5.27.2011

A Chance To Make a Change

I just finished up writing a quick post on the FDA seizing birth pools that arrived in the U.S. and were slated to be delivered to home, birth center, and hospital birthing women around America.

Since the original notification, and as passion and frustration continues to mount, I ask that we take a moment to consider the implications of our words and actions. 

How can we help?
  • First off, let me say that the best help we can be for the business owners and companies who are being impacted by this action is not to bombard them with questions, phone calls, and emails. They are, no doubt, working hard to try to find resolution to this issue while also helping to maintain women's options and access to water birthing pools. This is undoubtedly a frustrating time, and our impassioned words should be tempered (myself included) with prudence and wisdom.
  • Second, until there is resolution, we should not stoke the fires of panic. Instead, reduce, reuse, recycle. Have a birth pool in the attic? Consider offering it to other women in your community who are planning on a water birth. Have extra liners? Share. Run out of liners? Use California King mattress covers as liners. :) Until this is resolved, we know that our access to birth pools will be limited, so let's rally support for one another. 
  • Third, write NON-HOSTILE letters to our state representatives and on our own social media sites encouraging positive change and support for these companies and the women they serve.  
  • And last, if you KNOW someone who has had a water birth in what might be able to be considered a water birthing POOL/TUB before 1976, PLEASE have them contact Barbara Harper so that she can get you both in contact with those who could use the information to attempt to grandfather the birthing pools in.

Our focus should be to elicit positive change, while also influencing the powers that be to consider the implications of limiting women's birthing options. Just as midwifery that was outlawed simply forced midwives underground... and outlawing home birth just forced home birth underground, so would, ultimately, strictures on birth pool availability.

The goal, then, should be to make sure that we don't allow it to get to that point.

Taking a cue from the Big Push and other organizations that have much experience in birth option government limitations, I recommend that we begin a letter writing campaign to the state legislatures that can lobby on our behalf to reign in the FDA, release our birth pools, and start a positive discourse for resolution to this issue so that it does not come up again.

This might mean that we have to come up with a classification of approval in order to retain active access to our birthing options. But, in the mean time, let's get our birthing pools back into the hands of the women who they benefit.
"The use of water as an option, a choice, a way of receiving comfort in labor, has always been for me, a platform upon which I stand to have a conversation about birth - all aspects of birth.  I don't really care what pool one uses, or where that birth happens, as long as the birth AND the baby are respected.  Do I have personal preferences?  Of course, but there is a joy that happens when I see waterbirth introduced into a hospital and the cesarean rate drops or when other practices change in the hospital after the staff witnesses the power of undisturbed birth.


I firmly believe we can continue to use this platform to talk about all the issues that plague us today and stop the polarization of home versus hospital, CNM versus CPM, OBs versus midwives.  All women deserve the choice of undistrubed birth and how we come together to make that happen will be the deciding factor.  Let's use this current confrontation to our best advantage and form a united movement to insure that waterbirth, midwifery, home birth, and undistrubed birth in any setting by any provider remain options for all women, all babies and all families throughout the US and around the world." - Barbara Harper
The Letter
Please see the letter below and feel free to cut/paste/modify as you see fit.

Then, send it..

send it to your local representatives, Tweet it, FaceBook it, and email it to your friends, peers, and coworkers.
Dear ______________________,
I’m writing in response to the recent FDA's hold on a shipment of birthing pools destined for pregnant women who were looking forward to using them during their labors and/or births.

The FDA has placed a detention on incoming shipments of portable birth pools and have given the distributors/manufacturers various deadlines for compliance. The FDA claims that these pools are unregistered medical equipment, but they are, as of yet, not providing a way or means 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, we are potentially looking at of years of clinical trials and legal fees that can cost up to a million or more.

While a new classification is being drafted, outlined, and implemented, numerous women around the United States will be without birthing pools, a very valid means of labor pain management utilized by many of the home birth community and some of the birth center and hospital community.
As taxpayers and as mothers, we find it unacceptable that our choices are being limited by the restrictions and detention of these pools as set forth by the FDA.
The option of water birth has been shown in numerous medical studies to decrease the use of medical intervention, which, in turn, reduces the incidence of cesarean and iatrogenic risk, resulting in healthier and safer labors and births. Additionally, with health care costs rising, the use of something as simple as a birthing tub can drastically reduce the costs associated with childbirth.

