Last spring, two long-established (and unrelated) fertility clinics in Ohio and California made headline news when they both experienced failures that resulted in the destruction of thousands of eggs and embryos. While the failures at both clinics are still being investigated, it appears that they are both a combination of human error and mechanical failure. As a mother of three children, two of whom were conceived with assisted reproductive technology (or ART) via in vitro fertilization, my heart breaks for these couples and women whose hopes and dreams have been destroyed.
According to the Society of Reproductive Technology, the number of American women freezing their eggs has shot up from 475 in 2009 to 6,207 in 2015. The European Society of Human Reproduction and Embryology estimates that there is a total of 5 million IVF babies worldwide and approximately 900,000 people in the U.S. who were born from IVF cycles. This means that more and more women and couples are relying on fertility clinics and their technology to have children. I know from my own experience that most people choosing IVF as their path to becoming parents are making a huge sacrifice and have already faced loss, heartache and tragedy.
One woman I read about whose embryos were damaged or possibly lost at one of the aforementioned clinics had undergone an emergency IVF cycle prior to having a hysterectomy and chemotherapy. She had trusted not only in the clinic’s technology but in their practices as well. I can’t imagine the devastation she must be feeling now, knowing that her only chance to have children has been taken from her.
I was puzzled when I read about the “oversight” at the clinic in Ohio that left the staff unaware that the remote alarm system on the storage tank had been turned off. This allowed the fluctuation in temperature to go unnoticed. In California, the level of liquid nitrogen in one of the cryo-storage tanks was found to be too low when there was no embryologist or staff present. With egg retrieval and freezing costs ranging anywhere from $6,000 to $20,000 (not to mention the emotional cost), one would assume there were sophisticated and redundant back-up systems in place to guarantee the eggs, sperm and embryos would be safely frozen until needed.
How I wondered, could this happen? Why didn’t the tanks have 24-hour monitoring? Were the clinics simply trying to cut costs? It would also seem logical to divide the samples (when possible) into separate tanks. It’s hard to believe nobody has thought of this notion. My biggest question is how can it be possible that this industry is so unevenly regulated?
After doing my own detective work, I discovered a very interesting fact. In 2016, The American Society for Reproductive Medicine along with the Society for Assisted Reproductive Technology and the Society for Reproductive Biologists And Technologists developed joint guidance and recommendations for all IVF clinics to have a plan to protect human tissue in the event of an emergency.
Emergency however, is defined as:
• Natural disaster
• Terror attack
Nowhere in these guidelines is there any mention of hospital, clinic or equipment failure. I know enough from being married to an attorney that this loophole in the language is what allows these clinics to remain non-compliant with the recommended practices.
The larger picture here is of course legislation. We need laws in place to protect human tissue and to protect access to assisted reproductive technology. Believe it or not, there are lobbyists and political action committees hard at work trying to limit the access of individuals to assisted reproductive technology.
Not a day goes by that I don’t marvel at the miracle of our two-year old twins. Four years ago, our twins were frozen at the blastocyst (5 day old) stage for over two years before being thawed and transferred into our gestational carrier. My husband and I will be eternally grateful to our fertility specialist Dr. Schoolcraft and his team for all of his medical wisdom and for having practices in place that safeguarded our babies until it was their time to be welcomed into the world.
There are now approximately 500 fertility clinics throughout the nation and fertility medicine is now a billion-dollar industry. Across-the-board regulation and legislation is needed to protect the thousands of eggs and embryos whose life is suspended while frozen – just as our precious twins were. It is evident that more needs to be done at the state and federal level to develop a uniform regulatory agency for this growing area of medicine. The industry cannot continue to regulate itself; it is time to hold fertility clinics to a higher standard.