Show Search Form

Search Results

registered interest	true false
date	exactly: or between: and
answering body
answering dept id
answering dept short name
answering dept sort name
house id
legislature	pref label
question text
tabling member constituency
tabling member printed
uin
answer	is ministerial correction true false date of answer exactly: or between: and answer text answering member constituency answering member printed grouped question UIN question first answered answering member label
tabling member	label

Search

48547

	registered interest
	date	25/04/2014
	answering body	Department of Health
	answering dept id	17
	answering dept short name	Health
	answering dept sort name	Health
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health, how many (a) meetings, (b) items of written correspondence, (c) phone calls, (d) consultation responses, (e) tenders and (f) other individual communications and contacts his Department has had with (i) Johnson & Johnson, (ii) Ethicon and (iii) BARD.
	tabling member constituency	Livingston
	tabling member printed	Graeme Morrice
	uin	196778
	answer	answer is ministerial correction date of answer 06/05/2014 answer text <p>Within the last 12 months, the Department has had regular communication with a number of pharmaceutical, device and diagnostic manufacturers, on a wide range of topics. However, the information requested could only be provided at disproportionate cost.</p> answering member constituency North Norfolk answering member printed Norman Lamb question first answered 06/05/2014 12:00:00 answering member 1439 label Biography information for Norman Lamb
	tabling member	4012 label Biography information for Graeme Morrice

