According to Barbara Harper, author of Gentle Birth Choices and founder of Waterbirth International, the FDA has seized a shipping container of AquaBorn birthing pools at a dock in Portland, Oregon, and have ordered agents to “inspect and destroy.”
“They claim they are unregistered medical equipment, but they are not providing a way or means to get them registered. In other words, if the medical authorities can’t stop waterbirth, then just have the FDA take away the birth pools,” she explains in a lengthy discussion that began yesterday.
While birth pools are imported to Canada under the category “paddling pools” and some are imported here in the U.S. under the category “sitz baths,” they have no legal standing as medical equipment at this time.
But why would they? They are often purchased or rented for personal use in private homes. Barbara’s conversation with an FDA official may shed some light on this as a clash of perspectives. She explains that she was told, “Pregnancy is an illness and birth is a medical event. Therefore, a pool that a woman gives birth in should be classified as medical equipment.” So what about our toilets, our bathtubs, our showers? Kiddie pools, horse troughs, hot tubs? Oh, and what about the fact that pregnancy is *not* an illness?
What the FDA Wants
Martha Blackmore Althouse, owner and manager of Waterbirth Solutions in Beaverton, Oregon, has been interacting with attorneys and the FDA on the issue. She explains:
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, potential of years of clinical trials and legal fees that can cost up to a million or more. Obviously not feasible.
One potential loop hole is a “PreAmendment Status” product. If there was anyone in the US using birth pools (yes, troughs, tubs of any kind) prior to May 1978, we can get “Birth Pools” grandfathered in to the FDA as an approved Medical Device. Waterbirth would have permanent legitimacy and could not be questioned any further.
So it seems that there could be a solution to this, but not before enduring a long process full of red tape and bureaucracy.
FDA Returns Birth Pools, Warns ‘We’ll be back’
Two of the four major U.S. distributors of birth tubs have recently received warning letters from the FDA, thus halting their sales and shipments. A shipping container of birth tubs was temporarily held at U.S. Customs in Portland, OR earlier this week, and underwent FDA inspection before being released to the distributors.
But Barbara says the FDA made it clear that even though the distributors were allowed to take their shipments to their own warehouses, the FDA is still in control of the property. She says their attitude was, ‘We own it. You can’t sell it, you can’t ship it.’ They came in, inspected and counted the birth tubs, and left with a ‘We’ll be back.’
An Attack on Birth Choices?
The public response to this story seems to have been either along the lines of ‘This is one more battle in the government’s war on water birth and birth choices in general,’ or ‘The FDA is just doing their jobs trying to protect birthing women from harm.’ Perhaps the reality is somewhere in the middle.
“If there is an effort to take away water birth,” Barbara explains, “We have to enlist the hospital midwives and obstetricians. It’s not just about home birth,” since many hospitals are allowing water births these days, with some even using portable, inflatable birthing tubs such as the ones seized in this FDA fiasco.










