Surgeons have used mesh since the 1950s to assist in repairing hernias. Since the 1970s, surgeons started to consider mesh had a use for reversal of prolapse (a slipping forwards/down) of organs in the pelvis (the uterus, vagina, bowel and bladder). However, there have been growing concerns with the use of mesh, particularly in the last decade, with the growth of litigation in the United States and the growth of social media, spreading the word across borders. The UK is certainly lagging behind other countries currently.
The differences between use of abdominal mesh in hernia repair and use as vaginal mesh are more thoroughly explained in an article that you can access by clicking the link here. Essentially, hernia mesh is not subject to the same stresses as vaginal mesh, particularly during intercourse and does not sit in such delicate body tissues, often postmenopausal tissues. Vaginal mesh lies in a non-sterile environment and so is more subject to infection risks. Women’s responses to mesh are thought to vary depending upon the strength of their own immune system and how the mesh was inserted. There is also debate about abdominal mesh but this page focuses solely on transvaginal and pelvic mesh.
Women have been reporting a multitude of problems including (but not limited to) nerve damage, vaginal scarring, perforation of organs, bleeding, severe pelvic pain, other life-changing injuries eg. inability to walk, inability to work, pain during intercourse etc.
United States-compensation for mesh problems
In the U.S, there have already been successful lawsuits against manufacturers, Johnson & Johnson, Avaulta and Align, with actions pending against others. In 2013, a very large award was given to Linda Gross.
Linda, a nurse from South Dakota, was awarded around £2million in compensation from Ethicon (a subsidiary of medical giant Johnson & Johnson) for her suffering and also another £5million in punitive damages after a jury decided the company had misled her and her surgeon about the risks of the operation.
By 2016, there were over 90,000 actions registered in the U.S. against various manufacturers and Johnson & Johnson offered a settlement of $120 million dollars (USD) to approximately 2,000 to 3,000 litigants across the United States.
Australia -Compensation for mesh problems
In Australia, there are already class actions underway with hundreds of claimants (started in 2017, run by Shine Lawyers) against Manufacturer, Johnson & Johnson (via Ethicon) and also another separate AMS Group Action. Johnson & Johnson stopped importing the mesh to Austrailia and, since early January 2018, sale of existing supplies was banned.
A Senate enquiry delivered its final report on 28 March 2018. The inquiry called for a major overhaul of Australia’s regulation of medical devices, including the creation of a national register tracking high-risk implantable devices and forcing the mandatory disclosure of complications, so that defective products can be quickly identified and addressed. The full report can be accessed by clicking here.
In Australia, the banned products now cover manufacturers, Johnson & Johnson, Coloplast and others. Some product codes can be found by clicking here.
The president of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists, Professor Steve Robson, wrote to all members to alert them to the development. However, it is thought that some hospital surgeons continued to use existing stocked supplies of mesh. It may also be the case that some surgeons have been looking at sourcing other mesh manufacturers.
Scotland-Compensation for Mesh problems
In 2014, the Scottish Health Secretary wrote to Scottish Health Boards requesting suspension in use of transvaginal mesh. In March 2017, a final independent review report was published and there followed various debates, culminating in a 2-hour debate in December 2017 that slammed the independent review as a ‘whitewash’ with accusations of self-interested parties having been involved, video link below:
Wales
The Welsh Government set up a ‘Task and Finish’ Group to advise on the use of synthetic mesh tape and sheets for stress urinary incontinence and pelvic organ prolapse. This was as a result of the serious and life-changing complications experienced by some women who had undergone the procedures in the UK, including Wales. The Task and Finish Group was made up of clinicians and academics in the area of uro-gynaecology, colorectal surgery, primary care, independent healthcare, physiotherapy, continence and pain management. Victims of mesh chose not to sit on the Group but the Welsh Mesh Survivors Group relayed its members’ experiences The Group investigated between October 2017 and January 2018.
The Report states that 6.4% of women have to undergo further surgery for removal or repair of mesh. The report says that mesh surgery should in future be the ‘last resort’ and proposes a new continence care pathway with physiotherapy at its heart
Vaughan Gething, Cabinet Secretary for Health and Social Services is to make an oral statement on Tuesday 8 May 2018 setting out the key findings and recommendations.
Developments in the UK
The Advisory Committee for the Uk National Institute for Clinical Guidelines (NICE) published draft Guidelines 20 December 2017 proposing the ban of transvaginal mesh for prolapse because of serious but well-recognised safety concerns.
On 30 January 2018, in the light of increasing pressure, the UK Government announced that there will be a review in England, with a full audit to be carried out. The audit should establish how many women in England have suffered from complications because of vaginal mesh implants. In the meantime, it is estimated that more than 800 women have commenced claims for compensation because they have vaginal mesh problems that are significantly impacting upon their lives.
