According to Barbara Harper, author of Gentle Birth Choices and founder ofWaterbirth 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 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.”