Tongue-Ties In Infants: Are Oversight and Guidelines Needed?
J Hernandez, F Abboud, J Haddad, P Clark, A Aggarwal, B Scaccia Liscano
Keywords
ankyloglossia, assessment tools, breastfeeding difficulties, frenotomy, lactation consultants, national guidelines., speech impediments, speech pathology, tongue-ties
Citation
J Hernandez, F Abboud, J Haddad, P Clark, A Aggarwal, B Scaccia Liscano. Tongue-Ties In Infants: Are Oversight and Guidelines Needed?. The Internet Journal of Pediatrics and Neonatology. 2024 Volume 24 Number 1.
DOI: 10.5580/IJPN.57080
Abstract
Commonly associated with breast-feeding difficulties in neonates and infants, tongue-ties have increasingly become a center of media attention in the twenty-first century. Between 1997 and 2012, the recorded cases of tongue-ties diagnoses in the United States rose by 834%, largely reported in neonates and infants.[6] However, the concurrent lack of medical literature and research into the epidemiology of tongue-ties has led to indecisiveness among physicians with respect to treatment approaches. While some physicians advocate for immediate surgical intervention, others prefer to delay surgery and attempt non-surgical treatment as they track further development of the tongue-tie. Moreover, considering the lack of uniform national guidelines and protocols, there exists an apparent discrepancy over criteria and assessment tools of tongue-tie severity among medical professionals across different specialties. Parents have expressed unease with this inconsistent medical appraisal of tongue-ties, raising the question of the need for the establishment of national guidelines.
The purpose of this paper is thus threefold: First, to provide a general overview of tongue-ties, addressing the need for national guidelines; second, to offer an ethical basis for our stance; and third, to offer recommendations on how to address the ambiguity surrounding treatment of tongue-ties.
Introduction:
Tongue-ties, also known as ankyloglossia, is a congenital physical condition that is characterized by an abnormally developed lingual frenulum, a fold of mucous membrane that connects the midline at the undersurface of the tongue to the ground of the mouth.1,2 The lingual frenulum assists in tongue movement, confining the latter to the mouth cavity.3,4 The lingual frenulum in tongue-tied individuals, however, develops into a short or tight band of tissue that limits tongue movement.5 It was previously held that there are two types of ankyloglossia: anterior and posterior ankyloglossia. Anterior ankyloglossia occurs when a lingual frenulum connects the tip of a tongue to the base of the mouth; Posterior ankyloglossia manifests with lighter restriction in tongue mobility, with the lingual frenulum, sometimes identified as a submucosal tissue, connecting the back of the tongue’s underside midline to the base of the mouth.2 Hence, anterior ankyloglossia was thought to have been more easily identified than posterior ankyloglossia.1 However, recent anatomical evidence gathered from microdissection of human lingual frenulum located at low attachment points with respect to the mouth cavity showed a complex mucosal multi-layered structure suggesting that posterior ankyloglossia does not exist.6
Tongue-ties range from fairly mild—where only the back of the tongue is bound to the base of the mouth—to severe, associated with the tethering of the entire tongue to the base of the mouth cavity.7 With a prevalence of anywhere between 0.02% to 10.7% in neonates, infants, and adolescents in the United States,8 ankyloglossia has variable incidence rates between males and females—the ratio of tongue-tied males to females is approximately 3:1.9
Etiology-wise, ankyloglossia is still not completely understood, although genetic predisposition may play a role.5 A 1996 inpatient- and outpatient- pediatrics study yielded that 21% (26 out of 123 cases) of the evaluated tongue-tied infants had a family history of ankyloglossia.10
Currently, one of two different types of treatments, surgical or non-surgical, is performed to address ankyloglossia. Surgical intervention either through a frenotomy or frenectomy has become the most common medical approach. Data from the Kids Inpatient Database (KID), Healthcare Cost and Utilization Project (HCUP), and the Agency for Healthcare Research and Quality (AHRQ), suggests that the recorded frenotomy procedures in the United States increased by almost 866% between 1997 and 2012, coinciding with the 834% national increase in tongue-tie diagnosis, despite an almost stable number of births within the same time period.8 On the other hand, alternative non-surgical treatments such as speech therapy and lactation consulting may sometimes be preferred over surgery, fueling the discordance between medical professionals on an appropriate and uniform assessment and/or treatment approach of ankyloglossia.
