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<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>
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