Update on Vaginal Mesh medical devices

Problems with trans vaginal mesh medical device products, also known as pelvic mesh, mid-urethral slings or bladder sling, which are used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI) caused by childbirth or the menopause, have been highlighted in the media for some time now.  The surgical mesh is known to erode and disintegrate and can cut through organs and vaginal walls.  First introduced to the market in the 1970s in the U.S. to treat POP, these medical device products have adversely affected thousands of women around the world, exposed a questionable regulatory process in some countries and have raised serious questions about the relationship between the medical profession and the medical device companies.  Some U.K. politicians have called it the “biggest health scandal since thalidomide”.  On the 10th of October 2018, the Australian government issued a national apology to women affected by the vaginal mesh product, noting decades of “agony and pain” caused to women who have had the implant inserted in them.

As a result of the personal injuries many women have suffered from surgical mesh including chronic and debilitating pain as well as causing a devastating impact on relationships and careers, lawsuits are being taken by affected women (and in some cases their spouses) in the U.K., U.S., Australia and Ireland.

Notwithstanding the growing concern and unease about the medical devices, certain regulators and those in the medical profession are standing by surgical mesh on the basis that they offer the best treatment available for most women with SUI and that mesh still has an invaluable role in treating certain women with POP.  Yet a recent Netflix U.S. documentary entitled the ‘Bleeding Edge’, alleges these products were rushed to the market by regulators and clinicians.  Lawmakers and patients interviewed in the documentary, allege there was inadequate testing of the mesh to ensure patient safety.

U.K.

Around 100,000 women are estimated by NHS England to have had a mesh device fitted since its introduction to the market in the 1990s.  In February 2018, the Cumberlege Review was set up to look into how the U.K. authorities responded to concerns over three major medical issues including vaginal mesh implants. The review is to make recommendations and also consider whether compensation should be available to victims.  On the 9th July 2018, health authorities in England and Northern Ireland imposed a temporary ban on the use of mesh on the recommendation of the Independent Medicines and Medical Devices Safety Review (IMMDS).  The decision came after the National Institute for Health and Care Excellence (NICE) ruled in 2017, against vaginal mesh as a treatment for POP, but stated mesh implants could still be used to treat SUI. Baroness Cumberlege who is heading the Inquiry, has stated the pause should last until March 2019, when conditions to mitigate the risk of injury could be put in place.  U.K. mesh victims’ campaign group, ‘Sling the Mesh’ has called for the current suspension to become an outright ban on the use of mesh products.

Ireland

On foot of developments in the U.K., the Minister for Health Simon Harris stated on the 24th July 2018, that a pause is to be put in place on the use of procedures involving synthetic mesh for treatment of SUI and POP, in HSE run hospitals. We understand the Chief Medical Officer at the Department of Health is preparing a report for the Minister concerning the use of vaginal mesh in Ireland. The Minister has said this pause would remain in place until the HSE confirms the implementation of recommendations relating to surgical training, informed consent and the development of an agreed dataset of mesh procedures.  The Department has also written to the Institute of Obstetricians and Gynecologists, the Royal College of Surgeons in Ireland and the Continence Foundation of Ireland, requesting that they assist the HSE in progressing these recommendations on an urgent basis.

According to the Health Product Regulatory Authority (HPRA), the regulatory status of synthetic mesh implants in Ireland remains unchanged and they continue to be CE marked as medical devices. The HPRA state on their website that they are conducting a review of the regulatory aspects of the mesh products as a matter of priority.  In the meantime, the HPRA states it continues to encourage reporting of adverse incidents relating to mesh devices, both from patients who have experienced complications with these devices and from healthcare practitioners who have used these devices.  Despite this, a recent report by the journal.ie discovered surgeons did not report Irish women’s problems with vaginal mesh products to the HPRA.  This information came to light on foot of an FOI request by the journal.ie to the HPRA, where it was apparent that while the HPRA had received 76 reports in total about these devices, all of these complaints were from members of the public.

Common injuries from surgical mesh

The most common complications and side effects of plastic surgical mesh devices may include:

• Urinary problems.
• Vaginal bleeding.
• Vaginal infections.
• Pain during intercourse.
• Vaginal pain not related to intercourse.
• Chronic vaginal drainage.
• Exposure and Erosion of the vaginal tissue – when the mesh cuts through the vaginal wall or internal tissue.
• Lower back pain.
• One or more surgeries to repair or remove mesh.
• Perforations of the bowel, bladder or blood vessels.
• Pressure in the lower abdomen.

Victim support and legal advice

If you have suffered serious injuries or complications from a surgery involving transvaginal mesh, you are not alone.  If you had a transvaginal mesh implant and are suffering from painful, serious side effects after one or more revision surgeries, Cantillons Solicitors can assist you in evaluating your legal options.

Contact us at Cantillons Solicitors at +353 (0)21 -4275673 or info@cantillons.com if you would like more information.

* In contentious business, a solicitor may not calculate fees or other charges as a percentage of any award or settlement.