History:
Midwives and doctors have been performing procedures to snip lingual frenulums for centuries. The Ancient Greeks were one of the first to realize the uncertain benefit of frenotomy for improved speech. Celsus wrote, “In some the tongue is really attached to its base from the first day of life onwards, who therefore cannot speak.” The Byzantine surgeon Paul of Aegina further noted, “Those who have the fault congenitally begin to speak late and have a tight band under the tongue.”11
Midwives since the 17th century have commonly divided the frenulum with a sharp fingernail as medical authors of that time began recommending it for infants with breastfeeding difficulties.12 In fact, the first documented case of frenotomy for this reason comes from a 1601 diary entry by the physician of the infant Louis XIII, remarking that the toddler's tongue-tie release markedly increased his feeding capability.13 As the procedure gained popularity, however, 18th century midwives in Germany noted the abundance of frenotomies being performed despite the scarcity of tongue ties. In 1752, one midwife said, “Among thousand infants there is barely one suffering from this defect,” and in 1791, another remarked, “Frequently the parents are deceived, for profit, greed and ignorance this aid is abused, and one unties where nothing is tied.”14
Starting in the 1940s, the frenotomy fell out of favor. In 1941, Dr. Eugene McEnery observed that the neonatal frenulum is “always short and should never be considered causally related to speech difficulties of any type.”15 Additionally, with the rising popularity of formula feeding and the concurrent decline in breastfeeding, frenotomies became less common as most tongue-tied infants could bottle feed without issue. In the 1980s and 1990s, however, the tides shifted back, as intensifying pressures on women to breastfeed resurrected the popularity of frenotomies. Global organizations found a correlation between breastfeeding and maternal and infantile health, and recommended exclusive breastfeeding for at least six months postpartum.16,17 A 2004 article in the American Academy of Pediatrics newsletter proposed that even infants with minor lip, cheek, or tongue restrictions could benefit from release procedures. Their warnings spurred a surge in ankyloglossia diagnoses in breastfeeding infants, and social media groups dedicated to tongue-ties ballooned to thousands of members.18 From 1997 to 2012, both the numbers of ankyloglossia diagnoses and frenotomy procedures performed in hospitals increased by over 800%.19
But this wave of tongue-tie frenzy is not without controversy. In 2020, a panel of 16 ENT experts published guidelines cautioning that tongue-ties were being overdiagnosed and that the releases should not be performed at all. That same year, a large New Jersey practice sent an email to families expressing alarm over the exponentially high rates of babies undergoing clipping, snipping, and lasering procedures. In 2022, a Kentucky medical office cited multiple incidents of babies refusing food and enduring severe pain after laser surgeries. As a result, the medical community is divided regarding the appropriateness and necessity of the surgeries for many infants.
Though the history of frenotomy procedures traces back centuries, the scientific understanding of tongue-tie is still developing, while popular ideas about it have raced ahead. This gap increases the risk of overdiagnosis and unnecessary operations in many infants. For now, doctors are caught between wanting to help breastfeeding babies who need it and knowing they're operating on more babies than is truly necessary.
