Government announces review into vaginal mesh devices

A review into a number of medical products that have caused public scandals has been announced by the government.

Speaking during prime minister’s questions, Theresa May stated that a review into health scandals including primodos, vaginal mesh and sodium valproate would be undertaken.

When asked about the situation by Conservative MP Mike Penning, the prime minister responded saying: “The concerns raised by campaign groups about not just primodos, but issues such as vaginal mesh and sodium valproate, have highlighted that there is an issue with our regulatory and healthcare system, and we are determined to address it. I have been clear that we need to do better. I was very struck by the powerful stories I heard. We need to see a faster, more understanding response when patients raise concerns.”

Health and social care secretary, Jeremy Hunt, announced shortly after prime minister’s questions that a review would be undertaken by Conservative peer Julia Cumberlege.

In his statement, Hunt said: “The response they have received from those in positions of authority has not always been good enough. From primodos to mesh and sodium valproate, patients and their families have had to spend too much time and energy campaigning for answers in a way that has added insult to injury for many."

In relation to vaginal mesh products, Hunt stated that the products had been linked to “crippling, life-changing side-effects”.

“We must acknowledge that the response to these issues, in those in positions of authority, has not always been good enough.” Hunt stated.

The review will take nine months and will examine the safety of the medical devices mentioned during Jeremy Hunt’s statement.

Hunt mentioned that a full ban of vaginal mesh products was not an option as “clinical experts here and abroad agree that when used appropriately, many women gain benefits from this intervention”.

He went on to announce that an audit will be produced investigating the links between patient data and outcomes and that £1.1 million will fund a vaginal mesh database to help improve clinical practice and identify issues.

In response to the announcement, founder of vaginal mesh campaign group, Sling the Mesh, Kath Sansom, said: “If a woman has had a good outcome it is only “for now”. Any woman who has had mesh is a ticking time bomb as the product can shrink or twist years down the line. No amount of surgeon training can counteract that.

“It is wrong that women have had to fight for years to get their voices heard, often being dismissed as mad, hysterical or a minority suffering. Had men been hurt by drugs or implants on this scale there would be an outcry. Instead we have been left to suffer in silence. Every woman affected by primodos, valproate or mesh implants have suffered personal tragedies that can never be compensated for.”

“We are delighted that the government has announced a review into Mesh, primodos and valproate. but also deeply saddened that so many women’s and families lives have been shattered by medical devices and drugs that were never tested on humans before being released en masse to women globally. We were the human guinea pigs. These are three huge women’s health disasters. The people who benefited most were the share holders and big CEOs.”

Commenting on the news, Chair of the APPG on Surgical Mesh Implants, Owen Smith said: “I am delighted that the government has listened to our concerns about the safety of mesh devices and has agreed to conduct this review. Lessons must be learned from the awful complications many women have experienced since undergoing mesh surgery and proper processes must be put in place to stop this happening in the future.

“The mesh scandal shows what can go wrong when devices are aggressively marketed to doctors and then used in patients for whom they were unsuited or unnecessary. Mesh devices should be seen against that history of medicalisation and miss-selling and should be subject to the most stringent clinical trials before being deployed in surgery.

“The news of a prospective registry is also hugely welcome, and is one of the key things we’ve been asking for. I’m pleased that the government has listened and this registry, together with the recently announced retrospective audit currently being undertaken, will provide us with a better understanding of problems related to mesh.”

“It is a shame however that NICE is still unable or unwilling to bring forward its review into the safety and efficacy of Mesh and that the government will not suspend mesh until the reviews have been undertaken, as has happened in New Zealand.”