Babies 'don't need tongue-tie surgery to feed' - Rapid Response

"Babies 'don't need tongue-tie surgery to feed" is today's BBC headline, which had reached my inbox before I opened my eyes this morning (thank you readers).

We know the media sensationalise studies, so you want to know what it really says right?

Course you do, let's go.

112 babies who had been referred for tongue tie treatment, were assessed by "Speech and language pathologists, who examined the infants' ability to breastfeed prior to a surgical consultation".

112?  That's really one step beyond "large classroom experiment".

My next thought was:

Wow, do Speech and Language Therapists (SALTs) have breastfeeding training in the US?

So I of course asked the man in the know, Dr Ghaheri. His reply:

"Er no".

Errrrrm ok then.

He continues:

"Their professional organization (ASHA) doesn’t recognize TT as being a problem in breastfeeding, solid foods or speech. They are not the practitioner of choice when it comes to breastfeeding pathology either."

I want to clarify this early on (then probably repeat it 10 times throughout this piece for those who will still miss it) - NOT ALL BABIES WITH A TONGUE TIE NEED A RELEASE TO BREASTFEED WELL. At least I'm assured this is the case - people rarely ring an IBLC to say their baby has a tie but hey, they're feeding great and don't need our support.  

This study is exploring infants who were diagnosed as tied and symptomatic with feeding problems, thus had been referred and recommended for release. This means anyone not experiencing a feeding problem from their tie, wouldn't be included in this study.

I pushed on. The SALTS then:  

"offered techniques for mothers to address any feeding difficulties prior to surgical intervention was developed. Infants either found success in feeding and weight gain through this program or underwent procedures."

Ok, that sounds fair enough right?  Try other techniques such as improving attachment, positioning and so on. Indeed these interventions are listed. 

Brace yourself.

"If sleep state regulation was determined to be the primary issue (with the baby falling asleep and transitioned to a nonnutritive sucking pattern causing maternal nipple pain/ injury/prolonged feeding), interventions included arousal actions such as applying a wet facecloth or tapping the infant’s foot."

I had to stop and take a moment here to suck air through my teeth.

News flash - babies fall asleep when the flow of milk isn't worth staying awake for because their attachment is shallow. Tapping a baby or applying a cold wet cloth, may temporarily wake the baby, who will take a few more sucks/swallows before nodding back off again.

Next:

"If volume or rate of breast-milk flow (tongue clicking, gulping, or pulling off the nipple) appeared to be the primary issue, modifications included the following strategies to slow the flow of milk: placing the mother in a supine position (gravity to slow flow), expressing milk prior to breastfeeding, and/or placing the mother and baby in a side lying position."

If a baby is in a shallow latch, they will often perceive the breastmilk supply to be too fast. We can see video examples of that here: with a tongue tie. However with a deep latch, the flow is easily tolerated as we can see here: post tongue tie release.

"If previously-diagnosed reflux appeared to be the primary issue (eg, arching, pulling off nipple), verbal reassurance to continue gastroesophageal reflux disease medication treatment was provided"

Woah woah woah. Wait a moment.

First - pulling on and off the nipple and arching can mean many things.  It can mean "hey the milk has stopped", "I have trapped wind/gas" (top or bottom end), "my mouth is sore" or "my neck is stiff in that position".  Since when did the assumption these symptoms mean reflux become a given?

Shallow latch and feeding technique can cause reflux (NICE) - indeed the baby in the clips above was symptomatic prior to release. It seems though we're just ignoring that in this study and carrying on with medications.

This is where my alarm bells really started ringing.

The authors opened this paper with the statement:

"Inpatient surgical release of lingual frenulums rose 10-fold between 1997 and 2012 despite insufficient evidence that frenotomy for ankyloglossia is associated with improvements in breastfeeding

This is a rather confusing claim, since there are really quite a lot of studies exploring tongue tie and breastfeeding (1-15), my list isn't exhaustive. They consistently demonstrate breastfeeding improvement, none evidence any risk of significant harm and they include is comments such as:

 "No complications were reported with frenotomy."(2)

and

"Ankyloglossia, which is a relatively common finding in the newborn population, adversely affects breastfeeding in selected infants."(4)

and

"This review of research literature analyses the evidence regarding tongue-tie to determine if appropriate intervention can reduce its impact on breastfeeding cessation, concluding that, for most infants, frenotomy offers the best chance of improved and continued breastfeeding. Furthermore, studies have demonstrated that the procedure does not lead to complications for the infant or mother." (6)

and

"Frenotomy is a safe, short procedure that improves breastfeeding outcomes, and is best performed at an early age" (7)

and

"After lingual frenotomy, changes were observed in the breastfeeding patterns of the the tongue-tied infants while the control group maintained the same patterns. Moreover, all symptoms reported by the mothers of the tongue-tied infants had improved after frenotomy."(8)

and

"Tongue-tie is not uncommon and is associated with breastfeeding difficulty in newborn infants." (10)

and

This should provide convincing evidence for those seeking a frenotomy for infants with significant ankyloglossia.(15)

Apparently not.

What we should perhaps also explore some other stats too.

Prescriptions of a a child-friendly liquid formulation of a popular reflux medication (PPI), saw a 16-fold increase in use between 1999-2004.  Between 2006 and 2016, prescriptions of specialist formula milks for infants with cow’s milk protein allergy (CMPA) increased by nearly 500%. (16)

If we want to talk about things lacking an evidence base - let's start here.

