U.K. health secretary mandates vaginal mesh safety audit

Jeremy Hunt, the U.K.’s health & social care secretary, this week ordered a National Health System safety audit of the use of plastic mesh implants to treat vaginal prolapse and female urinary incontinence.

Hunt said the review of vaginal mesh and two other products – the Primodos hormone-based pregnancy test and the anti-epilepsy drugsodium valproate – were prompted by “serious concerns … raised by patients and their families.”

Some of those complaints about vaginal mesh included calls for the products to be banned in the U.K. The health secretary said he asked NHS chief medical officer Dr. Sally Davies for advice on a ban.

“She has been clear that clinical experts here and abroad agree that, when used appropriately, many women gain benefit from this intervention, hence a full ban is not the right answer in the light of the current evidence available,” Hunt said during a Feb. 21 address to the House of Commons. “However, this is not to minimize the suffering many women have experienced, which is why today I can announce that we will be publishing a retrospective audit to investigate the links between patient-level data to explore outcomes, and investing £1.1 million [$1.5 million] to develop a comprehensive database for vaginal mesh to improve clinical practice and identify issues.”

The Primodos test led to miscarriages and birth defects during the 1960s and ’70s before it was withdrawn in 1978, he added, and sodium valproate was “definitively linked” to autism and learning disabilities in children when taken during pregnancy.

Hunt pledged to offer full genetic clinical evaluations to families in the Assn. for Children Damaged by Hormone Pregnancy Tests and to introduce a new warning label for sodium valproate packaging, updating national guidance on its use and push for it to be contra-indicated for women of childbearing potential not using contraception, among other things.

“Of course our first thoughts are with the individuals and families whose lives have been turned upside down by these issues,” Hunt said. “I pay particular tribute to those who have responded to such experiences not just with understandable anger, but with resolute determination to campaign for change on behalf of others.

“We must acknowledge that the response to these issues from those in positions of authority has not always been good enough,” he said. “To do better in the future, we need to ensure that patient voices are bought to the table as systematically and consistently as other voices in the system.”

Hunt said he asked Baroness Julia Cumberlege to review “what happened in each of these three cases, including whether the processes pursued to date have been sufficient and satisfactory, and to make recommendations on what should happen in future.”

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