48571

	registered interest
	date	25/04/2014
	answering body	Department of Health
	answering dept id	17
	answering dept short name	Health
	answering dept sort name	Health
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health, how many cases of complications with transvaginal mesh implants have been reported by health professionals in each of the last three years.
	tabling member constituency	Livingston
	tabling member printed	Graeme Morrice
	uin	196741
	answer	answer is ministerial correction date of answer 06/05/2014 answer text <p>The Department of Health does not hold information on the number of patients who have required further operations due to complications with transvaginal mesh implants in each of the last three years or the costs of these operations.</p><p> </p><p>The Department has had two meetings in which polypropylene transvaginal mesh implants were either discussed or on the agenda.</p><p> </p><p>NHS England manages the National Reporting and Learning System (NRLS) for patient safety incident reports from the NHS. NHS England shares incident reports concerning harms arising from medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA).</p><p> </p><p>Manufacturers of medical devices such as transvaginal mesh implants are legally required to report adverse incidents (ie death, serious injury or potential serious injury) involving their devices to the MHRA. General Medical Guidance published in February 2013 makes it clear that clinicians should report medical device incidents to the MHRA, and make information available to patients about how they can report side effects to the MHRA. The MHRA also encourages voluntary reporting of adverse incidents by healthcare workers, carers, patients and members of the public and participates in monthly telephone meetings with regulators in other European Union member states to share information about medical device safety.</p><p> </p><p>The Department is currently engaged in work to assess the effectiveness of existing arrangements for reporting complications relating to transvaginal mesh implants. NHS England is leading this work, which also involves the MHRA, the Royal College of Obstetricians and Gynaecologists, and the relevant professional societies (the British Society of Urogynaecology and the British Association of Urological Surgeons).</p><p> </p><p>Finished Consultant Episodes for women who have received a primary or secondary operative procedure for the insertion of Transvaginal Mesh, Transobturator Tape, Transvaginal Slings and Transvaginal Tape.</p><p> </p><table><tbody><tr><td><p>Procedure</p></td><td><p>2010-11</p></td><td><p>2011-12</p></td><td><p>2012-13</p></td></tr><tr><td><p>Insertion of Transvaginal Mesh</p></td><td><p>1,636</p></td><td><p>1,524</p></td><td><p>1,310</p></td></tr><tr><td><p>Insertion of Transobturator Tape</p></td><td><p>5,426</p></td><td><p>4,885</p></td><td><p>4,476</p></td></tr><tr><td><p>Insertion of Transvaginal Sling</p></td><td><p>130</p></td><td><p>134</p></td><td><p>135</p></td></tr><tr><td><p>Insertion of Transvaginal Tape</p></td><td><p>8,087</p></td><td><p>8,172</p></td><td><p>7,627</p></td></tr></tbody></table><p> </p><p><em>Source</em>: Hospital Episode Statistics (HES), Health and Social Care Information Centre.</p><p><em>Note</em>: Activity in English NHS Hospitals and English NHS commissioned activity in the independent sector.</p><p> </p><p> </p><p>Adverse events reported to MHRA by Health Professionals concerning Vaginal tape and mesh implants are as follows</p><p> </p><table><tbody><tr><td> </td><td><p>Vaginal Tapes for Stress Urinary Incontinence</p></td><td><p>Vaginal Mesh for Pelvic Organ Prolapse</p></td><td><p>Vaginal Mesh for unknown* indication</p></td></tr><tr><td><p>2011</p></td><td><p>3</p></td><td><p>1</p></td><td><p>0</p></td></tr><tr><td><p>2012</p></td><td><p>23</p></td><td><p>31</p></td><td><p>2</p></td></tr><tr><td><p>2013</p></td><td><p>27</p></td><td><p>20</p></td><td><p>0</p></td></tr><tr><td><p>Up to March 2014</p></td><td><p>16</p></td><td><p>7</p></td><td><p>0</p></td></tr></tbody></table><p>*The reporter did not provide enough information on what type of mesh it was</p><p> </p><p> </p><p>Number of patient safety incidents relating to mesh used in gynaecological procedures reported to the NRLS (Year of occurrence by reported degree of harm)</p><p> </p><table><tbody><tr><td><p> </p></td><td><p>No Harm</p></td><td><p>Low</p></td><td><p>Moderate</p></td><td><p>TOTAL</p></td></tr><tr><td><p>2011</p></td><td><p>0</p></td><td><p>2</p></td><td><p>4</p></td><td><p>6</p></td></tr><tr><td><p>2012</p></td><td><p>7</p></td><td><p>4</p></td><td><p>3</p></td><td><p>14</p></td></tr><tr><td><p>2013</p></td><td><p>4</p></td><td><p>1</p></td><td><p>1</p></td><td><p>6</p></td></tr><tr><td><p>TOTAL</p></td><td><p>11</p></td><td><p>7</p></td><td><p>8</p></td><td><p>26</p></td></tr></tbody></table><p>Search strategy: All incidents from gynaecological specialties in the NRLS were searched on 2 December 2013 for the keyword ‘mesh'</p><p> </p><p> </p><p> </p><p>Adverse events reported to MHRA by patients/members of the public concerning Vaginal tape and mesh implants are as follows</p><p> </p><table><tbody><tr><td> </td><td><p>Vaginal Tapes for Stress Urinary Incontinence</p></td><td><p>Vaginal Mesh for Pelvic Organ Prolapse</p></td><td><p>Vaginal Mesh for unknown* indication</p></td></tr><tr><td><p>2011</p></td><td><p>33</p></td><td><p>7</p></td><td><p>3</p></td></tr><tr><td><p>2012</p></td><td><p>26</p></td><td><p>2</p></td><td><p>0</p></td></tr><tr><td><p>2013</p></td><td><p>30</p></td><td><p>10</p></td><td><p>3</p></td></tr><tr><td><p>Up to March 2014</p></td><td><p>7</p></td><td><p>0</p></td><td><p>0</p></td></tr></tbody></table><p>*The reporter did not provide enough information on what type of mesh it was</p><p> </p><p>No incidents relating to transvaginal mesh have been reported to the NRLS by patients.</p><p> </p><p>The Department has answered 11 previous Parliamentary Questions, 27 letters from hon. Members and Peers and 17 letters from members of the public since 1 September 2011. The Chief Executive of the MHRA has replied to six letters from hon. Members since 1 September 2011.</p><p> </p> answering member constituency North Norfolk answering member printed Norman Lamb grouped question UIN 196738 196739 196740 196742 196743 196744 question first answered 06/05/2014 12:00:00 answering member 1439 label Biography information for Norman Lamb
	tabling member	4012 label Biography information for Graeme Morrice