"There was no significant difference for both outcome measures while taking either omeprazole or placebo.  Compared with placebo, omeprazole significantly reduced esophageal acid exposure but not irritability." (17)

and

"PPIs are not effective in reducing GERD symptoms in infants. Placebo-controlled trials in older children are lacking. Although PPIs seem to be well tolerated during short-term use, evidence supporting the safety of PPIs is lacking." (18)

and

"As more extensively discussed below, the inappropriate use of acid suppressive drugs has been indeed associated with consistent modifications in the intestinal microbiota by inducing gastric hypochlorhydria, delaying gastric emptying and increasing gastric mucous viscosity [48]. In adults, chronic acid suppression has been linked to an increased risk of small intestine bacterial overgrowth (SIBO). Although not reaching statistical significance, a trend towards an increased risk of SIBO has also been recently observed in children under long-term PPIs therapy (6 months) [49]. Apart from SIBO, the chronic use of acid suppressive agents is a well-known risk factor for gastrointestinal (acute gastroenteritis, Clostidium difficile infection, candidemia and necrotizing enterocolitis) and extra-intestinal (lower respiratory tract infections, community acquired pneumonia) infections, particularly in infants." (19)

and

"Several micronutrients require an acidic environment for optimal absorption. Iron, vitamin C, and vitamin B12absorption are dependent on the intestine's acidic environment. Several studies and case reports describe associations of omeprazole with altered calcium, magnesium, and vitamin B12 absorption. To date, there have been no prospective trials evaluating the effect of proton pump inhibitors (PPIs) on iron absorption.
Conclusions:
Existing data support the conclusion that the acid-suppressing effect of omeprazole can have important clinical implications for vitamin and mineral therapy. Clinicians should be cognizant of this issue in practice. Further studies exploring the relationship of PPIs and iron deficiency are warranted, especially in high-risk populations such as the elderly." (20)

And presumably infants.

I won't bore you with however many more studies and turn this into a reflux post, if you're interested you can read more here. The point is, there are recognised and potentially significant risks associated with reflux medications. As a result, current recommendations are to minimise use whenever possible, giving as a last resort not a first line response; it makes no logical sense as a preferred treatment pathway compared to frenulotomy.

The question this study really asks is - can we breastfeed tongue tied infants ie, provoke weight gain and not suffer nipple trauma, even when the baby is tied.

We of course all know that a lot of the time - yes you can!   2/3rd of the time according to this study. We can employ multiple compensatory strategies. 

Many do constantly jostle their babies awake and feed them 20 times per day to provoke gain or because it's the only way baby settled.

They may give reflux medications, keep baby upright an hour after feeds, use a specialist milk or undertake a restricted diet, at times completely unnecessarily:

"Inappropriate elimination diets have been imposed on pregnant and lactating women and their infants to prevent allergies without scientific evidence proving their efficacy. Even when well indicated in infants and children diagnosed with an allergy, the type of dietary products to eliminate and the duration of such elimination are not always logical."(21)

They may accept their baby is "higher needs" and sleeps badly or has "wind" or is "fussy" as they won't be put down or settle for long.

They may use techniques such as expressing before a feed, reclined feeding or catching the first "letdown" in a muslin.

They may accept they won't take a bottle and feed hourly.

Any family being offered tongue tie division should always be offered the option of doing nothing -  to carry on managing the situation as they have been up until this point, with added tips and tricks for positioning, wind and colic management, expectations and so on.

The problem though is, especially in the patriarchal world of medicine - often the only things valued as markers of "successful breastfeeding" are weight gain and nipple pain. "Symptoms of reflux" are medicated rather than looking the resolve the problem and mothers are told to rub their baby with wet flannels to keep them awake.

These studies don't consider maternal satisfaction levels and overall well-being - is this sustainable in terms of getting through a day?  Is this situation conducive to good mental health for family members?

As usual, social media comments sum things up best:

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1. Ghaheri BA, Cole M, Fausel SC, Chuop M, Mace JC. Breastfeeding improvement following tongue-tie and lip-tie release: A prospective cohort study. Laryngoscope. 2017;127(5):1217–1223. doi:10.1002/lary.26306
2. Srinivasan, A., Al Khoury, A., Puzhko, S., Dobrich, C., Stern, M., Mitnick, H., & Goldfarb, L. (2018). Frenotomy in Infants with Tongue-Tie and Breastfeeding Problems. Journal of Human Lactation. https://doi.org/10.1177/0890334418816973
3. Emond A, Ingram J, Johnson D, et al. Randomised controlled trial of early frenotomy in breastfed infants with mild–moderate tongue-tie Archives of Disease in Childhood - Fetal and Neonatal Edition 2014;99:F189-F195.
4. Messner AH, Lalakea ML, Aby J, Macmahon J, Bair E. Ankyloglossia: Incidence and Associated Feeding Difficulties. Arch Otolaryngol Head Neck Surg. 2000;126(1):36–39. doi:10.1001/archotol.126.1.36
5. Elvira Ferrés-Amat, Tomasa Pastor-Vera, Paula Rodríguez-Alessi, Eduard Ferrés-Amat, Javier Mareque-Bueno, and Eduard Ferrés-Padró, “Management of Ankyloglossia and Breastfeeding Difficulties in the Newborn: Breastfeeding Sessions, Myofunctional Therapy, and Frenotomy,” Case Reports in Pediatrics, vol. 2016, Article ID 3010594, 5 pages, 2016. https://doi.org/10.1155/2016/3010594.
6. Edmunds, Janet & Miles, Sandra & Fulbrook, Paul. (2011). Tongue-tie and breastfeeding: a review of the literature. Breastfeeding review : professional publication of the Nursing Mothers' Association of Australia. 19. 19-26.
7. Sharma, S., & Jayaraj, S. (2015). Tongue-tie division to treat breastfeeding difficulties: Our experience. The Journal of Laryngology & Otology,129(10), 986-989. doi:10.1017/S002221511500225X
8. MARTINELLI, Roberta Lopes de Castro, MARCHESAN, Irene Queiroz, GUSMÃO, Reinaldo Jordão, HONÓRIO, Heitor Marques, & BERRETIN-FELIX, Giédre. (2015). The effects of frenotomy on breastfeeding. Journal of Applied Oral Science, 23(2), 153-157. https://dx.doi.org/10.1590/1678-775720140339
9. BAXTER, R., HUGHES, L.. Speech and Feeding Improvements in Children After Posterior Tongue-Tie Release: A Case Series. International Journal of Clinical Pediatrics, North America, 7, jun. 2018. Available at:<https://www.theijcp.org/index.php/ijcp/article/view/295/254>
10. Sopapan Ngerncham, Mongkol Laohapensang, Thidaratana Wongvisutdhi, Yupin Ritjaroen, Nipa Painpichan, Pussara Hakularb, Panidaporn Gunnaleka & Penpaween Chaturapitphothong (2013) Lingual frenulum and effect on breastfeeding in Thai newborn infants, Paediatrics and International Child Health,33:2, 86-90, DOI: 10.1179/2046905512Y.0000000023
11. Hogan, M. , Westcott, C. and Griffiths, M. (2005), Randomized, controlled trial of division of tongue‐tie in infants with feeding problems. Journal of Paediatrics and Child Health, 41: 246-250. doi:10.1111/j.1440-1754.2005.00604.x
12. Ankyloglossia: Assessment, Incidence, and Effect of Frenuloplasty on the Breastfeeding Dyad
Jeanne L. Ballard, Christine E. Auer, Jane C. Khoury
Pediatrics Nov 2002, 110 (5) e63; DOI: 10.1542/peds.110.5.e63
13. Shaul Dollberg, Eyal Botzer, Esther Grunis, Francis B. Mimouni,Immediate nipple pain relief after frenotomy in breast-fed infants with ankyloglossia: a randomized, prospective study,Journal of Pediatric Surgery,Volume 41, Issue 9,2006,Pages 1598-1600,ISSN 0022-3468,https://doi.org/10.1016/j.jpedsurg.2006.05.024.
14. A Double-Blind, Randomized, Controlled Trial of Tongue-Tie Division and Its Immediate Effect on Breastfeeding. Janet Berry, Mervyn Griffiths, and Carolyn WestcottBreastfeeding Medicine 2012 7:3, 189-193
15. Efficacy of Neonatal Release of Ankyloglossia: A Randomized Trial Melissa Buryk, David Bloom, Timothy Shope Pediatrics Aug 2011, 128 (2) 280-288; DOI: 10.1542/peds.2011-0077
16. Van Tulleken Chris. Overdiagnosis and industry influence: how cow’s milk protein allergy is extending the reach of infant formula manufacturers BMJ 2018; 363 :k5056
17. Double-blind placebo-controlled trial of omeprazole in irritable infants with gastroesophageal reflux. Moore, David John et al. The Journal of Pediatrics, Volume 143, Issue 2, 219 - 223
18. Efficacy of Proton-Pump Inhibitors in Children With Gastroesophageal Reflux Disease: A Systematic Review. Rachel J. van der Pol, Marije J. Smits, Michiel P. van Wijk, Taher I. Omari, Merit M.Tabbers, Marc A. Benninga. Pediatrics May 2011, 127 (5) 925-935; DOI: 10.1542/peds.2010-2719
19. Rybak A, Pesce M, Thapar N, Borrelli O. Gastro-Esophageal Reflux in Children. Int J Mol Sci. 2017;18(8):1671. Published 2017 Aug 1. doi:10.3390/ijms18081671
20. Humphrey, M. L., Barkhordari, N., & Kaakeh, Y. (2012). Effects of Omeprazole on Vitamin and Mineral Absorption and Metabolism. Journal of Pharmacy Technology, 28(6), 243–248. https://doi.org/10.1177/875512251202800604
21. Lifschitz, C. & Szajewska, H. Eur J Pediatr (2015) 174: 141. https://doi.org/10.1007/s00431-014-2422-3
    

All Tongue Tie Providers Now Need to Register with the CQC - Outcome & Implications for Parents

Many people still don't truly understand the whole hoo-ha with the CQC.  The confusion I think is the result of a number of factors; the embellishment of whispers, passed along morphing into a "ban" and resulting in a rather bizarrely worded petition to "reinstate providers" - so I've tried to form an analogy that might help give a better understanding.

In your local area is a private road that connects a housing estate to a busy working area. Nobody really knows who the road belongs to, only that some have permission to use the road and some don't need permission. There's a list of prohibited activities that can't be undertaken on the road - for example dancing and shouting, but walking isn't mentioned.

The police don't do anything about people walking on the road, since it isn't causing anybody any problems. The risks to the public of people walking down the road are minimal, because only people who work at the end of the road are carefully walking down it, and in 20 years, there's been no problem; all "walkers" are trained in road safety and their regulatory body ensures they follow standards, to use roads in a safe and responsible manner. A local group check on two occasions if they can use the road and the police reply that they can.

One day, a member of aforementioned local group contacts the police call centre independently to ask if he needs permission to use the road. The call handler (who has no idea about the road in question as they haven't heard of it before), gives the standard response which is to have a look at the local maps, ownership deeds and decide for themselves.

The person takes this back to the local group - concerned they now don't have permission to use the road. The local group contacts the police again, asking for confirmation they legally have express permission to use the road. The call handlers again say it's up to them to decide - there isn't a blanket rule as when it comes to roads, some need permission and some don't..

