Translate the text from English to Welsh.



 
Jocelyn Davies AM raised concerns in the Assembly on 14 January 2014 about adverse events connected to surgery for bladder problems using tension\-free vaginal tapes (TVTs) and meshes.  I undertook to provide a Written Statement on this matter.  


Urinary incontinence (UI) is a common symptom that can affect women of all ages, with a wide range of severity and nature. While rarely life\-threatening, incontinence may seriously influence the physical, psychological and social wellbeing of affected individuals.


The National Institute for Health and Care Excellence (NICE) first published guidance on the management of urinary incontinence in women in 2006 and updated guidance (clinical Guideline CG171\) was published in September 2013\. This guidance is supported by two sets of interventional procedures guidance:


* on surgical repair of vaginal wall prolapse using mesh (IPG267\) and
* sacrocolpopexy using mesh for vaginal vault prolapse repair (IPG283\).


The Medical Healthcare products Regulatory Agency (MHRA) commissioned York University to review the published literature on the most frequently reported adverse events in the light of concerns expressed by patient groups about TVT and mesh procedures. York University Health Economics Consortium reported in 2012 on the rates of common adverse events associated with TVTs for the treatment of stress urinary incontinence (SUI), and meshes for pelvic organ prolapse (POP).


In summary the report confirmed;


* that adverse event rates associated with the various surgical techniques using TVTs for SUIs are generally in the range 1\-3% (9% for deterioration in sexual function for one technique); and
* adverse event rates for surgical techniques using vaginal meshes for POP are in the range 2\-6% for most outcomes, but 14\-15% for deterioration in sexual function.


The report concluded that interpretation of these findings was not straightforward as many patients experience symptoms such as sexual problems before surgery, and rates of adverse events for surgery not using implants are believed to be as high as or higher than those using implants. Further information was felt to be required and an ongoing trial looking at evidence of the relative safety of prolapse repairs using native tissue repair and mesh implants, which is due to report in 2014\.


A letter to Medical Directors in NHS Wales was issued by Dr Heather Payne, Senior Medical Officer, in January 2013 regarding surgical management of SUI and POP. This letter drew attention to the York University report recommendations and the need for compliance with existing NICE and professional guidance on the safe and appropriate use of these devices.


In response to these earlier concerns, the MHRA, working with the two professional associations – the British Society for Urological Gynaecology (BSUG) and the British Association of Urological Surgeons (BAUS), developed a range of materials for clinicians and patients, including patient information leaflets, and a set of questions which patients should ask their surgeons when considering possible surgery. These are available on the MHRA website.


The MHRA's current view is that for the vast majority of women, mesh and tape implants are a safe and effective operation, but as with all surgery, there is an element of risk. While a small number of women have experienced distressing and severe effects, the current evidence shows that when these products are used correctly they can help with the very distressing symptoms of these conditions and as such the benefits still outweigh the risks.


The MHRA continues to encourage voluntary reporting of adverse incidents from all health care workers, as well as carers, patients and members of the public, although it is acknowledged that there is considerable under reporting of complications. There are currently no plans in place to introduce mandatory reporting of medical device adverse incidents by health care professionals; however, the situation is under constant review to ensure that appropriate systems are in place to facilitate the reporting of adverse incidents from all sources. Attached at Annex 1 is the data available in relation to the number of these procedures undertaken but I would draw your attention to the limitations of the data.  


NHS England have recently (December 2013\) issued further advice to clinicians on this issue drawing their attention to updated guidance and summarising a number of actions highlighted below and this updated guidance is currently being issued to NHS Medical Directors within Wales, covering the need to demonstrate good clinical practice in:


1. **Consent:**  standardisation of all consenting processes to comply with up to date evidence and risk management at all levels from individual, local NHS and also at UK level.
2. **Audit:** compliance with NICE recommendations that mesh insertion should be part of regular audit; and that **all** procedures and incontinence operations, but particularly those involving mesh, are recorded on a recognised database.
3. **Adverse event reporting**: reporting of all adverse events involving Mesh used operatively to the Medicines and Healthcare Products Regulatory Agency (MHRA)
4. **Surgery for removal of mesh**: demonstrating that any surgery for removal of TVTs or prolapse mesh, or repeat surgery for incontinence or prolapse is to be performed in units which can demonstrate relevant levels of specialist care (through audited volume and outcome of surgery)




### Documents


* #### Annex 1,
 file type: doc, file size: 76 KB



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Translation:


 
Cododd Jocelyn Davies AC bryderon yn y Cynulliad ar 14 Ionawr 2014 am ddigwyddiadau niweidiol yn gysylltiedig â llawdriniaethau ar gyfer problemau gyda’r bledren gan ddefnyddio tapiau di\-densiwn y wain a rhwyllau.  Rwyf wedi ymgymryd â’r gwaith o baratoi Datganiad Ysgrifenedig ar y mater hwn.  


