The UK government and NHS have accepted the recommendation from the Independent Medicines and Medical Devices Safety Review, 17 July 2018
Following their acceptance of the recommendation from the Independent Medicines and Medical Devices Safety Review, the government and NHS have paused the use of vaginally inserted surgical mesh for stress urinary incontinence until a set of conditions to ensure that patients receive safe and high-quality care are met. This pause has been extended to include vaginally inserted surgical mesh for pelvic organ prolapse and will be implemented through a high vigilance programme of restricted practice.
These procedures have not been banned and during this pause, they will continue to be used when there is no viable alternative and after close and comprehensive consultation between patient and clinician.
There has not been any new evidence which would prompt regulatory action and the position of MHRA remains the same on these medical devices. We continue to work with other regulators in the EU and wider, as well as colleagues across the health sector, to monitor and examine evidence as it becomes available.
… continue reading the GOV.UK News story, 17 July 2018.
UK Parliament, House of Lords Hansard, 28 February 2019
“For the families involved, it is life-changing and extremely distressing. For those women who took Primodos and sodium valproate, there is an intense feeling of guilt. They took the medication and they blame themselves. However hard one tries to persuade them that it was not their fault, the guilt remains.”
“That tells me something is seriously wrong; the system is not working as it should. People who have been harmed should not have to fight to be heard or to access the care they need.”
FDA takes action to protect women’s health, orders manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse to stop selling all devices
April 16, 2019 – The U.S. Food and Drug Administration today ordered the manufacturers of all remaining surgical mesh products indicated for the transvaginal repair of pelvic organ prolapse (POP) to stop selling and distributing their products in the U.S. immediately. The order is the latest in a series of escalating safety actions related to protecting the health of the thousands of women each year who undergo surgery transvaginally to repair POP.
The FDA has determined that the manufacturers, Boston Scientific and Coloplast, have not demonstrated a reasonable assurance of safety and effectiveness for these devices, which is the premarket review standard that now applies to them since the agency reclassified them in class III (high risk) in 2016. As part of the 2016 reclassification, manufacturers were required to submit and obtain approval of premarket approval (PMA) applications, the agency’s most stringent device review pathway, in order to continue marketing their devices in the U.S. The companies will have 10 days to submit their plan to withdraw these products from the market.
… continue reading the FDA press announcement.
Read the meshCNN press release. Image credit leakylily.
In the UK
How concerned should we be about treatment side-effects, innovation and regulatory failures?
Prof Carl Heneghan discusses the evidence about three NHS treatments undergoing government review:
- vaginal mesh implants
- and the anti-epilepsy sodium valproate.
Oxford University Department for Continuing Education,
Open Event Dec 2018.
Prof Carl Heneghan is Director of the Centre for Evidence-Based Medicine. Information about the postgraduate courses and qualifications in EBHC can be found here.
Baroness Cumberlege will lead an examination of the circumstances in all three health cases and consider whether there are grounds for wider inquiries
The UK Prime Minister has ordered a review of public health scandals involving the hormone-based pregnancy test drug Primodos, the use of vaginal mesh implants and the anti-epilepsy drug sodium valproate.
I look forward to undertaking this tremendously important review and in particular to working with patients to ensure that our health system learns from those it may have failed. It’s essential that voices aren’t just listened to, but properly heard, and that whenever appropriate, the system promptly learns lessons and makes changes.
Baroness Cumberlege, Chair of the review
In the Commons, Jeremy Hunt has announced a review into public health scandals caused by failings in the regulation of vaginal mesh implants, anti-epilepsy drug sodium valproate and hormone-based pregnancy test drug Primodos.
See The Independent Medicines & Medical Devices Safety Review website.