48548

	registered interest
	date	25/04/2014
	answering body	Department of Health
	answering dept id	17
	answering dept short name	Health
	answering dept sort name	Health
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health, how many children of each (a) age and (b) gender have died while in-patients (i) at psychiatric hospitals in total as either forcefully detained or voluntary in-patients and (ii) in each institution in each year since 2000.
	tabling member constituency	Feltham and Heston
	tabling member printed	Seema Malhotra
	uin	196781
	answer	answer is ministerial correction date of answer 06/05/2014 answer text <p>Since April 2008 all Local Safeguarding Children Boards have had a statutory duty to review the death of all children from birth to age 18. Statistics on these Child Death Reviews are collated and published by the Care Quality Commission (CQC) and are available on the CQC's website:</p><p> </p><p>www.gov.uk/government/collections/statistics-child-death-reviews.</p><p> </p><p>Statistics on the location of child deaths are available from 2010 onward and show that in this time, no child has died in an inpatient mental health unit.</p><p> </p><p>According to data from the Mental Health Act Commission, six females and one male under 18 died between 2003 and 2008. Owing to patient confidentiality these figures cannot broken down to each institution.</p><p> </p> answering member constituency North Norfolk answering member printed Norman Lamb question first answered 06/05/2014 12:00:00 answering member 1439 label Biography information for Norman Lamb
	tabling member	4253 label Biography information for Seema Malhotra

49060

	registered interest
	date	29/04/2014
	answering body	Department of Health
	answering dept id	17
	answering dept short name	Health
	answering dept sort name	Health
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health, how many hospital attendances there were from each prison in each of the last four years.
	tabling member constituency	Tooting
	tabling member printed	Sadiq Khan
	uin	197046
	answer	answer is ministerial correction date of answer 06/05/2014 answer text <p>This information is not collected centrally by the Department or NHS England.</p> answering member constituency North Norfolk answering member printed Norman Lamb grouped question UIN 197047 question first answered 06/05/2014 12:00:00 answering member 1439 label Biography information for Norman Lamb
	tabling member	1577 label Biography information for Sadiq Khan

49061

	registered interest
	date	29/04/2014
	answering body	Department of Health
	answering dept id	17
	answering dept short name	Health
	answering dept sort name	Health
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health, how many hospital attendances there were from the (a) adult male, (b) adult female, (c) youth male, (d) youth female and (e) total prison estate in each of the last four years.
	tabling member constituency	Tooting
	tabling member printed	Sadiq Khan
	uin	197047
	answer	answer is ministerial correction date of answer 06/05/2014 answer text <p>This information is not collected centrally by the Department or NHS England.</p> answering member constituency North Norfolk answering member printed Norman Lamb grouped question UIN 197046 question first answered 06/05/2014 12:00:00 answering member 1439 label Biography information for Norman Lamb
	tabling member	1577 label Biography information for Sadiq Khan