Medical Analysis:
The diagnosis of ankyloglossia often occurs in outpatient settings when mothers report nipple pain with breastfeeding. Tongue-tied infants typically present with restricted tongue mobility because of a tight lingual frenulum.20 Several factors directly affect the morphology of the tongue, including the height of fascia and location of attachment of the fascia to the tongue. The widely varied morphological appearance of the lingual frenulum also complicates diagnosis. These morphological attributes seem to play a role in breastfeeding's clinical outcomes such as relief of nipple pain.20 The increase in breastfeeding rates appear to have also caused an increase in the diagnosis of ankyloglossia but the exact numbers are not known because of the variation in incidence found in literature.21
Symptoms of Ankyloglossia:
Clinical features of ankyloglossia often describe infants with a short frenulum with lack of or limited protrusion of tongue past the lower incisors. Additionally, there may be impaired lateral movement of tongue or difficulty with lifting and elevating the tip of the tongue.22 It is then suggested that these clinical features lead to poor latching in the infant and thus bring about maternal nipple pain.23 Furthermore, the inability for an infant to properly latch onto the breast and form a proper seal can cause ineffective milk drainage and nipple soreness. Poor sucking ability in infants can lead to decreased milk production, poor weight gain, and cessation of breast feeding in favor of formula supplementation. Nevertheless, insufficient milk drainage can then lead to breast engorgement and then to mastitis or infection of the breast tissues.24
Assessment Tools:
When diagnosing cases of ankyloglossia, different assessment tools are used to diagnose ankyloglossia in neonates and infants. The most common assessment tool, the Hazelbaker Assessment Tool for Lingual Frenulum Function (HATLFF), evaluates the appearance, functionality, and physiology of a tongue-tie based off a 24 point-system, hence quantitatively and qualitatively determining if a lingual frenulum is restricting an infant’s breastfeeding and/or oral functions. If the lingual frenulum is abnormally short, tight, or thick, further examination is necessary. Other criteria include an individual’s ability to extend, make a “clicking” sound, or lift his/her tongue upwards to determine if its mobility and function are limited. After years of its clinical use, HATLFF laid a foundation for the development of the Bristol Tongue Assessment Tool (BTAT). BTAT offers a straightforward and objective way for assessing tongue-tie severity, which, in turn, can be used to monitor the procedure's results and guide a clinician’s decision-making process when selecting which infants to have a frenotomy. Other assessment tools include the Coryllos Lingual Frenulum Classification System, by which clinicians can quickly characterize the lingual frenulum as one of four different types- types I, II, III, and IV- from a purely anatomical perspective of a patient’s oral cavity. Tongue-tie assessments using CLFCS factor weight loss, feeding durations, and nipple interaction into the equation.25 However, the Coryllos system neither accounts for the functionality of the tongue nor sets criteria for having a frenotomy.26
From a time-efficiency perspective, assessment tools vary in duration, and it is thought that assessment questionnaires/tools that typically take longer to complete could potentially offer a more holistic and comprehensive evaluation of ankyloglossia. Lactation specialists or private practitioners may utilize the Assessment Tool for Lingual Frenulum Function (ATLFF), which generates appearance and function scores for not only breastfed babies, but also those bottle-fed.27 On the other hand, the two-part Lingual Frenulum Protocol with Scores for Infants assessment, typically used by speech pathologists, requires more time to complete since it includes questions regarding the effectiveness and pain of breastfeeding as well as an assessment of the structure and appearance of the tongue.28 Other assessment tools vary in duration, and their efficiencies, like those of the tools mentioned above, depend on the physician’s discretionary diagnosis and/or the mother’s subjective opinion.
