The investigation published today in the BMJ brands mesh “a shameful episode”, calling for scrapping of its use and says a mandatory device registry is long overdue.

It is accompanied by an editorial from experts at Newcastle University who warn that Europe’s new device regulations “will fail to protect the public, unless they are reinforced.”

In the editorial, Mr Chris Allan, Public Health Specialty Registrar within the Institute of Health and Society at Newcastle University and colleagues Professor Allyson Pollock and Professor Tom Joyce at Newcastle University warn that Europe’s new device regulations “will fail to protect the public, unless they are reinforced.”

They argue that the new rules, which come into force on 26 May 2020, “require further tightening to protect public safety.” At the very least, for all high risk devices, national authorities such as Medicines and Healthcare products Regulatory Agency (MHRA) in the UK “should take over conformity assessments to reduce commercial conflicts of interest,” they write.

Tightening up regulation

They also say clinical studies of both efficacy and effectiveness “should be a condition of pre-market approval,” and all data including clinical studies and investigations “should be available to everyone, ending differential rights of access for regulators and the public.”

Dr Fiona Godlee, The BMJ’s Editor in Chief and Professor Carl Heneghan of Oxford University’s Centre for Evidence Based Medicine, say the postmarketing assessment of vaginal mesh has been “a shameful episode in the history of implantable devices.”

Surgeons, manufacturers, regulators, and governments have all played their part in this failing, they write in an editorial. “Mandated national registries are needed for all implantable devices, to protect patients, improve outcomes, reduce costs, and identify best practice. Another mesh tragedy is otherwise inevitable.”

BMJ's Editorial: Europe’s new device regulations fail to protect the public

For the whole investigation read the BMJ

Heading 3 example

Text only.  For subheading use ‘Heading 3’

Lorem ipsum dolor sit amet, consectetur adipiscing elit. Donec vel sapien lectus. Aliquam consectetur vitae tortor mattis sodales. Donec id quam id nulla tristique vestibulum. Ut vitae orci aliquam massa varius dapibus. Vivamus aliquet, lorem sit amet semper ultricies, ex tortor molestie felis, at ultrices tellus ligula vitae est. Sed gravida tortor sapien, in iaculis quam vestibulum vel. Duis et quam nec metus pharetra placerat. Donec in tellus pretium ex sagittis posuere. Nunc varius, libero at suscipit commodo, magna lacus facilisis velit, sed pellentesque magna eros vel dolor. Donec pretium neque ultrices, condimentum turpis non, porttitor neque. Suspendisse fermentum at lectus scelerisque mattis. Nam augue justo, iaculis quis euismod et, viverra in elit. Aliquam vitae justo malesuada, sodales urna et, aliquam nunc. Nulla placerat neque quis odio molestie, mattis bibendum turpis pellentesque.