Marian Fogarty: Pelvic mesh scandal exposes regulatory gaps and data failures

Marian Fogarty

Mesh implant surgeries were widely utilised in the treatment of stress urinary incontinence (SUI) and pelvic organ prolapse (POP) in women. However, they have been linked to serious complications, including pain, mesh erosion, infection, urinary issues, recurrent incontinence, dyspareunia, bleeding, organ perforation, neuro-muscular problems and vaginal scarring. Some women who have been harmed by these surgeries have taken litigation claims relating to medical negligence and/or and product liability.

In response to the worldwide media attention and patient safety concerns, Ireland put a pause on pelvic mesh surgeries in July 2018. The former CMO Tony Holohan produced a report on the controversy in November 2018 and it made 19 recommendations some of which were to strengthen the regulation of these devices. The former CMO recommended in his 2018 Report that guidance and governance mechanisms in relation to adverse event reporting should be reviewed by the HSE in conjunction with the Health Product Regulatory Authority (HPRA) and the State Claims Agency (SCA) to ensure appropriate reporting of device-related adverse outcomes to both the HPRA and the National Incident Management System (NIMS), with mandatory reporting of serious adverse events. The former CMO found in 2018, that clinicians in Ireland were under-reporting adverse events related to mesh surgeries to both the HPRA and the NIMS, which is operated by the SCA. Moreover in 2018, the Journal.ie found that the HPRA had not received any notifications from surgeons about issues with patients and vaginal mesh implants, despite reports of serious complications by some women who had these procedures.

The foregoing occurred notwithstanding the statutory duty on State authorities (who benefit from the Clinical Indemnity Scheme) to report adverse patient safety incidents to the SCA in accordance with Section 11 of the National Treasury Management Agency Act 2000. Noncompliance with this statutory duty by the health service providers ought to be addressed by the appropriate stakeholders before the current pause can be lifted.

In 2023, the National Vaginal Mesh Implant Oversight Group was established, to review and action the CMO’s recommendations re the use of uro-gynaecological mesh implants. They produced a Report which is currently with the Minister for Health for consideration and the pause on these surgeries remains in place. Recently there has been media commentary by some clinicians seeking that the pause be lifted for the treatment of SUI on the basis that all of the recommendations have been acted upon. However, the pause on these surgeries cannot be lifted until such time as the former CMO’s recommendations are all in place including those relating to regulatory improvements i.e. mandatory reporting of serious adverse events. Mandatory reporting of serious adverse events by clinicians is required because the current voluntary aspect to the reporting of device-related adverse patient safety outcomes to both the HPRA and NIMS is not working effectively.

The Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023 provides for mandatory reporting and disclosure of a prescribed and narrow list of serious Patient Safety Incidents (PSIs) through NIMS and certain external bodies as appropriate. However, the prescribed list of PSIs under the 2023 Act does not apply to all serious incidents including, in some cases, the type of harm that can be caused by mesh surgeries. In reality, the majority of PSIs are covered by voluntary disclosure as set out under Part 4 of the Civil Liability (Amendment) Act 2017.  Voluntary disclosure applies in cases where incidents occur that are not coming within the limited list of notifiable incidents under the 2023 Act.

The problem with the current system is the voluntary aspect to the requirement for clinicians to report PSIs, including relating to medical device surgeries. The under-reporting of PSIs re mesh surgery on NIMS/to the HPRA means that policymakers have an incomplete picture on the type, frequency and severity of PSIs re mesh implant surgery.

Under the Medical Devices Regulations (MDR) 2017/745, the mandatory reporting obligations apply to the manufacturers of the medical devices. They do not apply to clinicians/surgeons undertaking these surgeries. However, as there has been under-reporting of adverse incidents by clinicians, relating to these medical device procedures in the past, the manufacturers/regulator cannot know of all of these adverse outcomes and that compounds the under-reporting culture of patient safety incidents that already exists.

Until such time as mandatory reporting of serious adverse events caused by mesh implant surgery occurs, stakeholders will not have reliable data on the numbers of women harmed by this medical device and the nature/severity of the complications associated with mesh medical devices. It is speculative for some clinicians to be quoting statistics regarding low complication rates or real complication rates in incontinence mesh surgery when 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 cannot reflect the full rates of mesh complications in the absence of mandatory reporting of these adverse events. In addition, the lack of reliable data only serves to frustrate preventative regulatory action from being undertaken where appropriate. 

There is also a clear contradiction in the HSE’s ongoing pause on mesh procedures here while at the same time approving taxpayer funded mesh treatments for SUI abroad via the Treatment Abroad Scheme (TAS). These surgeries, it appears, are being carried out by Irish surgeons abroad under the TAS and if complications arise from those procedures, those women are treated for those complications in Ireland where the pause remains in place.

Before the pause on mesh implant surgeries can be lifted, the gaps in the regulatory and reporting requirements need to be satisfactorily addressed. There also needs to be a stronger focus by stakeholders on fostering a greater culture of open disclosure in practice and learning from litigation outcomes re mesh implant surgeries which would reduce the same PSIs occurring again if the pause was to be lifted even with restrictions. That includes mandatory reporting of serious adverse events and monitoring and tracking of PSIs related to mesh implant surgeries including against litigated cases together with the implementation of proper accountability and sanctions if it is not being done. If the pause is lifted, without all appropriate corrective measures being undertaken, then stakeholders risk the re-occurrence of more serious patient safety incidents associated with this implant surgery.

Marian Fogarty is a solicitor at Cantillons and has acted for women harmed by mesh implant surgery.