Surgical mesh lawyer calls for stronger action from MHRA as Scotland suspends their use
Medical device product regulatory body in England sounds cautious note on surgical polypropylene mesh and tape
Posted on 23 June 2014
The Medicines and Healthcare products Regulatory Agency (MHRA) has published a statement in reaction to news in Scotland that health authorities are being asked to think about suspending the use of surgical meshes.
The MHRA has asked the Scottish government to supply new evidence to the body so that it can make an assessment about its own position.
Medical device lawyer Jill Paterson thinks that the MHRA should be providing a stronger lead. She says, ‘injured women need to know that their health concerns are being taken seriously by the agency that regulates the safety of surgical products in England and Wales’.
Last week the Scottish Health Secretary Alex Neil announced that he was asking all NHS Boards in Scotland to suspend the use of vaginal mesh implants amidst growing concerns about their long-term health effects.
One authority, NHS Dumfries and Galloway, has already stopped using vaginal mesh.
The MHRA is part of a European Commission taskforce group on surgical meshes which has requested a scientific opinion from the European Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) on 'The safety of surgical meshes used in urogynecological surgery'.
This will be published in January 2015.
The Director of the MHRA, Dr Neil McGuire, said:
“We have asked the Scottish government to provide the new evidence which has led them to this conclusion so that we can assess it thoroughly. As always, we have listened to and understand the concerns that many women have about vaginal tapes and meshes.
“When we commissioned and published independent research in 2012 (557Kb) it reviewed the available evidence about the safety and adverse effects associated with vaginal tapes and meshes. At that time the findings showed that while a small number of women had experienced distressing complications of surgery, the benefit of these tapes and meshes outweighed the risks.
“The benefit was to a large number of women by dealing with upsetting and lifestyle-disrupting conditions such as urinary stress incontinence and pelvic organ prolapse.
"It must be re-emphasised that clinical advice to women and decisions about the use of vaginal meshes is the responsibility of healthcare professionals such as surgeons. We will, as with any medical device, continue to review the available evidence and this is why we have asked the Scottish government to continue to work with us and share any new evidence they have with us."
Jill Paterson said:
“We believe that the MHRA should not wait until the publication of the review into the safety of surgical meshes for fresh evidence, but should follow the example of the Scottish Government and suspend their use now.
“We are acting for dozens of women who have been left with serious long-term health problems which they believe have been caused by being implanted with polypropylene mesh or tape.”
If you would like to speak to a member of the surgical mesh claims team please contact Jill on 020 7650 1219 for a confidential and free initial enquiry. If you prefer, please fill in our enquiry form and someone from the team will get back to you to take more details.