FDA Returns Birth Pools, Warns ‘We’ll be back’

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.

Is this birth tub a piece of medical equipment? Photo by BirtherSage

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.

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17 responses to “FDA Returns Birth Pools, Warns ‘We’ll be back’

  1. A medical device… really. Next they will confiscate my ball…??!!! My rice sock??!! I’m more concerned about dangerous drugs, or food!!!
    I think they should culture the lead wires on the fetal monitor and see what they find……. or look at infection control issue of having 2 post partum mommies share one bathroom……

  2. I used to work as a Customs broker which oftwn ment dealing with the FDA. Absolutely without a shadow of a doubt protesting is a bad idea. Realistically, if they want to claim the right to regulate the tubs as a medical device, they can and will. There are many things seemingly out of the scope of the FDA over which they have control. Actually, I’m surprised they let it go to the warehouse (this is a VERY good sign). Truly, I found that the best way to deal with them is to let them be. Just know that I had a similar situation once with them and it just took time to sort out. Eventually they released the shipment after I sent documentation that my product wasn’t covered. All it takes is one misclassification to get into this situation. By working with them to correct it, the shipment will likely be relesed.

  3. Krista, working with them is like feeding some prisoner to the dragon. At some point you have to put on some goofy outfit made of metal and get on a horse.

    What happens next I don’t know. Monty Python only searched for the Holy Grail. They didn’t retrieve it. If it were a trilogy it might happen in “Monty Python and Retrieving the Holy Grail”.

  4. Pingback: Birth Pools Seized by FDA in Portland, OR « End Times News

  5. Regardless of the out come knowledge can be gained. One could file a foia regarding any and all information on this FDA action. This may take some time but eventually playing the long game a company or organisation would be able to make use of it. By using it they could craft a quick how to guide for the next time this happens. I would volunteer my Information Technology know how to put this or any related knowledge online and keep it free and open for the good of the birthing community and businesses or like minded organisations.

    At worst although if the FDA decides to limit the people’s choice nothing is stopping one to order a big inflatable boat or pool and use this!

  6. Not the same but aloongthe absurd lines and good for a laugh! I call it the only “funny epidural story”. I found a single dose epidural kit for $15 on eBay! Having taught Lamaze childbirth education and a childbirth teacher trainer I figured, what the heck? and ordered it.

    It didn’t come and it didn’t come and then I noticed that my money had been returned. So I called them and asked where my epidural tray was. The person told me at first that they do not ship to Hawaii. Debunking that with the company receptionist I pushed further. He wanted to know who I was and why I wanted an epidural tray. So I told him that I am a childbirth teacher (sent him to check out my presence on cb websites) and wanted to see it for myself and maybe show it to someone else some time. Once he saw who I was on several reliable websites he agreed to send it to me. He qualified that with the fact that they were just trying to be responsible and not let it fall into the WRONG HANDS as their client were mainly doctors. I laughed out loud and told him they sell it and put it into the

  7. …………………………WRONG HANDS everyday when they sell them to doctors! He was clueless about what I meant but I am sure you readers are very clear!
    Aloha from Janis,

    2012-Oct–Global Symposium on Birth with Michel Odent. Don’t miss it!

  8. What is really going on here? Who reported Barbara’s pools and only her pools as hazardous to the FDA and why? Seems to me that only her pools are being affected. Why? Why isn’t anyone asking who reported her and why? Somebody felt there was a problem and that should be researched, as well.

    Also, these pools are made of vinyl. This is one reason I did not want to give birth in a birthing pool. So, perhaps the FDA is just concerned with toxic vinyl leaching into the pores of the mother and baby during labor? If they did nothing, and it was later found to be a health problem, everyone would be up in arms.

    So, the bigger question to be asking is what is really going on? The FDA gets damned when they do nothing and damned when they do too much but no one will know what is really going on until you get to the bottom of this. It may not be a conspiracy against homebirth at all. Maybe it is just not healthy to give birth in a vinyl pool?

    And why are no other brands affected?

  9. Liberty Matters

    Next they will want an FDA sticker on your CAR WINDSHIELD (WITH AN EXPIRATION DATE FOR RE-REGISTRATION) before you can race to the hospital (because you are not an ambulance) or because after the water breaks you might have to give birth in the car- and you are not a doctor!

    Heaven help you if you borrow a friend’s car who does not have an FDA sticker in either case.

    Just sell these as kiddie pools. We used to have them in the yard as kids. Not much different. In fact, these above ground pools could sell attachments to section out part of it for birthing- and you could easily remove that section and put it in your living room if you want… somebody get on this…

  10. I gave birth in a children’s pool, complete with fish pictures on the sides. Is the FDA going to confiscate all children’s pools so that women can not use them for childbirth?

  11. What happened at the hearing on June 7th?

  12. Oh, but sure leave Cytotec in every Labor and Delivery med room. *eye roll*

  13. Oh Please!!! How ridiculous! I think removing pesticides from our food is much more important.

    • WOW, amazing viodes I just have a few comments/questions. I’m a mother of three (13, 9, 5). All my kids were born in hospitals. No medications or epidural with any of them. First was a 24 hours labor. Second, was induced b/c I was 14 days late. My question here, would be, do you think it is a MUST to induce or would you recommend the mother to go into labor on her own .no matter how long it takes?? Or does it really get dangerous for the baby to stay in for too long? My third one was really fast, we hardly made it to the hospital, he was born at the ER, b/c they had no time to take us upstairs. I do like the idea of home birth and did think about it, but I just got nervous for the baby .Just kept thinking, what if something goes wrong? What if the cord is around the neck and he/she needs oxygen right after coming into this word? Which actually happened with my second child. He was 9lb 3oz, big baby, 14 days old, yet he had a hard time breathing on his own! In cases like that, can’t a home birth put the child’s life into danger? One of this viodes show, when the baby seems so lifeless and the mother is so calm and keeps breathing air into the baby! Took her a few tries before the baby took his/her first one on it’s own!! I would just freak out!!!!!And I agree! The video with the Elephant is just amazing!!! Nature just does it job so well .thanks for posting all of this! Good luck in your birth, hopefully coming soon!!!

  14. Pingback: Birth Pools Seized by FDA in Portland, OR | S-P-E-C-T-R-U-M

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