FDA Can't Stop Home Birth, So They're Taking Your Birthing Pool Instead

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Look, I'm not exactly the Cheer Squad for the FDA. I know way too many "conflict of interest" employees, and they have a tendency to ban anything they can't regulate, even when it's way safer than the solutions that they've approved instead. Not to mention their lack of regulation on things that they really need to regulate. But I digress.

Now, their newest victim of "I can't regulate it so I'm destroying it instead" is inflatable birthing pools for home births.

Barbara Harper, author of Gentler Birth Choices and founder of Waterbirth International explains that the FDA wants them registered as medical equipment. She says, to prevent sale of birthing pools they've gone as far as to virtually seize an incoming shipment at a dock in Portland, Oregon and may "inspect and destroy" the pools.

Whaaaat?!

Marla Blackmore Althouse, owner and manager of Waterbirth Solutions explains there's a way to get them registered:

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.

So, there's a way to do it if midwives were millionaire corporations. What about kiddie pools? Some women use a kid pool instead of renting/buying the more expensive, much deeper and more comfortable birthing pool. Other women opt to use their own bathtub.

This would be just about as ridiculous as claiming that cotton balls should be registered as medical equipment because doctors, dermatologists use them every single day. Single-use gloves too! How about the roll of paper you sit on in the doctor's office? Is THAT medical equipment? A birthing pool is just a large inflatable tub you fill with water, and sit in. Ooh, so scary. Birthing pools have single-use liners so that none of the fluids touch the pool itself, making it a great option for midwives who then have a new, clean pool for every client, with nothing ever touching the pool itself.

Heck, an increasing number of hospitals even allow birth and labor in their bathtubs, which DON'T have the ability to have single-use liners. The only requirement to use a tub in most hospitals is that at least 2-3 sides of it are open to allow for medical assistance to have access to the mom. So frankly, the inflatable pools are not only cleaner, but are more comfortable (some have inflatable stools and grab handles, and an inflatable bottom even), and ALSO are completely open all the way around. So again, the difference is what? Are hospital bathtubs "registered medical equipment"? Nope.

There may be some hope though. Althouse says, "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."

Marla asks that if you know of midwives using birthing pools prior to 1978, let them know we need them! They're also looking for a high profile attorney "to highlight the ludicrous nature of this attempt at taking away women’s choices for comfort in labour."

Did you use a birthing pool? Do you consider it 'medical equipment'?


Image via Waterbirth International

baby prep, delivery, homebirth, natural parenting, health products

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Melissa Cline

This is ridiculous. Is any water-holding container now a medical device?! They'll get my Birth Pool in a Box from my cold, dead hands.

jmomm... jmomma2009

Home birth scares the crap out of me - There's just way too much that could go wrong, and we live too far away from the hospital for me to even consider it.  That said, I have no opinion on other people doing it - Your body, your birth, your child, your choice.  This seems ridiculous - Are they going to ban bathtubs in homes where there's a pregnant woman?

FebPe... FebPenguins

I consider it medical equipment about as quick as I consider giving birth a MEDICAL condition. What a joke. This is a free country! There are all kinds of drugs and medical procedurces that kill and maime every day. Giving birth is a NATURAL event. God Blessed us women with the bodies to do the job, we should be able to trust ourselves, to do what we were created to do!

Phils... PhilsBabyMama


So silly...I used a birthing tub aka a bathtub!   This is seriously getting ridiculous!


Madel... MadelynMc

It was obviously *such* a good idea to give the FDA more authority. I'm really beginning to wonder how far this kind of stuff will go. It seems like anything that helps people and hurts big interests is eventually going to come under attack. So. Sick. Of it.

Vanessa Birth-mama Silversmith

I used the Aqua Doula while I was in labor with my son. It sickens me that this is happening. Is there no way we can order them, then? Sounds like the tub will be seized before it's delivered, but do they really have the time to search for anything that could be a birthing pool?

Freela Freela

That's absolutely ludicrous.  I spend half of my labour in the shower to relieve my miserable back pain from my posterior baby... should we now consider all showers 'medical devices?'  Just plain silly!

Joanne Hokrein-Woodfin

I've heard that they are only confiscating hers because the plastic used to make them has chemicals in it that are not safe.

nonmember avatar NJ Mom

Why don't they focus on searching and destroying shipments which contain illegal drugs,tainted food, and toys with lead in them? I wouldn't personally birth at home but I believe its a woman's right! Are my breastpads a medical device? LOL

nonmember avatar WTF

If I would have had a "home birth" my baby or I (or both of us) would have probably died. The baby was in distress after over 24hours of labor and I had to have an emergency c-section to get him out. There are hospitals for a reason, and there is no need in modern American society to have a child in your bathtub. If you want to be a weirdo hippy, the hospitals will work with you and possibly let you have your animalistic water birth or whatever non traditional method you'd like. Women who want to control how their baby enters the world will most likely be the ones who insist on breastfeeding until their kid is 12. To me, insisting on a home birth is about the same as amputating your arm at home because it is broken.

Now there is no need for such drastic actions.

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