National Health System officials in the United Kingdom will be taking a hard look at the safety of mesh implants used to treat vaginal prolapse and female urinary incontinence. The U.K.'s health and social care secretary, Jeremy Hunt, ordered a safety audit of the devices in response to complaints from patients and their families asking for the products to be banned. The NHS will investigate the links between patient-level data to explore outcomes, and the organization will invest £1.1 million to develop a comprehensive database for vaginal mesh to improve clinical practice and identify issues.
Two other medical products, one being a hormone-based pregnancy test and the other being an epilepsy drug, will also be looked at.
"Many people have endured, and continue to endure, severe complications and tremendous pain, distress and ill health, alongside a strong sense that their concerns have not reached a satisfactory resolution," Hunt said during an address to the House of Commons. "I pay particular tribute to those who have responded to such experiences not just with understandable anger, but with a resolute determination to campaign for change on behalf of others."
The health secretary acknowledged that the response to these issues from those in public officials has not always been good enough.
"Sometimes the reaction has felt too focused on defending the status quo, rather than addressing the needs of patients, and as result patients and their families have spent too long feeling that they were not being listened to, making the agony of a complex medical situation even worse," Hunt said.
He said he asked Sally Davies, MD, chief medical officer at the NHS, for advice regarding a ban on vaginal mesh implants.
"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.
On Primodos, the pregnancy test, Hunt said the organization will implement expert recommendations aimed at better monitoring of medicines in pregnancy. That will include offering families of the Association for Children Damaged by Hormone Pregnancy Tests a full and updated genetic clinical evaluation, better information for pregnant women and their families, better training and support for obstetricians, better evidence around dosing recommendations, making electronic yellow card reporting available directly to clinicians at the point of care, plus stronger and more "joined-up messages" on safety.
Complications related to vaginal mesh implants have cost companies like Johnson & Johnson and Bard (now part of BD) millions in lawsuits, but recently scientists at the University of Sheffield in the U.K. have developed an alternative polyurethane material to treat pelvic organ prolapse and incontinence that could be better suited for use in the pelvic floor.