-hacking is that you scan the complete data for the research and select a subset that gives the conclusion you want. An example of this can be seen in the following comparison of two studies (best viewed on PC/laptop). These studies clearly come from the same dataset, with four of the same authors, almost the same date range and the same procedures being prepared. These studies were comparing Prosterior Vaginal repairs using mesh (POSTERIOR IVS) and Sacrospinous fixation (native tissues) for the management of pelvic organ prolapse. The first study states that “Both the procedures were highly effective in restoring anatomy in the upper vaginal segment.” , however, the second, which was used as a reference study for a mesh device needing FDA approval, concludes with some loosely worded text that is positive towards mesh and negative towards the native tissue repairs!
Does this make the researchers bad people? No – we have to realise that they are under immense pressure to produce positive results from studies. They can’t do studies if there is no funding, and most of the funding comes from big pharma. Again, their livelihood is under threat if they try to go against the current corrupt system.