Patients from all over the country are filing lawsuits against medical supply giant CooperSurgical, alleging that fluid the company sent to in vitro fertilization clinics destroyed their embryos.
The fluid, called culture media, is filled with nutrients that allow embryos to develop enough to ultimately be implanted into a uterus. CooperSurgical acknowledged that the batch of fluid may have stunted embryo growth in a product recall notice, but it hasn’t disclosed exactly what went wrong. Lawsuits claim the media lacked magnesium, a key nutrient, while a Cooper representative told STAT the cause is still under investigation.
The recall could be a one-off manufacturing fluke. But the debacle, and the uncertainty around the problems with the fluid, sheds light on a larger problem: IVF doctors rarely know the exact composition of culture media in the first place. The Food and Drug Administration asks manufacturers for a list of materials before the media goes on the market, an FDA spokesperson told STAT. Companies will sometimes give clinics this information voluntarily, along with required labeling information like mouse embryo data, instructions for use, and warnings. But the FDA doesn’t require companies to list the ingredients or their proportions publicly.
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