The group hires a barrister to ask the police for a definite yes or no answer - can we walk down this road without permission?  Who owns this road? Is it technically illegal to trespass? If so can you give us permission to trespass until we've planned an alternate route?  If we are acting illegally, will you, the police take action to stop any of us?

The police state that the road is privately owned, which can be in no doubt if we look at the deeds. The law states most need permission to walk down it - and no they can't give permission without application, because they don't own the road and can't break the law themselves.

They state if someone is acting illegally, of course they may take action to stop them, however if those who have always walked that way, choose to continue walking that way until they find an alternate route, they can consider each person passing on their own merits. For example, if they're from the area and are in the process of applying for permission to pass, are governed by the road safety regulatory body, following the rules and are insured to be in the area - the police can choose not to take any further action.

Frenulotomy has been undertaken by midwives and nurses in the UK for 20 years. Ironically the only fatality reported is at a CQC regulated hospital.  There seems to be confusion that registering with the CQC makes practices safer - and there are some areas of healthcare where this is true.  However tongue tie has historically always been performed by sole registered, insured, healthcare professionals, with an absence of significant adverse effects. If you have a complaint, you contact the healthcare provider's regulatory body (NMC, GMC etc) - this is still the case when CQC registered.

The CQC is designed to regulate hospitals, GPs, Care homes and suchlike - "to monitor, inspect and regulate services to make sure they meet fundamental standards of quality and safety".  The OFSTED of healthcare, they are body bound to act in the interest of the public.

Hospitals, clinics etc employ a lot of staff, not all are HCP, they need to know places are following safety protocols and have ways of monitoring satisfaction in the setting.  If we look at their fundamental standards - how many even apply to a self-employed midwife treating 3 tongue ties per week in someone's home? 

When it's one or two people working alone as registered healthcare professionals, their own training and insurance ensures fundamental standards of quality and safety are met -they're not bloody Bupa!

As soon as the ATP started pinning down the CQC, some members (including the chair herself) started completing their CQC applications. - knowing they would have little choice but to deem tongue tie a surgical procedure. By virtue of the law and their own guidance, when backed into a corner, they had little choice but to require registration.

The question is, what happens next?

The costs of preparing and maintaining CQC registration are huge (the application form alone takes weeks to complete, in part again because it's really designed for larger organisations with "staff policies", not a "one-man band").  No doubt some who just did a few here and there will decide not to continue in practice - and for those who do register, these costs will likely be passed on to parents.  Many who ceased practicing before Christmas as advised by the ATP, may have already had such an impact to their business and earnings from which it could be difficult for them to recover.

This is likely to make tongue treatment less attainable to those least able to afford it, leading the way for larger clinics and hospital treatments over the personal one to one service many have valued for so long.

------------------------------------

I spoke with the CQC 18.2.19 and clarified the following (posted initially on the Infant UK tongue tie group)

1) Since pressed legally, the CQC now really have little choice but to regulate frenulotomy. They recognise that it's low risk, has been practiced for years and so on, and as such wasn't an area of interest to them; however, legally it's impossible for them to argue that scissors, a frenulum and blood isn't surgical. Therefore, when asked to define the legal position - they've had to concede pin holding HCPs need to register. The CQC don't write the laws (parliament do), they interpret and enforce them.
.2) The only exemptions in terms of "practicing privileges" apply to doctors with GMC registration (as outlined in numerous pieces of legislation). Petitioning parliament would be the only way to potentially extend this exemption to other HCPs. Similarly if people wanted to propose frenulotomy should be on the list of exempt procedures (like toenails for example), they'd need to do the same.

3) They didn't/don't automatically expect midwives/nurses who are certified/insured and co-operating with the CQC, to stop practicing privately whilst applications are completed/processed. Under the law they cannot give permission for a "grace period", however they do decide who they do/don't prosecute and any action has to be in the public interest. Note - THERE IS NOT A BAN as some have claimed.

4) The CQC ONLY regulate registered healthcare professionals. In this RA osteopaths will require registration, however they do not regulate lay healthcare professionals eg IBCLCs, thus they will not be required to register.

5) If contacting the CQC, please remember those that answer are call handlers. Please ask to speak to the registration team for detailed information.

6) ETA: For the avoidance of doubt, frenulotomy does not fall under the regulated activity ‘maternity and midwifery services’, even where it is carried out by a midwife. Tongue-tie is a condition that is usually picked up in infancy, as a difficulty to breast feed and attach to the breast. Older children or adults may require the treatment related to speech difficulties and, where this is the case, the condition is treated by other healthcare professionals. Treating it is not part of midwifery care. It is post-natal care (see NICE interventional procedures https://www.nice.org.uk/guidance/IPG149).

Click here for Letter ATP received from the CQC and sent to ATP members

The UK, Frenulotomy, Private Services & the CQC - Separating Fact from Fiction

The UK "tongue tie world" was thrown into chaos just before Christmas, when the Association of Tongue Tie Practitioners (ATP) sent an email to all their members in private practice.

They reported that confusion had arisen over whether the Care Quality Commission (CQC - regulators of health and social care in England), considered tongue tie a surgical procedure that required CQC registration.

The ATP states that in both 2011 and 2013, the CQC had reassured them registration wasn't required. However recently, they've received reports that practitioners who contacted the CQC independently, have been advised it’s up to them to establish whether they need to register using the framework published.  

Further communications between at ATP and CQC, have so far not resulted in obtaining the blanket guidance for all practitioners that the ATP seek.

As a result the ATP sought legal advice. Whilst this was under investigation over Christmas, the ATP warned if practitioners were not registered, yet it turned out they needed to be - they could face a hefty fine and even prison.  

