The seized birthing tubs have now theoretically been returned to their owners, but this fight is far from over. Barbara Harper, author of Gentle Birth Choices and founder of Waterbirth International, outlined the situation to me this morning.
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.
If this situation truly turns out to be about eliminating water birth as a choice for pregnant women, Barbara adds, “How long do you think it’s going to be before they put yellow caution tape on every hospital bathtub?”
Aside from the right to choose how, where, and with what equipment one gives birth, this stall in the supply of birth tubs will likely have economic effects for midwives and small businesses, such as distributers & suppliers of water birth supplies, plus midwives, doulas and other birthworkers who provide birth tub rentals.
Making Birth Tubs ‘Legal’
There seem to be three potential paths out of this quagmire:
- Apply for Approval - One of the importing distributors could apply for FDA approval, which would involve somewhere between 1-10 years and $1-$10 million dollars. We’re talking about clinical trials, product testing, safety inspections–and all the while, these distributors would be unable to sell their birth tubs. While FDA approval of birthing pools could be a gigantic step forward for the home birth and water birth movements, there’s always the possibility of being denied.
- Alternative Application Process – In the Alternative Application Process, the distributors could argue the truth–that birth pools are not medical devices, end of story. Barbara pointed out that the operating tables found in hospitals are not treated as medical equipment by the FDA, and they serve a similar function to that of birth tubs.
- Grandfathering In – If the distributors can prove to the FDA that birthing pools were in use and being sold across state lines in the U.S. prior to 1976, then the ‘medical devices’ will be automatically granted approval. The search is on for an elder midwife to speak up about their experiences in the early years of U.S. water birth.
- Apply for Approval as ‘Sitz Baths’ - The one distributor who’s been previously granted FDA approval for importing birth pools did so under the category of ‘sitz baths,’ since there was no designation, category or clearance number for birth pools. While it’s theoretically possible that the same process could be repeated for these distributors, it doesn’t seem likely. If the FDA was interested in a simple, logical solution to this issue, you probably wouldn’t be reading this post right now.
What to Expect in the Months Ahead
An FDA hearing is set for June 7 to make a ruling in the case, and the future of birth tubs will be much clearer on that day, once we hear what the FDA has to say. The way Barbara Harper sees it, in a best-case scenario, the FDA would relinquish control over the current stock of birth tubs and allow the distributors to go on about their business, as it has been for decades. In a worst-case scenario, they could issue a standard FDA recall of all unregistered birth tubs purchased since 2006.
In the case of a recall, owners of personal birthing pools, other than the one single FDA-approved model, would be expected to ship their pools to the FDA to be destroyed. These are not items with any known risks, side effects, flaws or dangers, mind you–they’re perfectly good birthing pools that would be destroyed simply as retribution for existing outside of the FDA’s scope.
“No home-birthing mom is going to send their pool back, period,” Barbara quips. She states that she’s already heard from families who were considering selling or giving away their birth tubs, but who have now decided to hold onto them due to the insecurity around this FDA situation. In the worst-case scenario Barbara described, birth tubs could become a hot commodity. Imagine that…an underground black market for birth pools.
Taking Action in the Name of Water Birth
The passionate response to this story has been overwhelming for the people involved, as water birth advocates across the country have spoken up in outrage at the FDA’s actions. Many folks have commented on this blog and elsewhere about staging a protest in Portland, perhaps at the dock or Customs or the FDA. But Barbara Harper has a different hope.
“Anything we do that causes a confrontation will make us feel good, but could negatively affect” the June 7 ruling, she explains. ”Instead of holding signs up and protesting in Portland, I want people to get on their phones, to call their Senators, call their hospitals and say, ‘Do you offer water birth?’ And if not, ask them why.”
Nicole at Bellies & Babies has posted a fantastic sample letter to your representatives, along with some broader ideas on a proactive response to this FDA situation. In the meantime, we’ll see what June 7th has in store for the future of water birth as we know it.