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'First Do No Harm' - A medicines and medical devices safety review

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First Do No Harm - A medicines and medical devices safety review

The Independent Medicines and Medical Devices Safety Review has been published following a 2 year investigation into three medical interventions: Primodos, sodium valproate and pelvic mesh, interventions used on and by women.

Primodos was a hormone pregnancy test withdrawn from the market in the 1970s and thought to be associated with birth defects and miscarriages. Sodium valproate is an anti-epileptic drug which, when used by pregnant women, causes physical malformations, autism and developmental delay in their children. Pelvic mesh, which has been more widely scrutinised leading to restrictions on its use even before the publication on the review, is used in surgical repairs following pelvic organ prolapse and to manage female incontinence. Use of the mesh has been linked with chronic pain to the extent that it limits mobility, recurrence of the incontinence it was used to treat, loss of sexual function, recurrent infections and the huge psychological impact of these intrusive symptoms.

The review team, led by Baroness Julia Cumberlege, heard testimony from women and their families whose lives have been irreparably damaged by these medical interventions. They heard that, particularly with the pelvic mesh, symptoms and concerns were disregarded by the medical establishment and blamed on “women’s issues” and “that time of life”. Women spoke of being “gaslighted” (made to question their own sanity) by doctors when they complained of the impact the pelvic mesh was having.  

Sadly, this attitude of dismissal and derision over a number of years has meant that many more women have undergone the insertion of pelvic mesh and experienced the same avoidable symptoms. The review team also found women who were not properly informed as to the potential for adverse reactions to mesh, meaning that women did not have the opportunity to give “informed consent” to the surgery they were about to undergo.

The review makes a number of recommendations to the government which include an apology to patients and their families, the appointment of a patient safety commissioner and an overhaul of adverse event reporting and medical device regulation. The latter would include a central database so that medical implants and devices used on patients can be tracked, hopefully leading to a quicker resolution if problems with other medical devices occur in the future.

There will hopefully be a number of lessons learnt as a result of this review. One of which I hope will be a change in culture in the medical profession to one that places an even greater emphasis on obtaining informed consent from patients, one that is open to listening to patients’ concerns and transparent in sharing information to prevent further errors.

Read the report: First Do No Harm-The report of the IMMDSReview