The ATP of course would be neglectful not to share the legal information gleaned with their members. Since they formally provide guidance regarding registration, they're quite rightly likely to be concerned about potential litigation issues that could arise as a result of any advice they give. They recommended this course of action for all healthcare practitioners that were not CQC registered.

Since it may take months for applications to the CQC to be processed, they also provided a suggested letter members could use to inform others why their frenulotomy services had temporarily ceased.  

This information was disseminated to members, some of whom ceased practice.

As updated guidance from the CQC has been published since 2013, this could mean, as the ATP highlighted in their email, that a good chunk of practitioners have potentially been misadvised - resulting in them practicing without the appropriate registration for years. Concern was also raised the CQC could take retrospective legal action if and when members applied.

What hasn't happened:

I've heard all sorts of rumours over the last couple of weeks - that the ATP had forced suspension of services, that the government?! had decided nobody was regulating frenulotomy and so had banned private practice, through to claims anyone practicing without CQC registration was acting illegally!

Clearly some forgot that all healthcare providers with a pin are already really rather regulated - so unless your friend's non-registered uncle is having a bash down the pub, we were always far from the worryingly unsafe situation some are now suddenly purporting.

Who are the ATP?

We should clarify as there has been some confusion recently online, the ATP is not a governing body or regulatory in nature. The ATP was formed by a group of tongue tie practitioners and is a committee run, member organisation. They're perhaps best known for the UK directory, or list of their members who provide tongue tie services - although their scope is larger than this as they state they aim to increase tongue tie awareness, support parents to obtain safe, effective care and so on.  All practitioner members of the ATP must submit evidence of training and insurance. 

Tongue tie providers can therefore choose to become a member, but there is no requirement to do so.  Similarly of course, both members and non-members can choose to follow guidance from the ATP, or seek their own legal counsel.

Several providers I know (including ours), had already made contact with the CQC independently, typically when setting up their practice or moving to a clinic base. All seem to have been advised (as per recent reports), that the onus was on them to read the guidance and establish whether registration was required.

Because the framework is complex and different exemption pathways exist, for example here and here (with further details and caveats in other sections and sub-sections), some providers have already separately sought legal advice long before this recent news from the ATP.

Some practitioners have already faced investigation and answered to the CQC.  

I was notified early in 2018 that IFS (Milk Matters) were under investigation for unlawfully undertaking "Treatment of disease, disorder or injury" and "Surgical Procedure".

We probably shouldn't have been surprised as after I made THIS Facebook post here, I received this (ironically a year ago to the day!):

After providing all the required information/evidence about our setup, practitioner and so on (including offering to register ASAP if required) - the complaint was dismissed with no further action needed.  

Our legal guidance received since the ATP email therefore, is that we have already satisfactorily addressed this issue direct with the CQC.  

The latest legal advice the ATP shared with members, in response to some continuing to practice, can be found in the form of an email from their barrister:

"I am afraid it (frenulotomy) is registerable as far as independent practitioners are concerned and an offence to carry it out without registration (subject to the medical practitioner exemption, explained in the advice)."[sic]

Their opinion is frenulotomy is registrable and if you don't meet the required exemptions, to not do so would be an offence.  Logical.  This however is not the same as saying all providers need to register.

It also makes the next move by the ATP yesterday incredibly confusing.

The chair Sarah Oakley writes:

Why, I wonder, do parents need to ensure a provider is CQC registered? 

The onus is not on patients to ensure their healthcare professional holds appropriate CQC registration, because they can't be expected to be aware of exemptions or the laws surrounding registration.  Despite what has been suggested recently - parents visiting a non-registered CQC provider are NOT "colluding in an illegal act".  Providers who fail to register when they need to however, can face prosecution.

What are the benefits of using a practitioner that is CQC registered rather than exempt from needing to register?  

The ATP may need to expand further and provide evidence supporting their rationale, should they be challenged legally regarding this recommendation. I can't imagine paying members (who have been advised by their own solicitor they are exempt from needing to register) will be massively impressed at this point.

It's even harder to understand the recommendations in terms of benefits to parents, as this leaves us for the most part with surgeons and dentists - the very group from which parents on the UK Infant Tongue Tie Group report the lowest satisfaction levels, when it comes to frenulotomy and infant feeding.

More about the CQC

Given what I've read in recent days, I think there is much confusion about what the CQC actually does - Here you can see what CQC fundamental standards are.

Despite what many seem to think, the CQC won't undertake complaints from those dissatisfied with their private care (as outlined here).  

"We cannot make these complaints for you or take them up on your behalf. That may seem confusing but it’s because we don’t have powers to investigate or resolve them."

The CQC inspect and ensure the provider is qualified, that general clinical standards are met and so on, but should someone be unhappy with a treatment received - whether CQC registered or not, complaints would be addressed to the relevant governing body eg the General Medical Council, Nursing and Midwifery Council or General Dental Council.

One might argue - why doesn't everyone just register with the CQC anyway, even if they don't need to, surely this is win win all round?

The problem with this is the vast majority of tongue tie providers work alone or with a colleague - yet the CQC is setup to regulate large hospitals, care homes and suchlike.

If a provider has 2 bases (working say half a day from each), the annual cost for registration to the CQC is in the region of £4000. 

In addition to this, sources quote anywhere between forty and hundreds of staff hours are needed to apply for and prepare for an inspection (rather like when Ofsted at inspecting schools).  If we pitch that even at forty hours (which would likely be unrealistically low for someone with no experience of the process), that's around a further £2500.

