Birth Pools Seized by FDA in Portland, OR

According to Barbara Harper, author of Gentle Birth Choices and founder of Waterbirth International, the FDA has seized a shipping container of AquaBorn birthing pools at a dock in Portland, Oregon, and have ordered agents to “inspect and destroy.”

“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,” she explains in a lengthy discussion that began yesterday.

While birth pools are imported to Canada under the category “paddling pools” and some are imported here in the U.S. under the category “sitz baths,” they have no legal standing as medical equipment at this time.

Is this birth tub a piece of medical equipment?

But why would they?  They are often purchased or rented for personal use in private homes.  Barbara’s conversation with an FDA official may shed some light on this as a clash of perspectives.  She explains that she was told, “Pregnancy is an illness and birth is a medical event. Therefore, a pool that a woman gives birth in should be classified as medical equipment.”   So what about our toilets, our bathtubs, our showers?  Kiddie pools, horse troughs, hot tubs?  Oh, and what about the fact that pregnancy is *not* an illness?

What the FDA Wants

Martha Blackmore Althouse, owner and manager of Waterbirth Solutions in Beaverton, Oregon, has been interacting with attorneys and the FDA on the issue.  She explains:

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.
So it seems that there could be a solution to this, but not before enduring a long process full of red tape and bureaucracy.

How to Help

Martha and Barbara need help – specifically, a high profile attorney and support from any midwives who were practicing waterbirth before 1978.

“If you know of anyone practicing waterbirth prior to 1978, please let them know we could use their help,” Martha pleads.  That would be the only way to establish birth pools as eligible to be grandfathered in.  Also, “We need a high profile attorney to highlight the ludicrous nature of this attempt at taking away women’s choices for comfort in labour,” explains Barbara.

This whole thing seems pretty baffling, and I still find myself wondering if it could possibly be real.  But evidently, according to several trusted names in the birth world, it is.  So let’s get on it–Facebook, Twitter, and your whole Rolodex full of powerful connections.  Hit ‘em up.

________________________________________________________

UPDATE from Barbara Harper 05/26/11 12:33pm MT

“I have spent the past five hours on phone calls in the US and internationally.  Yes, the FDA is in virtual control over the current stock of birth pools in the US.  This is an undeniable truth.  Marla Althouse of Waterbirth Solutions has been consulting with an FDA expert attorney on the case ever since she received her first notice of non-compliance. There is a current deadline of June 7 for a ruling in the case.  At tht point, the choices may be to recall all birth pool stock and re-export or destroy. Because of the Facebook notice, she has been put in touch with experts in Customs, FDA compliance and import rules and regulations.  Thank you all for your amazing support and your justifiable outrage that our birth choices can be regulated and controlled by a government agency.”

________________________________________________________

UPDATE 05/27/11 FDA Returns Birth Pools, Warns ‘We’ll Be Back’

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46 responses to “Birth Pools Seized by FDA in Portland, OR

  1. As a Mama and natural birth advocate who is local to Portland, I am wondering if we should arrange a protest at the holding site or local FDA office… I mean this is just ridiculous!

    • Excellent idea!!!

    • I labored in a tub at a birth center in spokane washington where i live. i had planned birthing in it too. i couldnt find a good position and ended up on the bed to push baby out. but i would have been a lot worse in labor without the tub! how dare they try to steal this away from us! if we can have an abortion why can’t we birth the way we want? away from cruel doctors and nurses and in a safe warm and familair environment? If i owned a home instead of living in an apartment i would have birthed in my home! i would have rented a birthing pool! how dare they say our birthing is a medical event! It is Not an Illness! its a miracle beautiful and natural! only when something goes wrong should we go to the hospital! at home you have the freedom to decide for yourelf about your own body. you are having the baby not the hospital! i think that this is a way to get more money in their greedy hands and take away more womens rights! women take back your healthcare right! take back a woman’s right to be respected during our childbearing years! remember what our female ancestors did for us so that we could vote and own our own property? that we are no longer the property of our husbands? if a woman can keep her last name and the man takes her last name in marraige then we should have the right to rent buy a pool and give birth to it in our own homes! bring on a new revolution i will be there to protest!