Mae Anymataliaeth Wrinol yn symptom cyffredin all effeithio ar ferched o bob oed, gan amrywio’n fawr o ran difrifoldeb a natur. Er mai anaml y bydd yn peryglu bywyd rhywun, gall anymataliaeth gael effaith ddifrifol ar les corfforol, seicolegol a chymdeithasol yr unigolion sy’n dioddef.


Cyhoeddodd Y Sefydliad Cenedlaethol dros Iechyd a Rhagoriaeth Glinigol (NICE) ganllaw am y tro cyntaf ar reoli Anymataliaeth Wrinol mewn merched yn 2006 a diweddariad ar y canllaw (Canllaw Clinigol CG171\) ym mis Medi 2013\. Cefnogir y canllaw hwn gan ddwy set o ganllawiau gweithdrefnau ymyriad:


* ar atgyweirio cwymp wal y wain drwy lawdriniaeth gan ddefnyddio rhwyll (IPG267\) a
* sacrocolpopecsi gan ddefnyddio rhwyll ar gyfer atgyweirio cwymp cromen y wain (IPG283\)


Comisiynodd Asiantaeth Rheoli cynnyrch Gofal Iechyd Meddygol (MHRA) Brifysgol Efrog i adolygu’r llenyddiaeth a gyhoeddwyd ar y digwyddiadau niweidiol yr adroddir amlaf amdanynt, yng ngoleuni’r pryderon a fynegwyd gan grwpiau cleifion am dâp di\-densiwn y wain a gweithdrefnau rhwyll. Adroddodd Consortiwm Economeg Iechyd Prifysgol Efrog yn 2012 ynglŷn â chyfraddau digwyddiadau niweidiol cyffredin sy’n gysylltiedig â Thapiau Di\-densiwn y Wain ar gyfer trin straen anymataliaeth wrinol a rhwyllau ar gyfer cwymp organau’r pelfis.


Yn gryno, roedd yr adroddiad yn cadarnhau:


* fod digwyddiadau niweidiol sy’n gysylltiedig â’r amrywiol dechnegau llawdriniaethol sy’n defnyddio Tapiau Di\-densiwn y Wain ar gyfer Straen Anymataliaeth Wrinol fel arfer o fewn yr amrediad 1\-3% (9% ar gyfer dirywiad mewn swyddogaeth rywiol i un dechneg); a
* mae cyfraddau digwyddiadau niweidiol gan ddefnyddio rhwyllau’r wain ar gyfer cwymp organau’r pelfis o fewn yr amrediad 2\-6% ar gyfer y rhan fwyaf o ganlyniadau, ond 14\-15% ar gyfer dirywiad mewn swyddogaeth rywiol.


Daeth yr adroddiad i’r canlyniad nad oedd dehongli’r darganfyddiadau hyn yn rhwydd gan fod nifer o gleifion yn profi symptomau megis problemau rhywiol cyn cael llawdriniaeth, a chredir fod cyfraddau digwyddiadau niweidiol ar gyfer llawdriniaeth heb ddefnyddio mewnblaniadau, yr un mor uchel neu’n uwch na’r rhai sydd yn defnyddio mewnblaniadau. Teimlwyd bod angen mwy o wybodaeth ac mae disgwyl i dreial sydd ar y gweill i edrych ar dystiolaeth o ddiogelwch cymharol trwsio cwymp gan ddefnyddio dulliau trwsio’r meinwe cynhenid a mewnblaniadau rhwyll, adrodd yn 2014\.