Some Limitations of Assessment Tools:
Coupled with the existence of different ankyloglossia assessment tools is a disagreement among clinicians on a standardized tongue-tie clinical assessment protocol. This national and interdisciplinary discord has led to variable use of classification methods, thus rendering research on tongue-tie management more difficult. Because classification systems vary, comparative analysis is challenging when determining which cases mandate a frenotomy. Furthermore, ankyloglossia assessment tools, such as the Coryllos Classification System which lacks criteria for evaluating tongue-functionality, have shown mismatches between positive cases of ankyloglossia and typical tongue-tie symptoms. A 2014 study including 200 infants found no correlation between breastfeeding difficulties and what the Coryllos classification system classified as type I, type II, type III and type IV palpable lingual frenulum.29 However, by including criteria that evaluate tongue-function, the HATLFF system evaluates a tongue-tie more holistically. Although current data suggests that tongue-tie division can resolve speaking and breastfeeding issues short-term, the effectiveness of assessment tools in identifying tongue-tied patients who would show improved symptoms if he/she underwent frenotomy is yet inconclusive. A meta-analysis of 14 studies investigated the association between an overall alleviation of symptoms and the severity of tongue-ties diagnosed using one of three tongue-tie classification assessment tools (HazelBacker, Coryllos, and Kotlow classification tools). The 14 studies encompassed a total of 1145 tongue-tied patients, of which 921 underwent a frenotomy, and whose ages ranged from 0 weeks to 12 years of age. Although not curated to infants, the meta-analysis concluded that the severity score gauged using current classification assessment tools is not a reliable predictor of whether a frenotomy would alleviate reported symptoms, notably speech difficulties and breastfeeding issues. Precise quantification of any improvement cannot be determined due to uncertainties over pre-treatment assessment techniques, different outcome measures, and methodology. Consequently, the existing classification systems lack the ability to accurately predict the benefits of frenotomy.30
Surgical Intervention:
Although there is a lack of sufficient evidence for its efficacy in surgical management of ankyloglossia, frenotomy remains the primary intervention. The procedure involves a clinician positioning and stabilizing the infant’s head to better visualize the tongue. The clinician then uses two fingers to hold the tongue midline and moves the tongue back and up towards the palate to expose the frenulum. The clinician ensures that the area to be cut is devoid of large blood vessels upon inspection. Sterile scissors are then used to cut the frenulum using either one or multiple cuts depending on the tightness of the frenulum. Tight pressure is applied to the area that was cut to provide blood stasis. Suturing is not required, and infants are usually observed for one round of feeding following the procedure. Meanwhile, pain control is achieved through administration of acetaminophen as needed while antibiotics are not necessary. Follow up is done on an as needed basis or at the child’s next visit.22
In cases of severe tongue-ties, a frenectomy—procedure in which the lingual frenulum is completely excised out of the mouth—is sometimes preferred over a frenotomy. Frenectomies are the preferred treatment approach if the lingual frenulum is too thick, additional repair is needed, major bleeding is a possibility, and/or the child suffers from speech difficulties.
More innovative techniques have been developed throughout the years to minimize some of the complications. Use of a CO2 laser in lingual frenotomies has recently been documented as a safe and successful technique with benefits of a shorter surgical time, ease of application, lack of postoperative infections, reduced discomfort and edema, and resulting in a small or absent scar.31 Patients tend to tolerate these less painful lasers better than the traditional scalpel. Also, research conducted by Patel et al. confirms reduced intraoperative bleeding during laser-assisted frenectomy.32 Studies show that the laser frenotomy procedure can be seen as an acceptable alternative. One possible explanation for decreased pain perception is protein coagulation at the wound surface; the proteins function as a biological dressing, sealing the terminals of the sense neurons.33
Non-Surgical Intervention:
Multidisciplinary approaches to difficulties with breastfeeding often involve a medical provider working with pediatric speech language pathologists, lactation consultants, and occupational therapists. Nonsurgical interventions to attain correct latch are designed to promote optimal positioning such as providing proper head and body support of the infant, tactile stimulation to allow an infant to associate feeding times, and manual support of breast by mother. For issues with breast milk drainage and flow, strategies often involve teaching mothers about manual expressions of milk before breastfeeding.34 If there is concern that breast feeding issues stem from discoordination during swallowing phases, then consultation with speech therapists may be beneficial. Speech therapists can assess an infant’s coordination with feeds. Furthermore, if there are significant concerns about aspiration, a speech therapist can issue further recommendations to obtain a videofluoroscopic swallowing study for the assessment of the infant’s swallow mechanism.
