FDA seizing birth pools (GOOD NEWS UPDATE in post #29)

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MrsMangoBabe's picture
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FDA seizing birth pools (GOOD NEWS UPDATE in post #29)

http://www.facebook.com/permalink.php?story_fbid=10150637887300711&id=756570710#!/notes/barbara-harper/fda-seizes-portabale-birth-pools/10150257850942082

I originally had a different link about this, but it won't work because the preg.org software keeps editing the link (because the blog has the c word in the title) One of the midwives I am probably hiring (the one I haven't met in person yet, but will be meeting tomorrow) was getting involved with this on facebook (she is the one who commented who's profile pic is a green birth pool with the words "come and take it!"). The FDA is *trying* to remove the option of waterbirth by claiming that birth pools are "unregistered medical equipment."

kridda_88's picture
Joined: 01/28/08
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I doubt that will work. But that's BS! The midwife that works with my midwife uses a horse trough for a birthing tub. She pads it with blankets and then puts a liner in. Midwifes will just find some other thing to use if they do that. I'm beginning to really hate the FDA. They are great when they are actually helping but when it comes to something they don't get money out of then they have to say it's dangerous and bad.

MrsMangoBabe's picture
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More information: http://www.facebook.com/Hypnobabies?ref=ts#!/notes/barbara-harper/more-information-on-the-fda-situation/10150258460847082

Obviously, waterbirth can still happen in kiddie pools, bath tubs, hot tubs, etc if there are no official "birth tubs" available, but I hope they won't even be able to go that far! Right now it looks like the only option is to "prove" that births occurred in water prior to 1978, so that birth pools can be "grandfathered in." People are talking about forming a facebook group about it. I will post any new information here as it comes up.

kridda_88's picture
Joined: 01/28/08
Posts: 1798

This really is such BS. No matter what I'm still having my birth in water if that is what I want. I'll do it in my bath tub. They really are idiots. Sorry, I'm a little overly irritated at things right now due to the pregnancy. lol. But seriously they are idiots.

kridda_88's picture
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Oh and Thanks for the updates Brittany! I'll be checking in to see how things are going.

daria's picture
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That is some crazy stuff. They really don't have anything better to do?

heatherliz2002's picture
Joined: 02/02/08
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Wow, that is completely ridiculous. But considering that it's the FDA, I can't really say that I'm surprised.

mandi04's picture
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I really, really hope this doesn't mean bad things for the birthing pool at my hospital. They just installed it the month after I had DS and I will be pissed if something as silly as this takes that option away from me this time. I've wanted a water birth since DD1 and now is the first time I have a real opportunity to actually do it.

shiregirl's picture
Joined: 09/23/10
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"daria" wrote:

That is some crazy stuff. They really don't have anything better to do?

Well, they HAVE been doing really important things like chasing down those crazy Amish criminals who sell raw milk, but when they found out about the criminal water birth element with their birth pools, they realized they couldn't wait!

mandi04's picture
Joined: 08/10/03
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Right, like they couldn't be going after all the artificial dyes in our food that many countries have already banned because they are proven to have harmful effects...whereas water has likely been used for birth since the beginning of time. Don't forget all the junk in our disposable diapers that other countries have also banned...priorities

emommyof2's picture
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"shiregirl" wrote:

Well, they HAVE been doing really important things like chasing down those crazy Amish criminals who sell raw milk, but when they found out about the criminal water birth element with their birth pools, they realized they couldn't wait!

OMG... LOL! You crack me up!

Jen

MrsMangoBabe's picture
Joined: 04/09/07
Posts: 2276

"mandi04" wrote:

I really, really hope this doesn't mean bad things for the birthing pool at my hospital. They just installed it the month after I had DS and I will be pissed if something as silly as this takes that option away from me this time. I've wanted a water birth since DD1 and now is the first time I have a real opportunity to actually do it.

I *think* it only applies to imported portable birth pools the kind that are used almost exclusively for homebirths--that is all they have seized at this point, as I understand.

