implications of inserting synthetic mesh, which, according to the manufacturer, may ‘shrink or stretch’ once in situ. The surgery was frequently offered to women who had relatively minor stress incontinence and often without trying conservative treatments first. As with the prescribing of sodium valproate, informed consent was absent from the process and patients had little understanding of how new the procedures were and how little data existed. The report notes that the use of patient decision aids had impressed them in Scotland. Decision aids set out information about medical conditions, the treatments available, and the benefits and risks of these options. They help people consider which benefits and risks are most important to them, and to make a decision that reflects their own values. However, they are not widely used as clinicians find it takes longer to deal with an informed patient. There is, at present, an imposed pause in the surgeries for implanting mesh, until a number of conditions can be satisfied. All these conditions had been suggested by others before the Review Team, but never implemented. These are:

l Surgeons should only undertake operations for Stress Urinary Incontinence (SUI) if they are appropriately trained, and only if they undertake operations regularly;

l They report every operation to a national database;

l A register of operations is maintained to ensure every procedure is notified and the woman identified who has undergone the surgery;

l Reporting of complications via the MHRA is linked to the register;

l Identification and accreditation of specialist centres for SUI mesh procedures, for removal procedures and other aspects of care for those adversely affected by surgical mesh;

l NICE guidelines on the use of mesh for SUI are published.

The Report team have asked NHS Digital to undertake an audit to determine how many mesh implants have taken place since 2010 and for a follow up to take place, so that there is an understanding of the size of the problem. An apology is long overdue, and support is required by those who have complications. In the development of specialist centres, it is suggested that support services are co-located, so they are easily accessed.

Hormone pregnancy tests This is a sad story of ineffective regulation, secrecy and denial. Since 1967, Hormone pregnancy tests (HPT) have been the cause of concern and heightened risk to foetal development in UK, Primodos was the most commonly used HP. They worked by giving a dose of sex hormone usually both an oestrogen and a progestergen. If the woman was not pregnant, she would have a period-type bleed after a few days, if she was pregnant, she would not bleed. The outcomes described are similar to those for sodium valproate, a devastating list of foetal abnormalities to almost every system which also describe multiple anomalies or just one congenital anomaly.

Those suffering have struggled to be heard over a great many years and whether or not a definite link can be made between the hormones and the abnormalities is not


what the Cumberlege Review was asked to report, but on the patient safety issues and on the robustness of our systems of regulation, monitoring, review and support. All of which, in the case of those affected by the hormone pregnancy test, have been failed to a greater or lesser degree. They recommend that an apology is due and, as with the other two groups of affected people, that support should be enabled. Again, they suggest that specialist centres should be established where medical and social care expertise can be found to support and assist them to access services which they need.


There are many other generic and important changes recommended by Baroness Cumberlege and her team which will be the subject of a further article in the near future. The disasters reported by the team could still happen and the recommendations may help to prevent them. England in particular prides itself that its frameworks and mechanisms for patient safety are second to none. In order to ensure that we continue to support patients who have been harmed and not listened to, further measures will need to be in place, so that they have a single place where they can be heard and justice be seen to be done.CSJ

References 1 Cumberlege Review. First Do No Harm 2020 Accessed at Report.html

2 The Medicines and Medical Devices Bill Summary 2019-2021 Accessed at https://services.parliament. uk/bills/2019-21/medicinesandmedicaldevices.html

3 CQC Opening the door to change 2018 https:// openingthedoor_summary.pdf


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