First Do No Harm Cumberlege Mesh Review
Today the report about those who have suffered avoidable harm in the First Do No Harm Cumberlege Mesh Review has been published. It is good news and highlights the devastating impact that mesh has had on ladies. It looks at how they have been treated by the medical profession for speaking up about problems.
It is now time for the Governement to apologise to all women affected and offer full compensation for the harm suffered. Forcing women to litigate to gain compensation for the harm so clearly suffered is a further cruelty of the flawed system. This legal system is being used by the NHS to avoid liability for the harm suffered at their hands. It has to stop.
The recommendations within the report call for “the Government to immediately issue a fulsome apology on behalf of the healthcare system to the families affected by Primodos, sodium valporate and pelvic mesh”.
There should then be the appointment of a ‘Patient Safety Commissioner and an independent Redress Agency’. The First Do No Harm Cumberlege Mesh Review suggests that the Redress Agency will administer decisions using a ‘non-adversarial process’. It will make determinations based on avoidable harm looking at ‘systemic failings rather than blaming individuals’.
This is certainly a welcome outcome. Removing the adversarial nature of claiming compensation for injury caused on such a large scale will help women feel that they are listened to and taken seriously.
The First Do No Harm Cumberlege Mesh Review calls for separate schemes for each intervention to meet the cost of providing additional care and support to those who have experienced avoidable harm and are eligible to claim. Does this mean the end to litigation for clinical negligence in such cases? The victims need proper recourse and redress for the injury suffered, the loss of earnings and future earnings, long term care needs and surgery. It is hoped that this process will offer full redress without deductions.
With specialist centres to provide comprehensive treatment, care and advice it is hoped that those affected by implanted mesh will receive the best of care. However, there should be caution before offering unnecessary surgical intervention and any ‘new’ treatments to address complications which carry unknown risks and complications.
The First Do No Harm Cumberlege Mesh Review suggests that’the Medical and Healthcare products Regulation Agency (MHRA) needs substantial revision in relation to adverse reporting and medical device regulation’. It needs to ‘engage with patients and their outcomes’. A ‘central patient identifiable database should be created to collect key details of implantation of all devices at the time of the operation’. This helps patient tracing and reporting of adverse events. This stops women being told that problems are ‘just you’.
Transparency of payments made to clinicians needs to improve and the Government is asked to set up a task force to implement this Reviews recommendations. Let us hope that it is set up immediately and we are not waiting several years for such implementation.
There is a question in the report as to whether Transvaginal Tension Free Vaginal Tape-Obturator (TVT-O) should be offered at all. This mesh carried the greatest risk of chronic pain due to the placement near the obturator nerve. It cannot be removed successfully from the groin area. There can be few who would advocate for the reintroduction of this mesh device given the devastating impact it can have and we support a complete ban.
Quite rightly the report recommends that conservative measures should be offered to women before surgery. There needs to be further investment in conservative treatment options to cope with demand. All women following childbirth should routinely be offered a pelvic floor physiotherapy course to strengthen the pelvic floor. It should not become an acceptable norm for women to experience incontinence following childbirth and surgery to be their only option.
The report recommends that pelvic floor education should be encouraged in schools and antenatal classes. It recommends the French model for universal post-natal pelvic floor rehabilitation. There are too many cases of young women post-delivery being offered TVT or TVT-O surgery to address incontinence without rehabilitation and without consideration as to whether they have completed their families.
“I am delighted that Baroness Cumberlege has delivered her report on three very important issues. It is a long report to read but we encourage everyone to do so. It is an important document and I sincerely hope that it will be a pivotal moment for change in how healthcare is delivered and problems are dealt with. I hope that there will be a less adversarial approach to dealing with these claims on behalf of women. They have been through enough and even when their claims are settled they are still living day to day with the effects of mesh in their bodies and on their families. That needs to be recognised”.
If you have been affected by mesh then get in touch with Dr Handley today by email email@example.com or by telephone on 0800 470 2009. We are here to help you.