Well, I have finally come in her cross-hairs and can no longer sit idly by. Perhaps I should have spoken up sooner, but I truly felt the anger and accusations she was spewing would be her own downfall. I am responding now because I need to share truth and light in order to dispel shadows and doubt, besides, It is time for me to continue my campaign of evidence-based education backed by references and research.
For those who desire to see the "complaint" so you can understand my thorough frustration and confusion of why she projects blame on a teaching tool (that was not even widely marketed during the time she experienced) her for her child's condition, well, please refer to the claim she submitted here:
https://www.saferproducts.gov/ViewIncident/1600450
Now for my complete response:
US Consumer
Product Safety Commission
Attn:
Clearinghouse
4330 East
West Highway
Bethesda, MD
20814-4408
January 29, 2017
Dear US Consumer Product Safety Commission and Reviewers:
I appreciate and respect the authority of your office and
understand the gravity used in evaluating the safety of products. I recently
received a notification that an invention I manufacture and market, the
Lactation Lanyard, has been mentioned in a complaint. I am writing to clarify
the utility of the product, the evidence that supports its use, and the fallacious
nature of the accusations launched against this important teaching tool.
I understand that the complaint has been published and a
response from myself or my company is not required, but I would be remiss if I
did not respond to the false accusations directed at my product. I assure you
that this is not an anonymous complaint by a “concerned citizen” but rather a
spiteful person searching for an outlet for her anger and frustration. I feel compelled to address the complaint and
expose the misleading (and selective) information that the author of the
submission provided on your form.
The individual who submitted the claim against my product has
suffered a personal tragedy (as documented in her submission and on social
media) and is trying desperately to find someone or something to blame for her
circumstances.
She has gone to great lengths to skew information, and now I
fear she has stooped to using your office to submit a frivolous complaint in an
effort to execute a personal vendetta against lactation professionals. She has
been making these claims on social media and appears frustrated that they have not
been taken seriously by a wide audience.
Allow me to share some background information. The person
who submitted the claim is part of an organization called “Fed is Best.” Her
counterpart wrote a blog post attempting to discredit my lanyards and the
established research that validates their utility. This new complaint issued to
the Safety Commission appears to be yet another effort to grow an audience for
their blog which recently featured complaints about the Lactation Lanyard. The
picture of the Lactation Lanyard was removed from the editorial when I
threatened a cease and desist letter. Even in the poorly written narrative, the
author admits that the stomach capacity of a newborn is unknown, which is not
entirely accurate. I am frustrated that this individual continues to spout misleading
information in hopes of winning people over to her cause. In this case, the
means definitely do not justify the ends.
 |
| Blog by Jody Segrave-Daly, RN, IBCLC |
Allow me to address each aspect of her accusations
systematically. I believe once the scientific evidence is reviewed, it will be
clear that there is absolutely no basis for her claims, and her complaint to
the Commission will be disregarded.
First, the Product
Detail section on the US Consumer Product Safety Commission report contains
false information. The submitter states,
“The lactation lanyard and
keychain are visual tools used to convince mothers that their newborns are not
in need of supplemental feeding. It claims a newborn stomach size of 5-7 mL
when in fact the scientific data has shown it is 20 mL. This is leading to
dangerous newborn starvation and brain injury…”
My product is indeed a visual tool that shows the
approximate intake of a newborn at day one and at day three, based on the
anatomy and physiology of human newborns. The card attached to the lanyard also
states that a newborn should be fed frequently and that the stomach grows as
milk supply increases. The product comes with an instruction card and website address
where we offer additional resources. The lanyard in no way communicates that a
mother should never supplement; that is a medical decision to be undertaken by
the patient and her medical, nursing and lactation team. In reference to the
last statement in the Product Detail, a visual aid cannot lead to starvation or
brain injury; neglect and withholding nourishment can, and we would never condone
anything remotely associated with that advice.
The complaint stresses the stomach size on day one.
