Stronger regulation of pelvic mesh medical devices in incontinence surgery is required before the current pause on their use can be lifted.

Reports in the media about some doctors wishing to end the pause on the use of mesh in incontinence surgery are concerning, particularly from a patient safety perspective. 

In November 2018, the former Chief Medical Officer (CMO) reported to the then Minister for Heath, amid growing concerns about the frequency and severity of complications associated with the use of life long implantable mesh medical devices in the surgical treatment of Stress Urinary Incontinence (SUI) and Pelvic Organ Prolapse (POP) in women in Ireland.  Those debilitating complications include chronic pain, mesh exposure through vaginal tissues, sexual problems and injury to surrounding organs.  When complications occur, mesh removal surgery is complex and comes with risk because these devices are intended to become permanently embedded into the surrounding tissue.  One patient who had to have pelvic mesh removal surgery described it as trying to remove chewing gum from her hair.

The 61-page CMO report of 2018 made 19 recommendations, some of which were to improve the regulation of this medical device, including mandatory reporting of “serious adverse events,” a review of the governance mechanisms re adverse event reporting and mandatory registration of implants used in the treatment in POP and SUI on a national Register. Since that time there has been a pause on the use of vaginal mesh medical devices in this jurisdiction and the pause remains in place.

According to the HSE website, it subsequently prepared an Implementation Plan for the complete set of recommendations set out in the former CMO’s report.  A Mesh Devices Advisory Group was also set up by the HSE to progress the recommendations set out in the CMO’s report.  Some seven years later, it remains unclear how many of the recommendations set out in the CMO’s report have been implemented satisfactorily by the HSE and other stakeholders to date.  The HSE’s website states that the Report of the Oversight Group was expected to be published in 2023.  It has still not been published.

There are several areas of concern which remain extant on this issue, including the regulation of these medical devices. The HPRA is responsible for the regulation of medical devices in this country. It is clear, the HPRA’s current policy of “encouraging” the reporting of adverse incidents relating to medical devices is not sufficient, particularly having regard to the serious harm some women have suffered as a result of mesh surgery.  The voluntary aspect of reporting of adverse incidents by some stakeholders to the HPRA means these cases (where harm occurred) have been under-reported.   Indeed, the former CMO in his 2018 Report opined that the data he reviewed suggested that there was under-reporting of mesh-related adverse events by clinicians to both the HPRA and the NIMS (National Incident Management System).  His Report went on to state that it is the professional duty of clinicians to engage in open disclosure and communication with patients when things go wrong in healthcare. Some women suffering complications following mesh procedures for SUI or POP reported that individual clinicians responded to their concerns in an inappropriate manner, which greatly added to their distress. Women also reported feeling that they were not believed, or that their clinicians minimised or did not understand the severity of their complications.

Until mandatory reporting of adverse events occurs, stakeholders will not have reliable data on the number of women harmed by this medical device and the nature/severity of the complications associated with mesh.  It is speculative for some clinicians to be quoting statistics regarding low complication rates or real complication rates in incontinence mesh surgery when, in reality, the absence of mandatory reporting of adverse incidents associated with mesh surgery means that there has never been an accurate record of the level of associated complications.  Data collected to date simply cannot reflect the full rates of mesh complications in the absence of mandatory reporting of these adverse events.  In addition, the lack of reliable patient-focused outcome data in this area only serves to frustrate preventative regulatory action from being undertaken where appropriate.

It also remains unclear as to whether a national searchable database of all mesh procedures undertaken and their adverse outcomes (and not just in HSE-funded hospitals) has been set up, which would enable long-term follow-up and surveillance in this area.   Moreover, it remains unclear if a national Register of these Implants (with mandatory registration of the implants) used in the treatment of incontinence and prolapse in women, as per the former CMO’s recommendation, has been established.

It is obvious that all stakeholders, including clinicians would benefit from more reliable data on the complications of mesh surgery, which would better inform future clinical practice on this type of surgery and hopefully would ensure women are given all of the information to make a fully informed choice before undergoing these risky surgeries in the future.

Rather than seeking that the pause on mesh for incontinence surgery be lifted, the focus ought to be on first ensuring that the valid concerns about the safety of mesh implant surgery and the regulation of these implants are satisfactorily addressed. It is foreseeable that if the pause is lifted prematurely, without all appropriate corrective measures being taken, then stakeholders risk the recurrence of further patient safety issues (and therefore avoidable harm) associated with this implant surgery.

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

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