Mesh scandal: conflict of interests in review confirmed by investigation
A 2017 review into the use of transvaginal mesh implants has been discredited because it contained conflicts of interest, a new report has found.
Last May the three-year safety review was branded “a whitewash” by campaigners after it was significantly altered before the final draft was published, recommending that the controversial procedure should be reinstated in Scotland, albeit not “routinely”.
Then health secretary Shona Robison ordered an investigation into the way the review was conducted.
Professor of medical law at Glasgow Caledonian University Alison Britton, who led the investigation, has now concluded the original review was “ill-conceived, thoughtlessly structured and poorly executed”.
The report details that conflicts of interest were not declared or even discussed in the review. These included members being paid by big pharmaceutical companies, members who were being sued and members who were suing others.
One of the clinicians involved was actually the surgeon who had operated on another member of the review.
“Involvement in litigation, or a doctor patient relationship, has the potential to compromise the independence of any review,” Britton’s report said.
“We believe that it was a major failing that these were not declared and discussed. The credibility or accessibility of outcome tends to determine public perception of independence.”
Mesh is a synthetic implant used to treat pelvic organ prolapse and stress urinary incontinence. While the majority of women have suffered no side effects, complications can be severe.
In September chief medical officer Catherine Calderwood wrote to health boards to immediately halt the procedure after the implant was listed as a factor in the death of a woman in West Lothian.
SNP MSP Alex Neil, who ordered the original review, Scottish Conservative Jackson Carlaw and Scottish Labour’s Neil Findlay have campaigned on the issue and questioned the integrity of the Medicines and Healthcare products Regulatory Agency (MRHA), who authorised the products.
Britton has made 46 recommendations of how future government-ordered reviews can avoid the issues, including establishing a “test of impartiality” from the outset.
“It is important to be honest about our past failures,” she said in her foreword to the report. “But it is equally important to learn lessons from the past and to shape the future in light of those lessons.”