In July 2018, following an independent safety review led by Baroness Cumberlege, the use of vaginal mesh treatment for women suffering from stress urinary incompetence (SUI) was paused. Similarly, a restriction on the use of vaginally inserted mesh to treat pelvic organ prolapse was also put into place and abdominally inserted mesh to treat pelvic organ prolapse was made subject to an NHS high vigilance regime to address safety concerns. These recommendation s came as a result of thousands of women having complained of pain and suffering, in some cases with life changing consequences, following their mesh procedures. The aim of the pause was to allow steps to be taken to mitigate the risks to patients.
Baroness Cumberlege outlined conditions that would need to be met before March 2019 in order for the use of vaginal mesh to treat SUI to be considered safe. These conditions were as follows:
- Surgeons should only undertake operations for SUI if they are appropriately trained, and only if they undertake operations regularly;
- They report every procedure to a national database;
- A register of operations is maintained to ensure every procedure is notified and the woman identified who has undergone the surgery;
- Reporting of complications via MRHA is linked to the register;
- 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.
2019 NICE Guidelines
In April 2019 however, The National Institute for Health and Care Excellence (NICE) updated its Guidelines and once again states that vaginal mesh procedures can be used following physiotherapy once the pause has been lifted. The Guidelines also reintroduce mesh procedures for prolapse surgery despite the above restriction. Despite safeguards which have been included within the new Guidelines (including vaginal mesh being offered only to women for whom non-surgical approaches have failed or been rejected, the need for women to be counselled about the possible complications and that both short- and long-term outcomes must be recorded in a national registry) patient groups are concerned that the new Guidelines ignore their concerns and could lead to future harm.
Indeed some people believe the Guidelines are essentially the same as those published by NICE 16 years ago in 2003, and that evidence which has been provided by thousands of women who have suffered life changing injuries as a result of vaginal mesh have been ignored. The Labour MP Owen Smith said he was “deeply disappointed that the updated guidelines appear to disregard mesh-injured women’s experiences by stating that there is no long-term evidence of adverse effects”.
What is most concerning is that Baroness Cumberlege herself, as the chair of the Independent Medicines and Medical Devices Safety Review, feels that the 5 conditions she outlined have not been met. In light of the recently published Guidelines, she stated: “We set five conditions that would need to be met before the pause could be lifted and the use of mesh could be contemplated. Those conditions have not yet been met, and it is clear to us that it will be some considerable time before they are. This means that now and for the foreseeable future mesh should not be used to treat stress urinary incontinence either in the NHS or the independent sector”.
Vaginal mesh has been linked to a number of serious complications for women. Such complications often require extensive medical treatment and multiple surgeries. One of the most common complications is mesh erosion, which occurs when the implanted mesh breaks down shortly after placement. These fragments can slice and perforate nearby organs and cause internal bleeding, with the associated risks of infection and other injury.
The evidence of these complications is overwhelming and in addition there does appear to be strong evidence of long term adverse effects, contrary to what is stated within the NICE guidelines. According to one study, one in ten recipients of vaginal mesh surgery have experienced complications within 5 years of surgery. The Clinical Negligence department at Osbornes Law have received enquiries from patients reporting complications dating as far back as 2003. Further, the campaign group Sling The Mesh have stated “our Sling The Mesh survey shows 1 in 20 women have attempted suicide and more than half have regular suicidal thoughts because of chronic pain, loss of sex life, constant infections and auto immune disease…These are unacceptable risks from what is sold to women as a simple fix”.
In light of the above, the concerns of patient groups that the new Guidelines could lead to future harm are arguably justified.
A Slight Improvement?
However a closer look at the new Guidelines does reveal that in comparison with the guidelines previously published, patient choice, autonomy and consent have been placed at the centre of the decision making process when it comes to treatment options. The newly published Guidelines for the surgical management of stress urinary incontinence advise medical practitioners to “use the NICE patient decision aid on surgery for stress urinary incontinence to promote informed preference and shared decision making”. Further, practitioners are urged to include the following in their discussions with women considering surgery:
- the benefits and risks of all surgical treatment options for stress urinary incontinence that NICE recommends, whether or not they are available locally;
- the uncertainties about the long-term adverse effects for all procedures, particularly those involving the implantation of mesh materials;
- differences between procedures in the type of anaesthesia, expected length of hospital stay, surgical incisions and expected recovery period; and
- any social or psychological factors that may affect the woman’s decision.
Similar discussions are advised for those women contemplating surgical treatment of pelvic organ prolapse.
Thus is it clear that whilst some concerns do remain, the new NICE guidelines do go a great deal further than previous guidelines in ensuring that women are more fully informed of the risks associated with these procedures and better placed to make an informed choice.
At Osbornes Law we care about how you are treated both by medical professionals at your GP surgery or at hospital and also under the care of private providers of health services. If you think that the care you or a loved one has received fell below the standard expected of a reasonably competent professional, then please do not hesitate to contact Partner and specialist medical negligence lawyer Stephanie Prior on 020 7681 8671. You can also fill in an online enquiry form.