Based on the Center for Disease Control (CDC)’s 2021 Fertility Clinic Success Rates Report, approximately 238,126 patients had 413,776 ART cycles performed at 453 reporting clinics in the United States during 2021. An “ART” refers to Assisted Reproductive Technology. ART cycles resulted in 91,906 live births (deliveries of one or more living infants) and 97,128 live born infants.
Of the 413,776 ART cycles performed in 2021, 167,689 were egg or embryo banking cycles in which all resulting eggs or embryos were frozen for future use. Although the use of ART is still rare as compared to the potential demand, its use has more than doubled over the past decade.
ART includes the use of IVF (in vitro fertilization). IVF is the process of creating an embryo outside of the birthing parent’s body to assist with pregnancy.
Approximately 2.3% of all infants born in the United States every year are conceived using ART. For more information from the CDC click here. https://www.cdc.gov/art/artdata/index.html
In December 2023, CooperSurgical issued a recall notice for three batches of its embryo culture media regarding the alleged complaints of impaired and unusable embryo development before the blastocyst stage. A blastocyst is a cluster of dividing cells made by a fertilized egg. It’s the early stage of an embryo. A blastocyst forms about five to six days after a sperm fertilizes an egg. Cells in the blastocyst divide become the case that eventually encompass the developing fetus and provide nourishment essential for growth.
According to the available information, the media recall was due to a lack of Magnesium in the culture media, an essential nutrient for the embryos to grow.
Embryos are kept in culture media (a solution to increase cell growth after fertilization). They grow after being created through IVF before they are ready to be transferred to the patient’s uterus.
The three culture media LGGG Lots that were recalled include the following:
Women and families have suffered the loss of embryos that were being developed for implantation and potential pregnancy. Some have lost multiple embryos and some have no other options available to them. IVF itself is an expensive process and is not pleasant, requiring hormone treatment and preparation to harvest the eggs. These losses can be astronomical. Potential damages from the defective product recall include:
Click here (Class 2 Device Recall global Medium (fda.gov)) to view the FDA Class 2 Device Recall.
If you or a loved one has experienced unexpected embryo or pregnancy loss from a clinic that you believe used the recalled and defective CooperSurgical culture media, call or text our trial lawyers at Oliver Law Office at 614-220-9100 for a free consultation.
Our CEO & Founder, Jami S. Oliver, has 30 years of defective products experience and has made her career holding large companies accountable for defective pharmaceuticals and other products. She was named 2024 Lawyer of the Year for Defective Products in Columbus, Ohio by Best Lawyers.
