The Daily Record– the newspaper of Scotland – reports that due to front page headline reports by its sister publication, The Sunday Mail, the country’s Health Secretary, Alex Neil, is calling for tougher regulations concerning transvaginal mesh and more informed consent.
The Sunday Mail, and reporter Marion Scott, have done a series of hard-hitting exposes about mesh-injured women and their adverse events ranging from disability and chronic pain to infection, mesh migration and nerve damage. Fortunately her editors have allowed her to pursue the topic and Marion is a contributor to Mesh News Desk as well.
Mr. Neil admits that “campaigners” want to establish a national registry for medical devices.
Like the U.S., the U.K. does not follow a medical device after a device is sold and used in real-life conditions. Given that the bulk of medical devices do not undergo human clinical trials before being sold, there are no assurances a device is actually safe and effective. A post-approval national registry would at least determine how a device is faring when it is used by patients.
It was the Australian device registry, for example, that was the first to notice the DePuy metal-on-metal hips (MoM) were failing at an alarming rate. As a result, they were first to remove them from the market.
In the U.S., the Food and Drug Administration required that 35 mesh makers conduct three years of post-approval monitoring to see how women were faring who had been implanted with mesh. The FDA has the authority to require such monitoring under its 522 regulation.
Both Johnson & Johnson and C.R. Bard removed their most controversial meshes from the market right after that mandate and the FDA waived any requirement for monitoring the Prolift and Avaulta meshes.
Ever since the FDA required the monitoring in January 2012, there has been no update on the status of the testing.
The Daily Record, November 12, 2013
The Sunday Mail
FDA Requires Post-Approval Marketing, January 2012, Mesh Medical Device News Desk