48572

	registered interest
	date	25/04/2014
	answering body	Department of Health
	answering dept id	17
	answering dept short name	Health
	answering dept sort name	Health
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health, how many patients have received polypropylene transvaginal mesh implants through the NHS in each of the last three years.
	tabling member constituency	Livingston
	tabling member printed	Graeme Morrice
	uin	196740
	answer	answer is ministerial correction date of answer 06/05/2014 answer text <p>The Department of Health does not hold information on the number of patients who have required further operations due to complications with transvaginal mesh implants in each of the last three years or the costs of these operations.</p><p> </p><p>The Department has had two meetings in which polypropylene transvaginal mesh implants were either discussed or on the agenda.</p><p> </p><p>NHS England manages the National Reporting and Learning System (NRLS) for patient safety incident reports from the NHS. NHS England shares incident reports concerning harms arising from medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA).</p><p> </p><p>Manufacturers of medical devices such as transvaginal mesh implants are legally required to report adverse incidents (ie death, serious injury or potential serious injury) involving their devices to the MHRA. General Medical Guidance published in February 2013 makes it clear that clinicians should report medical device incidents to the MHRA, and make information available to patients about how they can report side effects to the MHRA. The MHRA also encourages voluntary reporting of adverse incidents by healthcare workers, carers, patients and members of the public and participates in monthly telephone meetings with regulators in other European Union member states to share information about medical device safety.</p><p> </p><p>The Department is currently engaged in work to assess the effectiveness of existing arrangements for reporting complications relating to transvaginal mesh implants. NHS England is leading this work, which also involves the MHRA, the Royal College of Obstetricians and Gynaecologists, and the relevant professional societies (the British Society of Urogynaecology and the British Association of Urological Surgeons).</p><p> </p><p>Finished Consultant Episodes for women who have received a primary or secondary operative procedure for the insertion of Transvaginal Mesh, Transobturator Tape, Transvaginal Slings and Transvaginal Tape.</p><p> </p><table><tbody><tr><td><p>Procedure</p></td><td><p>2010-11</p></td><td><p>2011-12</p></td><td><p>2012-13</p></td></tr><tr><td><p>Insertion of Transvaginal Mesh</p></td><td><p>1,636</p></td><td><p>1,524</p></td><td><p>1,310</p></td></tr><tr><td><p>Insertion of Transobturator Tape</p></td><td><p>5,426</p></td><td><p>4,885</p></td><td><p>4,476</p></td></tr><tr><td><p>Insertion of Transvaginal Sling</p></td><td><p>130</p></td><td><p>134</p></td><td><p>135</p></td></tr><tr><td><p>Insertion of Transvaginal Tape</p></td><td><p>8,087</p></td><td><p>8,172</p></td><td><p>7,627</p></td></tr></tbody></table><p> </p><p><em>Source</em>: Hospital Episode Statistics (HES), Health and Social Care Information Centre.</p><p><em>Note</em>: Activity in English NHS Hospitals and English NHS commissioned activity in the independent sector.</p><p> </p><p> </p><p>Adverse events reported to MHRA by Health Professionals concerning Vaginal tape and mesh implants are as follows</p><p> </p><table><tbody><tr><td> </td><td><p>Vaginal Tapes for Stress Urinary Incontinence</p></td><td><p>Vaginal Mesh for Pelvic Organ Prolapse</p></td><td><p>Vaginal Mesh for unknown* indication</p></td></tr><tr><td><p>2011</p></td><td><p>3</p></td><td><p>1</p></td><td><p>0</p></td></tr><tr><td><p>2012</p></td><td><p>23</p></td><td><p>31</p></td><td><p>2</p></td></tr><tr><td><p>2013</p></td><td><p>27</p></td><td><p>20</p></td><td><p>0</p></td></tr><tr><td><p>Up to March 2014</p></td><td><p>16</p></td><td><p>7</p></td><td><p>0</p></td></tr></tbody></table><p>*The reporter did not provide enough information on what type of mesh it was</p><p> </p><p> </p><p>Number of patient safety incidents relating to mesh used in gynaecological procedures reported to the NRLS (Year of occurrence by reported degree of harm)</p><p> </p><table><tbody><tr><td><p> </p></td><td><p>No Harm</p></td><td><p>Low</p></td><td><p>Moderate</p></td><td><p>TOTAL</p></td></tr><tr><td><p>2011</p></td><td><p>0</p></td><td><p>2</p></td><td><p>4</p></td><td><p>6</p></td></tr><tr><td><p>2012</p></td><td><p>7</p></td><td><p>4</p></td><td><p>3</p></td><td><p>14</p></td></tr><tr><td><p>2013</p></td><td><p>4</p></td><td><p>1</p></td><td><p>1</p></td><td><p>6</p></td></tr><tr><td><p>TOTAL</p></td><td><p>11</p></td><td><p>7</p></td><td><p>8</p></td><td><p>26</p></td></tr></tbody></table><p>Search strategy: All incidents from gynaecological specialties in the NRLS were searched on 2 December 2013 for the keyword ‘mesh'</p><p> </p><p> </p><p> </p><p>Adverse events reported to MHRA by patients/members of the public concerning Vaginal tape and mesh implants are as follows</p><p> </p><table><tbody><tr><td> </td><td><p>Vaginal Tapes for Stress Urinary Incontinence</p></td><td><p>Vaginal Mesh for Pelvic Organ Prolapse</p></td><td><p>Vaginal Mesh for unknown* indication</p></td></tr><tr><td><p>2011</p></td><td><p>33</p></td><td><p>7</p></td><td><p>3</p></td></tr><tr><td><p>2012</p></td><td><p>26</p></td><td><p>2</p></td><td><p>0</p></td></tr><tr><td><p>2013</p></td><td><p>30</p></td><td><p>10</p></td><td><p>3</p></td></tr><tr><td><p>Up to March 2014</p></td><td><p>7</p></td><td><p>0</p></td><td><p>0</p></td></tr></tbody></table><p>*The reporter did not provide enough information on what type of mesh it was</p><p> </p><p>No incidents relating to transvaginal mesh have been reported to the NRLS by patients.</p><p> </p><p>The Department has answered 11 previous Parliamentary Questions, 27 letters from hon. Members and Peers and 17 letters from members of the public since 1 September 2011. The Chief Executive of the MHRA has replied to six letters from hon. Members since 1 September 2011.</p><p> </p> answering member constituency North Norfolk answering member printed Norman Lamb grouped question UIN 196738 196739 196741 196742 196743 196744 question first answered 06/05/2014 12:00:00 answering member 1439 label Biography information for Norman Lamb
	tabling member	4012 label Biography information for Graeme Morrice