On 19 April 2018 there was a debate in the House of Commons. Link to the debate appears below:
Why are patients entitled to bring Compensation Claims for Vaginal mesh problems?
About 100,000 women in the UK have had mesh surgery for prolapse. Mesh can migrate and the pelvic organs are delicate. Prolapse indicates weakness and the surrounding structures into which mesh is inserted can break down, allowing the mesh to move away from its intended position (this is called ‘migration’). This can cause agony and infection for patients treated with mesh surgery. Big business manufacturers (Ethicon have admitted) knew more about potential risks than they let on when promoting their mesh products. A video about this can be accessed via a sub-titled link below:
VIDEO TO EMBED HERE
The various types of mesh for pelvic procedures in women are as follows:
Mini-sling: This implant is embedded with a metallic inserter. It sits close to the mid-section of a woman’s urethra. The use of an inserter is thought to lower the risk of cutting during the procedure.
TVT sling: Such a sling is held in place by the patient’s body. It is inserted with a plastic tape by cutting the vagina and making two incisions in the abdomen. The mesh sits beneath the urethra.
TVTO sling: Inserted through the groin and sits under the urethra. This sling was intended to prevent bladder perforation.
TOT sling: Involves forming a ‘hammock’ of fibrous tissue in the urethra. Surgeons often claim this form of implant gives them the most control during implantation.
Patients should be fully informed of the risks of the proposed surgery and have the choice to refuse a particular surgical option if the risks appear too high. There are alternatives to mesh, being trial of proper physical therapy (pelvic floor exercises), surgical placement of sutures for support and surgical repair without mesh products that carry lower risks than vaginal mesh. Therefore, it can lead to compensation claims if patients were clearly better candidates for other methods. Patients should be advised as to the various alternatives to mesh surgery and able to make a fully informed choice about which type of treatment they wish to undergo.
Even if it may have been reasonable to recommend a mesh repair (which is highly debatable now as there are Gynaecologists in the Uk who are now refusing to offer mesh), in some cases patients have been shown to have had problems because of an inexperienced surgeon doing the mesh procedure. There may have been substandard placement of the mesh.
In other cases, problems that were preventable may arise even under the care of a more experienced surgeon. If a patient has a particularly complicated history (such as significant bowel issues e.g. Crohn’s disease, diverticular disease etc) and an obvious risk of abdominal adhesions, then it may also be important that the surgeon consults with and involves a colorectal surgeon in the procedure. Failure to do so can lead to devastating consequences for a patient. If a bowel perforation occurs during surgery and a colorectal surgeon is not present to deal with a repair, then a woman can be left with a very significant and life-changing outcome, such as having to live with a stoma. Some women have found that their symptoms have been made significantly worse by the mesh surgery.
The potential for a product liability claim also has to be considered in every case. We know of no reported cases, as yet, against manufacturers of transvaginal mesh in the UK. However, there are various specialist firms, including Medical Solicitors, who are accepting calls from victims of mesh surgery. The clear intention is for a Group Action and a London firm has set out its stall as intended co-ordinator of a Group Action. That firm will need to apply to court for a Group Litigation Order in due course and all of the specialist firms will network to ensure proper access to justice for all. As these potential claims involve so many victims, it will take a few firms to look after the very large numbers of highly vulnerable Claimants.
About Medical Solicitors
Our Louise Haslam has successfully litigated in the Uk in a claim for a poor lady suffering from terrible problems after mesh surgery. She recovered a large 5 figure sum for that client on the basis that the mesh (when removed) was identified as having been placed incorrectly. Therefore, regardless of the issue of whether mesh should be used at all, this client had a successful claim because it was proven that there was substandard surgical technique meaning the procedure was doomed to failure in any event.
Our friendly team of specialist lawyers at Medical Solicitors have a lot of experience in bringing successful medical negligence claims. We have an expert register for surgeons who undertake medico-legal work and prepare reports commenting on surgical claims in the fields of gynaecology, urogynaecology and colorectal surgery.
Compensation can be claimed where there has been inappropriate advice given concerning care options and risks and benefits of such options, where there have been excessive delays in providing actual treatment, or where there has been any substandard surgical care that amounts to actual Medical Negligence.
Do contact our friendly team of specialist lawyers at Medical Solicitors. We conduct most of our Clinical and Medical Negligence claims under ‘No Win, No Fee’ agreements, also known as Conditional Fee Agreements. So, you do not have to worry about how you are going to afford to bring a medical negligence claim for compensation. You have nothing to lose in speaking to us.
Contact our Expert Medical & Clinical Negligence Lawyers
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