Medical experts at Oxford University in the UK have related inadequate regulatory processes with the harm caused due to vaginal mesh products used for the treatment of stress incontinence and pelvic organ prolapse.
Led by Oxford University Centre for Evidence-Based Medicine professor Carl Heneghan, the team revealed that the lack of long-term evidence from clinical studies led to unnecessary harm to women.
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More than 100,000 women are currently suing manufacturers for developing serious complications due to the transvaginal mesh devices.
According to the Oxford team, the meshes, which were initially classified as class II devices, were marketed based on equivalence to other existing devices despite changes.
The experts traced marketing clearance for 61 mesh products through a chain of equivalence claims and found that only two unique originating devices were approved in 1985 and 1996.
Results further indicated lack of new trial data during the approval of these 61 devices.
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By GlobalDataThe team said that the important technological changes made to the device design should have negated the equivalence use and alerted regulators.
They added that the evidence from large pragmatic trials, which revealed serious concerns, emerged only 20 years after the launch of the first products and 12 years following the call for long-term studies.
Heneghan said: “In our view, to be considered safe and approved for widespread use, long-term implantable devices should have been evaluated in studies with follow-up of at least five years.”
He added that restricting the use of such devices through temporary licences to within trials with longer follow-up would ensure the availability of safety and effectiveness results before complete marketing authorisation.
