FDA to take away birthing pools

Katherine - posted on 05/31/2011 ( 18 moms have responded )

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A wave of controversy swept through Facebook like a bad virus. Many members of the natural birthing community could hardly believe their eyes as they read birthing pools were being called medical devices by the FDA. Many jokes ensued like you better be careful or the FDA will come and take away your kids paddling pool, your toilet or your birthing ball. One may think...this must be a joke because birth isn't a medical event, but according to the FDA it is (by their definition anyway).

Birth isn't seen as a natural body function of bringing life into the world, but as a disease and is being treated as such.

The FDA has seized a shipment of birthing pools to inspect and destroy at a dock in Portland Oregon, according to Barbara Harper, author of Gentle Birth Choices and founder of Waterbirth International.

Barbara Harper explains on a note on Facebook “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,”

According to Martha Blackmore Althouse of Water Birth Solutions who has been interacting with the FDA on this: 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.

This entire situation is ridiculous and insulting to the home and water birth community, that is gaining momentum and growing faster than ever (since birthing in hospitals became mainstream). Are the FDA and US government worried about losing profits because women will not birth in their hospitals?

http://www.thebirthingsite.com/birthing-...




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Do they seriously have nothing better to do? They won't even get them registered and are providing quite the loophole on banning it.

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Mary - posted on 06/01/2011

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Okay, I did a little research on this...and, yet again, I think there is a whole bunch of indignant outrage where there most likely doesn't need to be. I think some people have made some sensationalized claims about the FDA and medical community that really have no foundation, and whose only goal is to deceive a bunch of susceptible women into supporting their anti-establishment cause.



This is the specific pool they are referring to:



http://aqua-eez.com/aquaeez4.pdf



And this is the event that prompted FDA involvement:



http://www.accessdata.fda.gov/scripts/cd...



From what I can gather, there has not been any nationwide ban on all birthing tubs or pools. Seriously, don't you think that if this had happened, it might have made the news when all the hospitals and birthing centers across this country had to cease using them? I'm pretty sure we'd be seeing Matt Lauer interviewing some indignant midwives and birth advocates, and most likely Rikki Lake as well, if this was in any way accurate.

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Jocelyn - posted on 06/01/2011

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Even IF they wanted a straight out ban on birthing pools, there are ways around it. I gave birth to my daughter in a blow up pool I bought at Canadian Tire for $20 :P There are sharks on the side of the pool...it's pretty bad ass.

Mary - posted on 06/01/2011

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TBH, I was probably most suspicious because I have a number of friends who are midwives, and I was pretty sure that, if all birthing tubs were being banned, there would have been a whole lot of outcry from them, as well as tons of petitions clogging up my email! The lack of any noise about this issue within my own personal circle of OB friends made me a think that this wasn't completely accurate.

Katherine - posted on 06/01/2011

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It's really sad that they do this and make people think certain things.

Dana - posted on 06/01/2011

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LOL Mary, you beat me to it. Of course there's always more to these outrageous claims. It's amazing how people just jump on these bandwagons without looking further into it.

Tara - posted on 06/01/2011

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thanks Mary for clearing that up. I didn't think they had actually banned the use of pools or the practise of water birthing.
Our birth pool was a birth pool but looked like a deep kiddy pool. And if anyone really has a problem with not having that particular pool, they can simply order one online or buy a kiddy pool.
The FDA needs to stop interfering in these kinds of things and maybe concentrate on why some meds that have been shown to reduce the size of cancerous tumours are not being approved. Why there are re-calls everyday of medications and foods that enter our society and market.
They have way too many other more important issues to deal with, this just seems like they are being overly cautious about this particular pool.

Katherine - posted on 06/01/2011

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It may not be that bad. They may be able to get them grandfathered in. LOL. Grandfathered in. A birthing pool. God, use a freakin swimming pool.

Becky - posted on 05/31/2011

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Do they really think this is going to stop women from having waterbirths? Pretty sure you can have a water birth in anything you can fit it that can hold water!

Amber - posted on 05/31/2011

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Hmm..I wonder if hospitals are going to be forced to hand their birthing tubs over? Our hospital just spent millions of dollars renovating to add natural water birthing suites. I was really excited because I want a water birth for our next one. (Chad is freaking out after working in an OB for years and doesn't know how to take it haha!). If they confiscate them I'm going to be cursing and protesting.

Chad already vetoed the home birth idea. He's paranoid from our complications the first time....this was my compromise.

Jessica - posted on 05/31/2011

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Ill be using a birthing tub in september for my 2nd little one. So glad I'm in Canada, lol.

Lady Heather - posted on 05/31/2011

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Perhaps it will be any device both large enough to contain an adult human and capable of holding water.

Kate CP - posted on 05/31/2011

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I wonder if the FDA plans on banning all bathtubs...cause I know plenty of moms who birth in bathtubs.

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Buy one at the store. Give birth in a tub. Drive your butt across the state and buy one out of state and drive it back home. Whatever works for you. Personally I like having natural birth in a hospital where I know I am taken care of if something goes wrong.

Lady Heather - posted on 05/31/2011

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What in the hell? We have a birthing tub at the hospital here (in the midwife's room! Maybe I can use it this time!), but dude - with the amount of totally shitty stuff the FDA approves out there, they have a problem with birthing pools? Couldn't possibly be any sort of bias there.

Kimberly - posted on 05/31/2011

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Will someone please tell me why I moved back to the US before I was finished having children??

Laressa - posted on 05/31/2011

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I think its funny.Here in Canada its starting to become an option to birth in a pool at the hospital. That is their way of competing. They were on order but not yet arrived apparently at the time we went to prenatal class

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