MrsMangoBabe's picture
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Chimmy's picture
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It is complete & utter BS - I've been following this on FB as well & among the birthing community in which I live. The FDA is not out to protect consumers, they are all about the mighty dollar - they are beyond corrupt & I find their actions as of late (with this & other misc things like raw milk/small family farms/urban homesteaders) incredibly frustrating. Shame on them.

tanismom's picture
Joined: 11/07/06
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"shiregirl" wrote:

Well, they HAVE been doing really important things like chasing down those crazy Amish criminals who sell raw milk, but when they found out about the criminal water birth element with their birth pools, they realized they couldn't wait!

literally ROFL!!! great answer!! this should be reworded for a t-shirt... love it!

elizamommy's picture
Joined: 04/07/10
Posts: 84

"MrsMangoBabe" wrote:

http://www.facebook.com/permalink.php?story_fbid=10150637887300711&id=756570710#!/notes/barbara-harper/fda-seizes-portabale-birth-pools/10150257850942082

I originally had a different link about this, but it won't work because the preg.org software keeps editing the link (because the blog has the c word in the title) One of the midwives I am probably hiring (the one I haven't met in person yet, but will be meeting tomorrow) was getting involved with this on facebook (she is the one who commented who's profile pic is a green birth pool with the words "come and take it!"). The FDA is *trying* to remove the option of waterbirth by claiming that birth pools are "unregistered medical equipment."

I have been following this and I have wondered why everyone keeps thinking this applies to all birthing pools. Everything I have read makes it sounds like it is only Barbara Harper's pools that are affected. Her pools were the result of a complaint filed at the FDA called a MAUDE report. If you go to the FDA's website and search birth pool, you can find it.

So, why does everyone, and I mean all over Facebook and talk forums and chats and blogs, everyone - why do they all think it applies to all birth pools when there are still birth pools for sale? The way I read this is it only applies to her pools and her pools alone. We don't know why someone filed the complaint but I have seen no evidence that this applies to all pools. Am I missing something? Does anyone have actual proof that this applies to other pools?

From what I can tell, the FDA got a complaint about THESE pools and as the agency in charge of our health they seized the pools and checked them and have released them back to Ms Harper but they don't want her to sell them yet. Since they are made of vinyl, I am wondering if it is possibly unsafe to birth in a vinyl pool? Maybe that is the issue?

Anyway, I am just wondering if there is any further information along the lines of my questions. Thanks!

Also, I posted another question here:

http://www.pregnancy.org/bulletinboards/showthread.php?p=8565394&posted=1#post8565394

elizamommy's picture
Joined: 04/07/10
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"Chimmy" wrote:

It is complete & utter BS - I've been following this on FB as well & among the birthing community in which I live. The FDA is not out to protect consumers, they are all about the mighty dollar - they are beyond corrupt & I find their actions as of late (with this & other misc things like raw milk/small family farms/urban homesteaders) incredibly frustrating. Shame on them.

How do you know this is about money?

MrsMangoBabe's picture
Joined: 04/09/07
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"elizamommy" wrote:

I have been following this and I have wondered why everyone keeps thinking this applies to all birthing pools. Everything I have read makes it sounds like it is only Barbara Harper's pools that are affected. Her pools were the result of a complaint filed at the FDA called a MAUDE report. If you go to the FDA's website and search birth pool, you can find it.

So, why does everyone, and I mean all over Facebook and talk forums and chats and blogs, everyone - why do they all think it applies to all birth pools when there are still birth pools for sale? The way I read this is it only applies to her pools and her pools alone. We don't know why someone filed the complaint but I have seen no evidence that this applies to all pools. Am I missing something? Does anyone have actual proof that this applies to other pools?

From what I can tell, the FDA got a complaint about THESE pools and as the agency in charge of our health they seized the pools and checked them and have released them back to Ms Harper but they don't want her to sell them yet. Since they are made of vinyl, I am wondering if it is possibly unsafe to birth in a vinyl pool? Maybe that is the issue?

Anyway, I am just wondering if there is any further information along the lines of my questions. Thanks!