Correlation between Ankyloglossia and Reported Symptoms:
Frenotomy remains a controversial procedure for the treatment of ankyloglossia. The research available often lacks validated assessment tools to grade ankyloglossia and properly screen and distinguish between candidates for determining surgical and nonsurgical interventions. Data is limited to case series that often lack control groups which raises concerns for reporting bias in favor of frenotomies. Even with available randomized controlled studies, no clear evidence suggests that frenotomies yield long-term outcomes, such as increasing the length of time that infants are breast-fed. However, randomized and/or controlled studies have provided some evidence for the short-term effectiveness of frenotomies on infants. A 2011 randomized study that investigated the efficacy of the release of tongue-ties in neonates (n=30) compared to a sham procedure group (n=28) reported significant decreases in the SF-MPQ score (a maternal nipple pain index) after the respective treatments for both the sham procedure and the frenotomy groups. However, the SF-MPQ score in the frenotomy group decreased significantly more than that in the sham group, yielding an effect size of about 0.38 and p < 0.001. In addition, the study, recording the Infant Breastfeeding Assessment Tool (IBFAT) score for infants before and after their treatments, showed that the IBFAT score increased significantly more in the frenotomy group than in the sham procedure group (p = 0.029), corresponding to an improved infant breastfeeding experience.35 Nonetheless, optimal timing of surgical intervention remains another area of research that is severely lacking as numerous studies show wide variation in times in which infants underwent frenotomies.36
A systematic review in 2015 revealed that only 1 out of 5 randomized controlled studies showed a significant reduction in maternal nipple pain after undergoing a frenotomy. This puts into question the need for a frenotomy to manage breast feeding difficulties. This review also highlighted the lack of studies comparing the efficacy of nonsurgical and conservative approaches to ankyloglossia management.37 Another systematic review in 2015 highlighted the same concern and noted a lack of high-quality comparable studies. These studies could not provide strong evidence for clinical benefits of a frenotomy outside of the context of breastfeeding.38 A more recent systematic review, published in 2017, stressed the lack of sufficient sample sizes, inconsistent blinding, high risk of bias, and inconsistencies with clinical assessment tools in the diagnosis and treatment of ankyloglossia.39
Financial Analysis:
Frenotomy Expenses:
Given the recent surge in frenotomy operations and the partly public, partly professional skepticism of the need for surgery, financial incentives certainly become a concern. Nowadays, the average price-tag on a tongue-tie release procedure is in the vicinity of a $1000,40 which is significantly high considering that the average national weekly pay for men and women was $1,154 and $958, respectively, in 2022.41 Furthermore, prices are prone to radical variation from one private dentistry practice to another depending on the experience of the dentist, the severity of the tongue-tie, and the surgical tool used (CO2 lasers, diode lasers, surgical scissors, scalpel, or electrocautery).42,43 Although no national estimate of the average cost of a laser-based tongue-tie release is available, the average private practice typically charges more for laser-based than for customary scalpel or surgical scissors-based frenotomies. Also, the cost of a frenotomy is heavily tied to the conditions of the operation, specifically anesthesia; in fact, a frenotomy under general anesthesia may cost an additional $500 to $900 if performed in a dentist’s office and range anywhere from an additional $500 to $8,000 if performed in a hospital setting (not considering costs of post-operative care–e.g. antibiotic therapy and hospital stays).44
According to a 2023 release of the CareQuest Institute for Oral Health, about 68.5 million Americans, a fifth of the American population, lack any type of dental insurance coverage, compared to about 26 million medically uninsured U.S citizens.45,46 In fact, the ADA Health Policy Institute reported that almost 12% of children seeking dental care do not have dental insurance.47 Although federal law entitles women who are eligible for Medicaid to full medical coverage of prenatal care and pregnancy-related medical services up to 60-days postpartum, Medicaid-inclusive dental insurance coverage and policies for infants is up to the states to decide. Aside from Medicaid, mothers who do not satisfy the Medicaid income condition—income at or below the 133 % of the Federal Income Poverty level—may be eligible for the Children Health Insurance Program (CHIP).48 Neonates and infants of CHIP mothers are automatically covered, from the moment of birth until the age of a year, under their mothers’ policies. Meanwhile, private insurance companies may or may not cover frenotomies for infants depending on the insurance policy and the medical professional (physician assistant, nurse practitioner, dentist, … etc.) performing the surgery.