Cyhoeddwyd llythyr i Gyfarwyddwyr Meddygol GIG Cymru gan Dr Heather Payne, yr Uwch Swyddog Meddygol, ym mis Ionawr 2013 ynglŷn â rheolaeth lawdriniaethol straen anymataliaeth wrinol a chwymp organau’r pelfis. Roedd y llythyr hwn yn tynnu sylw at argymhellion adroddiad Prifysgol Efrog a’r angen i gydymffurfio gyda chanllawiau presennol NICE a chanllawiau proffesiynol parod ynglŷn â defnydd diogel a phriodol o’r dyfeisiadau hyn.


Wrth ymateb i bryderon cynharach, datblygodd yr MHRA, drwy weithio gyda dwy gymdeithas broffesiynol \- Cymdeithas Brydeinig Gynaecoleg Wrolegol (BSUG) a Chymdeithas Brydeinig y Llawfeddygon Wrolegol (BAUS), amrediad o ddeunyddiau ar gyfer clinigwyr a chleifion, gan gynnwys taflenni, a set o gwestiynau y dylai cleifion eu gofyn i’w llawfeddyg wrth ystyried llawdriniaeth bosibl. Mae’r rhain ar gael ar wefan MHRA.


Barn yr MHRA ar hyn o bryd yw bod rhwyll a mewnblaniadau tâp yn llawdriniaeth ddiogel ac effeithiol, i’r mwyafrif o ferched, ond fel yn achos pob llawdriniaeth, mae rhywfaint o risg. Er bod nifer fechan o ferched wedi profi effeithiau gofidus a difrifol, mae’r dystiolaeth ar hyn o bryd yn dangos pan fydd y cynnyrch yma’n cael eu defnyddio’n gywir, y gallant helpu gyda symptomau gofidus y cyflyrau hyn, ac oherwydd hynny, mae’r manteision yn gorbwyso’r peryglon.


Mae’r MHRA yn parhau i annog adrodd yn wirfoddol am ddigwyddiadau niweidiol gan bob gweithiwr gofal iechyd, yn ogystal â gofalwyr, cleifion a’r cyhoedd, er y derbynnir mai prin iawn yw’r adrodd am gymhlethdodau. Nid oes cynlluniau ar hyn o bryd i gyflwyno adrodd gorfodol am ddigwyddiadau niweidiol am ddyfeisiadau meddygol gan weithwyr gofal proffesiynol; ond, mae’r sefyllfa’n cael ei hadolygu’n gyson er mwyn sicrhau bod systemau priodol mewn lle i hwyluso’r adrodd am ddigwyddiadau niweidiol o bob ffynhonnell. Ynghlwm yn Atodiad 1, mae’r data sydd ar gael ynglŷn â nifer y gweithdrefnau hyn a wnaed, ond hoffwn dynnu eich sylw  at gyfyngiadau’r data.  


Yn ddiweddar (Rhagfyr 2013\), mae GIG Lloegr wedi rhoi rhagor o gyngor i glinigwyr ynglŷn â’r mater hwn i dynnu eu sylw at ganllawiau a ddiweddarwyd a chrynhoi nifer o gamau y tynnir sylw atynt isod, ac mae’r canllaw diwygiedig hwn yn cael ei gyhoeddi ar hyn o bryd i Gyfarwyddwyr Meddygol y GIG yng Nghymru, gan gynnwys yr angen i ddangos arfer dda yn glinigol mewn:


1. **Caniatâd**  safoni’r holl brosesau caniatâd er mwyn cydymffurfio â’r dystiolaeth ddiweddaraf a rheoli risg ar bob lefel o’r unigolyn, GIG lleol ac ar lefel y DU hefyd.
2. **Archwilio** cydymffurfio ag argymhellion NICE y dylai gosod rhwyll fod yn rhan o archwilio rheolaidd; a bod **pob** gweithdrefn a llawdriniaeth anymataliaeth, ond yn enwedig y rhai sy’n cynnwys rhwyll, yn cael eu cofnodi ar fas data cydnabyddedig
3. **Adrodd am ddigwyddiadau niweidiol**: adrodd am bob digwyddiad niweidiol yn ymwneud a Rhwyll a ddefnyddir mewn llawdriniaeth wrth yr Asiantaeth Rheoli Cynnyrch Gofal Iechyd (MHRA)
4. **Llawdriniaeth i dynnu rhwyll**: dangos lefelau perthnasol o ofal arbenigol (drwy archwiliad o nifer a chanlyniadau llawdriniaethau)




### Dogfennau


* #### Atodiad 1,
 math o ffeil: doc, maint ffeil: 76 KB



76 KB