48578

	registered interest
	date	25/04/2014
	answering body	Department of Health
	answering dept id	17
	answering dept short name	Health
	answering dept sort name	Health
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health, how many patients have reported complications with polypropylene transvaginal mesh implants in each of the last three years.
	tabling member constituency	Livingston
	tabling member printed	Graeme Morrice
	uin	196739
	answer	answer is ministerial correction date of answer 06/05/2014 answer text <p>The Department of Health does not hold information on the number of patients who have required further operations due to complications with transvaginal mesh implants in each of the last three years or the costs of these operations.</p><p> </p><p>The Department has had two meetings in which polypropylene transvaginal mesh implants were either discussed or on the agenda.</p><p> </p><p>NHS England manages the National Reporting and Learning System (NRLS) for patient safety incident reports from the NHS. NHS England shares incident reports concerning harms arising from medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA).</p><p> </p><p>Manufacturers of medical devices such as transvaginal mesh implants are legally required to report adverse incidents (ie death, serious injury or potential serious injury) involving their devices to the MHRA. General Medical Guidance published in February 2013 makes it clear that clinicians should report medical device incidents to the MHRA, and make information available to patients about how they can report side effects to the MHRA. The MHRA also encourages voluntary reporting of adverse incidents by healthcare workers, carers, patients and members of the public and participates in monthly telephone meetings with regulators in other European Union member states to share information about medical device safety.</p><p> </p><p>The Department is currently engaged in work to assess the effectiveness of existing arrangements for reporting complications relating to transvaginal mesh implants. NHS England is leading this work, which also involves the MHRA, the Royal College of Obstetricians and Gynaecologists, and the relevant professional societies (the British Society of Urogynaecology and the British Association of Urological Surgeons).</p><p> </p><p>Finished Consultant Episodes for women who have received a primary or secondary operative procedure for the insertion of Transvaginal Mesh, Transobturator Tape, Transvaginal Slings and Transvaginal Tape.</p><p> </p><table><tbody><tr><td><p>Procedure</p></td><td><p>2010-11</p></td><td><p>2011-12</p></td><td><p>2012-13</p></td></tr><tr><td><p>Insertion of Transvaginal Mesh</p></td><td><p>1,636</p></td><td><p>1,524</p></td><td><p>1,310</p></td></tr><tr><td><p>Insertion of Transobturator Tape</p></td><td><p>5,426</p></td><td><p>4,885</p></td><td><p>4,476</p></td></tr><tr><td><p>Insertion of Transvaginal Sling</p></td><td><p>130</p></td><td><p>134</p></td><td><p>135</p></td></tr><tr><td><p>Insertion of Transvaginal Tape</p></td><td><p>8,087</p></td><td><p>8,172</p></td><td><p>7,627</p></td></tr></tbody></table><p> </p><p><em>Source</em>: Hospital Episode Statistics (HES), Health and Social Care Information Centre.</p><p><em>Note</em>: Activity in English NHS Hospitals and English NHS commissioned activity in the independent sector.</p><p> </p><p> </p><p>Adverse events reported to MHRA by Health Professionals concerning Vaginal tape and mesh implants are as follows</p><p> </p><table><tbody><tr><td> </td><td><p>Vaginal Tapes for Stress Urinary Incontinence</p></td><td><p>Vaginal Mesh for Pelvic Organ Prolapse</p></td><td><p>Vaginal Mesh for unknown* indication</p></td></tr><tr><td><p>2011</p></td><td><p>3</p></td><td><p>1</p></td><td><p>0</p></td></tr><tr><td><p>2012</p></td><td><p>23</p></td><td><p>31</p></td><td><p>2</p></td></tr><tr><td><p>2013</p></td><td><p>27</p></td><td><p>20</p></td><td><p>0</p></td></tr><tr><td><p>Up to March 2014</p></td><td><p>16</p></td><td><p>7</p></td><td><p>0</p></td></tr></tbody></table><p>*The reporter did not provide enough information on what type of mesh it was</p><p> </p><p> </p><p>Number of patient safety incidents relating to mesh used in gynaecological procedures reported to the NRLS (Year of occurrence by reported degree of harm)</p><p> </p><table><tbody><tr><td><p> </p></td><td><p>No Harm</p></td><td><p>Low</p></td><td><p>Moderate</p></td><td><p>TOTAL</p></td></tr><tr><td><p>2011</p></td><td><p>0</p></td><td><p>2</p></td><td><p>4</p></td><td><p>6</p></td></tr><tr><td><p>2012</p></td><td><p>7</p></td><td><p>4</p></td><td><p>3</p></td><td><p>14</p></td></tr><tr><td><p>2013</p></td><td><p>4</p></td><td><p>1</p></td><td><p>1</p></td><td><p>6</p></td></tr><tr><td><p>TOTAL</p></td><td><p>11</p></td><td><p>7</p></td><td><p>8</p></td><td><p>26</p></td></tr></tbody></table><p>Search strategy: All incidents from gynaecological specialties in the NRLS were searched on 2 December 2013 for the keyword ‘mesh'</p><p> </p><p> </p><p> </p><p>Adverse events reported to MHRA by patients/members of the public concerning Vaginal tape and mesh implants are as follows</p><p> </p><table><tbody><tr><td> </td><td><p>Vaginal Tapes for Stress Urinary Incontinence</p></td><td><p>Vaginal Mesh for Pelvic Organ Prolapse</p></td><td><p>Vaginal Mesh for unknown* indication</p></td></tr><tr><td><p>2011</p></td><td><p>33</p></td><td><p>7</p></td><td><p>3</p></td></tr><tr><td><p>2012</p></td><td><p>26</p></td><td><p>2</p></td><td><p>0</p></td></tr><tr><td><p>2013</p></td><td><p>30</p></td><td><p>10</p></td><td><p>3</p></td></tr><tr><td><p>Up to March 2014</p></td><td><p>7</p></td><td><p>0</p></td><td><p>0</p></td></tr></tbody></table><p>*The reporter did not provide enough information on what type of mesh it was</p><p> </p><p>No incidents relating to transvaginal mesh have been reported to the NRLS by patients.</p><p> </p><p>The Department has answered 11 previous Parliamentary Questions, 27 letters from hon. Members and Peers and 17 letters from members of the public since 1 September 2011. The Chief Executive of the MHRA has replied to six letters from hon. Members since 1 September 2011.</p><p> </p> answering member constituency North Norfolk answering member printed Norman Lamb grouped question UIN 196738 196740 196741 196742 196743 196744 question first answered 06/05/2014 12:00:00 answering member 1439 label Biography information for Norman Lamb
	tabling member	4012 label Biography information for Graeme Morrice