Also, I posted another question here:

http://www.pregnancy.org/bulletinboards/showthread.php?p=8565394&posted=1#post8565394

The original link I tried to post said that the pools, siezed at a dock in Portland, OR, were AquaBorn pools. AquaBorn (http://www.aquaborn.co.uk/) is a UK company. The complaint on the FDA website (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=526511) is from 2004, and refers to a permanent birth tub (I believe it is the first one shown here: http://www.waterbirthsolutions.com/Permanent_Pools.php). The complaint claims that the tub should be classified as a "powered bath" and it is not FDA approved under that authorization. It is my understanding that the issue here is only with importing portable birth pools. Apparently permanent tubs can have an FDA approval--there is a category for them, but there is no category for portable birth pools, most of which are manufactured overseas and imported. The portable tubs have previously been imported under the category "sitz baths" because there was no FDA category for inflatable birth pools, but I guess the FDA is saying they can't do that anymore, but they aren't providing a way to get a category for inflatable birth pools as a medical device, since FDA approval is required BEFORE sale of medical devices begins.

elizamommy's picture
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"MrsMangoBabe" wrote:

The original link I tried to post said that the pools, siezed at a dock in Portland, OR, were AquaBorn pools. AquaBorn (http://www.aquaborn.co.uk/) is a UK company. The complaint on the FDA website (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=526511) is from 2004, and refers to a permanent birth tub (I believe it is the first one shown here: http://www.waterbirthsolutions.com/Permanent_Pools.php). The complaint claims that the tub should be classified as a "powered bath" and it is not FDA approved under that authorization. It is my understanding that the issue here is only with importing portable birth pools. Apparently permanent tubs can have an FDA approval--there is a category for them, but there is no category for portable birth pools, most of which are manufactured overseas and imported. The portable tubs have previously been imported under the category "sitz baths" because there was no FDA category for inflatable birth pools, but I guess the FDA is saying they can't do that anymore, but they aren't providing a way to get a category for inflatable birth pools as a medical device, since FDA approval is required BEFORE sale of medical devices begins.

Oh, okay, thanks for the clarification.

So, what is the issue with the inflatable pools? This makes it more of a mystery.

MrsMangoBabe's picture
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I guess hospitals can use a tub as a "medical device"--they use them for other purposes besides birth--hydrotherapy used in rehab comes to mind. So permanent tubs can be approved under another category. But inflatable birth tubs are only used for births, and I guess the FDA hasn't technically approved "birth tubs" as a category for medical devises (and there is no need to if birth is not a medical event, but the FDA is claiming that it is). I really think it is really a "failure to comply with regulations" issue, and not a SAFETY issue. This is just my understanding, though.

Chimmy's picture
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"elizamommy" wrote:

How do you know this is about money?

Because it is. I think I explained why I feel this way in my original reply as well. Although if I wasn't clear my comment was about the FDA as a whole - not just in regards to this situation. Can I link you to proof? No, not at this moment (am at work & my internet access is limited) but I've been following other issues like the organic food industry, raw milk groups & small farms (esp. in my area) & can see for myself what they stand for & it's anything but consumer saftey & honesty - they're more concerned about protecting their profits than anything. Really, all one has to do is look at some of the things they do & don't approve. Birth is a big thing & with more & more women going the natural, birth center & home birth route this is an excellent way to step in.

Joined: 01/18/06
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I completely agree Julia. It's infuriating.

elizamommy's picture
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"Chimmy" wrote:

Because it is. I think I explained why I feel this way in my original reply as well. Although if I wasn't clear my comment was about the FDA as a whole - not just in regards to this situation. Can I link you to proof? No, not at this moment (am at work & my internet access is limited) but I've been following other issues like the organic food industry, raw milk groups & small farms (esp. in my area) & can see for myself what they stand for & it's anything but consumer saftey & honesty - they're more concerned about protecting their profits than anything. Really, all one has to do is look at some of the things they do & don't approve. Birth is a big thing & with more & more women going the natural, birth center & home birth route this is an excellent way to step in.

I am 100% supportive of the feds regulating raw milk. That kills people! They should regulate it so it is safe!

And I don't think this is all about profits. I don't get that at all. I guess that is why I am not all upset about this, because I don't think this is about the feds going after profits, etc.

But oh well, to each her own.

