Trust tells woman she cannot have her stored ovary tissue because of law changeBMJ 2012; 344 doi: https://doi.org/10.1136/bmj.e1285 (Published 21 February 2012) Cite this as: BMJ 2012;344:e1285
A woman who had an ovary removed and tissue from it frozen 12 years ago before undergoing chemotherapy for cancer has been told that she cannot have it transplanted at the moment because UK rules on processing tissue changed in 2007 and became much more stringent.
Kate Oliver, 28, had the ovary removed at Leeds Centre for Reproductive Medicine at the age of 16 after she was told that treatment for Ewing’s sarcoma would probably leave her infertile.
She says she was told that all she had to do was contact the centre, now part of Leeds Teaching Hospitals NHS Trust, when she wanted to have a baby and the process would be put in train. But although she was told in February 2009 that it would take between six and nine months, she has still not been given the go ahead.
No woman in the United Kingdom has used her previously frozen ovarian tissue to conceive, although the procedure has been successfully carried out in other countries, notably the United States, Belgium, and Denmark.
The Leeds trust would not go into detail about what the difficulties were but highlighted the Human Tissue Authority’s quality and safety regulations brought in to implement the European Union tissue and cells directive. The directive was intended to harmonise regulation of the use of tissue and cells across Europe.
The trust said in a statement, “Leeds Teaching Hospitals is unable to carry out this procedure due to changes in legislation since Miss Oliver’s tissue was first stored. We do not currently have the facilities to meet the requirements set out in this legislation.
“This is a complex area which we are looking into further in the hope we can make progress on it soon, as we can fully understand the frustration of Miss Oliver.”
Denmark and Belgium, where the procedure has been performed, belong to the European Union, and the regulations were intended to harmonise practice throughout Europe. But Richard Anderson, professor of clinical reproductive science at Edinburgh University, told the BMJ: “If this were happening anywhere else the issue wouldn’t arise. The regulations under which tissue is currently stored in the UK are far more robust than elsewhere in Europe.”
Yacoub Khalaf, medical director of the assisted conception unit at Guy’s Hospital in London, said, “Since the introduction of the European tissue and cells directive it became clear that [tissues that were frozen] before the directive would be a little bit contentious because they were not stored under those standards, understandably because they didn’t exist.
“The people who froze the tissue did freeze it under clinical laboratory standards at the time. Now we work to the EU tissue and cells directive standards, which are very rigorous.”
Professor Anderson said that current regulations required, for example, that viral testing be done before freezing, which may or may not have been done in the past “but probably wouldn’t have been done to the current requirements.” He added: “It’s all a matter of having a document chain to show that the tissue has been handled properly and the identification of this, that, and the other has been done properly.”
Asked how Leeds could now fulfil Ms Oliver’s wishes, he said, “I imagine they would go to some review body locally and say to them, ‘What do you think?’ One would hope the body would say, ‘You acted in good faith at the time, and it seems appropriate, so you can go ahead.’”
Cite this as: BMJ 2012;344:e1285