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June 2001
MANUFACTURER/ SUPPLIER
Various
PROBLEM
Inappropriate use of breast implants as sizers
Breast Implants are not designed for use as implant sizers nor should they be reused. Both single-use and reusable sizers are available; only reusable sizers should be used for more than one case.
For attention by:
Health Authorities (England) - Chief Executives
NHS Trusts (England) - Chief Executives
Primary Care Trusts - Chief Executives
ACTION
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Do not use breast implants as sizers;
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Only use purpose made sizers for sizing breast implants;
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Always follow the manufacturer's instructions when using sizers and reprocessing reusable sizers.
DISTRIBUTION REQUIRED
Please bring this notice to the attention of all who need to know or be aware of it. This will include distribution by:
TRUSTS to:
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Liaison Officers (for onward distribution)
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Medical Directors
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Plastic and Cosmetic Surgeons and all Surgeons involved in breast reconstruction
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Directors of Surgical units involved in breast reconstruction
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Nurse Executive Directors
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Specialist Nurses involved in breast cancer care
HEALTH AUTHORITIES to:
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Liaison Officers (for onward distribution)
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Chairs of Primary Care Groups
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Registration Inspection Units
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Hospitals in the Independent Sector and clinics involved in cosmetic surgery
PRIMARY CARE TRUSTS to:
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Chief Executives (for onward distribution)
BACKGROUND
Breast Implant sizers are used during breast augmentation/reconstruction operations to help the surgeon determine which size of breast implant is required.
MDA has received as anecdotal report of surgeons using breast implants as reusable sizers during breast augmentation/reconstruction.
Several different models of breast implant sizers are available in the UK. Some are reusable, others are for single-use. As far as MDA is aware no breast implant on the UK market has been CE marked for use as a reusable sizer.
A reusable sizer will need to be able to withstand the stresses imposed by multiple insertion/removal procedures. Only those sizers labelled as reusable should be reused and the manufacturer's instructions regarding their cleaning and sterilization should be followed. The number of times a reusable sizer can be used depends on several factors and no absolute number can be given. Reusable breast implant sizers should be inspected, prior to each use, to ensure that they are undamaged.
Breast implants are CE marked and clearly labelled as single-use devices. In August 1999 the Chief Medical Officer for England issued advice1 regarding the reuse of medical devices which stated 'never reuse medical devices designed for single use'. MDA has also published advice on the implications and consequences of reuse of single-use devices2.
References
1. HSC 1999/179 - Control Assurance in Infection Control: Decontamination of Medical Devices, available from the Department of Health Website at www.doh.gov.uk/publications/coinh
2. MDA Device Bulletin DB2000(04) Single-use Medical Devices: Implications and Consequences of Reuse, available from MDA
ENQUIRIES
Enquiries to the MHRA should quote reference number 19991126.011-7
© Crown Copyright 2001
