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by Professor Christopher Chapple, MD, Secretary General of the European Association of Urology and Rapporteur of the SCENIHR Opinion on Surgical Meshes

by Professor Christopher Chapple, MD, Secretary General of the European Association of Urology and Rapporteur of the SCENIHR Opinion on Surgical Meshes

As the use of surgical mesh in urogynaecological surgery has become increasingly common, there have also been an increasing number of adverse effects reported in association with its use, such as infection, tissue erosion, mesh exposure, mesh shrinkage, pain and sexual dysfunction.  For this reason, the European Commission asked its independent Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) to assess the health risks linked to the use of surgical mesh.

The SCENIHR reviewed various options for the treatment of pelvic floor dysfunctions by examining recent pertinent scientific literature and guidelines from scientific societies and health authorities, looking at both non-surgical and surgical treatment methods and different types of mesh. The resulting Opinion focuses on the health risks of meshes used in urogynaecological surgery, how to identify high risk patient groups and what are the assessment needs.

The SCENIHR found that the clinical outcome following mesh implantation depends on a variety of factors including, material properties, product design, overall mesh size, route of implantation, patient characteristics, associated procedures (e.g. hysterectomy) and the surgeon’s experience, all of which should be taken into account when choosing an appropriate therapy.

When assessing the health risks of synthetic meshes there is a need to clearly separate the smaller risks associated with stress urinary incontinence (SUI) sling surgery from those of pelvic organ prolapse mesh surgery.

Based on its findings, the SCENIHR supports continuing the use of synthetic sling surgery for stress urinary incontinence (SUI), as it is an accepted procedure with proven efficacy and safety in the majority of patients with moderate to severe SUI, when used by an experienced and appropriately qualified surgeon.

The SCENIHR does not, however, advocate the use of synthetic mesh via the transvaginal route for female pelvic organ prolapse (POP) repair.   Because of increased risks associated with this type of surgery, it should only be used when other surgical procedures have failed or are expected to fail.

Assessment of the risks reported indicates that polypropylene type 1 meshes are the most appropriate synthetic meshes for vaginal use and polypropylene type 1 and polyester type 3 for insertion via the abdominal route.

Appropriate patient selection and counselling is extremely important for the optimal outcome for all surgical procedures, particularly those of this nature.

The SCENIHR recommends limiting the amount of mesh for all procedures where possible and introducing a certification system for surgeons, based on existing international guidelines and established in cooperation with the relevant European Surgical Associations.

For the full assessment and more details concerning the use of surgical mesh in urogynaecological surgery, please refer to the final Opinion, which was published in December 2015 following a public consultation on the preliminary Opinion.  A factsheet that provides an easy-to-read overview of the subject is also available.

In December 2015, the European Commission and its non-food Scientific Committees published their final Opinion on Synthetic Biology III: Risks to the environment and biodiversity related to synthetic biology and research priorities in the field of synthetic biology, which is the third and last of three scientific Opinions on Synthetic Biology (SynBio).

The first Opinion focused on the scope and definition of SynBio and on identifying how it is similar and dissimilar to genetic engineering.  Confirming the worldwide reputation of the Scientific Committees and the scientific excellence of their advice, the UN Ad Hoc Technical Expert Group on synthetic biology recently adopted the Scientific Committees' definition of SynBio, as "the application of science, technology and engineering to facilitate and accelerate the design, manufacture and/or modification of genetic materials in living organisms".

The second Opinion focused on the implications of likely developments in SynBio for humans, animals and the environment and on determining whether existing health and environmental risk assessment practices of the European Union for Genetically Modified Organisms are adequate for SynBio. Additionally, the Scientific Committees were asked to provide suggestions for revised risk assessment methods and risk mitigation procedures including safety locks.

The newly published third Opinion identifies major gaps in knowledge to be considered for performing a reliable risk assessment and also provides research recommendations on the basis of the identified knowledge gaps.

The Scientific Committees confined the scope of their analysis to the foreseeable future, acknowledging that its findings should be reviewed and updated again after several years, depending on developments in SynBio technology.

In related news, a SynBio workshop, organised by the European Commission, was held under the auspices of the Luxembourg Presidency on 10 December 2015 at the University of Luxembourg in Belval.   The workshop brought together scientists, risk assessment specialists, risk managers, policy makers, academics and provided the opportunity for the European Commission to present its Opinions on SynBio and discuss its other activities in this field, but also gave all the participants the opportunity to look at SynBio from various angles and to share their views and experiences.

The Notes of Guidance is a document compiled by the members of the Scientific Committee on Consumer Safety (SCCS) which contains information on different aspects of testing and safety evaluation of cosmetic substances in Europe. The emphasis is on cosmetic ingredients, although some guidance is also given for the safety assessment of finished products, and the guidance aims to help public authorities and the cosmetic industry comply with the current cosmetic EU legislation.  Although intended mainly for ingredients rather than finished products, the guidance can indeed be useful for compiling the product information file for a finished cosmetic product that is currently required by European law.

The "Notes of Guidance" are regularly updated. Since the last revision in 2012, new addenda, Opinions and memoranda of importance to the guidance's content were adopted, which prompted this latest update.  In addition, since 2013, European cosmetic legislation was amended and now prohibits the marketing of finished products containing ingredients or combinations of ingredients that have been subject to animal testing after 2013.

The Cosmetics Regulation specifies that a cosmetic product made available on the market shall be safe for human health when used under normal or reasonably foreseeable conditions of use. In practice, cosmetic products have rarely been associated with serious health hazards, but that doesn't mean that cosmetics are safe in use per se. Particular attention is needed for long-term safety, since cosmetic products may be used over much of a human lifespan.

For substances like colourants, preservatives and UV-filters which are of particular concern, safety evaluation is done at the Commission level by the SCCS by examining all available scientific data and relevant clinical data, epidemiological studies, information derived from accidents and any other appropriate human data.

In the 2015 update, which is the 9th revision of this document, the SCCS gave special attention to alternatives to animal testing that are suitable for the safety testing of cosmetic substances.  Some of the other most significant changes introduced by the new Cosmetic Regulation and reflected in this revision include the strengthened safety requirements for cosmetic products, the introduction of the notion of a “responsible person”, centralised notification of all cosmetic products placed on the EU market, the introduction of reporting serious undesirable effects (SUE), new rules for the use of nanomaterials in cosmetic products, and the introduction of a set of requirements for CMR (carcinogenic, mutagenic, reproductive toxic) substances.

The “Notes of Guidance” is not a checklist, but is intended to be used as part of case-by-case approach. In fact, the SCCS stresses that the safety evaluation of cosmetic substances and finished products can only be performed on a case-by-case basis.

The Scientific Committee on Health and Environmental Risks (SCHER) was asked to review available data on the ingestion of three types of toy material by children in order to evaluate if the current migration limits were still appropriate. It was questioned whether the daily ingestion limits up to an amount of 100 mg for dry, brittle, powder-like or pliable toy material and 400 mg for liquid or sticky toy material could be changed to weekly limits.

The SCHER reviewed relevant literature published since 2008 and subsequently produced its preliminary Opinion, in which the SCHER considers current migration limits to be appropriate and that all ingestion limits should remain classified as daily rather than weekly.

The preliminary Opinion is now available online and is open for public consultation through 14 February 2016.