The Cumberlege Review: First Do No Harm
The publication of the Independent Medicines and Medical Devices Review earlier this month has been a cause of both shock and relief to those reading it.
Recommendations of the Cumberlege review
After two years of analysing evidence, the Cumberlege review has reported on the use and impact of three medical treatments for women which have prompted years of complaints and campaigning.
The three treatments in question are the use of pelvic mesh, the use of Primodos as a pregnancy test and the use of sodium valproate to ease the symptoms of epilepsy.
Led by Baroness Cumberlege, the review has made a number of recommendations, including the following:
- That the government should apologise to the families affected by the use of these three treatments
- That a Patient Safety Commissioner us appointed to advocate and act on behalf of patients who have been affected
- That separate schemes should be established to fund support for those who have been affected Redress Agency should be established for patients who are harmed by medical interventions in the future
- The Medicines and Healthcare Products Regulatory Agency should review its regulation of medical devices and reporting of adverse events
- That the GMC should record any payments which doctors receive from the manufacturers of medical devices and drugs.
Primodos
Primodos is a hormone pregnancy test which has been associated with physical deformities in babies and which is now no longer used. Offered as a method of assessing pregnancy in the 1960s and early 1970s before being withdrawn from the market, Primodos has been linked with the birth of babies with problems such as limb and heart defects.
Sodium Valproate
Used to reduce the impact of epilepsy, sodium valproate has been linked with the birth of babies with physical problems and autism if taken during pregnancy.
Pelvic mesh implants
Mesh implants have been used to solve problems of incontinence and pelvic prolapse, but have caused many women to suffer intense, chronic pain for years. Many women have had to undergo further surgery to have the mesh removed. Underlying the campaigns and the frustration felt by many sufferers is the feeling that their complaints have not been listened to or taken seriously.
Government response
Nadine Dorries, the Minister for Patient Safety, Mental Health and Suicide Prevention, made a statement in the House of Commons in response to the findings of the Cumberlege review. In it, she commented, that the review made for "harrowing reading. Every page makes clear the pain and suffering that has been felt by so many patients and their families." She went on to make the following statement:
"On behalf of the health and care sector, I would like to make an apology to those women, their children and their families, for the time the system took to listen and respond.It is clear that the response to these issues from those in positions of authority has not always been good enough. The task now is to establish a quicker and more compassionate way to address issues of patient harm when they arise."
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