Untreated Tongue-Ties: The Potential Cost
On the other end of the spectrum, potential side effects of untreated ankyloglossia may entail hefty costs, for both the insured and uninsured families. If left untreated, a tongue-tie may cause difficulties with food intake, largely because of the abnormally restricted tongue-movement,49 and is often mistaken for food allergies, such as milk protein allergy, that bring about gastrointestinal issues similar to those caused by tongue-ties.50 One medical intervention in infants suffering from tongue-tie-related milk protein-allergy-like symptoms is a prescription of a modified cow milk-free baby formula such as the hypoallergenic formulas (e.g.: Alimentum, Nutramigen, and Pregestimil).51 Under normal childcare circumstances, the average baby consumes around 25 to 30 ounces of baby formula a day, that is between 9,125 and 10,950 oz/year. In 2022, prices of baby formula increased dramatically from $0.15/ounce to about $0.25/ounce for the cheapest baby formula; in other words, the cost of a year-worth of baby formula increased from $1500 to $2500.50 Furthermore, the U.S. Bureau of Labor Statistics Consumer Price Index has reported that baby formula prices increased by 8.7% between January 2023 and January 2024.52 Meanwhile, Nutramigen, a hypo-allergic feeding formula that’s commonly prescribed to tongue-tied infants mistakenly diagnosed as allergic to cow-milk protein, may cost anywhere in the vicinity of $0.50/ounce and thus amounting to around $5000/year in breast-feeding formula costs only. Other baby formulas such as PureAmino, an amino acid-based hypo-allergic feeding formula that is also prescribed for untreated tongue-tied infants, costs around $5,800/year.50 Although some insurance company policies recognize modified baby formula as “medically necessary” and hence may cover the costs, several insurance policies also require a large deductible before picking up the remainder of the bill.
In addition, commonly reported delayed and impaired speech as well as swallowing disorders, manifested in difficulty ingesting solid food, in tongue-tied infants typically warrant speech or feeding therapy.50 The cost of a single therapy session may fall anywhere between $100 and $250, depending on the clinic’s location, therapist’s experience, impairment severity, and payment method. Just as is the case with the feeding formula, states have different Medicaid program eligibility requirements and policies regarding covering speech-language pathology services. In some states, Medicaid covers speech therapy if deemed medically necessary but limits the number of visits per year, in others it may not register speech-language pathology as a covered service, and in some a copay may be required. For instance, while the states of Georgia, Texas and Virginia don’t cover speech therapy (as of 2023), the state of Alabama limits coverage of speech therapy visits to children younger than 21 years (as of 2023).53,54 With regards to private insurance plans covering speech therapy, significant deductibles/copays may be required. As different individuals may face different severities of speech or feeding impairments, the overall number of therapy sessions required may vary from one child to another. The overall cost of speech or feeding therapy sessions, about 2-3 per week spanning for several months, may range from $5,200 to as high as $13,000 per year, while just a $50 copay may amount into a $2,600 annual charge.50
Ethical Analysis:
Tongue-ties, also known as ankyloglossia, is a congenital physical condition that is characterized by an abnormally developed lingual frenulum, a fold in the mucous membrane that connects the midline and the undersurface of the tongue to the ground of the mouth.1,2 This condition can cause breast-feeding problems, speech difficulties, poor oral hygiene and challenges with other oral activities. This condition dates back to the ancient Greeks, but recently, between 1997 to 2012 the recorded cases of tongue-ties diagnosis in the United States rose by 834% largely reported in neonates and infants.8 There are two types of treatments for this condition, either surgical or non-surgical. Surgical intervention, either a frenotomy or a frenectomy, has become the more common medical intervention. Two of the non-surgical approaches are lactation training and interventions to help the infant latch to the breast, and speech therapy to support speech development. The ethical issue focuses on the increase in surgical interventions and the cost of these interventions when presently there are no national guidelines or protocols for these procedures and proper assessment tools seem lacking. The ethical question is to determine if it is medically appropriate to continue doing these surgeries without proper guidelines and oversight to protect the best interest of these infants.