    • Ready and willing to protest with my waterbirthed 15 month old in tow! People are insane and have nothing better to do than meddle in the affairs of others! Pregnancy is an illness?! Ha! I walked two miles to and from work every day until my 7th month. I worked with 15 1 1/2 year olds and kept pace with them jumping and singing all the while. I scaled a ten foot lattice when I was in my 8th month to break into my house when I was locked out. I never got sick, never saw a doctor, and had an easy, quick birth IN THE WATER! These people are just sick!

  2. That’s an awesome idea Daizee! I’m a local home birthing momma. I know I could rally some troops.

  3. This is so insane. I gave birth to both of my children at home using birthing pools. The first one I rented from a local company here in Portland. It would be vary sad indeed to have that option taken away.

  4. Tina Rahkonen

    This is crazy! I gave birth to my second child at home in a non birth-specific tub but have on order a rental from a company in California due to arrive in June. This is completely asinine and WRONG! Pregnancy is NOT an illness and birthing is NOT a medical event. If I am vomiting into a bucket, is the bucket a medical device?

  5. i wish i could fly up to portland and protest with you!! this makes me so mad.

  6. This is utterly mind boggling to me that the FDA even has birth pools on their radar. It’s completely and totally ridiculous! I laboured in my bathtub with my last homebirth so does that now make any bathtub a potential medical device?

    ~Laila

  7. Yeah. Utterly ridiculous. What’s left to say? Mass protest? Trickery?

  8. What happend to the birth pools people already have? Will we get in trouble for using them?

  9. http://www.inamay.com/?page_id=14

    This lady would likely know about prior usage in that time period.

  10. You should include the name of the FDA official that Barbara spoke to with the quote. In that way, once this story blows up, both the agent and the agency will have to publicly defend their definition of pregnancy as an “illness.”

  11. Let there be no mistake about it, this is all part of a bigger plan to shut down homebirth, and make midwives nothing more than medical assistants who do nothing more than prenatal visits. It’s a turf war.

  12. When I was pregnant, I was told that Legacy Emanuel Hospital allows water birth. There should be some way to use that to help prove this is okay.

  13. Pingback: Warning: FDA May Inspect & Destroy Your Bathtub! | The Trial of Labor

  14. As a labor doula and mother of 2 boys born at home in birthing tubs in Portland, this comes as both shocking and not suprizing. I have attended births and one water birth at Legacy Emanuel…you ladies in Portland should protest and demand answers! I no longer live there, but water birth is worth fighting for and in my opinion the best way to bring a baby into the world!

  15. Pingback: Warning: FDA May Inspect and Destroy Your Bathtub! | The Trial of Labor

  16. Pingback: Birth Pools Seized by FDA in Portland, OR | CUNTastic « Homebirth in Austin

  17. Are hospital birthing tubs regulated by the FDA? You would think that those would be subject to a much higher level of scrutiny than inflatable tubs for home use.

  18. contact me if there is a protest organized. i have given birth in a pool and would be there in support!

  19. If there was a Pfizer patent on these pools, and Pfizer was able to sell them for a 1,000% markup, they’d have no problem getting them into the country.

  20. I think before we fly off the deep end and start firing off conspiracy theories about the squelching of home births by the FDA, you should consider that whomever imported these tubs is an idiot who doesn’t understand federal law. If the product imported isn’t labeled for medical use or doesn’t have a claim of a medical purpose the FDA doesn’t have any jurisdiction.

    @Tina, no, if you throw up in a bucket it doesn’t make it a medical device but if you claim the bucket is for catching vomit when you sell it, then it’s a medical device.

    Biggest problem here is that someone said the wrong thing to the import agency, they has to call the FDA, the FDA had no lIsting for the product and has to declare it unapproved medical device. This was then compounded because the woman who wrote this misunderstood the FDA requirements (it’s 1976 not 1978) and comparison to a Pre-amendment product IS a 510k. I hope this was all written before you got the “FDA Expert” involved or you’ve picked a dumb regulatory specialist.