48539

	registered interest
	date	25/04/2014
	answering body	Department of Health
	answering dept id	17
	answering dept short name	Health
	answering dept sort name	Health
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health, how many patients have required further operations due to complications with transvaginal mesh implants in each of the last three years; and what the cost of such procedures was.
	tabling member constituency	Livingston
	tabling member printed	Graeme Morrice
	uin	196743
	answer	answer is ministerial correction date of answer 06/05/2014 answer text <p>The Department of Health does not hold information on the number of patients who have required further operations due to complications with transvaginal mesh implants in each of the last three years or the costs of these operations.</p><p> </p><p>The Department has had two meetings in which polypropylene transvaginal mesh implants were either discussed or on the agenda.</p><p> </p><p>NHS England manages the National Reporting and Learning System (NRLS) for patient safety incident reports from the NHS. NHS England shares incident reports concerning harms arising from medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA).</p><p> </p><p>Manufacturers of medical devices such as transvaginal mesh implants are legally required to report adverse incidents (ie death, serious injury or potential serious injury) involving their devices to the MHRA. General Medical Guidance published in February 2013 makes it clear that clinicians should report medical device incidents to the MHRA, and make information available to patients about how they can report side effects to the MHRA. The MHRA also encourages voluntary reporting of adverse incidents by healthcare workers, carers, patients and members of the public and participates in monthly telephone meetings with regulators in other European Union member states to share information about medical device safety.</p><p> </p><p>The Department is currently engaged in work to assess the effectiveness of existing arrangements for reporting complications relating to transvaginal mesh implants. NHS England is leading this work, which also involves the MHRA, the Royal College of Obstetricians and Gynaecologists, and the relevant professional societies (the British Society of Urogynaecology and the British Association of Urological Surgeons).</p><p> </p><p>Finished Consultant Episodes for women who have received a primary or secondary operative procedure for the insertion of Transvaginal Mesh, Transobturator Tape, Transvaginal Slings and Transvaginal Tape.</p><p> </p><table><tbody><tr><td><p>Procedure</p></td><td><p>2010-11</p></td><td><p>2011-12</p></td><td><p>2012-13</p></td></tr><tr><td><p>Insertion of Transvaginal Mesh</p></td><td><p>1,636</p></td><td><p>1,524</p></td><td><p>1,310</p></td></tr><tr><td><p>Insertion of Transobturator Tape</p></td><td><p>5,426</p></td><td><p>4,885</p></td><td><p>4,476</p></td></tr><tr><td><p>Insertion of Transvaginal Sling</p></td><td><p>130</p></td><td><p>134</p></td><td><p>135</p></td></tr><tr><td><p>Insertion of Transvaginal Tape</p></td><td><p>8,087</p></td><td><p>8,172</p></td><td><p>7,627</p></td></tr></tbody></table><p> </p><p><em>Source</em>: Hospital Episode Statistics (HES), Health and Social Care Information Centre.