Dr. Silber, can you tell us a little about the Cleveland and California clinics and what they are going through with their egg-thawing / freezing issues?
It is scaring a lot of patients and you shouldn’t be frightened if your eggs, embryos, ovarian tissue, or sperm are with us.
There are several problems:
– they had an alarm system that really didn’t work
– the person on call didn’t respond to the alarm
and that kind of thing can happen – where your alarm system goes bad. In fact, you often have so many false alarms that you can become complacent.
What’s most important is the diligence of the embryologist and their love for their work and what they really care about is the patient. And you simply have to top of these tanks every week and check them regularly.
So you have an alarm, which is nice, but you really have to have the diligence to make sure that the liquid nitrogen tanks are always refilled.
There is another problem. And this is an example of kind of the stupidity of a lot of government regulations. They were using a vapor system for their freezing. In other words, these eggs and embryos were not in liquid nitrogen – they were in a liquid nitrogen vapor. And they are huge, expensive tanks, actually. It’s not like the clinics involved didn’t try to spend money to do it the right way, but it is a terrible idea – a terrible system. It was designed to avoid the eggs or embryos being directly in the liquid nitrogen because of a theoretical fear of transmission of infectious diseases.
Well, there have been 10 million transfers of embryos & eggs vitrified in liquid nitrogen, and there’s no transmission of any disease and it is completely safe. But because everybody is afraid the FDA would get down on them, and not allow vitrification, they put up these expensive vaporizer systems which were terrible and fragile and it was just a setup for a thaw occurring.
We don’t have anything like that. We have a reliable system – the biologic material is in liquid nitrogen, not in a vapor. This liquid nitrogen is topped off on a regular basis. It is very disciplined and the embryologists are very diligent, and the system really really works and is reliable and safe. But if you are just going to rely on an alarm and have it in vapor… this tragedy was bound to happen at those clinics. It won’t happen here.