By limiting, even short-term, women’s access to inflatable pools used in labor and birth, the FDA is seeking to limit access to a safe and effective means for reducing risk during the process itself.

Additionally, the very definition of medical equipment is debatable. Should toilets, rebozos, couches, and physical therapy balls be subjected to FDA approval for the act of birth? Like birth tubs, these are all routinely used in healthy, normal pregnancy and births. Should these also be considered durable medical equipment and be regulated?

The term, medical, is defined as: relating to the science or practice of medicine. Likewise, the definition of medicine is: The science or practice of the diagnosis, treatment, and prevention of disease (in technical use often taken to exclude surgery), or a drug or other preparation used for the treatment or prevention of disease.

As such, medical equipment would be defined as: equipment related to the science or practice of the science, or practice of the diagnosis, treatment, and prevention, of disease.

The use of birth tubs are, in most cases, reserved for the healthy and low-risk birthing woman. As such, her care does not automatically fall under the classification of a medical event and birth pools should not be denoted under the classification of medical equipment.

We urge you to advocate for the women within your communities; women who are giving birth and who have a right to safe and effective health care.

Please support us in allowing the birthing pools that have been confiscated by the FDA to be distributed to their rightful owners. Help us also then to work with the FDA, the manufacturers of these pools, and the caregivers who assist us during our labors, to come to a consensus as to how to move forward, without putting restrictions on our safe birth practices in the process.

Sincerely,
Cole Deelah
Supporter of Women’s Birth Options
and mother of five beautiful children

You can send this letter by email, by mail, or by hand to your local representatives.
  • If you are in Texas, reach out to your legislatures here
  • If you are in Michigan, see here
  • If you are in Tennessee, see here.
  • If you are anywhere else and need help finding out who your representatives are, see here.

Remember, this is time sensitive. Change is inevitable, let's make sure that it is good change.

UPDATE: please note there has been an update on everything! The pools have been released to the company that had them shipped in, but the FDA has told them they are not to sell them. The companies are still working with the FDA to be able to reach their personal deadlines of compliance and are attempting to work out a reasonable solution for the future of water birth pools.

Our letter writing campaign is still very important! Please continue to contact your local representatives, but consider changing the verbiage to reflect these updates.

Please read Laurel's follow up post here for more information.

11 comments:

Danie Nicole said...

Thank you for this. I have sent my variation of your letter off. And I added that I am an Army wife in hopes they won't blow me off.

Barbara Harper said...

Thank you so much, Cole. You are the very voice of reason that we need. I'm going to repost this on my site, as well. Could not have stated it better. A thousand thank yous and hugs too.

FairFlowers said...

The Texas Legislature has just ended its session and will not return until 2013.

Shouldn't we be sending these to our representatives at the federal level? The FDA is a federal agency, not state.

I suggest sending this letter to your representative in Washington.

Laura Dunn, LPN, IBCLC said...

Got it. Thanks. Reposting.

Anonymous said...

Sent it and Facebooked it!

Mama Goddess Birth Shop said...

Hi Nicole - Thank you so much for this! This is Mayu from Mama Goddess Birth Shop. We've reposted this on our facebook page. Thank you!!

heatherp said...

Shouldn't we be contacting our states' US representatives and not our state legislatures? All of those links were for the state level.

Anonymous said...

Elicit not illicit. These becoming illicit is what you're upset about. You want to elicit support. I make these kinds of mistakes, too, and they turn my serious statements into something impossible not to laugh at.

Laurel Ripple Carpenter said...

http://blog.cuntastic.org/2011/05/27/interview-with-barbara-harper/

Anna Clarke said...

Don't know if this will help, but for all momma's that were planning on a waterbirth, you can go to your local farm supply and get a rubbermaid horse trough (sounds strange) My midwives use these, they work very well and are deep and sturdy. I used one for my waterbirth and I would do it again.
It is a terrible thing that the FDA is doing!

Jo said...

I was born August 1976. There was a Family Practice doctor in West Virginia on the border with Virginia in the I81 corridor. I don't know this doctor's name, but I know he was doing home waterbirths and using a birthing pool. I know he had been doing it for awhile at the point I was concieved, so that would have put him practicing in 1975. I know this because my mother considered having me as a home waterbirth and chickened out. She had me in the hospital instead and forever regretted it.

Sorry I don't know his name. However, if you can try to find connections in that area, you might be able to find him and document that someone was using waterbirthing tubs before 1976.

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