Regulatory Focus™ > News Articles > EU Launches Probe into Safety of Transvaginal Mesh

EU Launches Probe into Safety of Transvaginal Mesh

Posted 24 March 2014 | By Alexander Gaffney, RAC

The European Commission's Scientific Committee on Emerging Newly Identified Health Risks (SCENIHR) -a scientific committee which conducts risk assessments for EU officials-has announced it is launching an investigation into the safety of transvaginal mesh products used in urogynecologic surgery.


Transvaginal mesh has been used to treat female urological conditions, and in particular those caused by weakened pelvic muscles, which can lead to a pelvic organ prolapse. In the EU, they have been used since the 1950s to repair abdominal hernias, and since the 1990s to treat stress urinary incontinence (SUI).

The products have been subject to numerous safety concerns, especially in the US, where the US Food and Drug Administration (FDA) has noted its "serious concern" about the safety of the devices.

A 2011 safety communication by FDA identified thousands of adverse events associated with the devices, including mesh erosion, pain, infection, bleeding, dyspareunia, organ perforation and urinary problems. FDA has also required the companies to study rates of organ damage and conduct at least three years of safety studies, according to Bloomberg.

FDA did not remove the products from the market, but one major manufacturer, Johnson & Johnson, announced it would cease marketing the product in June 2012.

Numerous other companies still market the device in both the US and EU.


But in the EU, where medical devices are regulated on a country-by-country level, and not by the European Medicines Agency (EMA), regulators have been slower to ramp up their scrutiny of the device.

That's now changing.

On 21 March 2014, SCENIHR announced that the European Commission had requested that it deliver an opinion regarding the safety of transvaginal mesh devices used in urogynecologic surgery.

"Current data suggest that the use of mesh in surgery is associated with both benefits and risks, but few randomized controlled trials have been published," the commission wrote in its request to SCENIHR. The EC also noted many of the same adverse events highlighted by FDA, and said that it wants to know more about the factors that result in increased risks for consumers.

In particular, SCENIHR is directed to determine:

  1. Are specific meshes, in terms of designs and/or materials, considered to be of a higher risk?
  2. Are certain surgery techniques of higher risk?
  3. Are any combinations of the above (designs/materials and surgical techniques) of a higher risk?
  4. Are there specific limitations (e.g. clinical, designs/materials, surgical techniques) to the use of meshes in urogynecological surgery?
  5. What are the risks of surgical interventions using mesh compared to classic surgical interventions?
  6. What factors could affect the outcome of the surgical interventions?
  7. Are there patient groups (e.g. in relation to age, weight or other co-morbidities) for which the use of meshes would carry a specific risk?

The committee is now calling for experts to help it conduct a "comprehensive assessment" of the safety of the devices, and hopes to receive responses by April 2014.




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