Society, in general, has always recognized that in our complex world there are times when we are faced with situations that have two consequences—one good and the other evil. The time-honored ethical principle that has been applied in these situations is called the principle of double effect. As the name itself implies, human action has two distinct effects. One effect is intended and good; the other is unintended and harmful. As an ethical principle, it was never intended to be an inflexible rule or a mathematical formula, but rather it is to be used as an efficient guide to prudent moral judgment in solving difficult moral dilemmas. This principle focuses on the agent in terms of intentions and accountability, not just contingent consequences. The principle of double effect specifies four conditions, which must be fulfilled for an action with both a good and a harmful effect to be ethically justified:
1) The action, considered by itself and independent of its effects, must not be morally harmful. The object of the action must be good or indifferent.
2) The harmful effect must not be the means of producing the good effect.
3) The harmful effect is sincerely not intended, but merely tolerated.
4) There must be a proportionate reason for performing the action, in spite of the harmful consequence.55
The principle of double effect is applicable to the issue of tongue-ties because with over an 800% increase in surgical procedures it has two effects, one good and the other harmful. The good effect is that the frenotomy or lip tie laser surgery increases the ability to successfully breastfeed, as well as prevents possible dental problems associated with this condition. The harmful effect is the infliction of pain on these infants, risk of bleeding and infection and damage to the tongue and salivary glands. To determine if this surgery is ethical when there are non-surgical options, this issue will be examined in light of the four conditions of the principle of double effect.
The first condition allows for the surgical intervention if assessed as necessary because the object of the action, in and of itself, is good. The moral object is the precise good that is freely willed in this action. The moral object of this action is to increase better latching, maternal nipple pain reduction, and maintenance of breast-feeding practices. The immediate goal is not to inflict unnecessary pain on the infant. Rather, the direct goal is offering an effective surgery to increase the infant’s quality of life. The second condition permits surgical intervention if there is sufficient scientific data to support the surgery option and it is available to all financially. As long as both the surgical and non-surgical options are examined and explained to the parents, including the risks and benefits, the good effect of the surgery is not produced by means of the harmful effect. The two effects are completely independent. The ethical issue here is that there seems to be a lack of studies and thus data comparing the efficacy of surgical versus non-surgical approaches. As O’Shea stated in his 2017 article, there seems to be a lack of sufficient sample sizes, inconsistent blinding, high risk of boas, and inconsistencies with clinical assessment tools in the diagnosis and treatment of ankyloglossia.39 For the second condition to be met there must be accurate diagnostic and treatment tools in order to give the parents informed consent about the two options. The third condition is met because the direct intention of the surgical intervention is to correct the breast-feeding problems, correct any speech difficulties, overcome poor oral hygiene and address any other oral activities that might be impacted by this condition. Nevertheless, there are concerns about the price tag of this surgical intervention. As stated above, the average price for this surgical procedure is in the vicinity of $1000. Since there is no data about the laser-based surgical procedure, all we can estimate is that it would cost even more than the traditional surgery. In addition, we know that 12% of children seeking dental care do not have dental insurance.47 We know that women are eligible for Medicaid for full medical coverage of prenatal care and pregnancy-related medical services up to 60 days postpartum.48 Medicaid inclusive dental insurance coverage and policies for infants is determined by individual states. Therefore, the cost factors seem to be unknown. Finally, the argument for the ethical justification of surgical intervention for infants with the tongue-tie condition by the principle of double effect focuses on the fourth condition of whether there is a proportionately grave reason for allowing the unintended possibility of surgical risks and financial costs when they may not be medically or ethically appropriate. Proportionate reason is the linchpin that holds this complex moral principle together.
Proportionate reason refers to a specific value and its relation to all elements in the action. The specific value in the surgical option is to correct the tongue-tie condition so the infant can breastfeed better. The harm, which may come about by trying to achieve this value, is the foreseen but unintended possibility that the non-surgical techniques may be just as beneficial for the infant with less risks. The ethical question is whether the value of the surgical procedure outweighs the risks and harms of the surgery when there are non-surgical alternatives available. To determine if a proper relationship exists between the specific value and the other elements of the act, ethicist Richard McCormick, S.J. proposes three criteria for the establishment of proportionate reason:
1) The means used will not cause more harm than necessary to achieve the value.
2) No less harmful way exists to protect the value.