</p><p><em>Note</em>: Activity in English NHS Hospitals and English NHS commissioned activity in the independent sector.</p><p> </p><p> </p><p>Adverse events reported to MHRA by Health Professionals concerning Vaginal tape and mesh implants are as follows</p><p> </p><table><tbody><tr><td> </td><td><p>Vaginal Tapes for Stress Urinary Incontinence</p></td><td><p>Vaginal Mesh for Pelvic Organ Prolapse</p></td><td><p>Vaginal Mesh for unknown* indication</p></td></tr><tr><td><p>2011</p></td><td><p>3</p></td><td><p>1</p></td><td><p>0</p></td></tr><tr><td><p>2012</p></td><td><p>23</p></td><td><p>31</p></td><td><p>2</p></td></tr><tr><td><p>2013</p></td><td><p>27</p></td><td><p>20</p></td><td><p>0</p></td></tr><tr><td><p>Up to March 2014</p></td><td><p>16</p></td><td><p>7</p></td><td><p>0</p></td></tr></tbody></table><p>*The reporter did not provide enough information on what type of mesh it was</p><p> </p><p> </p><p>Number of patient safety incidents relating to mesh used in gynaecological procedures reported to the NRLS (Year of occurrence by reported degree of harm)</p><p> </p><table><tbody><tr><td><p> </p></td><td><p>No Harm</p></td><td><p>Low</p></td><td><p>Moderate</p></td><td><p>TOTAL</p></td></tr><tr><td><p>2011</p></td><td><p>0</p></td><td><p>2</p></td><td><p>4</p></td><td><p>6</p></td></tr><tr><td><p>2012</p></td><td><p>7</p></td><td><p>4</p></td><td><p>3</p></td><td><p>14</p></td></tr><tr><td><p>2013</p></td><td><p>4</p></td><td><p>1</p></td><td><p>1</p></td><td><p>6</p></td></tr><tr><td><p>TOTAL</p></td><td><p>11</p></td><td><p>7</p></td><td><p>8</p></td><td><p>26</p></td></tr></tbody></table><p>Search strategy: All incidents from gynaecological specialties in the NRLS were searched on 2 December 2013 for the keyword ‘mesh'</p><p> </p><p> </p><p> </p><p>Adverse events reported to MHRA by patients/members of the public concerning Vaginal tape and mesh implants are as follows</p><p> </p><table><tbody><tr><td> </td><td><p>Vaginal Tapes for Stress Urinary Incontinence</p></td><td><p>Vaginal Mesh for Pelvic Organ Prolapse</p></td><td><p>Vaginal Mesh for unknown* indication</p></td></tr><tr><td><p>2011</p></td><td><p>33</p></td><td><p>7</p></td><td><p>3</p></td></tr><tr><td><p>2012</p></td><td><p>26</p></td><td><p>2</p></td><td><p>0</p></td></tr><tr><td><p>2013</p></td><td><p>30</p></td><td><p>10</p></td><td><p>3</p></td></tr><tr><td><p>Up to March 2014</p></td><td><p>7</p></td><td><p>0</p></td><td><p>0</p></td></tr></tbody></table><p>*The reporter did not provide enough information on what type of mesh it was</p><p> </p><p>No incidents relating to transvaginal mesh have been reported to the NRLS by patients.</p><p> </p><p>The Department has answered 11 previous Parliamentary Questions, 27 letters from hon. Members and Peers and 17 letters from members of the public since 1 September 2011. The Chief Executive of the MHRA has replied to six letters from hon. Members since 1 September 2011.</p><p> </p> answering member constituency North Norfolk answering member printed Norman Lamb grouped question UIN 196738 196739 196740 196741 196742 196744 question first answered 06/05/2014 12:00:00 answering member 1439 label Biography information for Norman Lamb
	tabling member	4012 label Biography information for Graeme Morrice