    Let’s all take a breath, remember that the FDA doesn’t regulate medical practice and this all came about because someone wasn’t paying attention to what they were claiming when they brought in the product.

  21. I was very happy to be able to do my births and labors in water would be happy to join a protest should one be formed!

  22. Pingback: Attack the System » Blog Archive » Birth Pools Seized by FDA in Portland, OR

  23. Seems they DO sell to hospitals…so I think someone needs to do a little more research before they blog. http://www.yourwaterbirth.com/hospital-systems-pid-23.html

  24. MomOfFour, this article doesn’t say anything about whether or not anyone sells birth tubs to hospitals…how in the world would that matter? Even if the birth tubs are for use in hospitals, that doesn’t change anything here. Hospitals also use kleenexes and shower curtains and other things that are used in homes. The FDA has never cared about birth tubs before, and it’s not time for them to start now.

  25. My bed is a medical device???

  26. Welcome to the NEW US Government.

  27. There’s gotta be some other sort of pool that women can use if this gets outta hand, right? A kiddie pool? lol

    I really hope that whoever said that pregnancy is an illness was being sarcastic. How could anybody honestly believe that?

  28. Pingback: FDA Returns Birth Pools, Warns ‘We’ll be back’ | CUNTastic

  29. Had waterbirth in England 1994 and 1996- great experiences… Sorry this is happening here. Terrible. Ridiculous with fda…Pls keep me informed. Gina

  30. Pingback: Birth Pools Seized by FDA in Portland, OR (via CUNTastic) « Diary of a struggling domestic goddess

  31. I live in the suburbs just outside of portland and if there is a protest, you can count my husband and myself in! We are planning on birthing our first child at home, in the water. I find myself most at home when floating or swimming now at 6 months pregnant, the same I have for my whole life as a swimmer, lifeguard, water polo player and swim instructor. I can’t imagine being anywhere but in the water for the birth of our son. PS- at least they cant take away my jacuzzi bathtub, even if its harder to get into and smaller than a birthing tub!

  32. have you or ms. harper sent a press release to the AP? there is no coverage about this in larger news outlets. while the story in itself may not be that interesting to mainstream audiences, the fact that someone from the FDA said, “pregnancy is a disease and birth is a medical event..” is kind of a PR nightmare. this should be out there!

  33. Well, Walmart better get registering then, because that’s where I bought my aquarium pool for my first babe! Infuriating…

  34. Seems like they are protecting the pharmaceutical companies who sell all the medications needed during a birth in the hospital. Pitocin for example. Perhaps they noticed an overwhelming increase in natural births and home births and decided to attack.

  35. hey, just change the category of what the pool is called. call it a freaking kiddie wading pool!! if the gov’t in all it’s infinite wisdom can change the definition of nuclear waste so they can put it where ever they want, than these birthing pools can be called something esle. take a lesson from the masters of deception!

  36. Why do so many people say ” myself’,
    as in,
    “if there is a protest, you can count my husband and myself in”
    ?
    One would never say
    “if there is a protest, you can count myself in”
    so why would ANYONE ever say
    “if there is a protest, you can count my husband and myself in”

  37. Pingback: FDA Vs. JC Penny The Birthing Duck « The Mommypotamus

  38. According to this, pregnancy is an *illness* and birth is a *medical event*. So, I guess having a BM should be considered *a medical event* and my *toilet* needs to be FDA approved as a piece of durable medical equipment. Remember, being constipated is an illness. ROTFL

  39. PLEASE protest this. Whomever organizes and attends such an event are heroes to the rest of the nation and future moms. I live in Ohio, so I will not be joining. This is outrageous. The FDA only protects big pharma and big agriculture. It comes down on those who question vaccines for their children, those who want food that contains nutrients, those who grow organic food (free of toxins, GMO’s; has more nutrients because they care for the soil), those doctors who practice nutritional, non-toxic medicine, and now, those who choose to bring their children into the world in a less tramatic, easier way. A protest will also help you all unite. It is so encouraging seeing so many parents and parents to be excercise their parenting rights.

  40. Pingback: FDA has seized birth tubs - Page 2 - Herbalist Hut Forums

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