3) The means used to achieve the value will not undermine it.56
The application of McCormick’s criteria to promoting the surgical intervention either through a frenotomy or frenectomy over non-surgical interventions will focus on whether there are appropriate data and studies, accurate assessment tools, and uniform national guidelines that supports the argument that there is a proportionate reason for allowing these surgical procedures. First, we know there are possible complications with a frenotomy or frenectomy. These possible complications include bleeding, infection, pain, injury to salivary ducts, swelling, allergic reaction to anesthesia and although rare, reattachment of frenum. Non-surgical interventions focus on managing the effects of a tongue-tie on the infant’s ability to breastfed, eat, and speak. Examples of non-surgical approaches would be lactation training and speech therapy to support speech development. Without standardized assessment tools and national guidelines, it would be very difficult for parents to give informed consent for the surgical procedures. Second, at present, there is a less harmful approach than the surgical techniques. There are non-surgical interventions that have proven to be effective with tongue-tied infants. There is lactation training and interventions to assist the infant to latch to the breast. Lactation training will provide basic knowledge on composition of human milk, physiology of milk production, maternal and infant assessment, latch on and positioning, counseling skills, breastfeeding challenges, milk supply issues, medication concerns and promotion of breastfeeding.57 The second non-surgical, less harmful alternative is speech therapy to support speech development. Speech therapy will help to develop new muscle movements that can help with enunciation, improve awareness of the total range of motion that the tongue can present and address other speech delay issues that may have been inaccurately attributed to the child’s tongue tie.58 With the proper assessment tools and national guidelines, parents would be able to give informed consent about choosing a surgical or non-surgical approach to their infant’s condition and understand if one approach is less harmful and risky than the other. Third, it appears that surgical intervention does not undermine the value of human life. One can argue that the surgical intervention might be advantageous for the infant, but without proper criterion and assessment tools and uniform national guidelines, it would be very difficult to determine if the surgical interventions would be in the best interest of the infant. Therefore, it is not ethically justified under the principle of double effect to advocate for surgical intervention for infants with tongue-tie as the medical standard of care. More clinical studies, data and research are needed in this field. After further studies are completed on the effectiveness of tongue-tie surgery, assessment tools can be created and implemented, and a uniform national protocol can be established to assist parents in making an informed decision about what is in the best interest of their infant. Ethically, the greater good of these infants at-risk and the common good of society are advanced by creating guidelines that assist parents in deciding for surgical or non-surgical interventions for infants with the tongue-tie condition. In addition, with established medical guidelines and protocols in place, oversight committees can be established to protect individuals, families and society as a whole from any financial conflicts of interest.
Recommendations/Conclusion:
Considering the multitude of opinions on tongue-ties, a common denominator with regard to ankyloglossia, available treatments, assessment tools and classification systems, and financial burdens if opting for or out of treatment is a lack of consensus. In fact, the American Dental Society has yet to release a consensus statement regarding diagnosis and treatment protocols for tongue-ties. The American Academy of Pediatric Dentistry, however, recommends that children reported with difficulties breastfeeding must undergo an oral examination to determine if surgery is required.59 Still, this recommendation falls short of national guidelines.
One reason for this shortcoming in establishing a national uniform diagnostic and treatment approach is lack of sufficient scientific data supporting the effectiveness of one classification tool over another. Likewise, lack of data supporting the association between tongue-ties and symptoms, such as speech difficulties and G.I. issues, remains another point of dispute. This has resulted in much inconsistency among medical professionals who have thus resorted to the safer routes, assuming an existent tongue-tie as too severe to be left untreated, choosing surgery or non-surgery, and even recognizing or discrediting that a tongue-tie causes a specific symptom.
We, therefore, recommend that further studies on the effectiveness of frenotomies in alleviating symptoms, e.g.: breastfeeding issues and limited tongue-mobility, be conducted with larger sample sizes. Bigger sample sizes would lend additional credibility to the obtained data and thus offer a more definitive conclusion than that derived today on the effectiveness of current means of treating tongue-ties. National guidelines and oversight must then ensue and thus reduce parents’ concern about the relatively swift and substantial increase in the number of frenotomies performed annually.