THE US FOOD and Drug Administration (FDA) has ordered medical device companies to stop all sales and distribution of surgical mesh used in surgeries to repair pelvic organ prolapse.

Painful complications have been reported by thousands of women across the world – including in Ireland – following procedures involving the use of vaginal mesh devices.

In November last year Minister for Health Simon Harris confirmed the suspension of all surgeries involving these devices until the HSE implements a number of recommendations.

Vaginal mesh devices are used in operations to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP); two conditions women can suffer from after natural childbirth or in their later years.

A report from the Chief Medical Officer in Ireland last year found devices known as transvaginal mesh implants (TVMIs), used for the treatment of pelvic organ prolapse, are no longer regarded as appropriate as the first line treatment.

Dr Tony Holohan said these devices should only now be used in the management of complex cases, where other treatment options have failed or are not appropriate.

Now the regulator in the US has ordered the two remaining manufacturers of mesh products for the transvaginal repair of pelvic organ prolapse (POP) to stop selling and distributing their products in the country immediately. These are the same products Ireland’s CMO deemed inappropriate as first-line treatment.

In a statement the FDA said it has determined that the manufacturers, Boston Scientific and Coloplast, “have not demonstrated a reasonable assurance of safety and effectiveness for these devices”.

As part of a 2016 reclassification of the devices as high risk, manufacturers were required to submit and obtain approval of premarket approval (PMA) applications, the agency’s most stringent device review pathway, in order to continue marketing their devices in the US.

Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health said the FDA needed evidence that the devices worked better than the other procedure for POP that does not use mesh. The alternative procedure uses native tissue to repair the prolapse. 

This evidence was lacking in the applications and the FDA “couldn’t assure women that these devices were safe and effective longterm”.

“Patient safety is our highest priority, and women must have access to safe medical devices that provide relief from symptoms and better management of their medical conditions,” he said.

The Irish suspension

In Ireland, the use of these devices in the transvaginal treatment of prolapse is only expected to continue in complex cases.

However the use of other vaginal mesh devices is likely to recommence – including for treatment of prolapse.

The Chief Medical Officer said there was an evidence base to support the use of abdominally placed mesh (as opposed to transvaginally placed, which is a different procedure). 

He also found there was evidence to support the use of what is known as a mid-urethral sling (made from the same mesh material) for the treatment of stress urinary incontinence. 

Many of the Irish women who reported complications had the sling surgery to address their incontinence. Their complications include chronic pain, reduced mobility and recurrent infections. 

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Many have spoken of an inability to be intimate with their partners and some have had to have multiple surgeries to remove parts of the mesh after it moved inside them, sometimes eroding through the vagina.

The current pause on the use of these particular devices in Ireland will remain in place pending the implementation of three “urgent recommendations”.

• Surgery should only be carried out by appropriately trained surgeons on the specialist registrar who have undertaken relevant subspeciality training. HSE should establish a list or registry of persons qualified to undertake them.
• Develop appropriate patient information material and consent material.
• Develop and maintain data collection of all mesh procedures in HSE hospitals. Holohan referenced safety concerns about other devices such as breast implants and hip prostheses and the need for long-term monitoring.

The CMO’s report stated that many women who have undergone these procedures have had satisfactory outcomes and he highlighted the fact that a number of women suffering from these conditions have had their procedures postponed.

However the Mesh Survivors Ireland group, which represents women who suffered complications, has expressed concerns about the lifting of the suspension.

“[The report] recognises that the consent procedures and pathways were lacking and the HSE did not take heed of warnings of the device,” said solicitor and spokesperson for the group Melanie Power after the publication of the report last year.

It recognises under reporting by clinicians, a lack of readily available data on the number affected due to failings in the HSE system which all beg the question; how can complications rates as provided by Irish consultants be calculated?

“The suspension must continue until the science behind the device proves it is safe. Irish women deserve quality independent research before a lift on the suspension is considered.”