If we then consider the insurance to undertake tongue tie independently is already expensive (as you might imagine), plus other "hidden costs" like accountancy fees, ongoing CPD hours to keep up to date with current practice, conferences and re-certification costs for IBCLCs and so on) - many may soon find it's not financially viable to practice.

It would also be very difficult to argue any benefits in terms of safety, of everyone blindly registering with the CQC even if they're eligible for exemption.  

Frenulotomy has been performed extensively in the UK since the 1990s and is considered an extremely safe procedure which can be performed in the home (like a heel prick/neonatal blood-spot or blood test) - complications are considered very rare (NICE: Division of ankyloglossia (tongue-tie) for breastfeeding). 

Independent nurses and private health visitors in any great number are relatively new in terms of private UK services, from the perspective of member interests - an urgent dialogue regarding clarifying current and possible further exemptions with the CQC would seem prudent before issuing guidance.  

Assistance for different types of provider in navigating the exemptions seems necessary - yet instead we're seeing recommendation every private practitioner in the UK should race to register or be deemed "legally unsafe" and avoided by parents.  

This seems both reactionary and unnecessary to many I've discussed this with, leaving both practitioners and parents stuck.  One health professional I spoke with who is CQC registered for other activities, said they'd expect practitioners to explore all routes thoroughly for CQC exemption, offering yourself up for regulation unnecessarily they felt was madness.  Whilst unfortunately nobody was prepared to speak "on the record", this is clearly a large can of worms lacking a lid.

Upper Lip Tie Treatment in Infants - Informed Choice, Risks & Efficacy

In all the noise about lip ties, is there risk of misdiagnosis?  And are parents really making an informed decision?

We acknowledge there are risks to most things - from getting out of bed, to taking a paracetamol or treating a tongue tie. We typically weigh up what the benefits may be, what risks are involved and we (hopefully) get the chance to make an informed choice. 

When it comes to treating tongue ties, we have (thanks to diligent practitioners and researchers) over 20 years of studies under our belts.  NICE have explored the research, discussed this with experts in the field and drafted guidelines.  These tell us (among other things) that frenulotomy (treatment for tongue tie), is a procedure of minimal risk for most healthy neonates.  

Risks & Benefits need examining both short and long-term.

Short-term risks of tongue tie treatment would include for example infection in the wound site, baby bleeding more heavily then expected following the procedure or perhaps later in the day after the event.  Long-term risk may include say keloid scarring at the wound site, if you're genetically predisposed.

In short - aside from discussing the potential benefits and effectiveness of tongue tie treatment, we've also established what the potential knock on associated effects may be, and we can examine rates to discuss risks.

Recently some seem to have made the leap of logic to assume it's also therefore safe and beneficial to release other oral frena babies have too - if it is considered "tied".  Tied means that the frenulum is shorter, thicker or placed abnormally compared to a typical frenulum.

So here are the things I think we need to know:

1)  What is a normal infant upper lip frenulum & what is its function?
2)  How do we diagnose an abnormal infant upper lip frenulum?
3)  What problems can an abnormal upper lip frenulum cause?
4)  When & how should we treat it?
5)  What are the benefits, risks and outcomes of treatment?

Language that features below:

Frenulum/Frenum/Frena/Frenula:  The "string" that attaches to the top lip or tongue (or bottom lip/ cheeks)
Maxillary/ labial fraenum: Upper lip frenulum
Diastema:  Gap in the front teeth

Babies should have an upper lip frenum that attaches to the gum or palate.  Seriously I want to drive round with a loudspeaker on the top of my car simply repeating this phrase.

These pictures below show you normal infant placement.  Infant upper lip frena are supposed to be "low sitting".

SOME EXAMPLES OF NORMAL UPPER LIPS.

These babies had no feeding problems, reflux, wind or any other issues.

The confusion as to why everyone at the moment thinks these are ties, is I believe is explained well here.  It's because they can see the low sitting frenum.  As I discuss in this piece 93.4% of babies do, as the frenum attaches to the gum or palate.

Why?

People are concerned their child has a gap in their teeth, and yet this is exactly as it should be.  

Here we can see a normal ADULT MOUTH:

image pocketdentistry.com

In contrast let's look at the ideal INFANT MOUTH:

Image Glenn Carty Orthodontics 

See how different it looks?  And note the low sitting frenulum. Glenn Carty Orthodontist tells us:

"Did you know that Adult front teeth are 2-3 mm wider than baby front teeth? Adult front teeth therefore occupy more space than baby front teeth. A young child's smile should appear very different to that of an adult's. The smile should resemble a picket fence. The baby front teeth should be spaced. While this might not look pretty, the extra space is needed for proper alignment of the adult front teeth"

The frenulum moves up the gum-line in the first 10 years of life, until it sits in the adult position. The gap closes as second teeth align - as per the photo below.

Same child: shows normal frenulum regression and appropriate dental development during childhood

This spacing also makes teeth easier to keep clean.

A 2011 paper states:

The superior labial frenum is triangular in shape and attaches the lip to the alveolar mucosa and/or gingiva. It extends over the alveolar process in infants and forms a raphe that reaches the palatal papilla. Through the growth of alveolar process as the teeth erupt, this attachment generally changes to assume the adult configuration. [1] Taylor has observed that a midline diastema is normal in about 98% children between six and seven years of age, but the incidence decreases to only 7% in persons 12-18 yrs old. [2] But in some instances, the infantile arrangement is retained.

So normally they regress but sometimes this doesn't happen and the frenulum remains lower on the gum. Sometimes a gap (or a diastema) can be seen.  A very famous example of this being of course, Madonna:

Diastema is heavily prevalent in some cultures - for example Nigeria has incredibly high rates.  In turn it's considered extremely attractive and surgery exists to create the gap.  In contrast it's very uncommon in other areas such as china.  