Immediately following birth, families are usually followed by a health
professional whether a physician or medical staff in a hospital, or a midwife at
a home birth or birth center. Families are cared for and educated by qualified
staff who assess a baby for anything out of the ordinary. Knowing many
hospitals and birth centers utilize the lanyards encourages me that these
professionals share in the belief that breastmilk is the appropriate and
sufficient nutrition for newborns, and will advise a family if supplementation
becomes necessary. Dyads are closely monitored by health professionals during
the postpartum stay, and surveys include tracking weight and output regularly.
The first 24 hours postpartum is mostly about rest and
recovery. Newborns take in small quantities of milk during each feed. The exact
amount measurable in milliliters is a moot point. When a mother is feeding from
her breast, there is no need to use a feeding device and measure intake. Health
care professionals have many ways to assess milk transfer, including
documenting diaper count. Even though I will share references for the
approximate capacity of a newborn on day one, the reality is we are not actually
measuring 5-7 mL and feeding with a syringe, but rather feeding at the breast
and ensuring milk transfer is occurring. The measurement of 5-7 mL thus
reflects the stomach size and not the exact amount of milk transferred.
I am completely bewildered by the author’s paragraph on the
Incident Details of the report. It is highly concerning that a Health Care
Professional (stated in the submitters report and on her bio), would draw such
utterly unscientific conclusions regarding a simple product. The author states:
Lanyards “…prevent them from
supplementing newborns who are crying inconsolably for milk when there is not
enough. The most recent scientific data shows that in fact, the newborn stomach
size is 20 mL using ultrasound and autopsy…these…are leading to accidental
newborn starvation and its complications, namely severe dehydration,
hypernatremia, hypoglycemia and excessive jaundice which are all know causes of
brain injury and permanent disability”
Again, there is not now, nor would there ever be a
recommendation to “prevent them from supplementing newborns who are crying
inconsolably for milk when there is not enough.” That would not only be
barbaric, but unprofessional and dangerous. I will not justify the author’s
accusation with further answers.
To address the author’s assertion about the newborn’s
stomach capacity, there have been numerous studies performed a variety of ways
that give approximations of a newborn’s stomach capacity, but all offer margins
of error. There are no perfect studies, and each resource reiterates that the
capacity is an estimate.
I will address the three resources the author cited as her evidence
of the dangers of the Lactation Lanyard. I believe it will shed light on the
situation and reveal the nature of her complaint.
The author confidently states that the “most recent
scientific data shows that in fact…” But she neglects to mention that the “new”
scientific data is a review of six previous studies. The studies cited were
from 1920, 1987, 1988, 1992, 1997, 2000, 2001. Thus, even though the article
was written in 2013, it was based on research from as early as 1920. Dr. Nils
Bergman, the author of the article cited as documentation for the 20 mL stomach
capacity, arrived at that volume based on an average. It is also important to
mention that not all stomachs were measured right at birth. The author’s
conclusion stated the need for shorter intervals in feeding since a newborn has
a small stomach capacity. I do not
believe Dr. Bergman would approve of his research being used to justify a
greater volume of feeds since his research centers on promoting frequent
feeding, skin-to-skin and Kangaroo Mother Care. The point made in the article
is regarding feeding intervals, it is not focusing on stomach capacity.
The abstract clearly proclaims, “There is insufficient
evidence on optimal neonatal feeding intervals, with a wide range of practices.
The stomach capacity could determine feeding frequency. A literature search was
conducted for studies reporting volumes or dimensions of stomach capacity
before or after birth. Six articles were found, suggesting a stomach capacity
of 20 mL at birth.”
Dr. Nils Bergman’s brilliant work
is worth reviewing Bergman, Nils J. "Neonatal Stomach Volume and
Physiology Suggest Feeding at 1-h Intervals." Acta Paediatrica 102.8
(2013): 773-77. Web.
The following studies suggest a stomach capacity of
approximately 5-7 mL.
Hanson, L., Korotkonva, M., The
Importance of Colostrum, Breastfeeding May Boost baby’s Own Immune System.