48282

	registered interest
	date	10/04/2014
	answering body	Department of Health
	answering dept id	17
	answering dept short name	Health
	answering dept sort name	Health
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health, how the National Institute for Health and Care Excellence (NICE) assesses the cost-effectiveness of an intervention when the data available are uncertain; what assessment NICE has made of the average range around the most-plausible cost-per-QALY in its technology appraisals; and if he will make a statement.
	tabling member constituency	Eddisbury
	tabling member printed	Mr Stephen O'Brien
	uin	196424
	answer	answer is ministerial correction date of answer 06/05/2014 answer text <p>The National Institute for Health and Care Excellence (NICE) follows a rigorous process in the appraisal of technologies to ensure that judgements regarding the cost-effective use of NHS resources are consistently applied. This includes consideration of the uncertainty generated where available data have serious limitations.</p><p> </p><p>When making judgements on cost effectiveness, the NICE appraisal committee will consider a number of factors including the strength of the clinical-effectiveness evidence, the innovative nature of the technology, the robustness and plausibility of the economic models, the degree of certainty around the incremental cost-effectiveness ratio (ICER), the range and plausibility of the ICERs and the likelihood of decision error and its consequences. Full details of how the Committee takes uncertainty into account is contained within sections 5.8, 6.3 and 6.4 of NICE's Guide to the Methods of Technology Appraisal 2013, which is available at:</p><p>http://publications.nice.org.uk/guide-to-the-methods-of-technology-appraisal-2013-pmg9</p><p> </p><p>NICE advises that it has not carried out an assessment of the average range around the most plausible cost-per Quality Adjusted Life Year (QALY) in its technology appraisals. We understand that although NICE usually specifies the most plausible cost-per-QALY for each technology appraisal, it does not normally specify a range for this assessment.</p><p> </p> answering member constituency North Norfolk answering member printed Norman Lamb question first answered 06/05/2014 12:00:00 answering member 1439 label Biography information for Norman Lamb
	tabling member	427 label Biography information for Mr Stephen O'Brien

48281

	registered interest
	date	10/04/2014
	answering body	Department of Health
	answering dept id	17
	answering dept short name	Health
	answering dept sort name	Health
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health, if he will discuss with the National Institute for Health and Care Excellence (NICE) ensuring that assessments of treatments by NICE conducted through (a) normal technology appraisals and (b) highly specialised technology appraisals is consistent in its (i) engagement with stakeholders and (ii) wider methodological approaches.
	tabling member constituency	Eddisbury
	tabling member printed	Mr Stephen O'Brien
	uin	196428
	answer	answer is ministerial correction date of answer 06/05/2014 answer text <p>We have no plans to do so. As an independent body, the National Institute for Health and Care Excellence is responsible for developing its methods and processes and applying them consistently.</p> answering member constituency North Norfolk answering member printed Norman Lamb question first answered 06/05/2014 12:00:00 answering member 1439 label Biography information for Norman Lamb
	tabling member	427 label Biography information for Mr Stephen O'Brien