What criteria are we using to diagnose tied versus normal?  How was this established and is it reliable?

When it comes to tongues we look at what normal presentation and function is, and we establish (or we should) how far away from that each baby is.

When it comes to lips, there seems to be a lot of confusion and inaccurate information shared.

The advice many are given is to push the lip back and see if there is blanching, that if it pulls tight and there is a "notch" this will create a gap - and as such removing the frenulum prevents the risk of a diastema.  

But is this true?

It's not just as simple as the skin you can see...

Initially it was assumed the frenulum caused the gap, it seems obvious - we can see a thick meaty piece of skin between the teeth, thus it was assumed that the frenulum not regressing at the expected age, was the root cause of a persistent gap into adulthood.   Interestingly as researchers began exploring further, they discovered it wasn't quite so clear cut.

Some concluded that when the normal regression of the frenulum didn't happen, it wasn't the frenulum causing the gap, but the gap that resulted in the frenulum remaining low.   Another study found a cleft in the bone was associated with some gaps, and others found removing the frenulum did not alone, appear to make a difference to the gap compared to those that remained untreated;10 years later there was no identifiable differences between he two groups.   Some theorised certain types of frenulum could cause a gap, but researchers decided ultimately this wasn't so.  They noted gaps with frenula and frenula without gaps.  They also noted wide variance in the normal frenulum in terms of visual presentation - thickness and so on.

A 2012 review outlines the evidence concerning the cause of a persistent gap, and the possibility of closing it by removing the frenulum:

"At the beginning it was thought that the labial fraenum interfered with the closure of the midline diastema. This belief resulted in misdiagnosis and unnecessary surgical intervention of the fraenum 13,14.

They then outline all the papers and their findings - I've linked below if you want to look in more detail.

They continue:

"Since there is no evidence concerning the fact that the maxillary labial fraenum is the main causative factor for a midline diastema, some orthodontists propose the following therapeutic methodology 37,45: Initially, it is necessary for the dentist to make a diagnostic trial, in order to find out whether the fraenum is implicated in the pathogenecity of the diastema. 

1. Positive “blanch test” of the incisal papilla, when pulling the lips forward. By pulling the upper lip and exerting pressure on the fraenum, if there is a blanching, it is safe to predict that the fraenum will unfavourably influence the development of the anterior occlusion; 

 It is important to emphasize the fact that frenectomy has clinical validity only after the eruption of all 6 permanent teeth if it failed to close the diastema, and then only in conjunction with orthodontic treatment. So after the eruption of all 6 permanent teeth, 9,14,16,20,34,36,37 orthodontic appliances are used to close the diastema. A frenectomy is carried out, so as the scar tissue will hold the teeth together 16,20,27,33,37,39,48. During the primary dentition phase, surgical intervention of the labial fraenum is not recommended7."

This clarifies blanch tests etc are a tool that may be useful as a diagnostic tool once 6 permanent teeth are in.  They weren't designed for, nor tested in terms of accuracy or reliability, in babies and young infants who are expected to have a low sitting frenulum.

The above paper continues to explain the different opinions held by dentists and oral surgeons.

Surgeons tend to prefer removing the frenum and following immediately with orthodontics (so they have good, clear access to the tissue), some dentists agree; other dentists feel a better result is obtained by pushing the teeth together first with orthodontics, and then removing the frenulum, or only removing it if the teeth "drift" back apart again - so any resulting scar tissue holds the teeth together. The last group don't feel there are any benefits to frenectomy.

What all seem to agree on, is the risk of removing tissue from the gum when there are no teeth to push together, suggesting that this may at times result in scar tissue on the gum that makes it impossible to completely close the gap. They continue:

"In the orthodontic community there is unanimity on this issue 37. Orthodontists support that the fraenum should be maintained until the age of the eruption of all 6 permanent anterior teeth. After that, and only if the diastema remains the same, a frenectomy is indicated, with subsequent orthodontic closure of the diastema 9,16"

"Oral surgeons suggest that in case of a maxillary midline diastema, a small intervention of the fraenum is useful. In this way, the closure of the diastema is facilitated and the orthodontic treatment is not affected 9,2 "

So the "unanimous" view is that 6 permanent teeth should be in before the frenulum is removed - ie this is the optimal time for removal along with orthodontics.

What are the risks and benefits therefore to removing it earlier than this, or before the top teeth have even appeared?

I couldn't turn up any studies exploring this.

Here we can see the progression of teeth following lip tie removal in a child who should still have a low sitting frenum, as they do in the first picture:

We can see the child has typical spacing in the first picture, similar to that we saw above.  These pictures have been shared as evidence removing a tie removes a gap - and in this instance it seems clear that removal indeed rapidly resulted in adult dentition and lack of spacing between the teeth.

However we know already this is what happens in the majority of people with time, so what benefits and risks of hastening this process?  How will this impact on adult teeth spacing long-term?  

Interestingly we can note the top lip still looks thin and pinched.  There also appears to be slight yellowing between the teeth on the last photo, although I'm not sure whether that is just this particular photo and the light.

One mum has expressed concern her child's top teeth have come in crossed following his upper tie removal (he had no teeth at the time of the procedure):

Will this self correct as other teeth align and a correctly functioning tongue exerts appropriate pressure? Is this linked with premature removal of the frenulum and something parents need to factor their decision making process?

Without studies we're working from anecdote, which is non-transparent and unreliable.

Mr Sheehan (ENT) Manchester, proposes that as part of the role of the upper lip frenum is to stabilise the top lip, removal of the upper lip tie may also allow over extension when smiling in some people, perhaps those with naturally longer gums.

