Another self-sufficient community that denies the medical establishment protocol has long been on the FDA’s radar: the natural birthing community. Recently, the FDA seized a shipment of birthing pools at a dock in Portland, Oregon, calling the pools “unregistered medical equipment.” Here’s a quote from a letter to congressman Sherrod Brown:
The FDA is requiring a 510(k) – PreMarket Authorization – to be turned in for each Inflatable Birth Pool. The problem is that there is no Pre-existing Medical Device – “Predicate” – already approved by the FDA. Hence, we are potentially looking at of years of clinical trials and legal fees that can cost up to a million or more.
While a new classification is being drafted, outlined, and implemented, numerous women around the United States will be without birthing pools, a very valid means of labor pain management utilized by many of the home birth community and some of the birth center and hospital community.
Such is the technique of a totalitarian regime with repressive arms such as the FDA: ban alternative practices (that is, any “alternative” to established protocol) by stretching language and abusing existing laws, and make the potential resolution impossible to achieve due to a lack of resources and/or impractical timelines, and therefore, obstacles become immutable and people will be forced to use standard conventions that benefit the rent-seeking, medical oligarchy. Thanks to Dora P. for the link. Follow me on Twitter @karendecoster.