(2002). Pediatric Infectious Disease Jour; 21:816-821
Silverman, W.A.: Dunham’s Premature
infants 3rd Edition. Paul B. Hoeber, Inc., Medical Division of Harper and
Brothers. New York. 1961. Pp. 143-144
Scammon, R.E. and Doyle, L.O.:
Observations on the capacity of the stomach in the first ten days of postnatal
life. Am. J. Dis. Child. 20:516-538, 1920
Spangler, A., Randenberg, A.,
Brenner, M., Howette, M., (2008). Belly Models as Teaching Tools: What is Their
Utility? Journal of Human Lactation. May 2008, vol 24; no 2
These studies demonstrate that there is plenty of scientific
research that can be found supporting the 5-7 mL stomach capacity reference. There
are also many studies that suggest that a newborn can hold a larger volume of
fluid. I concur that this is certainly a possibility. What a newborn can consume
and what a newborn should consume is
also worth mentioning. Newborns, along with the general population, have
physiological capacity and an anatomical capacity.
Even if a newborn’s stomach can hold more (as in the case of
the autopsied newborns where the procedure to measure stomach capacity took a
measurement when the stomachs began to bulge), it does not necessarily mean it
SHOULD hold more. Nutritionists promote small, frequent meals as the ideal
eating pattern for humans, a practice that seems to naturally begin at birth.
It also stands to reason that if women have small amounts of
colostrum on day one, the baby must need small amounts of colostrum on day one.
All of the emphasis on research and science laboratory studies is important,
but it is equally important to consider the anthropology and biological norm of
infant feeding.
The Lactation Lanyards have many uses, including supporting
the evidence that newborns consume small amounts of colostrum. This information
empowers mothers and gives them a more accurate consumption goal than the 2 oz.
formula bottles distributed in many hospitals. If families are not shown the
volume for an average feed on day one, they are apt to consider the formula
bottle as the standard of feeding rather than the anatomy of the infant.
Even though research has validated the small stomach
capacity of a newborn, perhaps the most compelling argument for educating
families on the infant’s stomach capacity is corroboration by the most trusted
health care agencies and organizations in the United States. The following agencies accept the information
shared on the Lactation Lanyards.
The Academy of Breastfeeding Medicine documents infant’s intake in
the first 24 hours to be between 2-10 mL per feed. BREASTFEEDING MEDICINE Volume 4, Number 3,
2009 © Mary Ann Liebert, Inc. DOI: 10.1089/bfm.2009.9991
American Academy of Pediatrics Section on Breastfeeding documents a
newborns intake on days 1-2 will be between 5-10 mL
American Nurses Association http://www.nursingworld.org/MainMenuCategories/Policy-Advocacy/Positions-and-Resolutions/Issue-Briefs/Breastfeeding.pdf
American Pregnancy Association: “It is normal to make only 1-4
teaspoons of colostrum per day.” http://americanpregnancy.org/breastfeeding/colostrum-the-superfood-for-your-newborn/
The Office of Women’s Health https://www.womenshealth.gov/breastfeeding/learning-to-breastfeed.html
La Leche League http://www.lalecheleague.org/faq/colostrum.html
The support of professional organizations and well-documented
research has spawned the development and spread of this valuable teaching tool.
Many pharmaceutical companies have similar products to our Lactation Lanyard
(see below), yet I did not see any reports on these products. I am surprised to be personally targeted; it
appears that the author’s complaint may be with me personally rather than truly
concerned about a product I created. Why have none of these other teaching
tools been reported?
The first picture is of the
Lactation Lanyard, the following pictures are samples of other very similar
items.
The Lactation Lanyard is a
portable teaching tool used by health professionals, perinatal professionals,
public health educators and breastfeeding advocates. Lactation Lanyards come
equipped with double-sided colostrum card and informational card. It also
displays the website which provides additional education and resources. www.Birthingandbreastfeeding.com
Baby Bellies Pocket Keychain
Many items are also sold internationally
Belly Balls http://www.premierhh.co.uk/ardo-belly-balls.html
Baby Bellies Display
Cascade Health Care Products https://www.1cascade.com/baby-bellies-display
Stomach
Size Badge Attachments http://www.geddesproduction.com/badge-attachments.php
Colostrum the Gold Standard Visual Aid
Many educational pamphlets and posters are available from
companies that support health facilities. A few examples are provided below.
http://blog.medelabreastfeedingus.com/2015/04/the-size-of-your-babys-stomach-breastfeeding-in-the-early-days/
These complaints seems to stem
from the offense the author takes regarding breastfeeding promotion and public
health advocacy in regards to breastfeeding supporter. I am assuming that she
is unaware that the formula companies
also use the same research to educate families about the infant’s small
stomach.