Helen Marshall (IBCLC) shares similar concerns:

"I had my upper tie removed at around 10 or 11 years old because of a gap in my teeth.  My lip pulls higher up and exposes more of the gum when smiling, and which started post-revision. You can see where it attached to my lip and gum, and my smile would not be the same if it hadn't been cut - --my lips wouldn't be able to ride up and uncover my gums"

Assessing an infant for lip tie.

Even if we were to establish the blanch test above may accurately determine the lip is tight, does that mean we can assume the cause is the length of the frenulum?  We talk about assessing function not appearance, but even this isn't straightforward.

Tongue ties can cause tension through the lips that makes them tight:

The above baby had incredible tension pulled through his mouth by his tongue tie. When we "flipped his lip", it didn't flip at all - instead it blanched and felt incredibly tight.   His parents commented they didn't know where he got his mouth shape as they both had full, plump lips. After the tongue was released and baby turned to his parents, the first thing they both noted was the phenomenal difference in his lips and mouth shape.

The little girl below didn't just have her lips bound down by her tongue tie, her whole chin and jaw was pulled back too.  We saw her chin move forward when feeding immediately post revision, and function was completely changed.

Something as simple as being hungry can cause a baby to tighten their lips. When we assess hungry infants post feed and note tightness, this often presents different when baby is full and relaxed.

Therefore in order to accurately hope to assess function, don't we need to release the tongue first?

What people also often don't understand is that if baby is in a shallow latch on the breast or bottle, the top lip can sometimes curl under when feeding, appearing as though it can't do anything but - to try and compensate.  

Image Milk Matters - tongue tied baby compensation

This is extremely common in tongue tied babies as this post demonstrates. However as anyone who fully understands the mechanics of milk transfer and has observed thousands of dyads will know - it is not desirable for the top lip to flange outwards when feeding either -  it should be neutral as the post above highlights (and the image below shows), flange suggests anything from slightly shallower to very shallow latch.

Below is the same breastfed baby as above with the curled under top lip, immediately after tongue tie release:

Image Milk Matters 

If we just treat the lip, do we sometimes just allow for more or better compensation?

"The added ability to fully flange the top lip will allow a baby to compensate for continued poor positioning or tongue function issues. But of course this is treating a symptom and not the underlying cause. Improving positioning, tongue –tie division, tongue exercises and suck training to promote effective tongue mobility would be more appropriate. "(Oakley 2016)"

And of course, again without studies - what about possible negative consequences? 

One mum on Facebook explained how her journey developed.

Her son had a tongue tie, he had learnt to feed gripping extra hard with his top lip - just like the babies above.  However they were unable to find anyone who would release the tongue and so only the lip was treated.

Following this, he was no longer able to adequately grip with the excess force he had been doing to compensate, and was no longer able to breastfeed.

This proved an extremely traumatic time for all involved and mum feels more studies are needed.

Lack of Guidance

We have no NICE guidance pertaining to lip tie, nor recommendations from any other recognised authority.

Nobody has (in any official capacity), questioned whether the procedure is beneficial to infant feeding, or for the prevention of diastema; whether it has the desired outcome or when the best time for treatment is. Whether the area needs numbing and if pain relief afterwards is required.  Whether both tongue and lip should be released together, given not only the change in presentation post tongue tie release, but because of the difficult or discomfort baby may have feeding with two sore areas in the mouth.

At the moment different practitioners use different lasers (some use heat to cauterise the area, others use intense water jets to vapourise tissue).  This paper discusses that scarring can occur, and describes a surgical technique combining the frenectomy with a "laterally positioned pedicle graft", to give the best aesthetically pleasing response- are infant frenectomies different?  Which method is safest, most effective?

Best practice should surely be based on best for baby, not "we've travelled a long way so may as well just do both..."

Perhaps most importantly,  nobody seems to have explored whether there could be any unintended risks associated with the procedure.  Some argue those who treat would have observed problems should that be the case - however long-term risks can be very difficult to identify in practice rather than research, especially if we're approaching with a bias, and we're not clarifying what "normal" is.

Abnormal lip frena of course exist, and whilst those promoting removal of the ULT claim we in the UK are "behind" and "ignorant" when it comes to diagnosis and treatment, I'm not entirely convinced.

I've found when there is truly abnormal presentation (such as a excessively wide, tight frena that have bound down the lip) the NHS have treated.

Interestingly they tend to release the tissue up where it is attached to the lip, not touching tissue on the gum margin.  In the private sector I have seen both methods used, suggesting we also need assessment and standardisation of this area too. 

However, when presented with normal low sitting frena being called a tie, the NHS (as evidence supports), recommend reassessing again age 8-10 and treating if appropriate.

This is why controlled studies are key.

We need to start asking questions, so that we continue to push for studies and evidence to support guidance for practice.  Simply accepting the word of those performing the procedure is not enough.

Some charge as much as £500 for a consult and release lasting around 15 minutes, enabling them to see 4 per hour.  A 7 hour day that's potentially £14,000, or £70k per week, 280k per month, and so on. Further charges may be applied for feeding support, which many parents report is often needed. 

That's of course not to say there aren't situations where removal may be beneficial - lack of evidence isn't lack of efficacy, but we need to know more!

Parents need facts on which to base a decision, as do those supporting infant feeding.

MUST READ LIP TIE LITERATURE:
The Maxillary Labial Fraenum -A Controversy of Oral Surgeons vs. Orthodontists

The midline diastema: a reviewof its etiology and treatment 

Upper Lip Tie – 4 Facts About Breastfeeding And Upper Lip Ties