Sclera substitutes: a cautionary note
- Director of Tissue Banking, Division of Ophthalmology, University of Bristol, Bristol Eye Hospital, Lower Maudlin Street, Bristol BS1 2LX, UK; w.j.armitage{at}bristol.ac.uk
In their article in the BJO,1 Mehta and Franks provide a valuable and timely review of the use of human sclera in ophthalmic surgery. The article was prompted by the implications of using human sclera in the light of the as yet unquantified risk of iatrogenic transmission of variant Creutzfeldt-Jakob disease (vCJD). The authors list a number of alternatives to sclera, including dura mater. While they point out that the surgical use of dura mater has itself resulted in a significant number of cases of transmission of classic CJD, it is also stated that a commercial preparation of dura mater, treated to reduce the risk of CJD transmission, is available. In the United Kingdom, the Medical Devices Agency (MDA) withdrew the licences issued under the Surgical Materials Act 1971 for the two available commercial preparations of dura mater in 1991 and 1992, respectively. According to the MDA, no products containing human dura mater are currently licensed for clinical use in the United Kingdom. It is clearly not appropriate to recommend use of an unlicensed product whatever claims have been made about its preparation. It should be noted that individuals who have received dura mater allografts are excluded from subsequently donating tissues for transplantation.2 Finally, it would be important to know whether any ophthalmic surgeons in the United Kingdom have in fact used preparations of dura mater since 1992 as further guidance may need to be sought.