A large formula manufacturer,
Gerber, states:
“Your baby’s
tummy is tiny at birth—the size of a marble—and grows to the size of an egg
around day 10. Many babies eat a lot quickly, so spit-up is common, and often the
result of overeating or air entering the stomach during feeding. ‘Happy
spitters’ spit up one to two mouthfuls during, or shortly after, each feeding
and show no sign of discomfort.
As your baby’s stomach grows and her digestive system matures, the rate and frequency of spit-up will decrease. Your baby will likely outgrow spitting up around the time he can sit up, but it can continue through the first year in some babies.” (www.Gerber.com)
As your baby’s stomach grows and her digestive system matures, the rate and frequency of spit-up will decrease. Your baby will likely outgrow spitting up around the time he can sit up, but it can continue through the first year in some babies.” (www.Gerber.com)
Below are two samples of parent
education provided by Similac, one of the top three formula manufacturers in
the United States.
If the author desires to take on the Lactation Lanyards, she must also work to discredit the American Nurses Association, Department of Women’s Health, AAP, ABM, Public Health Agencies, WIC, La Leche League, hospitals, formula companies and many educational institutions. There are a plethora of products and information sheets that she will need to prove provide “unsafe information.” We believe we are in good company and do not feel threatened by the baseless rhetoric being directed at our teaching tool.
In addition to Dr. Nils Bergman’s research, the author of
the complaint offered two additional pieces to justify her submission to the
Product Safety Commission. One such documentation, I will not address as it is
her own blog about her story—hardly evidence-based research. The second is
equally subjective, but I will address it as I feel it may be the main reason
for her witch hunt.
The submitter shares a story about her son. It appears that she
experienced a personal tragedy. The narrative on the report to Commission
mirrors the story she shares across social media. Her story clearly states that
she was followed by a lactation consultant and a pediatrician following the
hospital birth of her son. She explains the feelings she encountered on day
four, when she realized she had been starving her baby. There is not one
mention of my lanyard in her story. There is not one reference to its use in
leading to dehydration. The second part of her story reveals that she was
diagnosed with retained placenta, a condition that results in inhibiting milk
production (along with other complications). It is pertinent to note that it
would not matter if her baby’s stomach capacity was 5 mL or 30 mL, the newborn
was experiencing weight loss and dehydration due to little or no milk transfer,
not because he had a small stomach. There is absolutely no parallel that can be
drawn between our product and her baby’s consequences. I can only speculate how she must have felt
allowing her child to go hungry. She may have been failed by her medical team
and may have ignored her own instincts—but whatever led to her withholding food
from her newborn is in no way associated with a lanyard. She will have to come
to grips with her own feelings and emotions. As a doctor, she is no doubt aware
that complications and poor outcomes occur in spite of the best available care.
Sometimes, there is not one to blame. https://fedisbest.org/2015/04/letter-to-doctors-and-parents-about-the-dangers-of-insufficient-exclusive-breastfeeding/
I can respect the concerns this individual shares. As a
medical doctor working in an emergency room, she undoubtedly faces many
difficult situations and hopes to avoid others going through what she
experienced. I only hope she channels her energy in a positive, honest way. I
question her lack of scientific evidence and knee-jerk reaction to attack those
she perceives led to his condition—the science just does not back up her
accusations.
According to the About Section on the Fed is Best Foundation’s
Facebook page, “Christie del Castillo-Hegyi, M.D investigates the real-life
breastfeeding stories of mothers through social media and holds the largest
collection of breastfeeding stories in existence on her Facebook page.” I have
no idea if her claims are true, but I do know she solicits stories from her
followers that include “unacceptable outcomes” from breastfeeding and requests
they sign her petition to “Protect
Newborns from Brain Injury Caused by Insufficient Breast Milk Intake.”
