The case of a mix-up of frozen embryos in a Michigan IVF program in Feb. 2009 yet again became a media splash with the affected couple appearing on ABC News to promote their new book, “Misconceptions”. The couple who already had a set of twins as a result of a successful IVF recounts a story about their experience including the fact that the frozen embryos were mistakenly transferred into the wrong woman. This woman carried the pregnancy and after delivery handed the baby back to his biological parents. Reports of the mix-up have triggered calls from a few to make IVF illegal.
Mixing up gametes and embryos is tragic and society must do everything humanly possible to prevent such a mix up except disallow the practice of IVF. As with other societal advances, accidents have rarely and unfortunately happened in the field of IVF but, weighed against the benefit of all the babies who otherwise would never have been born, we should strive to improve the safety of IVF, not eliminate it.
Many of the greatest advances have had tragic results, unintended accidents that should have been avoided. Usually, they are the result of human error often preventable with the institution of carefully designed safeguards with a system of checks and balances.
Significant risk, including that of injury or death, is part of nearly everything we do in life today. The construction industry has always been plagued with accidental deaths. Not a bridge or a great high rise has been completed without misfortune. Do we stop construction? No, we ensure that all possible regulations that could protect those involved are in place and followed as strictly as possible to prevent further accidents.
Nuclear power is controversial because of the fear of accidents. Despite past accidents at Chernobyl and Three Mile Island, nuclear power plants continue to be constructed throughout the world because it is perceived that the possible benefits of this alternate source of energy outweighs the concerns for the risks.
Cardiac bypass surgery and other surgeries save lives and relieve suffering but, occasionally, patients intended to benefit are hurt or even killed accidentally. Rules and regulations are instituted to avoid problems such as performing the wrong operation on the wrong patient, using the wrong medication, operating on the wrong limb. Yet situations rarely occur, usually because of a human slip. Rules are broken and mistakes result. When they do hospitals review the procedures and protocols and insure a sufficient system is in place to catch errors before they have an effect on patient care.
Just as we have safeguards in the operating room, we have them in place for identifying gametes and embryos with checks and balances that should prevent a mix-up such as the one in this case.
In the operating room, patients are identified while they are awake by the embryologist, nurse, physician and anesthesiologist by full name and birth date. As soon as the ovaries are aspirated, the eggs are identified and put in dishes with the patient’s full name and birth date on them. When the dishes are changed to replace the media, again matching names are put on the new dishes with a unique case number. A partner’s sperm specimen is labeled by him and processed in tubes labeled to match the partner’s name and the corresponding patient’s name and the case number. This is doubly checked with the patient’s record which will also reflect the unique case number. It is reviewed by two embryologists for accuracy prior to fertilization. Finally, when the embryo is loaded in a catheter for transfer, the identity of the dish from the embryo is checked by the physician, embryologist, nurse and the patient herself prior to the transfer being performed.
Every attempt is made to confirm the identity of the gametes and embryos throughout the IVF process prior to transfer. In 25 years of practicing IVF, my program has not mixed up gametes or embryos.
There are approximately 1 million babies born through IVF and only a few rare mix ups reported.
Perhaps we don’t hear about every mix up. I’d estimate that between 1/50,000 and 1/100,000 pregnancies from IVF have occurred with some mix up in the embryo or gamete. When it occurs, it is tragic and requires the attention of our field and a refocus on those checks and balances we have in place to prevent such mishaps.
I work hard and I pray that we do everything possible so that this never happens again. The FDA regulates gamete donation. The New York State Department of Health regulates our labs and our operating rooms. These checks and balances are in place and are included in the monitoring performed by these agencies.
Perhaps, if the other states required as strict a monitoring to ensure their clinics and doctors are adhering to the necessary safeguards as well then the mix-ups would not occur.