Homebirth and midwifery are increasingly popular in my area and birthing tub availability is not going to change that, imo.

Anyway, I guess that is why I don't get the fury over this issue. Birth tubs seem kinda icky to me in the first place so I can totally see that they are not able to clean thoroughly thus the feds might be interested in their safety.

Anyway, thanks for helping me understand the issue. I appreciate it.

Chimmy, don't argue back with me. I am done. Thanks for your two cents. Dirol

Joined: 01/18/06
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Use a birth tub, or don't. That's your prerogative.

But to seize them IS outlandish.

There are FAR grosser, ickier things in a hospital that can and do cause infection on a much more regular basis than a portable birth tub used for homebirth. And I'm not saying that cause I have something against anyone birthing in a hospital. I'm saying that because it's a fact.

There are already so few choices and support for those wanting natural birth. To take this away is absolutely a huge dig. Thank FSM I live in Canada and was able to use those tubs for my births. They made all the difference in my labours and deliveries.

Chimmy's picture
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"JorgieGirl" wrote:

Use a birth tub, or don't. That's your prerogative.

But to seize them IS outlandish.

There are FAR grosser, ickier things in a hospital that can and do cause infection on a much more regular basis than a portable birth tub used for homebirth. And I'm not saying that cause I have something against anyone birthing in a hospital. I'm saying that because it's a fact.

There are already so few choices and support for those wanting natural birth. To take this away is absolutely a huge dig. Thank FSM I live in Canada and was able to use those tubs for my births. They made all the difference in my labours and deliveries.

Exactly :thumbsup: Nevermind the fact that the FDA are concentrating more on the idea that a portable birth pool doesn't currently have a "category" to be "approved" under - cleanliness hasn't been such a big issue & really I don't see how they could even win that argument considering hospital & birth center tubs aren't sterile either. If they were truly trying to help one would think that they would also be just as quick to provide a way to categorize them. But their not.

And I'm sorry but the FDA have approved MANY things that have killed people - so that argument has no standing.

MrsMangoBabe's picture
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Honestly, I still feel like I don't quite have all of the facts yet, but I did some more searching and found this, which I think helps explain what is going on a little better:

http://www.facebook.com/notes/birth-freedom-for-oregon/more-about-birth-pools-and-the-fda/219520781400517

Especially this part, from the end:

1) The FDA has not 'seized' any birth pools. They do not have birth pools in their possession.

2) Two new shipments of birth pools that have arrived in the United States have been placed on FDA "Detention". This means that the product can not be dispersed (sold). If a company is out of stock, it will be noted on their website - please do not call.

3) The FDA has decided that Birth Pools are Medical Devices. As Medical Devices, the FDA will require companies selling Birth Pools in the United States to first meet specific guidelines and to prove that waterbirth does no harm. This will be done with scientific data.

4) New inventory of birth pools will not be allowed into the United States until this matter is resolved.

5) Each company involved is doing everything they can to work with the FDA to resolve this situation

So, I stand corrected on the use of the word "siezing," but they are preventing the sale of two recent shipments of birth pools and preventing more stock from being imported.

Mom2ThreeKiddos's picture
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"MrsMangoBabe" wrote:

Honestly, I still feel like I don't quite have all of the facts yet, but I did some more searching and found this, which I think helps explain what is going on a little better:

http://www.facebook.com/notes/birth-freedom-for-oregon/more-about-birth-pools-and-the-fda/219520781400517

Especially this part, from the end:

So, I stand corrected on the use of the word "siezing," but they are preventing the sale of two recent shipments of birth pools and preventing more stock from being imported.

Talk about big brother stepping in. I doubt this is resolved quickly.

MrsMangoBabe's picture
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NEW UPDATE! The pools have been released! The FDA apparently has agreed, for now, that birth pools do not need to be classified as medical devices!

http://www.facebook.com/notes/barbara-harper/fda-releases-tubs-but-needs-further-assistance-with-education/10150270554527082

Mom2ThreeKiddos's picture
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That is great news!

Chimmy's picture
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I'm very happy to read this :thumbsup:

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Awesome. Glad to hear.