Medical Device Alert: Heliosphere Bag Intragastric Balloon manufactured by Helioscopie Medical Implants (MDA/2009/040)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2009/040 or 2009/005/019/401/009.

Technical aspects
Guido Fumagalli or Katy Hopkins
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London SW8 5NQ

Tel: 020 7084 3144 / 3176
Fax: 020 7084 3106

E-mail: guido.fumagalli@mhra.gsi.gov.uk or katy.hopkins@mhra.gsi.gov.uk

Clinical aspects
Dr. Susanne Ludgate
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London SW8 5NQ

Tel: 020 7084 3123
Fax: 020 7084 3111

E-mail: susanne.ludgate@mhra.gsi.gov.uk

How to report adverse incidents
Please report via our website http://www.mhra.gov.uk
Further information about CAS can be found at https://www.cas.dh.gov.uk/Home.aspx

Alerts in Northern Ireland will continue to be distributed via the NI SABS system.
Enquiries and adverse incident reports in Northern Ireland should be addressed to:

Northern Ireland Adverse Incident Centre (NIAIC)
Health Estates
Estate Policy Directorate
Stoney Road
Dundonald
Belfast
BT16 1US

Tel: 02890 523 704
Fax: 02890 523 900

E-mail: NIAIC@dhsspsni.gov.uk

http://www.dhsspsni.gov.uk/index/hea/niaic.htm

How to report adverse incidents in Northern Ireland
Please report directly to NIAIC, further information can be found on our website http://www.dhsspsni.gov.uk/niaic
Further information about SABS can be found at https://sabs.dhsspsni.gov.uk

Enquiries and adverse incident reports in Scotland should be addressed to:

Incident Reporting and Investigation Centre
Health Facilities Scotland
NHS National Services Scotland
Gyle Square
1 South Gyle Crescent
Edinburgh
EH12 9EB

Tel: 0131 275 7575
Fax: 0131 314 0722

E-mail: iric.nss@nhs.net

http://www.hfs.scot.nhs.uk/online-services/incident-reporting-and-investigation-centre-iric/

Enquiries in Wales should be addressed to:

Dr Jane Ludlow
Senior Medical Officer
Medical Device Alerts
Welsh Assembly Government
Cathays Park
Cardiff
CF10 3NQ

Tel: 029 2082 3505 / 3922

E-mail: Haz-Aic@wales.gsi.gov.uk

Possible bowel obstruction due to full or partial early deflation of the balloon during the intended six months implantation period caused by a manufacturing welding problem.

MHRA is aware of eleven incidents where the balloon has fully or partially deflated (this implies a UK reported deflation rate of 39%). On one occasion emergency surgery was necessary to remove the device after it had migrated beyond the stomach resulting in small bowel obstruction.

The manufacturer has identified the problem as being a manufacturing fault with the internal polyurethane pouch welding.

• Cease implantation of affected batches with immediate effect
• Quarantine and return the remaining stock of the affected batches to the manufacturer
• Schedule elective removal of implanted affected devices as soon as possible.

This MDA has been distributed to:

• NHS trusts in England (Chief Executives)
• Care Quality Commission (CQC) (Headquarters)
• HSC Trusts in Northern Ireland (Chief Executives)
• NHS Boards in Scotland (Chief Executives)
• Primary care trusts in England (Chief Executives)

Onward distribution
Please bring this notice to the attention of all who need to know or be aware of it. This may include distribution by:

Trusts to:
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:

• A&E consultants
• Diatetics departments
• Dieticians
• Equipment stores
• Gastro-intestinal surgeons
• General surgeons
• Health and safety managers
• Medical directors
• Risk managers
• Theatre managers
• Upper gastrointestinal endoscopists

Care Quality Commission (CQC) (England only) to:
Headquarters for onward distribution as appropriate to:

• Hospitals in the independent sector
• Independent treatment centres
• Private medical practitioners

Primary care trusts to:
CAS liaison officers for onward distribution to all relevant staff including:

• Nutritional nurse specialists

Change of address or removal from address list for Care Quality Commission:
National Contact Centre
Care Quality Commission
St Nicholas Building
St Nicholas Street
Newcastle-upon-Tyne
NE1 1NB

Tel: 03000 61 61 61

E-mail: enquiries@cqc.org.uk

Manufacturer
Helioscopie Medical Implants
Chantal Belin, Quality Manager
Rue des Freres Lumiere
B.P. 385
38217 Vienne Cedex
France

Tel: +33 474 161818
Fax: +33 474 161918

E-mail: cbelin@helioscopie.fr 

UK supplier
UK Surgical
Saf Ali, Managing Director
Elsie Whiteley Innovation Centre
Hopwood Lane
Halifax
HX1 5ER

Tel: +44(0)1422 361565
Fax: +44(0)1422 300171

E-mail: saf.ali@uksurgical.com