Her hobby of collecting stories has apparently
caused her to put metaphoric rhetoric above science. She is creating her own
truth—a very dangerous practice.
I believe I have done due diligence in refuting the
complaint issued against the Lactation Lanyard. Not only did the submitter not
prove the lanyards to be a safety concern, she used your organization and
submission process to pursue a vendetta as publicly as possible. She has wasted
everyone’s time engaging is this dispute.
I personally feel that Dr. Castillo-Hegyi acted irresponsibly
in abusing the Public Safety Commission Office by submitting an unfounded,
frivolous complaint. She has selfishly added to the demands of your office and
consumed a considerable amount of my time in her efforts at self-promotion. I
understand from the description on your website that this complaint should have
never reached your office.
The U.S. Consumer Product Safety
Commission (CPSC) is an independent federal regulatory agency that was created
in 1972 by Congress in the Consumer
Product Safety Act. In that law, Congress directed the Commission to
"protect the public against unreasonable risks of injuries and deaths
associated with consumer products."
From the statement on the complaint form, the submission was
regarding information and how one individual was able to twist it to her
perception. Your office handles complaints about a product. If your office is
now in the business of handling complaints about information shared, then
perhaps it is time for me to issue a counter-complaint about Dr. Castillo-Hegyi
who apparently is offering fear-based education and is negligent in respecting
the policy statements of her medical professional associations that recommend
exclusive breastfeeding for the first six months as the optimal feeding advice.
In closing, I realize the US Consumer Product Safety
Commission receives numerous complaints and must take each one seriously. However,
I was disappointed that there does not seem to be an independent investigation
prior to publishing complaints. A quick Internet search would have verified our
tool has not been responsible for any harm and promotes the same information
shared by our US health agencies.
I can sympathize with the doctor’s predicament, and her
desire to find a cause for her son’s condition, but I do not respect her
accusations against a product that promotes breastfeeding and supports every
major health organization’s recommendations (WHO, CDC, AAP, ACOG and many more).
While the physician submitting a complaint was undoubtedly
beside herself when her child became ill, my Lanyards cannot be faulted.
The author of the complaint shares her personal story as validation
that the Lactation Lanyards caused dehydration in her infant. Let me reiterate:
the Lanyards come equipped with a
double-sided instruction card that explains that an infant’s stomach grows
rapidly and babies must be fed frequently.
The size of the infant’s stomach is a moot point. No matter
how small a newborn’s stomach size is, if a mother is not producing any milk
due to retained placenta, the baby will become dehydrated. It is my
professional opinion as an International Board Certified Lactation Consultant
(IBCLC), that this scenario occurred due to insufficient milk transfer due to
low milk supply. The diagnosis of retained placenta is of utmost concern. I am
perplexed that a family doctor would try to blame a three dimensional teaching
tool on her child’s condition. She shares the rest of her story (most likely
what lead to low milk supply) here: https://fedisbest.org/2016/10/the-rest-of-my-breastfeeding-story/
This complaint appears to be an
attempt to promote her blog and discredit science for personal gain and
notoriety using the US Consumer Product Safety Commission platform. I am sorry
your office was summoned for this purpose.
Thank you for your diligence in
accepting complaints and rebuttals in an effort to improve safety for everyone.
Normalizing Breastfeeding through
Education and Support,
Christy Jo Hendricks, IBCLC, RLC,
CLE, CCCE, CD(DONA)
Medical professionals, health agencies, lactation consultants--should always assess the needs of the dyad. When supplementation is necessary or desired, a medical team should provide evidence-based, scientific information. We cannot neglect families by pretending to know what is best for their situation, nor should we use fear to force persuade them to breastfeed or formula feed. Human milk will always have benefits for humans--it was designed that way. Each mammal produces species-specific milk for their offspring. We must empower women who desire to breastfeed and support them to the full extent.
